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MicroPort’s TomaHawk Intravascular Shock Wave Therapy Device Approved by NMPA
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its TomaHawk intravascular shock wave therapy device, disposable coronary intravascular shock wave catheter (TomaHawk coronary intravascular shock wave catheter system). This approval marks a significant milestone in the…
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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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Jiangsu Yuyue Partners with Inogen for International Distribution and R&D
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China-based Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (SHE: 002223) has struck a partnership with US medtech company Inogen, Inc. (NASDAQ: INGN). The alliance aims to leverage the respective brand and product influence of both companies to work together on international distribution business, trademark licensing and distribution business, joint…
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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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Jiangsu Vcare PharmaTech Secures RMB200 Million in Series C+ Financing
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Jiangsu Vcare PharmaTech Co., Ltd., a China – based high – tech pharmaceutical company, has reportedly secured close to RMB200 million (USD27.6 million) in a Series C + financing round. The funding was led by Galaxy Finance, CMG – SDIC Capital, Yangtze River Industry Group, and other investors. The proceeds…
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GeneQuantum Secures $13 Billion Deals with Biohaven and AimedBio for ADC Development
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Suzhou based biotech firm GeneQuantum has announced a series of major commercial cooperation pacts worth USD 13 billion with US – based Biohaven Pharmaceutical (NYSE: BHVN) and South Korean biotech Aimed Bio Inc. The agreements coincide with the global launch of GeneQuantum’s IDiscovery, an intelligent automated development system for bioconjugated…
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Sinopharm Partners with Biogen for Comprehensive Service Agreement
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China-based Sinopharm Group Co., Ltd (HKG: 1099) has entered into a strategic partnership with US-based biopharmaceutical company Biogen (NASDAQ: BIIB). Under the agreement, Sinopharm will provide Biogen with a comprehensive suite of one-stop services, including import multi-port services, national multi-warehouse channel services, new product introductions, channel access, professional pharmacy integration,…
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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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Mirxes Holding Files for Hong Kong IPO with Focus on miRNA Test Kits
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Mirxes Holding Company Ltd, a Singapore – headquartered RNA technology company, has received a filing notice from the China Securities Regulatory Commission (CSRC) regarding its initial public offering (IPO) of 46,620,000 shares in Hong Kong. The company filed its prospectus with the Hong Kong Stock Exchange in November of last…
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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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Huadong Medicine’s Ellansé M Filing Accepted by China’s NMPA
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that its market filing for the injectable polycaprolactone-based dermal filler Ellansé M has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company as it seeks to expand its presence in the…
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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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ConjuStar Raises RMB100 Million to Advance X-Drug Conjugates Pipeline
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ConjuStar, a specialist in X-Drug conjugates (XDCs) based in Tianjin, has reportedly raised RMB100 million (USD13.73 million) in a Pre-Series A+ financing round. The funding was led by Fosun Health Capital, with participation from Hengqin Venture Capital and Shenzhen Qianhailiyuan Investment. The proceeds will be used to accelerate core product…
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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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AbbVie Partners with Neomorph on Molecular Glue Degraders for Oncology and Immunology
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with Neomorph, Inc., aimed at developing novel molecular glue degraders for multiple targets across oncology and immunology. The partnership seeks to leverage Neomorph’s innovative technology to address critical needs in cancer and immune-related diseases. Molecular Glue…
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Sino Medical Sciences Wins Peru Approval for Coronary Balloon Catheter
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving marketing approval from Peru’s Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) for its SC HONKYTONK coronary balloon dilation catheter. This marks another milestone in the global expansion of the company’s product portfolio, further solidifying its presence in international…
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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,…
