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RemeGen’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
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RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This…
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Shanghai MicroPort Initiates Pre-Marketing Clinical Study for Embolic Microspheres in Liver Cancer Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical technology company, has announced the commencement of a pre-marketing clinical study for its polyvinyl alcohol embolic microspheres. The company has completed the first pre-marketing clinical implantation in transcatheter arterial chemoembolization (TACE) surgery for left lobe lesions in patients with…
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Chongqing Zhifei Biological’s Influenza Vaccine Application Accepted by China’s Drug Evaluation Center
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On October 24, 2024, the Center for Drug Evaluation of the National Medical Products Administration indicated that the influenza virus split vaccine marketing application from Chongqing Zhifei Biological Products Co., Ltd. (SHE: 300122)’s wholly-owned subsidiary, Zhifei Longkoma, has been accepted, with the acceptance number CXSS2400114. Currently, Chongqing Zhifei Biological has…
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TheDerma’s Series A+ Round to Fund R&D and Commercialization of AhR Targeted Drugs
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TheDerma, a Shanghai-based pharmaceutical company, has announced the completion of a nearly CNY 100 million Series A+ financing round. The round was led by Qingdao Guoxin, with existing shareholders Baino Capital, Han Kang Capital, and Beta Fund continuing to add investments. Kaicheng Capital once again served as the exclusive financial…
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BMS Launches Cardiac Myosin Inhibitor Camzyos in China for Obstructive Hypertrophic Cardiomyopathy
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the official market launch of its cardiac myosin inhibitor Camzyos (mavacamten) in China. The drug is indicated for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded II to III under the New York Heart Association (NYHA) functional classification, aiming to improve…
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Boston Scientific Reports 19.5% YOY Increase in Q3 Net Sales, Driven by New Product Launches and Market Expansion
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Boston Scientific Corporation (NYSE: BSX), a leading medical device manufacturer in the U.S., has announced its financial results for the third quarter of 2024, highlighting a robust 19.5% year-on-year (YOY) increase in net sales, which reached USD 4.209 billion. The company’s business units reported significant growth, with MedSurg contributing USD…
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Hengrui Pharmaceuticals Considers HKEX Secondary Listing Amid Financing Challenges in Mainland China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, is reportedly planning a secondary listing on the Hong Kong Stock Exchange, according to multiple media sources. The move is anticipated to raise approximately USD 2 billion (RMB 14 billion) and comes amidst concerns regarding “difficulty in financing…
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Everest Medicines’ Velsipity Approved for Use in Select Hospitals in China’s Greater Bay Area
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval in the Greater Bay Area (GBA) for its drug Velsipity (etrasimod) to be used in Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University. These medical institutions are part of the…
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Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
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The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
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AbbVie and Gedeon Richter Expand Partnership to Develop Novel Neuropsychiatric Targets
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AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced a licensing agreement with Gedeon Richter Plc, aimed at strengthening the development of new potential targets for neuropsychiatric conditions. This collaboration builds upon the nearly two decades of successful partnership on central nervous system (CNS) projects, which…
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Asieris Pharmaceuticals Gets FDA Green Light for USP1 Inhibitor APL-2302 in Advanced Solid Tumors
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
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Sanofi’s Dupixent Demonstrates Positive Results in Phase III Study for Chronic Urticaria
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study…
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3SBio Secures Exclusive Rights to Commercialize Haihe’s Paclitaxel Oral Solution in China and Hong Kong
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Shanghai Haihe Pharmaceutical Co., Ltd and 3SBio Inc. (HKG: 1530), two Chinese pharmaceutical companies, have jointly announced a licensing agreement that grants 3SBio the exclusive rights to commercialize Haihe’s paclitaxel oral solution in mainland China and Hong Kong. According to the agreement, 3SBio will pay an undisclosed upfront sum along…
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NucMito and Amoytop Biotech Seal Deal for Development and Commercialization of NASH Drug Candidate in Greater China
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NucMito, a pioneering nuclear receptor drug developer headquartered in Xiamen, has entered into a licensing agreement with fellow Chinese firm Xiamen Amoytop Biotech Co., Ltd (SHA: 688278). The agreement, valued at up to RMB 145 million (approximately USD 20.37 million) in upfront and milestone payments, as well as royalties, grants…
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HELP Therapeutics Receives FDA Clearance for Phase I Clinical Trial of HiCM-188 Cell Therapy
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HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company headquartered in Nanjing, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its allogeneic human induced pluripotent stem cell-derived cardiomyocytes (HiCM-188). This treatment involves administration via intramyocardial…
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Merck Acquires Modifi Biosciences to Target DNA Repair Defects in Cancer Therapies
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has bolstered its oncology pipeline through the acquisition of Modifi Biosciences, Inc., a biotechnology company specializing in direct DNA modification-enabled cancer therapeutics. This strategic move provides MSD with preclinical compounds aimed at exploiting DNA repair defects in…
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Eli Lilly’s Alzheimer’s Drug Kisunla Secures Marketing Approval in Great Britain
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received marketing approval in Great Britain for Kisunla (donanemab), an Alzheimer’s disease (AD) treatment. Kisunla is an intravenous infusion administered every four weeks to eligible adults with mild cognitive impairment and mild dementia due to AD. Eligibility is restricted…
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Sino Medical Sciences Technology Secures Marketing Approval for Coronary Balloon Dilation Catheter in Morocco
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Sino Medical Sciences Technology Inc., (SHA: 688108) a China-based medical device company, has announced that it has received marketing approval in Morocco for its SC HONKYTONK coronary balloon dilation catheter. This product, designed for balloon catheter dilation of narrowed segments or bridging sites in coronary arteries to enhance myocardial perfusion,…
