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FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
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The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow…
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Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its BPI-452080 in von Hippel-Lindau (VHL) syndrome-related tumors and solid tumors. This marks a significant step forward in the development of new treatments for…
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Haisco’s HSK39004 Gains NMPA Approval for COPD Clinical Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HSK39004. The targeted small molecule inhibitor is now cleared to be assessed in clinical trials for chronic obstructive pulmonary disease (COPD), marking a significant step…
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Junshi Biosciences Receives NMPA Approval for JS213 Clinical Trials
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its JS213 sterile powder for injection. The drug is intended for use in combination with other anti-tumor drugs or as a standalone treatment for advanced…
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Harbour BioMed Receives NMPA Clearance for COPD Treatment HBM9378/SKB378
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China-based biopharmaceutical company Harbour BioMed (HKG: 2142) has announced receiving clinical clearance from China’s National Medical Products Administration (NMPA) for its investigational drug HBM9378/SKB378, also known as WIN378. This fully human antibody targets thymic stromal lymphopoietin (TSLP) and is intended for the treatment of chronic obstructive pulmonary disease (COPD). Drug…
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IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
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China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Health Sciences Authority (HSA) of Singapore. The therapy is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM)…
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MediLink Therapeutics’ YL217 Receives FDA IND Clearance for Novel ADC Targeting Gastrointestinal Cancers
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MediLink Therapeutics, a clinical-stage biotech company, announced today that its internally developed antibody-drug conjugate (ADC), YL217, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). YL217 is the 11th ADC candidate to enter clinical development based on MediLink’s proprietary TMALIN® platform. YL217: A Novel…
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Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received FDA approval for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast…
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FDA Clears sBLA for Eisai and Biogen’s Leqembi Maintenance Dosing
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has cleared their supplemental Biologics License Application (sBLA) for once every four weeks Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. The drug is approved in the US for the treatment…
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Guangzhou Innogen’s Efsubaglutide Alfa Approved by NMPA for Type 2 Diabetes
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China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its efsubaglutide alfa to treat type 2 diabetes (T2D). This approval marks a significant milestone in the development and commercialization of efsubaglutide alfa, positioning…
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MSD and Eisai’s Keytruda/Lenvima Combo Shows Promise in Gastroesophageal Cancer Study
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Partners Merck, Sharp & Dohme (MSD, NYSE: MRK) and Eisai (TYO: 4523) have announced the latest results from the Phase III LEAP-015 study, which evaluated the combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) with Eisai’s kinase inhibitor Lenvima (lenvatinib) plus chemotherapy. The study focused on the first-line treatment of patients…
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Novo Nordisk’s Amycretin Shows Promising Weight Loss Results in Phase Ib/IIa Study
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Denmark – based pharmaceutical giant Novo Nordisk A / S (NYSE: NVO) has announced topline results from a Phase Ib / IIa study of its investigational drug amycretin, a unimolecular GLP – 1 and amylin receptor agonist. The study was designed to evaluate the safety, tolerability, pharmacokinetics, and proof –…
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Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
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German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to its investigational drug nerandomilast. The drug is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and debilitating lung disease…
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Shenzhen Kangtai Halts COVID-19 Vaccine Development Amid Market Shifts
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Shenzhen based biopharmaceutical company Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the termination of its research and development efforts for the COVID – 19 inactivated vaccine (Vero cells). The decision was driven by the evolving nature of the novel coronavirus and the changing market environment for COVID…
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China Medical System Partners with MabGeek for Innovative Drug MG-K10
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China Medical System Holdings (CMS; HKG: 0867) has announced a new license agreement with MabGeek Biotechnology Co., Ltd., a fellow Chinese biotech firm, for the latter’s Category 1 drug MG-K10. This marks CMS’s second major licensing deal in less than a month. Financial details of the agreement were not disclosed.…
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BioCity Biopharma Launches Phase III Study for Kidney Disease Drug SC0062
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BioCity Biopharma, a leading biopharmaceutical company, has announced the initiation of a Phase III clinical study for its kidney disease drug SC0062 at the Guangdong Provincial People’s Hospital, the leading institution for the study. The study, named SUCCESS-01, aims to evaluate the efficacy and safety of SC0062 capsules in patients…
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Hengrui’s Long-Acting Insulin Analogue Accepted for Review by China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its market filing for a long-acting insulin analogue, a Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for Hengrui as it seeks to bring China’s first…
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Shenzhen Beike Initiates First Chinese Stem Cell Study for Systemic Lupus Erythematosus
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China-based stem cell specialist Shenzhen Beike Biotechnology Co., Ltd has announced the initiation of a Phase I/II clinical study for human umbilical cord mesenchymal stem cells in patients with moderate to severe systemic lupus erythematosus (SLE). This marks the first regulatory study for stem cell therapy targeting SLE in China,…
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United Laboratories’ Biosimilar Semaglutide Accepted for Review by China’s NMPA
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Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced that its market filing for a biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step towards introducing a more…
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Beijing Aosaikang’s ASKB589 Shows Promise in Phase I/II Study for Gastric Cancer
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has unveiled the latest results from a Phase I/II study of its Category 1 biologic product candidate ASKB589, which is being evaluated as a first-line treatment for advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma. The study assessed the efficacy and safety of ASKB589 in…
