On January 2, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that China’s National Medical Products Administration (NMPA) has approved the second New Drug Application (NDA) of DOVBLERON (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC (Press release, Innovent Biologics, JAN 2, 2025, View Source;taletrectinib-adipate-capsule-ros1-inhibitor-was-approved-by-chinas-national-medical-products-administration-302341276.html [SID1234649383]).

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The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated the safety, tolerability and efficiency of taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated that taletrectinib continued to show high and durable overall responses and robust activity against intracranial lesions. In ROS1 TKI-naïve (n=106) patients, confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) and intracranial cORR reached as high as 91% and 88%, respectively. After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. [Link]

In December 2024, DOVBLERON was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON is the 13th addition to Innovent’s commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise.

Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "We are glad to see that DOVBLERON has been approved for ROS1-positive NSCLC across treatment lines at a fast pace. DOVBLERON demonstrated superior efficacy compared to the first-generation TKIs. These TRUST-I results reinforce taletrectinib’s high overall response and prolonged PFS. The efficacy and safety profile of DOVBLERON offers a more effective first-line treatment option and I look forward to its benefit in the ROS1-positive NSCLC patients in China."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The two NDAs approval of DOVBLERON is a reflection of its potential best-in-class efficacy to fulfill the urgent need of patients with ROS1-positive NSCLC. We recently just launched the first batch of DOVBLERON to market, rapidly bringing this precision therapy to NSCLC patients who need novel treatment options. Innovent’s robust TKI product pipeline—including RETSEMOV, PEMAZYRE, DUPERT and DOVBLERON—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients’ quality of life."

About ROS1-positive Non-small Cell Lung Cancer

Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive[i]. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options. In patients with metastatic ROS1-positive NSCLC that progressed following initial treatment, many have tumors spread to their brain (up to 55%) or acquired resistance mutations, including G2032R. Next-generation ROS1 TKIs demonstrated robust intracranial and G2032R activity. In the clinical management of ROS1-positive NSCLC patients, the first-line application of the new generation ROS1 TKIs can bring a prolonged progression-free survival and provide patients with greater survival benefits.

About DOVBLERON (Taletrectinib Adipate Capsule)

DOVBLERON is an oral, potent, central nervous system-active, selective, next-generation ROS1inhibitor. Taletrectinib, the active ingredient in DOVBLERON is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

DOVBLERON was approved by China’s National Medical Products Administration (NMPA): 1) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs; 2) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval). This NDA was accepted by the U.S. FDA for priority review in December 2024.

In June 2021, Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

On January 2, 2025 Hanx Biopharmaceuticals, CO. Ltd, an innovative biotechnology company developing next-generation immunotherapies to address the challenges of unmet medical need diseases, reported the first patient dosing in Australia on Dec 30, 2024 for Phase 1 clinical trial of HX044 in patients with advanced solid tumors (HX044-I-01, A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies, NCT06649708) (Press release, HanX Biopharmaceuticals, JAN 2, 2025, View Source [SID1234649382]).

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HX044 is an innovative bispecific antibody independently developed by Hanx Biopharmaceuticals. It is a first-in-class and considered to be a next generation immune-checkpoint inhibitor designed to treat a wide range of malignant tumors, including PD-1-resistant solid tumors such as non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and gastrointestinal cancers. HX044 represents a new generation CTLA-4 immunotherapy by expanding the therapeutic window, optimizing safety, and enhancing antitumor immune responses, showcasing a breakthrough in CTLA-4 immunotherapy.

"We are thrilled to see the first patient entered into clinical study, which marks a significant development milestone for this therapeutic candidate in our pipeline. This achievement demonstrated our strong R&D and clinical development capacity, and it reflects our commitment to addressing unmet medical needs for the patients. We will be working diligently to move this project forward", said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals. "HX044 is a next generation CTLA-4 bispecific antibody fully developed in-house by the company, starting from molecule design. It enhances Treg-depletion function within tumor microenvironment through its effective cis-binding mechanism. It shows strong efficacy even against PD-1-resistant "cold" tumors in preclinical models, demonstrating superior therapeutic potential", commended by Dr. Henry Li, CEO/CSO of Hanx Biopharmaceuticals.

On January 2, 2025 Star Therapeutics,a clinical stage biotechnology company discovering and developing best-in-class antibodies, reported that it will present at the 43rd annual J.P. Morgan Healthcare Conference taking place on January 13-16, 2025 in San Francisco, CA (Press release, Star Therapeutics, JAN 2, 2025, View Source [SID1234649381]).

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Adam Rosenthal, Ph.D., CEO and Founder of Star Therapeutics, is scheduled to present an overview of the company and its lead drug candidate, VGA039, a therapy for von Willebrand disease (VWD) and other bleeding disorders. The presentation details are below:

Date: Tuesday, January 14
Time: 9:30 a.m. PT
Location: The Westin St. Francis

About VGA039

VGA039 is a monoclonal antibody therapy with a novel mechanism of action that targets Protein S, a key component in restoring balance to the blood clotting process. VGA039 has potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, with the first disease indication of von Willebrand disease (VWD). As a subcutaneously self-administered antibody therapy with a convenient dosing regimen, VGA039 has the potential to dramatically reduce treatment burden for patients.

On January 2, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that Sean P. Bohen, M.D., President and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California, on Tuesday, January 14, 2025 at 3:45 p.m. PT (6:45 p.m. ET) (Press release, Olema Oncology, JAN 2, 2025, View Source [SID1234649380]).

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A live webcast of the presentation and any accompanying materials will be available under the Events and Presentations section of Olema’s Investor Relations website at ir.olema.com. A recording of the presentation will be made available in the same location.

On January 2, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it has entered into two agreements to divest its 45% equity interest in Shanghai Hutchison Pharmaceuticals Limited ("SHPL") for approximately US$608 million (RMB4,478 million) in cash, to GP Health Service Capital Co., Ltd ("GP Health Service Capital") and Shanghai Pharmaceuticals Holding Co., Ltd. ("Shanghai Pharma") (HKEX:02607; SSE:601607) (Press release, Hutchison China MediTech, JAN 2, 2025, View Source [SID1234649379]). HUTCHMED has been exploring opportunities to monetize the underlying value of SHPL, a non-core, non-consolidated joint venture. These transactions would allow HUTCHMED to focus on its core business of discovering, developing and commercializing novel therapies for the treatment of cancers and immunological diseases, including advancing its next-generation antibody-targeted-therapy conjugate programs.

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HUTCHMED will host a short update call on Tuesday, January 7, 2025. Details will be available at www.hutch-med.com/event in due course.

SHPL primarily manufactures, sells and distributes its own-brand prescription medicines in China, predominantly for cardiovascular diseases. SHPL is a 50:50 joint venture established between HUTCHMED and Shanghai Pharma in 2001. In 2023, the consolidated net income attributable to HUTCHMED from SHPL was US$47.4 million. HUTCHMED does not consolidate revenue from SHPL.

HUTCHMED plans to invest the proceeds from these transactions to further develop its internal pipeline and drive its core business strategy forward. This pipeline and strategy includes its next-generation antibody drug conjugate ("ADC") platform, which builds on HUTCHMED’s extensive knowledge from pursuing oncological pathways and proven expertise in small molecule targeted therapeutics. By combining antibodies with targeted therapeutics instead of cytotoxins, these antibody-targeted therapy conjugates ("ATTCs") offer dual mechanisms for addressing a target. Pre-clinical research has shown robust anti-tumor activity with durable response following a single administration, and stronger anti-tumor activity compared to administration with the individual antibody and targeted therapy components, improving tolerability associated with targeted therapy. HUTCHMED plans to move the first of these ATTCs into clinical trials in the second half of 2025.

"This transaction to divest most of our holding in SHPL is another example of HUTCHMED delivering on the strategy outlined in 2022, accelerating our path to profitability and focusing on core operations. SHPL is a well-established business, having delivered over US$370 million in dividends to HUTCHMED throughout the years, and we are confident that it continues to have promising future growth prospects," said Dr Dan Eldar, Chairman and Non-executive Director of HUTCHMED. "We are focused on capitalizing on our two decades of deep research into oncogenic drivers of disease and discovering and developing highly optimized therapies, through our unique ATTC platform."

GP Health Service Capital is a China-based private-equity firm with no prior interest in SHPL. Prior to the transactions, HUTCHMED and Shanghai Pharma each holds a 50% equity interest in SHPL. Under the terms of the agreements, GP Health Service Capital has agreed to acquire a 35% equity interest in SHPL from HUTCHMED for approximately US$473 million in cash, and Shanghai Pharma has agreed to acquire a 10% equity interest from HUTCHMED for approximately US$135 million in cash and will hold a total of 60% equity interest in SHPL after the transactions. Out of its 35%, GP Health Service Capital retains the right to designate a third party investment fund to acquire up to a 10% equity interest in SHPL. HUTCHMED will retain a 5% equity interest in SHPL after the transactions.

HUTCHMED expects to record a gain on disposal of approximately US$477 million before taxation. The actual gain to be recorded is subject to review and audit. The proceeds are subject to deduction of withholding tax, which will be determined before Closing. There will be a three-year transition period in which HUTCHMED will propose the General Manager of SHPL, and will guarantee to GP Health Service Capital a minimum net profit growth of SHPL of at least approximately 5% annually, subject to total compensation not exceeding approximately US$95 million. Further details are contained in the HUTCHMED announcement entitled "Major Transaction in Relation to the Disposal of 45% Equity Interest in Shanghai Hutchison Pharmaceuticals Limited".

HUTCHMED expects to convene an Extraordinary General Meeting (EGM) for its shareholders to consider and, if thought fit, to approve the transactions. The transactions are expected to close by the end of the first quarter of 2025, conditional upon the satisfaction (or, where applicable, waiver) of certain conditions including approval by HUTCHMED shareholders and regulatory approvals. Closing of both transactions are also conditional upon the simultaneous closing of each other.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "We continue to invest in our prolific in-house R&D platform, including our new ATTC programs that we believe have significant potential impact on the treatment of cancers. This divestment brings us additional resources and further focus."

"Our continual approach to engineer our own innovative, highly selective drug candidates has delivered several medicines with enhanced selectivity and limited off-target activity, allowing sustained target inhibition and flexibility for use as part of combination therapies. We also gained substantial knowledge of these oncogenic pathways, and the issues involved in addressing them. In contrast to traditional cytotoxin-based ADCs, we believe that our antibody-targeted therapy synergistic approach may also be combinable with immunotherapy- or chemotherapy-based frontline standards of care, could overcome chemotherapy resistance, and could avoid cytotoxin-related toxicities that limit long-term administration. This platform also maximizes on our long history of addressing patients with genetic drivers, who benefit less from traditional ADC therapies."

All transaction-related figures stated in US dollars (US$) are included for illustrative purposes only, and are based on an assumed exchange rate of US$1:RMB7.36. All cash considerations will be denominated in Renminbi (RMB).