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VelaVigo and Avenzo Therapeutics Ink Global Partnership for Nectin4/TROP2 Bispecific ADC
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Shanghai-based biotech company VelaVigo, specializing in bispecific/multi-specific antibodies and antibody drug conjugates (ADCs), has announced a global strategic partnership with US oncology firm Avenzo Therapeutics, Inc. This collaboration will facilitate the global development, manufacturing, and commercialization of VelaVigo’s Nectin4/TROP2 bispecific ADC, excluding Greater China, where VelaVigo retains the rights. Details…
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Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
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C-Ray Therapeutics Secures Over $100 Million in Series A+ Financing for Radiopharmaceuticals
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C-Ray Therapeutics, a specialist in radiopharmaceuticals headquartered in Chengdu, has announced the successful completion of a Series A+ financing round, raising over USD 100 million. The funding was co-led by Shenzhen Capital Group’s Manufacturing Transformation and Upgrading New Materials Fund and Tailong Capital, with additional contributions from GL Ventures, 3SBio…
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Bliss Bio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
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GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
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Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
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Biocytogen’s First-in-Class B7H3/PTK7 Bispecific ADC Option Exercised by IDEAYA Biosciences
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315), a China-based biopharmaceutical company, has announced that its US partner IDEAYA Biosciences Inc. (NASDAQ: IDYA) has exercised its option for an exclusive worldwide license for Biocytogen’s IDE034. This potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) represents a significant step forward in…
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Alteogen Secures Exclusive Licensing Deal with Daiichi Sankyo for Subcutaneous Enhertu
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Alteogen Inc. (KOSDAQ: 196170), a South Korea-based biotechnology company, has announced an exclusive licensing agreement with Japan-headquartered Daiichi Sankyo (TYO: 4568). This strategic partnership grants Daiichi Sankyo worldwide rights to utilize Alteogen’s ALT-B4, a novel hyaluronidase based on Hybrozyme Technology, in the development and commercialization of a subcutaneous version of…
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Alphamab Oncology Presents JSKN033 Phase I/II Study Results at SITC 2024
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Alphamab Oncology (HKG: 9966), a China-based biopharmaceutical company, has announced the presentation of the latest results from the Phase I/II study of its investigational drug JSKN033 at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The study focuses on patients with HER2-expressing advanced or metastatic…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for Phase I Study of BL-M17D1 in Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-M17D1, in patients with advanced solid tumors. BL-M17D1’s…
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CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs
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The Center for Drug Evaluation (CDE) has issued the “Technical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).” This document complements the “Pilot Work Plan for Phased Manufacturing of Biological Products” released last month and aims to guide the pilot work of phased manufacturing…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
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Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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Gilead Sciences to Withdraw Accelerated Approval of Trodelvy in Urothelial Carcinoma
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Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy…
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Jiangsu Hengrui Pharmaceuticals Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
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LaNova Medicines Secures RMB 300 Million in Series C1 Financing to Advance Cancer Therapy Pipeline
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the successful completion of a Series C1 financing round, raising RMB 300 million (USD 42.1 million). The funding round was led by Sino Biopharmaceutical Ltd (HKG: 1177), with significant contributions from Shanghai Pudong Venture Capital, Zhangjiang Haoheng Innovative Equity…
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Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa study for its drug candidate HDM2027 (HDP-101). This antibody drug conjugate (ADC), co-developed with Heidelberg Pharma, targets the B cell maturation…
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RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
