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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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China’s NMPA and Denmark’s Medicines Agency Commit to Enhanced Regulatory Cooperation
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The National Medical Products Administration (NMPA) of China and the Danish Medicines Agency have signed a Letter of Intent for cooperation in the field of medical devices and pharmaceutical regulation. The agreement was formalized in Beijing between Li Li, the head of the NMPA, and Mette Eberhard Hansen, the acting…
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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,…
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Gan & Lee Pharmaceuticals Initiates Phase I Clinical Trial for Biosimilar Secukinumab
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the commencement of a Phase I clinical study for GLR1023, a biosimilar candidate to Novartis’ Cosentyx (secukinumab). The company has recently dosed the first patient in the trial, which is focused on evaluating the safety and efficacy of…
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Lundbeck’s Vyepti Migraine Treatment Available at Sun Yat-sen Memorial Hospital Through Greater Bay Area Policy
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Vyepti (eptinezumab), a migraine treatment developed by Denmark-based biopharmaceutical company H. Lundbeck A/S (OTCMKTS: HLBBF), has been introduced at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, facilitated by the “Hong Kong-Macau Drug and Device Access” policy. This policy, part of the broader Greater Bay Area initiative, enables patients to access…
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Lee’s Pharmaceutical’s Subsidiary Reports Positive Results from Phase III Myopia Treatment Study
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression. The Phase III study, a randomized, double-blinded,…
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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…
