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Henlius Biotech Secures Exclusive Rights to Sermonix’s Lasofoxifene for Breast Cancer Treatment in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) has entered into a partnership and licensing agreement with U.S.-based Sermonix Pharmaceuticals Inc. for exclusive development, manufacturing, and commercialization rights in China for the investigational drug lasofoxifene. This ESR1 antagonist is being developed as a treatment for breast cancer. Under the terms of the…
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GenFleet’s SLS009 Receives Fast-Track and Orphan Drug Designations from U.S. FDA for Lymphoma and Leukemia
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Shanghai-based biotech GenFleet Therapeutics announced that its CDK9 inhibitor, SLS009 (GFH009), has received fast-track and orphan drug designation (ODD) statuses from the U.S. FDA. These designations highlight the drug’s potential as a treatment for recurrent or refractory peripheral T-cell lymphoma (PTCL) and recurrent or refractory acute myeloid leukemia (AML). In…
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Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
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The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
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International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation
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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after…
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OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
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OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I/II study for its novel antibody drug conjugate (ADC) cancer therapy, OBI-992, which targets TROP2. The antibody molecules utilized in the development of…
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Johnson & Johnson to Acquire Ambrx Biopharma in a Deal Valued at USD 2 Billion
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has announced its intention to acquire Ambrx Biopharma (NASDAQ: AMAM), a U.S.-based developer of antibody drug conjugates (ADCs). The deal is valued at approximately USD 2 billion in equity and carries a net cash requirement of USD 1.9 billion, with…
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MSD to Acquire Harpoon Therapeutics for USD 680 Million, Expanding Its Oncology Pipeline
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced its intention to acquire Harpoon Therapeutics (NASDAQ: HARP) for approximately USD 680 million. The acquisition is expected to be completed in the first half of 2024, subject to approval by Harpoon’s stockholders and the fulfillment of…
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ShuWen Biotech’s MammaTyper Diagnostic Kit Receives NMPA Approval for Breast Cancer Molecular Classification
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ShuWen Biotech Co., Ltd, a biopharmaceutical company based in Zhejiang, has announced that its MammaTyper diagnostic kit has received market approval from the National Medical Products Administration (NMPA). The kit is intended for use in cases where immunohistochemistry (IHC) results are indeterminate or unsatisfactory, or when the IHC outcome significantly…
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Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
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The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC)…
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CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its small-molecule multi-kinase inhibitor, CSCJC3456. This molecule is now set to be evaluated in the context of general advanced malignant…
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Hengrui Pharmaceuticals Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
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MSD Advances Four Oncology Candidates to Late-Stage Trials, Including Partnerships with Kelun-Biotech and Orion
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline with the advancement of four candidates to late-stage trials that are currently enrolling participants. The first molecule is the LSD1 inhibitor bomedemstat, which is being developed for the treatment of essential thrombocythemia (ET). Nemtabrutinib, a…
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AbbVie Partners with Umoja Biopharma to Develop Next-Generation CAR-T Therapies
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AbbVie (NYSE: ABBV) has entered into a collaboration agreement with Umoja Biopharma, a US-based company specializing in next-generation in-situ CAR-T cell therapies. Under the partnership, the two companies will develop up to four programs targeting selected cancer therapies chosen by AbbVie. AbbVie has also secured an exclusive option to license…
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BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
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Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. Since June 2008,…
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Lion TCR Partners with MaxCyte to Develop mRNA-Based TCR-T Therapies for Solid Tumors and Viral Diseases
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Lion TCR, a Singapore-based clinical-stage biotechnology company with backing from Chinese investors, has entered into a partnership with U.S. firm MaxCyte Inc. to harness mRNA technology for the development of TCR-T therapies. These therapies are aimed at treating solid tumors and virus-related diseases. The collaboration will enable Lion to utilize…
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Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
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Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission of a new indication supplementary approval filing for its bispecific antibody (BsAb) drug candidate, cadonilimab (AK104). The company is seeking to expand the use of cadonilimab in combination with chemotherapy as a first-line treatment for…
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JW Therapeutics Secures NMPA Review for CAR-T Therapy in Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an additional indication application for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), targeting recurrent or refractory mantle cell lymphoma (r/r MCL). The National Medical Products Administration (NMPA) has accepted the filing…
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Jiangsu Hengrui Pharmaceuticals Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study. The study will assess the efficacy of three of the company’s novel pipeline candidates in combination regimens against general solid tumors. The drugs in…
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Allorion Therapeutics and Avenzo Seal Deal for Global Rights to CDK2 Inhibitor
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China-based Allorion Therapeutics has entered into a licensing agreement with Avenzo Therapeutics Inc., granting the US firm global development and commercialization rights (excluding Greater China) to Allorion’s cyclin-dependent-kinases 2 (CDK2) inhibitor. The agreement also includes an exclusive option for a pre-clinical program anticipated for IND filing in 2025. As part…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug abiraterone, a modified androgen synthesis inhibitor. The drug is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk…
