HUTCHMED Highlights Pipeline and Business Progress at R&D Updates Event




HUTCHMED Highlights Pipeline and Business Progress at R&D Updates Event

— HUTCHMED unveils its innovative ATTC platform, potentially providing precision oncology with synergistic dual-mechanism of action —

— Lead candidate HMPL-A251 harnesses a selective PI3K/PIKK inhibitor payload, demonstrating promising preclinical efficacy and safety —

— Progress in global and China trials, including FRUSICA-2, SANOVO, surufatinib’s PDAC and fanregratinib’s IHCC studies, advances HUTCHMED’s late-stage pipeline —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 02, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) announced key research and development (R&D) and business updates presented during its R&D Updates event held on October 31, 2025. The event highlighted HUTCHMED’s progress in advancing innovative cancer and immunology treatments, including the introduction of its next-generation Antibody-Targeted Therapy Conjugate (“ATTC”) platform, alongside updates on late-stage pipeline candidates.

“Our commitment to advancing innovative therapies drives HUTCHMED’s mission to address critical unmet needs in oncology and immunology,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “The ATTC platform’s potential to redefine precision oncology, combined with our robust pipeline and partnership strategy, positions us to deliver potentially transformative cancer and immunology treatments to patients around the world.”

Breakthrough ATTC Platform and Lead Candidate HMPL-A251

The ATTC platform represents potentially a groundbreaking approach to precision oncology, integrating monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. The ATTC platform integrates monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. In contrast to traditional cytotoxin-based antibody-drug conjugates (“ADC”), ATTCs leverage targeted therapies to achieve synergistic anti-tumor activity and durable responses, as demonstrated in preclinical models. These conjugates have shown superior efficacy and safety profiles compared to standalone antibody or small molecule inhibitor components.

Overcoming Cancer Challenges with PAM-Targeting Payload: The first wave of ATTC candidates focuses on payloads targeting the PI3K/AKT/mTOR (“PAM”) signaling pathway. The PAM pathway is a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant limitations, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery. The ATTC strategy tries to address these challenges by enhancing targeted delivery of PAM inhibitors directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure.

HUTCHMED’s Lead ATTC Candidate, HMPL-A251: HMPL-A251 is a PAM-HER2 ATTC consisting of a highly selective and potent PI3K/PIKK inhibitor payload conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker. Preclinical data for HMPL-A251 was recently presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In vitro, the PI3K/PIKK inhibitor payload exhibited high selectivity, potency, and robust anti-tumor activity across a diverse panel of tumor cell lines. HMPL-A251 demonstrated HER2-dependent antitumor activity, with potent inhibition of HER2-positive tumor cell growth regardless of PAM pathway alterations, and moderately reduced activity in HER2-low, PAM-altered lines. Notably, HMPL-A251 exhibited a strong bystander effect, impacting HER2-null cells when co-cultured with HER2-positive cells. In vivo evaluations showed superior anti-tumor efficacy and tolerability compared to the naked antibody and payload administered separately. When benchmarked against trastuzumab deruxtecan (T-DXd), a leading HER2-directed ADC, HMPL-A251 achieved comparable or superior efficacy at equivalent doses in most models tested. Furthermore, payload-related toxicities are anticipated to be improved, with plasma exposure of the free payload being significantly lower than that of HMPL-A251.

Encouraged by these promising preclinical results in both HER2-positive and HER2-low models, with or without PAM alterations, HUTCHMED plans to advance HMPL-A251 into clinical development starting in late 2025 using a data-driven strategy. Initial studies will evaluate the candidate across various cancer types with diverse HER2 and PAM alteration statuses.

Adaptable Payload and Antibody Design Unlocks Versatile Mechanisms: Beyond HER2-targeted antibodies, HUTCHMED aims to explore a broader range of antibody selections that synergize with the payload’s signaling pathways, leveraging the antibody as a delivery vehicle to enhance combination effects. Payload options are also adaptive, targeting a wide array of signaling pathways, positioning ATTCs as a versatile tool in overcoming resistance and improving treatment outcomes. Additionally, ATTC shows potential for combination with chemotherapy-based frontline standard-of-care treatments or as a chemotherapy-free adjuvant for long-term use, enhancing its possible application as combination therapy in early-line settings. Successful development of multiple ATTC molecules is expected to lead to collaboration and licensing opportunities in the future. Initial responses from potential partners are very positive.

Significant Progress from Late-stage Programs

In addition to the ATTC platform, the R&D Updates featured updates on some of the late-stage programs:

• Fruquintinib FRUSICA-2 Study: Data from the Phase III trial of fruquintinib in combination with sintilimab for second-line renal cell carcinoma was presented at ESMO Congress 2025. The combination achieved a progression-free survival (PFS) of 22.2 months versus 6.9 months with standard-of-care axitinib or everolimus (hazard ratio [HR]: 0.37; p<0.0001). The objective response rate more than doubled to 60.5% versus 24.3%, with a median duration of response of 23.7 months compared to 11.3 months.
• Savolitinib Registration Studies: Recruitment has been completed for the SANOVO China Phase III study in first-line EGFR-mutated non-small cell lung cancer (“NSCLC”) with MET overexpression. Recruitment for the SAFFRON global Phase III study for second-line EGFR-mutated NSCLC patients with MET amplification or overexpression is progressing well, with enrollment completion expected in late 2025.
• Surufatinib for Pancreatic Cancer: The Phase II/III study of surufatinib combined with Hengrui’s camrelizumab (a PD-1 antibody), nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) remains on track. Results from the Phase II portion will be presented at an upcoming scientific conference.
• Sovleplenib for ITP and wAIHA: Preparations for the resubmission of the new drug application for second-line immune thrombocytopenia (ITP) are progressing as outlined in the 2025 interim report, with resubmission planned for the second quarter of 2026. The ESLIM-02 study in second-line warm autoimmune hemolytic anemia (wAIHA) has completed enrollment, with topline results expected in early 2026.
• Fanregratinib in China: Recruitment for the registrational Phase II study in patients with advanced intrahepatic cholangiocarcinoma (IHCC) in China has been completed, with new drug application submission preparation underway for the first half of 2026.

For more information on the R&D updates presentation, please visit www.hutch-med.com/event/.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib, the further clinical development for HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib , its expectations as to whether any studies on HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Benitec Biopharma to Provide Phase 1b/2a Clinical Study Update for BB-301 in Oculopharyngeal Muscular Dystrophy




Benitec Biopharma to Provide Phase 1b/2a Clinical Study Update for BB-301 in Oculopharyngeal Muscular Dystrophy

Investor webcast to be held on Monday November 3, 2025 at 8:00 am EST

HAYWARD, Calif., Nov. 02, 2025 (GLOBE NEWSWIRE) — Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced that it will provide an update on the six treated patients from Cohort 1 of its Phase 1b/2a Clinical Study of BB-301 being investigated for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD).

Webcast details:
Date: November 3, 2025
Time: 8:00 am EST
To register for the webcast, please click here.

About Benitec Biopharma Inc.
Benitec Biopharma Inc. (“Benitec” or the “Company”) is a clinical-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary “Silence and Replace” DNA-directed RNA interference platform combines RNA interference, or RNAi, with gene therapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. The Company is developing Silence and Replace-based therapeutics for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy (OPMD). A comprehensive overview of the Company can be found on Benitec’s website at www.benitec.com.

Investor Relations Contact:

Irina Koffler
LifeSci Advisors
Tel: (917) 734-7387
ikoffler@lifesciadvisors.com

Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05




Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05

REYKJAVIK, Iceland, Nov. 02, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab).

The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application. The facility remains FDA approved to manufacture and continues supplying currently commercialized products.

Sales of Simponi in the U.S. in the first half of 2025 were less than $300 million, according to data published by IQVIA. Currently, there are no FDA approvals for a biosimilar to Simponi.

“As previously discussed, following the inspection of our facility, Alvotech submitted a comprehensive response to the FDA detailing our Corrective and Preventive Action (CAPA) plan. While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.

Following the receipt of the CRL, Alvotech has reevaluated its outlook for 2025. Total revenues in 2025 are now expected to be $570-$600 million and adjusted EBITDA $130-$150 million, lower than previously provided. The lowered adjusted EBITDA outlook is primarily driven by expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production. These investments, however, also serve to support Alvotech’s future growth plans and new product launches.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05




Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05

REYKJAVIK, ICELAND (November 2, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab).

The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application. The facility remains FDA approved to manufacture and continues supplying currently commercialized products.

Sales of Simponi in the U.S. in the first half of 2025 were less than $300 million, according to data published by IQVIA. Currently, there are no FDA approvals for a biosimilar to Simponi.

“As previously discussed, following the inspection of our facility, Alvotech submitted a comprehensive response to the FDA detailing our Corrective and Preventive Action (CAPA) plan. While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.

Following the receipt of the CRL, Alvotech has reevaluated its outlook for 2025. Total revenues in 2025 are now expected to be $570-$600 million and adjusted EBITDA $130-$150 million, lower than previously provided. The lowered adjusted EBITDA outlook is primarily driven by expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production. These investments, however, also serve to support Alvotech’s future growth plans and new product launches.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant




Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant

• MHRA response is based on the Phase 3 DRAGON interim analysis results 
• Topline final data expected in Q4 2025

SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) — Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

“We are extremely pleased with the outcome of our engagement with the MHRA. This is an incredibly exciting time for the Belite team as we see our perseverance bringing us closer to offering an effective therapy to patients living with Stargardt disease, who currently have no approved treatment options,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “We look forward to continuing our work with regulatory authorities as we advance Tinlarebant through late-stage development and toward the possibility of delivering the first approved therapy for this devastating disease.”

“With consistent feedback from major agencies across the world, we are encouraged that the DRAGON trial provides a strong foundation for global submissions and potential approvals,” said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio.

MHRA’s response is based on the interim analysis results which fulfil the criteria for a Conditional Marketing Authorization application. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the MHRA for full Marketing Authorization Application.

The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the U.S., United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability.

About Tinlarebant (a/k/a LBS-008)
Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, Tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation and Rare Pediatric Disease designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1.

About Belite Bio
Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as STGD1 and GA in advanced dry AMD, in addition to specific metabolic diseases. Belite’s lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook or visit us at www.belitebio.com.

Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking statements about future expectations and plans, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding the potential implications of clinical data for patients, and Belite Bio’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates, the ability of Tinlarebant to treat Stargardt disease and geographic atrophy, and any other statements containing the words “expect”, “hope” and similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the timing to submit trial data to regulatory authorities for drug approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; the potential efficacy of Tinlarebant, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. In addition, even if MHRA agreed that the Company may submit the Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from Phase 3 DRAGON trial, the Company is still subject to all applicable data, document and procedural requirements of MHRA for the Company’s Marketing Authorization Application. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly 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.

Media and Investor Relations Contact:
Jennifer Wu
ir@belitebio.com

Julie Fallon
belite@argotpartners.com

Fangzhou’s “XingJie” LLM Completes Key National Filing, Setting Stage for Further AI-Driven Chronic Care Innovations




Fangzhou’s “XingJie” LLM Completes Key National Filing, Setting Stage for Further AI-Driven Chronic Care Innovations

SHENZHEN, China, Nov. 02, 2025 (GLOBE NEWSWIRE) — Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leader in AI-driven Internet healthcare solutions, was presented with a Generative AI Service Filing Certificate at the first Guangdong Provincial LLM Filing Conference in Shenzhen.

At the event, Dr. Xie Fangmin, Founder, Chairman, and CEO of Fangzhou, remarked: “The successful launch of the ‘XingJie’ Large Language Model (‘XJ LLM’) marks another milestone in Fangzhou’s advancement of AI-driven chronic disease management. Building on this momentum, we will continue to optimize our models and enrich our AI+H2H (Hospital-to-Home) healthcare ecosystem, integrating frontier AI capabilities with professional medical services so that every user can experience smarter, more accessible, and more personalized care support.”

Dr. Xie Fangmin gave a speech at the first Guangdong Provincial LLM Filing Conference

Fangzhou’s proprietary XJ LLM, a healthcare focused AI model, officially completed the National Generative AI Service Filing (Filing No. Guangdong-XingJie-202509120089) with the Cyberspace Administration of China. The Company’s deployment of two flagship models — XJ LLM and XS LLM (announced in September 2025) — solidifies its position at the forefront of AI-powered chronic disease management. This achievement underscores the coming evolution of chronic disease management from traditional, passive inquiry based care, toward AI-powered paradigm of predictive insights and personalized care.

Serving as a cornerstone of Fangzhou’s AI+H2H ecosystem, the XJ LLM is built on three foundational innovations — technological advancement, application transformation, and operational efficiency — that collectively reshape the service experience. XJ LLM combines emotional perception and intent reasoning to anticipate user needs, acting as a central hub to coordinate multiple models for optimal speed and performance. This shift from app-based functionality to AI-driven experiences, enables natural interaction and autonomous task execution. XJ LLM’s knowledge base adapts to real-world data, reducing maintenance costs and allowing for extended AI-capabilities across end-to-end enterprise processes.

The successful filing of the XJ LLM represents a milestone in Fangzhou’s AI-enabled chronic disease management ecosystem. Alongside the previously launched XS LLM, this dual-model architecture forms an integrated AI+H2H ecosystem with comprehensive management capabilities across specialty disease areas. This ecosystem currently supports end-to-end intelligent services in fields including AI+weight management and AI+psoriasis care, delivering tailored medication guidance, and full-cycle support spanning disease education, targeted interventions, and ongoing monitoring.

Fangzhou has formed strategic partnerships with several leading pharmaceutical companies, including Novo Nordisk, Innovent Biologics, and Fosun Pharma, to jointly build industry-leading frameworks for AI-enabled disease management, accelerating the industry’s evolution towards intelligent, evidence-based care.

Going forward, Fangzhou will expand AI-driven solutions across the full spectrum of chronic disease management using its XS LLM and XJ LLM models. The company remains committed to its mission of achieving “better health for all,” by harnessing cutting-edge technology to contribute towards the vision for a healthier China.

About Fangzhou Inc.
Fangzhou Inc. (HKEX: 06086) is China’s leading online chronic disease management platform, serving 52.8 million registered users and 229,000 physicians (as of June 30, 2025). The Company specializes in delivering tailored medical care and AI-enabled precision medicine solutions. For more information, visit https://investors.jianke.com.

Media Contact
For further inquiries or interviews, please reach out to:
Xingwei Zhao Associate Director of Public Relations Email: pr@jianke.com

Disclaimer: This press release contains forward-looking statements. Actual results may differ materially from those anticipated due to various factors. Readers are cautioned not to place undue reliance on these statements.

A photo accompanying this announcement is available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/4d04246f-46cb-4314-827e-ee173662da8e

Bavarian Nordic Provides Clarification on the HERA Framework Agreement and the Public Preparedness Business




Bavarian Nordic Provides Clarification on the HERA Framework Agreement and the Public Preparedness Business

COPENHAGEN, Denmark, November 1, 2025 – Bavarian Nordic A/S hereby issues the following clarification regarding the Health Emergency Preparedness and Response Authority (HERA) framework agreement, announced yesterday, and the Public Preparedness business.

The initial order for 750,000 doses of MVA-BN smallpox/mpox vaccine that was announced yesterday will be delivered in 2026 and is the result of a new joint procurement contract by the European Commission, through the HERA. This represents the second order received for next year, following the earlier award of a contract option from Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) announced in May. The company anticipates additional orders for MVA-BN over the course of the next year, but the BARDA and HERA orders are an encouraging start to building a base preparedness business of DKK 1.5-2 billion for 2026, consistent with previous guidance. The award of the HERA agreement does not affect the 2025 guidance.

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com.

Contact investors:
Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com
US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03

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• Bavarian Nordic Provides Clarification on the HERA Framework Agreement and the Public Preparedness Business

Teva to Present at UBS Global Healthcare Conference and Jefferies London Healthcare Conference in November




Teva to Present at UBS Global Healthcare Conference and Jefferies London Healthcare Conference in November

TEL AVIV, Israel, Oct. 31, 2025 (GLOBE NEWSWIRE) —  Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva’s President and CEO, will present at two upcoming investor conferences in November as follows:

• UBS Global Healthcare Conference
  Monday, November 10, 2025, at 8:45 A.M. Eastern Time (ET)

• Jefferies London Healthcare Conference
  Tuesday, November 18, 2025, at 11:00 A.M. Greenwich Mean Time (6:00 A.M. ET)

To access a live webcast of the presentation, visit Teva’s Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations.

An archived version of the webcast will be available within 24 hours after the end of the live discussion.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This Document and the presentation at the conferences may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Teva Media Inquiries
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquires
TevaIR@Tevapharm.com

Protext Mobility, Inc. (OTC: TXTM) Announces CEO Statement Following Removal of Caveat Emptor Designation




Protext Mobility, Inc. (OTC: TXTM) Announces CEO Statement Following Removal of Caveat Emptor Designation

NEW YORK, Oct. 31, 2025 (GLOBE NEWSWIRE) — Protext Mobility, Inc. (OTC: TXTM) (“TXTM”), an emerging biotechnology company pioneering advancements in plant-based therapeutics, today released an official statement from Chief Executive Officer Mr. Dylon Du Plooy, addressing shareholders in light of the company’s continued operational and strategic progress following the removal of the Caveat Emptor designation.

Message to Shareholders:

Following the removal of the Caveat Emptor designation, Protext Mobility Inc. (OTC: TXTM) has entered a new phase of growth — one built on transparency, accountability, and leadership alignment.

As Chief Executive Officer, I firmly believe in TXTM’s long-term potential. To demonstrate that conviction, Our President and Chairman of the Board purchased more than 200 million shares of TXTM common stock on the open market since 2024. These purchases represent long-term holdings and serve as a clear signal that management and shareholders are fully aligned in our shared vision for sustained growth.

Additionally, I hold preferred shares that I have no intention to convert into common stock. This ensures there is no dilution risk from management. In fact, my plan is to acquire additional shares and donate a portion back to the company to further support business development and strategic initiatives.

Importantly, the company is not planning, considering, or preparing for any reverse stock split. Management’s commitment remains focused on strengthening fundamentals, driving organic growth, and protecting shareholder value without resorting to measures that could adversely impact the capital structure.

My goal as Chief Executive Officer is straightforward: to strengthen the company, protect shareholder value, and build continued momentum as we enter this exciting new chapter.

Thank you for your confidence and support.

Sincerely,
Mr. Dylon Du Plooy
Chief Executive Officer
Protext Mobility, Inc. (OTC: TXTM)

About Protext Mobility, Inc. (OTC: TXTM)

Protext Mobility, Inc. is a biotechnology company pioneering the development of plant-based therapeutics through proprietary live plant extraction technologies. The company’s mission is to deliver highly bioavailable botanical formulations for nutraceutical and pharmaceutical applications — driving innovation in global wellness through nature and science.

Investor & Media Contact

Dylon Du Plooy – Investor Relations
dylon@rsammd.co.za

Dr. J – Corporate Communications
exportintl@aol.com

Follow Protext Mobility on X: https://x.com/ProtextP

Safe Harbor Statement

This release contains forward-looking statements reflecting Protext Mobility, Inc.’s current views and expectations regarding future events and performance. Such statements are subject to risks and uncertainties that could cause actual results to differ materially. The company assumes no obligation to update forward-looking statements except as required by law.

Bavarian Nordic Announces Major Shareholder Notification from Morgan Stanley




Bavarian Nordic Announces Major Shareholder Notification from Morgan Stanley

COPENHAGEN, Denmark, October 31, 2025 – Pursuant to section 30 of the Danish Capital Markets Act, Bavarian Nordic A/S hereby announces that the Company has received notification from Morgan Stanley that they hold 4.99% of the shares and voting rights in Bavarian Nordic A/S as of October 27, 2025.

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com.

Contact investors:
Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com
US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03

Company Announcement no. 37 / 2025

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• Company Announcement no. 37 / 2025