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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…
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Tianjin Municipality Unveils Plan to Boost Synthetic Biology and Biomanufacturing Innovation
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The People’s Government of Tianjin Municipality has unveiled two significant implementation plans to bolster the bioeconomy and pharmaceutical outsourcing service industry within the region. The first plan, “Implementation Plan for Accelerating the Innovation of Synthetic Biology and Promoting the High Quality Development of the Biomanufacturing Industry in Tianjin,” aims to…
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Novo Nordisk’s Alhemo Receives CHMP Recommendation for Haemophilia Prophylaxis in Europe
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Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has been notified that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Alhemo (concizumab). This would make Alhemo the first once-daily subcutaneous prophylactic treatment for individuals aged 12 years or…
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Stem-Cell Startup Xellsmart Secures Over RMB 100 Million in Series B1 Financing for Neurological Therapies
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Xellsmart, a stem-cell startup headquartered in Suzhou, has reportedly secured over RMB 100 million (USD 14.08 million) in a Series B1 financing round. The round was led by Tialong/Taikun Equity Investment Fund, with additional investments from Septwolves Venture Capital and Sky World Capital, alongside returning investors Frees Fund, Qiming Venture…
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Novartis’s Kisqali Receives Positive CHMP Opinion for Early Breast Cancer Treatment in the EU
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth…
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Kanghong Pharmaceutical’s NASH Drug KH629 Approved for Clinical Trials in China
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug KH629, which is intended for the treatment of adult non-alcoholic steatohepatitis (NASH). This development follows the…
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Huadong Medicine Gets Green Light for HPK1 PROTAC Drug HDM2006 in Advanced Solid Tumors
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a study for its Category 1 chemical drug HDM2006, which targets advanced solid tumors. This development marks a significant step for Huadong as it…
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China’s NHSA Concludes Pre-Negotiation Talks for National Reimbursement Drug List
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According to the Economic Observer, an independent Chinese weekly newsletter, a series of discussions preceding the National Reimbursement Drug List (NRDL) price negotiation occurred from October 16 to 18. These pre-negotiation talks, which serve as one-on-one communications prior to the formal negotiation process, were divided into three groups this year.…
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Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
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Gilead Sciences to Withdraw Accelerated Approval of Trodelvy in Urothelial Carcinoma
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Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy…
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Jiangsu Hengrui Pharmaceuticals Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
