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NMPA’s Center for Drug Evaluation Issues New Guidelines for Domestic Transfer of Overseas-Produced Vaccines
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The Center for Drug Evaluation under the National Medical Products Administration (NMPA) has issued the “Requirements for Application Materials for Market Registration of Listed Drugs Produced Abroad and Transferred to Domestic Production (Preventive Biological Products),” which is set to take effect immediately. This new directive pertains to preventive biological products,…
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Eccogene Inc. Secures $60 Million Milestone Payment from AstraZeneca for ECC5004/AZD5004
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Sino-US firm Eccogene Inc. announced on October 23rd that it is set to receive a $60 million payment from AstraZeneca (AZ, NASDAQ: AZN) following the successful achievement of development milestones for ECC5004/AZD5004, including the dosing of the first patient in the Phase 2b trial. This payment is a part of…
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Sunshine Guojian Pharma Reports Q3 Revenue Growth and Advances in Clinical Trials
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), has released its financial report for the third quarter of 2024. The company reported revenues of RMB 939 million (USD 131.8 million) for the period, marking a 28.58% increase year-on-year. The net profit attributable to…
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LINDIS Biotech’s Catumaxomab Receives Positive Opinion from EMA’s COMP for Malignant Ascites Treatment
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LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with…
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China’s NMPA Launches Pilot Program for Phased Manufacturing of Biological Products
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The National Medical Products Administration (NMPA) has officially released the “Pilot Work Plan for Phased Manufacturing of Biological Products,” which is set to take effect immediately and continue through December 31, 2026. The plan calls for applicants and drug registration holders interested in participating in the pilot program to submit…
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Beijing Biostar Technologies Goes Public in Hong Kong to Fund Cancer Drug Development
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Beijing Biostar Technologies Ltd (HKG: 2563), a leading synthetic biology-driven anti-tumor drug specialist based in China, has successfully completed an initial public offering (IPO) on the Hong Kong Stock Exchange. The company issued 14,588,000 shares at a price of HKD 22 each, raising a total of HKD 320 million (USD…
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China Grand Pharmaceutical Receives NMPA Approval for Innovative Adjustable Thrombectomy Stent
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China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its adjustable intracranial thrombectomy stent, marking a significant milestone as the first domestically produced device of its kind in China for the treatment of…
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Grifols Partners with BARDA to Develop Treatment for Sulfur Mustard Ocular Injury
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Grifols (BME: GRF; NASDAQ: GRFS), a Spanish biopharmaceutical company, has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to test investigational ocular surface immunoglobulin (OSIG) eye drops for their potential to treat ocular damage resulting from sulfur mustard exposure. BARDA, which is part of the Administration…
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Hunan Province Launches Pilot Program for Retail Sales of VBP Drugs with Strict Guidelines
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The Hunan Healthcare Security Administration has released the “Pilot Implementation Plan for Volume-based Procurement (VBP) Drugs to Be Sold in Retail Pharmacies in Hunan Province,” outlining a strategic approach to integrating VBP drugs into the retail pharmacy landscape. The plan mandates the selection of at least one county (city) and…
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Walvax Biotechnology’s Weuphoria Vaccine Approved in Oman for Pediatric Pneumococcal Infections
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Walvax Biotechnology Co., Ltd (SHE: 300142), a Chinese biopharmaceutical company, has announced that it has received market approval in the Sultanate of Oman for its vaccine Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval marks a significant step for the company as it expands the reach of its…
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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…
