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DeepSeek Enhances Biopharma IND and NDA Processes with AI
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In the regulatory submissions for Investigational New Drug (IND) and New Drug Application (NDA) in the biopharmaceutical sector, DeepSeek, as an AI technology tool or service platform, can enhance the efficiency and compliance of the application process through the following means: Data Management and Analysis Document Automation and Compliance Support…
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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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Vigonvita Life Sciences Targets HKEX IPO with Integrated Biopharma Model
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On January 27, 2025, the Hong Kong Stock Exchange (HKEX) website displayed that Suzhou Vigonvita Life Sciences Co., Ltd submitted an application for listing on the HKEX, with CITIC Securities as the sponsor. Company Overview and MissionThe prospectus shows that Vigonvita Bio, established in 2013, is an integrated biopharmaceutical company…
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CStone Pharmaceuticals Partners with SteinCares for Sugemalimab Commercialization in Latin America
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CStone Pharmaceuticals (HKG: 2616), a China – based biopharmaceutical company focused on oncology drug development, announced on January 27 a strategic commercialization partnership with SteinCares, a leading pharmaceutical company in the Latin American market. Under the licensing and commercialization agreement, SteinCares will obtain the rights to commercialize sugemalimab in 10…
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MicroPort’s Fireliums Receives NMPA Approval for Coronary Bifurcation Stenosis Treatment
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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 coronary rapamycin drug balloon dilation catheter, Fireliums, for dilation treatment of primary coronary artery bifurcation stenosis. This approval marks a significant milestone in the commercialization of this…
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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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NHSA Targets Low-Volume Drugs in National Reimbursement List
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The National Healthcare Security Administration (NHSA) in China has released a list of 131 drugs that are included in the National Reimbursement Drug List (NRDL) but have seen little trade volume. The move aims to ensure the basic medication needs of insured patients by monitoring the production and supply of…
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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.…
