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

Nanoparticle Formulation Market Report 2025, with Profiles of Ascension Sciences, DIANT Pharma, ExonanoRNA, Nanoform, NanoVation Therapeutics, NanoVelos, NTT Biopharma, Organoid-X BioTech, & Vaxinano – ResearchAndMarkets.com




Nanoparticle Formulation Market Report 2025, with Profiles of Ascension Sciences, DIANT Pharma, ExonanoRNA, Nanoform, NanoVation Therapeutics, NanoVelos, NTT Biopharma, Organoid-X BioTech, & Vaxinano – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Nanoparticle Formulation Market Industry Trends and Global Forecasts to 2035, by Type of Nanoparticle, Scale of Operation and Key Geographical Regions” report has been added to ResearchAndMarkets.com’s offering.

The global nanoparticle formulation market is estimated to grow from USD 5.1 billion in 2025, to USD 15.1 billion by 2035, at a CAGR of 9.4% during the forecast period to 2035.

Nanoparticle Formulation Market: Growth and Trends

Having demonstrated a strong therapeutic potential across a myriad of diseases, nanoparticle-based drugs have emerged as a promising treatment alternative within a short span. In fact, given the current ongoing pace of research, experts believe that remarkable innovations in the field of nanoparticles (in terms of improvement in disease diagnosis and treatment specificity) are likely to revolutionize the pharma industry in the coming years. Furthermore, the recent initiatives focused on nanotechnology for the detection and control of vector-borne diseases, dialysis, and molecular imaging, have further fueled the demand for these nanoparticles.

In addition, the nanoparticles can be engineered to achieve optimal delivery and overcome the limitations of biological barriers (systemic, microenvironmental and cellular) in the patient’s body owing to their modifiable properties (such as size, shape, surface properties and charge). However, the complex interplay between nanoparticle properties and biological systems requires careful consideration to ensure the safety and efficacy of these nanoscale materials. Various stakeholders, such as contract research organizations, (CROs), and contract development and manufacturing organizations (CDOs / CDMOs) are likely to play a pivotal role in supporting researchers and drug developers to navigate the complexities associated with its design, development and manufacturing.

By leveraging the multifaceted expertise in the field, contract service providers can help streamline the nanoparticle development process, reduce costs, and accelerate the translation of promising nanoparticles from lab scale to clinical scale. Driven by technological advancements and the rising demand for nanoparticle-based drugs, the nanoparticle formulation services market is anticipated to witness notable growth in the foreseen future.

Nanoparticle Formulation Market: Key Insights

The report delves into the current state of the nanoparticle formulation market and identifies potential growth opportunities within the industry.

Some key findings from the report include:

• Presently, more than 100 nanoparticle formulation technologies are being offered by companies across the globe in order to augment the development and manufacturing of nanoparticle-based drugs.
• Close to 80% of technologies are designed for the formulation of organic nanoparticles; of these, nearly 50% are intended for drug delivery via injectable route, primarily targeting oncological disorders.
• The current service providers landscape has over 80 companies offering a wide range of nanoparticle formulation services at various scales of operation.
• The market landscape features the presence of both well-established players and new entrants with the requisite expertise to develop / manufacture nanoparticle-based drugs for an extensive range of application areas.
• Owing to the rise in demand for nanoparticle-based formulations, service providers are continuously expanding their existing capabilities to enhance their respective service portfolios.
• A steady growth in the partnership activity has been observed in recent years; R&D agreements have been the most prominent type of partnership model adopted by players based in the US.
• More than 1,700 patents related to nanoparticle formulation and development have been filed by / granted to various organizations in order to protect intellectual property.
• The nanoparticle formulation services market is likely to grow at a CAGR of ~9% over the next decade, driven by revenues generated from commercial scale operation.

Nanoparticle Formulation Market: Key Segments

Organic Nanoparticles are Likely to Dominate the Nanoparticle Formulation Market During the Forecast Period

Based on the type of nanoparticle, the market is segmented into organic nanoparticles, inorganic nanoparticles and carbon-based nanoparticles. At present, organic nanoparticles hold the maximum share of the nanoparticle formulation market. This trend is unlikely to change in the near future.

Protein-based Nanoparticles Segment is the Fastest Growing Segment of the Nanoparticle Formulation Market During the Forecast Period

Based on the type of organic nanoparticle, the market is segmented into polymeric nanoparticles, lipid nanoparticles, viral nanoparticles, protein-based nanoparticles, and other organic nanoparticles. It is worth highlighting that, currently, lipid nanoparticles hold a larger share of the nanoparticle formulation market. However, the nanoparticle formulation market for protein-based nanoparticles is likely to grow at a higher CAGR in the coming decade.

Commercial Operations Occupy the Largest Share of the Nanoparticle Formulation Market

Based on scales of operation, the market is segmented into preclinical, clinical and commercial scales. At present, commercial operations capture the maximum share of the nanoparticle formulation market. It is worth highlighting that the nanoparticle formulation market at the clinical scale is likely to grow at a higher CAGR in the near future.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the world. The majority share is expected to be captured by service providers based in North America and Europe. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Sample Players in the Nanoparticle Formulation Market, Profiled in the Report

• Ascension Sciences
• DIANT Pharma
• ExonanoRNA
• Nanoform
• NanoVation Therapeutics
• NanoVelos
• NTT Biopharma
• Organoid-X BioTech
• Vaxinano

Nanoparticle Formulation Market: Research Coverage

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the nanoparticle formulation market, focusing on key market segments, including type of nanoparticle formulated, type of organic nanoparticle formulated, scale of operation and key geographical regions.
• Market Landscape 1: A comprehensive evaluation of nanoparticle formulation technologies, considering various parameters, such as type of nanoparticle(s) formulated, type of molecule(s) delivered, therapeutic area(s), compatible dosage form(s) and route(s) of administration. Further, the chapter provides information on various technology developers, along with analysis based on multiple parameters, such as year of establishment, company size, location of headquarters and most active players (in terms of number of technologies developed).
• Market Landscape 2: A comprehensive evaluation of nanoparticle formulation service providers, considering various parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of facilities, type of service provider(s), type of nanoparticle(s) formulated, type of service(s) offered, scale of operation and application area(s).
• Technology Competitiveness: A comprehensive competitive analysis of nanoparticle formulation technologies, examining factors, such as developer power, technology strength and technology applicability.
• Company Competitiveness: A comprehensive competitive analysis of nanoparticle formulation service providers, examining factors, such as company strength and service strength.
• Company Profiles: In-depth profiles of key industry players offering technologies and services for nanoparticle formulation across North America, Europe and Asia-Pacific, focusing on company overviews, technology portfolio, service portfolio, recent developments and an informed future outlook.
• Partnerships and Collaborations: An analysis of partnerships established in this sector, since 2018, covering technology licensing agreements, research and development agreements, product development agreements, manufacturing agreements, mergers and acquisitions, technology integration agreements and other relevant agreements.
• Patent Analysis: Detailed analysis of various patents filed / granted related to nanoparticle formulation based on publication year, geographical region, CPC symbols, leading players (in terms of number of patents filled / granted) and type of organization. It also includes a patent benchmarking analysis and a detailed valuation analysis.
• Nanoparticle Evaluation Framework: An insightful framework evaluating types of nanoparticles based on various parameters, such as number of technologies, nanoparticle efficacy, number of clinical trials evaluating nanoparticle-based drugs, extent of innovation, trends in research activity and current global competition. It also provides a value addition matrix for respective types of nanoparticles currently adopted by stakeholders.
• Case Study: A case study of the recent technology licensing agreements, along with information on deal amounts.

Key Questions Answered in this Report

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What kind of partnership models are commonly adopted by industry stakeholders?
• What factors are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

Reasons to Buy this Report

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 10% Free Content Customization
• Detailed Report Walkthrough Session with Research Team

For more information about this report visit https://www.researchandmarkets.com/r/uh9gwr

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Digital Biomarkers Global Markets Report 2025-2030 with Profiles of Leading Players – Actigraph, AliveCor, Altoida, Evidation Health, and IXICO – ResearchAndMarkets.com




Digital Biomarkers Global Markets Report 2025-2030 with Profiles of Leading Players – Actigraph, AliveCor, Altoida, Evidation Health, and IXICO – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Digital Biomarkers: Global Markets” report has been added to ResearchAndMarkets.com’s offering.

The global market for digital biomarkers is estimated to grow from $5 billion in 2025 to $18.8 billion by the end of 2030, at a compound annual growth rate (CAGR) of 30.4% from 2025 through 2030.

This report provides an overview of the global market for digital biomarkers and analyzes market trends. It includes global revenue ($ millions) for the base year data of 2024, estimates for 2025 and projections of compound annual growth rates (CAGRs) from 2025 through 2030. The market is segmented based on system components, applications, therapeutic areas, end users and regions. The regions covered in this study include North America, Europe, Asia-Pacific and the Rest of the World (RoW), focusing on major countries in these regions.

The report focuses on the significant driving trends and challenges that affect the market and vendor landscape. It analyzes environmental, social and governance (ESG) developments and discusses emerging technologies related to the market.

The report includes:

• 53 data tables and 54 additional tables
• An overview of the global market for digital biomarkers
• Estimation of the market size and analyses of global market trends, with data from 2022 to 2024, estimates for 2025, and projected CAGRs through 2030
• Information regarding major market drivers, opportunities and challenges, industry chain structure, distribution channel and technological advancements that are affecting the overall market
• Evaluation of market potential and revenue forecast for the digital biomarkers market based on system component, application, therapeutic area, end user and region
• Insights into the industry structure, current competitive scenario, R&D activities, growth strategies and ESG trends of the market
• Identification of companies best positioned to meet this demand due to their proprietary technologies, mergers and acquisitions, joint ventures and strategic alliances
• Profiles of the leading companies, including Actigraph LLC., AliveCor Inc., Altoida, Evidation Health Inc., and IXICO Plc.

Company Profiles

• Actigraph LLC.
• Akili Inc.
• Alivecor Inc.
• Altoida
• Embic Corp.
• Empatica Inc.
• Evidation Health Inc.
• Feel Therapeutics
• Huma
• Ixico PLC
• Kinsa Inc.
• Koneksa Health
• Neurotrack Technologies Inc.
• Vivosensmedical GmbH
• Winterlight Labs

Key Attributes:

Key Topics Covered:

Chapter 1 Executive Summary

• Market Outlook
• Scope of Report
• Market Summary
• Market Growth Factors
• Emerging Technologies
• Segmental Analysis
• Regional Analysis
• Conclusion

Chapter 2 Market Overview

• Overview and Market Definition
• Digital Biomarker Types
• Comparison of Traditional and Digital Biomarkers
• Pestel Analysis
• Political
• Economic
• Social
• Technological
• Environmental
• Legal
• Impact of U.S. Tariff Laws on the Digital Biomarkers Market
• Increase in Product Costs
• Effects on Supply Chain
• Opportunities for Local Production
• Conclusion

Chapter 3 Market Dynamics

• Market Dynamics
• Market Drivers
• Rising Adoption of Mhealth Apps and Wearables
• Growing Application of Digital Biomarkers in Neurodegenerative and Psychiatric Disorders
• Increasing Role of Digital Biomarkers in Clinical Trials
• Corporate Wellness Programs and Incentives
• Market Restraints
• Data Standardization and Interpretation Issues
• Difficulties in Validation of Biomarkers
• Data Privacy and Protection
• Market Opportunities
• Growing Technology Innovations
• Increasing Research Collaborations and Partnerships

Chapter 4 Regulatory Landscape

• Regulatory Scenario
• The U.S.
• Canada
• Europe
• Asia-Pacific

Chapter 5 Emerging Technologies and Developments

• Artificial Intelligence-based Digital Biomarkers
• Enhancement of Digital Biomarkers by AI and ML
• Benefits of AI-Driven Digital Biomarkers

Chapter 6 Market Segmentation Analysis

• Segmentation Breakdown
• Market Breakdown by System Component
• Key Takeaways
• Data Collection Tools
• Data Integration Systems
• Market Breakdown by Application
• Key Takeaways
• Diagnostic Digital Biomarkers
• Monitoring Digital Biomarkers
• Predictive Digital Biomarkers
• Other Applications
• Market Breakdown by Therapeutic Area
• Key Takeaways
• Cardiovascular and Metabolic Disorders
• Psychiatric Disorders
• Neurological Disorders
• Musculoskeletal Disorders
• Respiratory Disorders
• Other Therapeutic Areas
• Market Breakdown by End-user
• Key Takeaways
• Pharmaceutical Companies and Research Institutions
• Healthcare Providers
• Patients and Caregivers
• Employers
• Payers
• Geographic Breakdown
• Market Breakdown by Region
• Key Takeaways
• North America
• Europe
• Asia-Pacific
• Rest of the World

Chapter 7 Competitive Intelligence

• Key Takeaways
• Prominent Digital Biomarkers Companies
• Competitor Types and Their Strategies
• Pharmaceutical Companies
• Large Technology Companies
• Small and Medium-Size Technology Companies
• Strategic Analysis
• Agreements, Collaborations and Partnerships
• New Product Launches
• Acquisitions and Mergers
• Regulatory Approvals

Chapter 8 Sustainability in Digital Biomarkers Market: ESG Perspective

• Introduction
• Sustainability Factors
• Environmental Sustainability
• Social Sustainability
• Economic Sustainability
• Other Factors
• Scaling Sustainable Practices in Healthcare
• Business Practices Implementing Sustainable Solutions
• Conclusion

Chapter 9 Appendix

For more information about this report visit https://www.researchandmarkets.com/r/sz3yzs

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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STAT Inhibitors Pipeline Market Insights Report 2025 | 18 Companies and 22 Pipeline Drugs in Stages Ranging from Clinical to Nonclinical – ResearchAndMarkets.com




STAT Inhibitors Pipeline Market Insights Report 2025 | 18 Companies and 22 Pipeline Drugs in Stages Ranging from Clinical to Nonclinical – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “STAT Inhibitors – Pipeline Insight, 2025” has been added to ResearchAndMarkets.com’s offering.

The “STAT Inhibitors – Pipeline Insight, 2025” report offers exhaustive insights into the emerging landscape of STAT Inhibitors, with over 18 companies and 22 pipeline drugs in stages ranging from clinical to nonclinical. The report delves into the therapeutic assessment categorized by product type, stage, route of administration, and molecular type, while also illustrating inactive pipeline products.

Signal Transducer and Activator of Transcription (STAT) inhibitors are pivotal in targeting aberrant STAT signaling, especially involving STAT3 and STAT5, which are linked to diverse diseases like cancers and inflammatory disorders. These inhibitors aim to disrupt the pathological cell behaviors associated with these conditions. Current research underscores their potential in targeted applications, predominantly in oncology and chronic inflammatory diseases.

STAT proteins, encompassing seven members, function as signal transducers directly influencing gene expression. Each protein plays distinct roles, with STAT1 crucial for antiviral responses, STAT3 extensively involved in oncogenesis, and STAT6 impacting immune regulations. Their structural design, comprising domains like the SH2 domain, facilitates signal transduction and transcriptional regulation. Stat proteins’ therapeutic targeting continues to be significant in oncology, autoimmune disorders, and as potential biomarkers for disease progression and treatment efficacy.

The “STAT Inhibitors – Pipeline Insight, 2025” report presents an in-depth look into the current scenario and growth prospects for these inhibitors. It features a detailed landscape of the STAT Inhibitors pipeline, including disease overviews and treatment guidelines, while thoroughly assessing the commercial and clinical facets of ongoing developments.

The report highlights leading drugs in development, providing insights into their mechanisms, clinical trials, approvals, and technological collaborations. Notably, TTI-101 from Tvardi Therapeutics, in Phase II trials, has shown promise against conditions like liver and breast cancer. Similarly, Kymera Therapeutics’ KT-621, a standout oral STAT6 degrader, is in Phase I trials for Atopic Dermatitis, showcasing superior preclinical efficacy. Vividion’s VVD-850, another STAT3 inhibitor, underpins broad cancer applications, currently in early Phase I trials.

A key component of the report is the therapeutic assessment, segmented by various parameters such as clinical stages including Phase III, II, I, preclinical, and discovery stages. Drugs are further categorized by their route of administration, product types, and molecular forms. Active collaborations, mergers, acquisitions, licensing activities, and narrative on clinical studies anchor the comprehensive view presented.

The report canvasses key players like Tvardi Therapeutics, Kymera Therapeutics, Bayer, and Vividion, among others, who are advancing the frontier of STAT Inhibitor research and development.

In summary, the STAT Inhibitors report encapsulates a robust analysis of the pipeline, therapeutic potential, and identifies current unmet needs in the market. It serves as a crucial guide for stakeholders witnessing the evolving capacities of STAT-targeted therapies across various medical disciplines.

Key Topics Covered:

Introduction

Executive Summary

STAT Inhibitors: Overview

• Introduction
• Structure
• Function
• Mechanism of action
• STAT Inhibitors as therapeutic target

Pipeline Therapeutics

• Comparative Analysis

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

STAT Inhibitors – Analytical Perspective

Late Stage Products (Phase III)

• Product Description
• Research and Development
• Product Development Activities

Mid Stage Products (Phase II)

• Comparative Analysis

TTI-101: Tvardi Therapeutics

• Product Description
• Research and Development
• Product Development Activities

Early Stage Products (Phase I)

• Comparative Analysis

VVD-850: Vividion Therapeutics

• Product Description
• Research and Development
• Product Development Activities

Preclinical and Discovery Stage Products

• Comparative Analysis

STAT Inhibitors Key Companies

STAT Inhibitors Key Products

STAT Inhibitors – Unmet Needs

STAT Inhibitors – Market Drivers and Barriers

STAT Inhibitors – Future Perspectives and Conclusion

STAT Inhibitors Analyst Views

STAT Inhibitors Key Companies

• Tvardi Therapeutics
• Kymera Therapeutics, Inc
• Vividion Therapeutics
• Bayer
• Moleculin
• Purple Biotech
• LEO Pharma
• Enanta Pharmaceuticals
• Kaken Pharmaceutical
• Astrazeneca
• Arrakis Therapeutics
• Accendatech
• JW Pharmaceutical
• Recludix

For more information about this clinical trials report visit https://www.researchandmarkets.com/r/psf77e

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900