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German Endoscope Maker KARL STORZ Secures Marketing Approval for Disposable Ureteroscope in China
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KARL STORZ SE & Co. KG, a leading German endoscope manufacturer, has announced that it has received marketing approval in China for its FLEX-XC1, a disposable electronic ureteroscope. This new product employs cutting-edge imaging technology to offer a broader field of view, ensuring ample brightness and detailed visibility of the…
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LENZ Therapeutics’ Presbyopia Therapy LNZ100 Accepted for FDA Review
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LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for LNZ100 (aceclidine), a therapy for presbyopia. The FDA has set an action date of August 8, 2025, for the application. LNZ100…
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Macrolux Raises Over RMB 100 Million in Series B Financing
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Macrolux, a leading medical technology company specializing in disposable endoscopes, has announced the completion of a Series B financing round exceeding RMB 100 million (over USD 14.75 million). The round was led by BioVenture VC, with continued support from existing investors Legend Capital and DALTON VENTURE, and HAOYUE CAPITAL serving…
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AstraZeneca’s Wainzua Earns CHMP Nod for hATTR-PN Treatment in the EU
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UK pharmaceutical juggernaut AstraZeneca (AZ, NASDAQ: AZN) has announced that Wainzua (eplontersen), an RNA-targeted therapy co-developed with US-based Ionis Pharmaceuticals (NASDAQ: IONS), has received a positive recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) within the European Union (EU). The treatment is intended for adults…
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Novo Nordisk’s Semaglutide Shows 14% Reduction in Cardiovascular Events in Landmark SOUL Trial
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Copenhagen-based healthcare giant Novo Nordisk (NYSE: NVO) has declared the primary outcomes of the SOUL cardiovascular outcomes trial, showcasing that its oral glucagon-like peptide-1 (GLP-1) analogue, semaglutide, successfully reduced major adverse cardiovascular events (MACE) by 14%. The SOUL trial, a global, multi-center, randomized, double-blinded, and parallel-controlled study, enrolled 9,650 individuals…
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Thermo Fisher’s Oncomine Dx Target Test Gets FDA Green Light as Companion Diagnostic for Servier’s Voranigo
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US pharmaceutical and biotechnology company Thermo Fisher Scientific (NYSE: TMO) has received marketing approval from the US Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, the first…
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GSK and Cambridge University Forge £50 Million Partnership to Tackle Immune Diseases
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UK pharmaceutical giant GSK plc (LON: GSK, NYSE: GSK) has unveiled a significant five-year partnership with the University of Cambridge and Cambridge University Hospitals, backed by a financial commitment of £50 million. This collaboration aims to enhance research and development efforts targeting immune-related diseases. Dubbed the Cambridge-GSK Translational Immunology Collaboration…
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AstraZeneca’s Saphnelo Approved for Use in Guangdong Under ‘Hong Kong-Macau Drug Access’ Policy
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that its drug Saphnelo (anifrolumab) has been approved by the Guangdong Medical Products Administration (MPA) bureau to be included in medical institutions as part of the “Hong Kong-Macau Drug and Device Access” policy. This policy, within the Greater Bay…
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InventisBio Acquires Immuno-Oncology Assets from Lyvgen Biopharma in RMB1.5 Million Deal
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InventisBio (Shanghai) Co., Ltd (SHA: 688382), a Chinese biotechnology company, has announced a transfer agreement with Lyvgen Biopharma, a Shanghai-based specialist in immuno-oncology therapeutics. According to the agreement, Lyvgen will transfer proprietary technology related to no more than three target antibodies to InventisBio, along with licensing patent rights and other…
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BeiGene’s Tevimbra Receives CHMP Recommendation for Expanded Use in G/GEJ and ESCC Cancers in EU
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of authorization for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The expanded authorization covers…
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Olymvax Bio Receives NMPA Approval for Clinical Study of Trivalent Influenza Vaccine
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Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its trivalent influenza virus split vaccine (MDCK cells). This vaccine is designed for the prevention of influenza caused…
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Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
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The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
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Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in…
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GenScript Dissolves Merger with CAR-T Specialist Legend Biotech, Reclassifies as Associated Company
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GenScript Biotech Corporation (HKG: 1548), a comprehensive life science research and application service and product provider based in China, has announced the dissolution of its merger with Legend Biotech Corporation (NASDAQ: LEGN), a specialist in chimeric antigen receptor (CAR) T-cell therapy. The decision to dissolve the merger was influenced by…
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China’s NMPA Greenlights Pilot Plan for Phased Manufacturing of Biological Products
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The National Medical Products Administration (NMPA) has given its stamp of approval to the “Pilot Work Plan for Phased Manufacturing of Biological Products,” a document that outlines a comprehensive framework for the phased production of certain innovative and urgently needed biological products through contract manufacturing. The plan, anticipated to be…
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Otsuka Holdings Weighs Sale of Stake in Medical Device Maker MicroPort Scientific
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Otsuka Holdings Co., a Japanese pharmaceutical and healthcare company, is reportedly considering the sale of its shares in Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853), according to a Bloomberg report. The company is said to be working with financial advisors to assess its minority stake in MicroPort after…
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Dongcheng Pharma Moves to Enhance Portfolio with Acquisition of Rongcheng Medical’s GSA Injection
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has announced its intention to acquire full rights to the 99mTc GSA Injection and GSA cold kit from domestic rival Rongcheng Medical Technology Wuxi Co., Ltd., for a purchase price of RMB 85 million (approximately USD 11.82 million). The 99mTc GSA…
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Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2…
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Everest Medicines’ Nefecon Approved in Taiwan for Primary IgAN Treatment
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received market approval from the Taiwan Food and Drug Administration for its targeted-release budesonide, Nefecon, for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. This approval allows for the use…
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BeiGene’s Tevimbra Approved in China for NSCLC Patients as Neoadjuvant and Adjuvant Therapy
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant…
