Curatis Expands Distribution Business With Phoenix Labs with up to CHF 5m Additional Annual Revenues




Curatis Expands Distribution Business With Phoenix Labs with up to CHF 5m Additional Annual Revenues

LIESTAL, Switzerland–(BUSINESS WIRE)–Curatis Holding AG (SIX: CURN, ‘Curatis’) announces a new distribution contract with Phoenix Labs (Ireland) for four products in Switzerland.

Significant revenue growth with new products

Curatis has signed a contract with Phoenix Labs (Ireland) to distribute four products in the areas of pain management and urology in Switzerland, starting from October 2025. These products generated revenues of approximately CHF 5 million in Switzerland in 2024. As the marketing authorisation holder, Curatis will be responsible for all regulatory, quality and pharmacovigilance services on behalf of Phoenix Labs in Switzerland.

About Curatis:

Curatis Holding AG is a publicly listed company (CURN.SW) specializing in the late stage development and commercialization of drugs for rare diseases and specialty care. Curatis has a sales portfolio of more than 40 products and a pipeline of orphan and specialist drugs. More information can be found on the website www.curatis.com.

Disclaimer:

The information contained in this media release and in any link to our website indicated herein is not for use within any country or jurisdiction or by any persons where such use would constitute a violation of law. If this applies to you, you are not authorized to access or use any such information.

This media release contains “forward-looking statements” that are based on our current expectations, assumptions, estimates and projections about us and our industry. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain the words “may”, “will”, “should”, “continue”, “believe”, “anticipate”, “expect”, “estimate”, “intend”, “project”, “plan”, “will likely continue”, “will likely result”, or words or phrases with similar meaning. Undue reliance should not be placed on such statements because, by their nature, forward-looking statements involve risks and uncertainties, including, without limitation, economic, competitive, governmental and technological factors outside of the control of Curatis Group, that may cause Curatis’ business, strategy or actual results to differ materially from the forward-looking statements (or from past results). For any factors that could cause actual results to differ materially from the forward-looking statements contained in this media release, please see the risk factors included in our listing prospectus in connection with the Business Combination. Curatis Group undertakes no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information, future events or circumstances or otherwise. It should further be noted that past performance is not a guide to future performance. Persons requiring advice should consult an independent adviser.

The information contained in this media release is not an offer to sell or a solicitation of offers to purchase or subscribe for securities. This media release is not a prospectus within the meaning of the Swiss Financial Services Act nor a prospectus under any other applicable laws.

Some financial information in this media release has been rounded and, as a result, the figures shown as totals in this media release may vary slightly from the exact arithmetic aggregation of the figures that precede them.

Contacts

Patrick Ramsauer

CFO

Phone: +41 61 927 8777

ir@curatis.com

ICON plc to Participate at Upcoming Investor Conferences




ICON plc to Participate at Upcoming Investor Conferences

DUBLIN–(BUSINESS WIRE)–ICON plc, (NASDAQ: ICLR) a world-leading clinical research organisation powered by healthcare intelligence, today announced that Mr. Barry Balfe, COO of ICON plc, will present at the Baird 2025 Global Healthcare Conference on Wednesday, September 10, 2025 at 1:25 pm ET and Dr. Steve Cutler, CEO of ICON plc, will participate at the Deutsche Bank 2025 Healthcare Summit on Thursday, September 11, 2025.

Any changes to these events and links to the live webcasts (where available) will be posted on the Investor section of our website under “Events”.

About ICON plc

ICON plc is a world-leading clinical research organisation powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 39,900 employees in 95 locations in 55 countries as at June 30, 2025. For further information about ICON, visit: www.iconplc.com.

This press release contains forward-looking statements, including statements about our financial guidance. These statements are based on management’s current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as other economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word “expected” and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, F-4, S-8, F-3 and certain other reports, which are available on the SEC’s website at http://www.sec.gov.

ICON/ICLR-G

Contacts

Kate Haven Vice President Investor Relations +1888 381 7923

US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively




US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

SHANGHAI & JERSEY CITY, N.J.–(BUSINESS WIRE)–Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS^® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA^® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.^1,2

“The FDA approvals of BILDYOS and BILPREVDA mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population.^3,4,5 Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women,” said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon.^3,4 “This approval underscores Organon’s unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health.”^4,5,6

BILDYOS is a RANK ligand (RANKL) inhibitor indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. See full indications below.

Patients with advanced kidney disease treated with BILDYOS are at greater risk of severe hypocalcemia. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported with denosumab products. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BILDYOS in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. See additional safety information below.

BILPREVDA is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumors, giant cell tumor of bone, and hypercalcemia of malignancy. See full indications below.

Hypersensitivity reactions, including anaphylaxis, may occur with use of denosumab products, including BILPREVDA. Discontinue permanently if a clinically significant reaction occurs. Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct hypocalcemia prior to initiating BILPREVDA. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting BILPREVDA. Monitor for symptoms. Avoid invasive dental procedures during treatment. Evaluate patients with thigh or groin pain to rule out a femoral fracture. When BILPREVDA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. BILPREVDA can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception. See additional safety information below.

“The FDA approvals of BILDYOS and BILPREVDA mark another set of Henlius’ self-developed and self-manufactured biosimilars approved in the United States, underscoring our commitment to scientific excellence and consistent product quality,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “We’re proud to continue expanding access to quality biologics through the collaboration with Organon, delivering biosimilar treatment options that are as safe and effective as the reference biologics to more patients across the US.”^5,7,8

BILDYOS and BILPREVDA were approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that BILDYOS and BILPREVDA are highly similar to and have no clinically meaningful differences to their reference products, PROLIA and XGEVA, respectively, in terms of safety, purity, and potency.^8,9

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA. The agreement covers exclusive global commercialization rights except for China.¹⁰

“These approvals are a testament to the strong collaboration between Henlius and Organon to expand patient access to quality and potentially more affordable biosimilars,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius.^4,5,8 “Together, we are working to broaden access to important treatment options and better meet the needs of both patients and providers in the US.”⁵

BILDYOS and BILPREVDA join Organon’s biosimilars portfolio in the US, which has been growing for over eight years and spans five major therapeutic areas.^11-14 This milestone reflects Organon’s long-standing commitment to expanding access to quality, cost-effective treatments and to advancing women’s health through a sustainable, patient-centered approach.^5,7,8

About BILDYOS^® (denosumab-nxxp)

BILDYOS is a RANK ligand (RANKL) inhibitor indicated for/to:

• Postmenopausal Women with Osteoporosis at High Risk for Fracture: BILDYOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BILDYOS reduces the incidence of vertebral, nonvertebral, and hip fractures.

• Increase Bone Mass in Men with Osteoporosis: BILDYOS is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

• Glucocorticoid-Induced Osteoporosis: BILDYOS is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

• Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: BILDYOS is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients, denosumab products also reduced the incidence of vertebral fractures.

• Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer: BILDYOS is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

SELECTED SAFETY INFORMATION

SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
Patients with advanced chronic kidney disease (eGFR <30mL/min/1.73m²), including dialysis dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported.

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.

Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BILDYOS in these patients should be supervised by a health care provider with expertise in the diagnosis and management of CKD-MBD.

CONTRAINDICATIONS

BILDYOS is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating BILDYOS. BILDYOS is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with BILDYOS. BILDYOS is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria.

WARNINGS AND PRECAUTIONS

Severe Hypocalcemia and Mineral Metabolism Changes
Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with BILDYOS. Adequately supplement all patients with calcium and vitamin D.

In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (eg, treatment with other calcium lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after BILYDOS injection.

Drug Products with Same Active Ingredient
The active ingredient in BILDYOS is denosumab. Patients receiving BILDYOS should not receive other denosumab products concomitantly.

Hypersensitivity
Clinically significant hypersensitivity, including anaphylaxis, has been reported with denosumab products. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of BILDYOS.

Osteonecrosis of the Jaw (ONJ)
ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. ONJ has been reported in patients receiving denosumab products. A routine oral exam should be performed by the prescriber prior to initiation of BILDYOS. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery), diagnosis of cancer, concomitant therapies (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (eg, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Good oral hygiene practices should be maintained during treatment with BILDYOS. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to denosumab products.

For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment.

Patients who are suspected of having or who develop ONJ while on BILDYOS should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of BILDYOS should be considered based on individual benefit-risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical low-energy, or low trauma fractures of the shaft have been reported in patients receiving denosumab products. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.

During BILDYOS treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Interruption of BILDYOS therapy should be considered, pending a benefit-risk assessment, on an individual basis.

Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment
Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab product discontinuation. Evaluate an individual’s benefit-risk before initiating treatment. If BILDYOS treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.

Serious Infections
In a clinical trial of over 7800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the denosumab group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with denosumab products. Endocarditis was also reported more frequently in denosumab-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.

Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. Consider the benefit-risk profile in such patients before treating with BILDYOS. In patients who develop serious infections while on BILDYOS, prescribers should assess the need for continued BILDYOS therapy.

Dermatologic Adverse Reactions
In a clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate with denosumab treatment compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing BILDYOS if severe symptoms develop.

Musculoskeletal Pain
In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients during denosumab treatment. Onset of symptoms varied from one day to several months after starting denosumab products. Consider discontinuing use if severe symptoms develop.

Suppression of Bone Turnover
In clinical trials in women with postmenopausal osteoporosis, treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment with denosumab products are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.

Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta
BILDYOS is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products.

ADVERSE REACTIONS

The most common adverse reactions (>5% and more common than placebo) reported with denosumab products in women with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions (>5% and more common than placebo) reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with denosumab products.

The most common adverse reactions (>3% and more common than active-control group) reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache.

The most common (per patient incidence ≥10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.

The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.

Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Before prescribing BILDYOS, please read the Prescribing Information, including the Boxed Warning about severe hypocalcemia. The Medication Guide also is available.

Please note, BILDYOS is part of the Risk Evaluation and Mitigation Strategy (REMS) program.

About BILPREVDA^® (denosumab-nxxp)

BILPREVDA is a RANK ligand (RANKL) inhibitor indicated for:

• Multiple Myeloma and Bone Metastasis from Solid Tumors: BILPREVDA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

• Giant Cell Tumor of Bone: BILPREVDA is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

• Hypercalcemia of Malignancy: BILPREVDA is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

Pre-existing hypocalcemia must be corrected prior to initiating therapy with BILPREVDA. BILPREVDA is contraindicated in patients with known clinically significant hypersensitivity to denosumab products.

WARNINGS AND PRECAUTIONS

Drug Products with Same Active Ingredient
Patients receiving BILPREVDA should not receive other denosumab products concomitantly.

Hypocalcemia
Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating BILPREVDA. Monitor calcium levels throughout therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk, and serum calcium should be closely monitored. Advise patients to contact a health care provider for symptoms of hypocalcemia.

An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Hypersensitivity
BILPREVDA is contraindicated in patients with known clinically significant hypersensitivity to denosumab products, including anaphylaxis. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue BILPREVDA therapy permanently.

Osteonecrosis of the Jaw (ONJ)
ONJ has been reported in patients receiving denosumab products, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure.

A history of tooth extraction, poor oral hygiene, or use of a dental appliance may be predisposing factors to developing ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

Perform an oral examination and appropriate preventive dentistry prior to the initiation of BILPREVDA and periodically during therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with BILPREVDA. Consider temporarily interrupting therapy if an invasive dental procedure must be performed.

Patients who are suspected of having or who develop ONJ while on BILPREVDA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fracture has been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (eg, prednisone) at the time of fracture. During BILPREVDA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of BILPREVDA therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons
Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab-treated patients with GCTB and in patients with growing skeletons. Hypercalcemia has been reported within the first year after treatment discontinuation. After treatment is discontinued, monitor patients for signs and symptoms of hypercalcemia, assess serum calcium periodically, reevaluate the patients’ calcium and vitamin D supplementation, and treat appropriately.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
MVF have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When BILPREVDA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.

Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of actions, denosumab products can cause fetal harm when administered to a pregnant woman.

Contacts

Organon Media Contacts:
Felicia Bisaro

(646) 703-1807

Kate Vossen

(732) 675-8448

Organon Investor Contacts:
Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

Henlius Media Contacts:
Bella Zhou

wenting_zhou@henlius.com

Janice Han

jiayi_han@henlius.com

Henlius Investor Contact:
Venus Hu

junyan_Hu@henlius.com

Read full story here

Polpharma Biologics and MS Pharma Sign Licensing Agreements for Proposed Vedolizumab (PB016), Ocrelizumab (PB018) and Guselkumab (PB019) Biosimilars




Polpharma Biologics and MS Pharma Sign Licensing Agreements for Proposed Vedolizumab (PB016), Ocrelizumab (PB018) and Guselkumab (PB019) Biosimilars

AMSTERDAM & ZUG, Switzerland & GDAŃSK, Poland–(BUSINESS WIRE)–Polpharma Biologics S.A. (“Polpharma Biologics”), specialized in the development and manufacturing of biosimilars, today announced that it has signed licensing agreements with MS Pharma, a leading biosimilar production and distribution company in the Middle East and North Africa (MENA) region, for the commercialization of its biosimilar candidates vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) in the MENA region.

Under the agreements, MS Pharma will be responsible for the registration, marketing, and distribution of these three biosimilars across MENA, while Polpharma Biologics will maintain responsibility for development, manufacturing, and supply. Furthermore, both Parties have agreed to transfer fill and finish activities to the MENA region. These operations will be carried out at MS Pharma’s first of its kind biologics manufacturing facility in Saudi Arabia.

Vedolizumab is a monoclonal antibody targeting α4β7 integrin (a molecule involved in the movement of immune cells to the gut), indicated for ulcerative colitis and Crohn’s disease. Ocrelizumab targets CD20-positive B cells, and by depleting them, helps reduce inflammation and slow the progression of disability in people with multiple sclerosis. Guselkumab – monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), a key cytokine involved in inflammatory and immune responses. It is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

Together, these biosimilars represent significant potential to expand access to high-quality, affordable biologic therapies for patients in the region.

Kalle Känd, CEO of MS Pharma:

“Expanding our biosimilar portfolio in high-need therapeutic areas such as gastroenterology, neurology, and dermatology is a strategic priority. These three products will significantly strengthen our offering and reinforce our leadership in the MENA region. Partnering once again with Polpharma Biologics underscores our commitment to delivering high-quality, accessible biologic medicines to patients across the region, through localizing advanced biologics production.”

Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group:

“We are proud to extend our collaboration with MS Pharma. Their deep regional expertise and strong commercial network make them an ideal partner to bring our biosimilar medicines to more patients in MENA, helping improve treatment accessibility and sustainability of healthcare systems.”

About MS Pharma

MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia — home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries.

For more information, please visit http://www.mspharma.com

About Polpharma Biologics

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

Learn more at www.polpharmabiologics.com

Important Note

This press release is for informational purposes only and does not constitute promotional material for PB016, PB018 and PB019 in Poland or any other jurisdiction. The commercialization of proposed vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars is solely the responsibility of MS Pharma, the marketing authorization holder, in accordance with all applicable laws and regulations.

Disclaimer

This press release is issued from Polpharma Biologics Group and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.

Contacts

Media contacts:

Polpharma Biologics
Natalia Kwiecień

natalia.kwiecien@polpharmabiologics.com

MS Pharma
Orayb Akeel

+ (962) 65 827 999

communication@mspharma.com

CN Bio Adds Computational Modeling Capabilities to ADME Services for Enhanced Bioavailability Profiling




CN Bio Adds Computational Modeling Capabilities to ADME Services for Enhanced Bioavailability Profiling

• New PhysioMimix in silico tools unlock deeper functional insights from existing assays, advancing translation of MPS data to predict human ADME behavior
• End-to-end support from experimental design to data interpretation

CAMBRIDGE, England–(BUSINESS WIRE)–CN Bio, a leading provider of Organ-on-a-chip (OOC) Systems and solutions that accelerate drug discovery and development workflows, today announced the expansion of its Contract Research Services (CRS) with new PhysioMimix^® computational modeling tools. These capabilities have been developed to enhance Absorption, Distribution, Metabolism and Excretion (ADME) profiling, for accelerated drug discovery and development workflows.

This launch represents the Company’s new in silico tools available to customers and is designed to enhance data generation from its range of predictive in vitro tools – unlocking deeper insights into key ADME parameters, including human bioavailability, and enabling more confident in vitro to in vivo extrapolation (IVIVE).

CN Bio’s computational tools combine the insights gained from microphysiological system (MPS) assays with powerful mathematical models. These tools complement the Company’s existing bioavailability assay based on its proprietary dual-organ Gut/Liver model, available via the CRS or as an off-the-shelf kit. The derived data is fully compatible with physiologically-based pharmacokinetic (PBPK) frameworks and can be used to extract additional data from preclinical studies, providing functional predictions of how compounds interact with human biology.

By working with CN Bio’s CRS team, customers gain access to broad support and expertise from both MPS and computational modeling specialists. The team collaborates closely with customers throughout the process, from ensuring robust study design to translating experimental data into meaningful ADME predictions. Raw data generated from projects is also translated into an easy-to-interpret format, suitable for supporting go/no go and drug dosing decisions.

Dr Yassen Abbas, Lead Scientist, CN Bio, said: “This year, the FDA made significant changes to phase out animal testing requirements, signaling a clear shift towards the use of more relevant human approaches for preclinical safety and toxicity testing. We are providing the tools to ensure our customers stay ahead of these regulatory changes.” He added: “The launch of our Bioavailability assay last year was a major step towards improving understanding of the appropriate dose regimens for safe and effective new therapies. Now, by integrating advanced in silico modeling into our offering, we are enhancing this service to bridge the in vitro to in vivo translation gap for drug developers. By working with our expert CRS team, customers have access to dedicated support throughout the entire process.”

For more information on CN Bio’s ADME CRS portfolio, please visit https://cn-bio.com/in-vitro-services/adme/

Contacts

Media Contact
Lily Jeffery

Tel: +44(0)7891 477 378

Email: lily.jeffery@zymecommunications.com

Naobios, Nuvonis and European Vaccine Initiative Collaborate on Manufacturing Influenza Challenge Agent




Naobios, Nuvonis and European Vaccine Initiative Collaborate on Manufacturing Influenza Challenge Agent

Working with the Inno4Vac consortium coordinated by European Vaccine Initiative, Naobios will leverage Nuvonis’ Vero Cell Bank to support development of a controlled human infection model based on influenza virus A(H3N2)

NANTES, France & VIENNA, Austria & HEIDELBERG, Germany–(BUSINESS WIRE)–Naobios, a CDMO providing bioprocess development and good manufacturing practices (GMP) production of clinical batches of virus-based products, Nuvonis, a biotechnological company providing innovative cell banks for the production of vaccines and other biologicals, and the European Vaccine Initiative (EVI), a leading European non-profit Product Development Partnership (PDP), today announce a joint effort through the Inno4Vac consortium to develop an influenza A(H3N2) Human Viral Challenge Agent with the long-term goal of addressing the low effectiveness of seasonal influenza vaccines in fighting influenza A(H3N2).

To address the ongoing need for more rapid and efficient vaccine development, the Inno4Vac consortium, a public-private partnership coordinated by EVI, is advancing the development of an innovative Controlled Human Infection Model (CHIM) for influenza A(H3N2).

For this project, Naobios will leverage Nuvonis’ well-characterised GMP Vero Working Cell Bank. This approach eliminates the need for time-consuming cell bank development and enables Naobios to proceed directly to GMP production of the Human Viral Challenge Agent using a fully tested, regulatory-compliant cell substrate manufactured to industrial standards.

Vero cells are widely accepted by national and international regulatory authorities, including the EMA and the FDA, and are used in commercial vaccine production.

Following manufacturing, the next step will involve conducting a CHIM study, led by the Inno4Vac consortium, targeted for Q3/Q4 2026.

About Naobios

Naobios is a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and offering GMP production of clinical batches of BSL2/BSL3 viral vaccines, oncolytic viruses, viral vectors and challenge agents. Based in France, Naobios joined the Clean Biologics group in 2019.

Having built up 15 years’ experience in bioprocess development, Naobios helps its clients to bring their drug candidates to the clinical stage as rapidly as possible – at the highest level of quality – whilst building on its technical know-how in scalable and industrial processes. With its adaptability and range of skills, the company can lead a project from the initial stages through to completion, with a motivated and dedicated team. Its highly qualified staff have the experience to deal with a wide range of viruses, as well as multiple cell substrate lines.

www.naobios.com

Contacts

celine@ala.associates

Brenus Pharma Announces First Patients Dosed in its First-in-Human Trial Evaluating STC-1010, a Next-Generation Immunotherapy




Brenus Pharma Announces First Patients Dosed in its First-in-Human Trial Evaluating STC-1010, a Next-Generation Immunotherapy

Approved by French regulatory authorities, the trial positions STC-1010 as a potential first-line treatment option for patients with unresectable, locally advanced or metastatic colorectal cancer (stage IIIC or IV)

LYON, France–(BUSINESS WIRE)–#Biotech–Brenus Pharma today announced that first patients have been successfully dosed in its first-in-human clinical trial evaluating STC-1010, the company’s lead in vivo immunotherapy candidate developed through its proprietary off-the-shelf platform. Three patients have already been enrolled in the study. The first completed eight weeks of treatment with no adverse events attributed to the investigational therapy. This trial targets patients with unresectable, locally advanced or metastatic colorectal cancer (CRC) — the second leading cause of cancer-related death worldwide — for whom chemotherapy remains the predominant treatment option.

This international “BreAK CRC-001”¹ Phase I/IIa, open-label, multicenter trial aims to assess the safety, tolerability, and preliminary efficacy of STC-1010 in over 80 patients in combination with an immunostimulatory regimen (GM-CSF low-dose and cyclophosphamide) and standard-of-care chemotherapy (mFOLFOX6 ± bevacizumab). First results are expected in the first half of 2026.

“This marks a pivotal step for Brenus and the future of new modalities in oncology with the potential to improve outcomes, with more accessible and scalable solution for patients who desperately need it,” said Paul Bravetti, CEO of Brenus Pharma.

“Treating the first patient represents more than a scientific milestone — It’s a profoundly meaningful moment, marking the start of broader clinical and pharmaceutical deployment,” said Benoit Pinteur, co-founder and CSO of Brenus Pharma.

“CRC remains challenging, as current immunotherapies are only effective in dMMR/MSI-H ‘hot’ tumors. For pMMR/MSS patients, there’s a strong need for drugs that can ‘heat up’ cold tumors. BreAK-CRC is eagerly awaited, and we’re excited to explore STC-1010’s potential in first-line combination,” said François Ghiringhelli, M.D., Ph.D., CGFL. Director of early clinical unit and study coordinator.

First sites are already open in France : CGFL, Dijon; Institut Bergonié, Bordeaux; ICM, Montpellier; and HCL, Lyon. Additional centers will open in 2026 in France and Belgium. Further centers will join the study for Phase II with an international U.S. expansion.

About Brenus Pharma

Brenus Pharma develops an off-the-shelf platform advancing novel modalities in immuno-oncology. This cutting-edge precision technology mimics tumor protein expression and makes it visible to the immune system, enabling a multi-specific in vivo immune response against evolving tumor cells.

www.brenus-pharma.com

Contacts

contact@brenus-pharma.com

QIAGEN Gains U.S. Clearance of Higher-Throughput QIAstat-Dx Rise, Expanding Patient Access to Rapid Syndromic Testing




QIAGEN Gains U.S. Clearance of Higher-Throughput QIAstat-Dx Rise, Expanding Patient Access to Rapid Syndromic Testing

• U.S. market entry set to begin for QIAstat-Dx Rise – a version of QIAstat-Dx for syndromic testing that combines unparalleled throughput with the easiest workflow
• QIAstat-Dx Rise launch can process up to 160 samples per day, initial launch includes Respiratory Panel Plus and Respiratory Panel Mini and additional panels in development
• Expansion of QIAstat-Dx instrument portfolio in the U.S. builds on the availability of both system options in Europe and other regions of the world

GERMANTOWN, Md. & VENLO, Netherlands–(BUSINESS WIRE)–$QGEN #QIAGEN–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of QIAstat‑Dx Rise – a version of the QIAstat-Dx automated syndromic testing system that offers unparalled throughput with the easiest workflow available to customers worldwide.

The new system, which received clearance from the U.S. Food and Drug Administration (FDA), is designed to meet the needs of hospitals and reference laboratories seeking highly automated syndromic testing with automated loading and unloading of cartridges, access to priority handling of urgent samples and only a minimum of hands-on time.

“The launch of QIAstat-Dx Rise marks a significant step forward in our commitment to expand access to infectious disease diagnostics across the U.S., and builds on the expansion efforts for this system in other areas of the world,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. “QIAstat-Dx builds on the strong customer response to the lower-throughput version, empowering labs to automate and scale up testing with minimal hands-on time while delivering the detailed diagnostic insights needed for timely treatment decisions.”

This clearance marks QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025, and builds on a growing portfolio of six panels cleared for the QIAstat-Dx family over the last 12 months. The system is already available in more than 100 countries, with over 4,600 instruments placed globally through the first half of 2025.

The first two panels for respiratory conditions are already available. QIAGEN also plans to add to the QIAstat-Dx Rise system in the coming months its family of gastrointestinal panels including the QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Gastrointestinal Mini B&V and QIAstat-Dx Gastrointestinal Panel Mini B. Additional panels for both QIAstat-Dx and QIAstat-Dx Rise are in development.

QIAstat-Dx Rise delivers automated, real-time PCR-based detection of multiple pathogens from a single sample, significantly increasing testing capacity while maintaining the speed and ease of use that QIAstatDx is known for. With the ability to run up to 160 tests per day across eight analytical modules – including 16 batch samples and two urgent slots per run – the system enables fast and accurate diagnoses in settings where turnaround time is critical.

QIAstat-Dx quickly multiplies many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.

To learn more about QIAGEN’s range of QIAstat-Dx devices and testing panels, visit https://www.qiagen.com/applications/syndromic-testing.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of June 30, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s products, development timelines, marketing and/or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results, such as expected adjusted net sales and adjusted diluted earnings, are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistics and supply chain dependencies), variability in operating results, and the commercial development of products for customers in the Life Sciences and clinical healthcare markets; changes in relationships with customers, suppliers or strategic partners; competition and rapid technological change; fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining product regulatory approvals; and challenges in integrating QIAGEN’s products into manufacturing process workflows and manufacturing at scale. Additional risks include market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other force majeure events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a more complete discussion of risks and uncertainties, please refer to the “Risk Factors” section in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Infectious Diseases

Contacts

Contacts QIAGEN:
Investor Relations
e-mail: ir@QIAGEN.com

Public Relations
e-mail: pr@QIAGEN.com

Number of Shares and Voting Rights of Innate Pharma as of September 1, 2025




Number of Shares and Voting Rights of Innate Pharma as of September 1, 2025

MARSEILLE, France–(BUSINESS WIRE)–#ANKET–Regulatory News:

Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as of September 1, 2025:

(1) The total number of theoretical voting rights (or “gross” voting rights) is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. The total number of theoretical voting rights includes voting rights attached to AGAP 2016, i.e. 130 voting rights for the AGAP 2016-1 and 111 voting rights for the AGAP 2016-2. No voting rights attached to AGAP 2017.

(2) The total number of exercisable voting rights (or “net” voting rights) is calculated without taking into account the shares held in treasury by the Company, with suspended voting rights. It is released so as to ensure that the market is adequately informed, in accordance with the recommendation made by the AMF on July 17, 2007.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).

Innate’s portfolio includes several ANKET^® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Innate Pharma
Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.com

Zai Lab Announces Approval of TIVDAK® for Patients with Recurrent or Metastatic Cervical Cancer in Hong Kong




Zai Lab Announces Approval of TIVDAK® for Patients with Recurrent or Metastatic Cervical Cancer in Hong Kong

SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

“Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China,” said Andrew Zhu, Chief Commercial Officer, Greater China, Zai Lab. “Treatment options for patients with recurrent or metastatic cervical cancer after initial therapy are limited. TIVDAK, the first antibody-drug conjugate (ADC) therapy in cervical cancer, delivers a clinically meaningful survival benefit to patients. With our established commercial infrastructure for ZEJULA in Hong Kong, we are uniquely positioned to ensure TIVDAK reaches patients without delay.”

TIVDAK is currently under regulatory review for its Biologics License Application by China’s National Medical Products Administration (NMPA), which was accepted in March 2025.

About TIVDAK^® (tisotumab vedotin-tftv)

TIVDAK^® (tisotumab vedotin) is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received full approval from U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).

About Zai Lab

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in Hong Kong, the potential benefits of TIVDAK, and the potential treatment of cervical cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov.

Contacts

For more information, please contact:

Investor Relations:
Christine Chiou / Lina Zhang

+1 (917) 886-6929 / +86 136 8257 6943

christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com

Media:
Shaun Maccoun / Xiaoyu Chen

+1 (857) 270-8854 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com