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NMPA Grants Marketing License to Abonisi Medical Technology’s Knee Joint Prosthesis System
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China’s National Medical Products Administration (NMPA) has issued a marketing license to Abonisi Medical Technology (Suzhou) Co., Ltd. for its knee joint prosthesis system, a significant advancement for domestic medical device innovation. Innovative Design of the Knee Joint Prosthesis SystemThe knee joint prosthesis system, designed for first-time knee replacement surgery…
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Isap Biotech Secures FDA IND Approval for iSAP-0909 for Bladder Cancer Imaging
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Beijing-based biotech firm Isap Biotech has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable agent, iSAP-0909. The agent will be assessed for its use in the auxiliary diagnosis and intraoperative localization of non-muscle invasive bladder cancer (NMIBC).…
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China Grand Pharmaceutical Completes Phase III Clinical Study for Post-Cataract Surgery Treatment
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints. GPN00833: A Nanosuspension Eye Drop for Inflammation and PainGPN00833…
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111 Inc. Appoints Yang “Luke” Chen to Board of Directors Following Resignation of Dr. Lian Yong Chen
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China-based online pharmacy 111 Inc. (NASDAQ: YI) has announced the appointment of its Senior Finance Executive, Mr. Yang “Luke” Chen, as a new director. This follows the resignation of Dr. Leon Lian Yong Chen from the company’s board due to personal reasons, effective immediately. Dr. Lian Yong Chen’s Background and…
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Shanghai RMX Biopharma and PharmaEngine Ink Distribution Deal for Liporaxel in Taiwan
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Chinese firms Shanghai RMX Biopharma Co. Ltd., a subsidiary of Haihe Biopharma Co., Ltd., and PharmaEngine Inc. have entered into a distribution agreement concerning Liporaxel (paclitaxel oral solution). The agreement grants PharmaEngine exclusive rights to handle the new drug application (NDA) filing, sales, and marketing of Liporaxel in the Taiwan…
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China’s National Allied Procurement Office Launches 10th VBP Tender Round Information Filing
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The National Allied Procurement Office has released a notification initiating the information filing process for drugs selected in the 10th national volume-based procurement (VBP) tender round. This marks another step in China’s ongoing efforts to streamline drug procurement and ensure accessibility. Information Filing Process and RequirementsEnterprises are required to log…
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NMPA Releases 84th Batch of Reference Drugs for GQCE and First Batch Stripped of Status
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The National Medical Products Administration (NMPA) has released the 84th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in the regulation of generic drug quality in China. Concurrently, the NMPA has also announced the first batch of reference drugs that have been stripped…
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J&J MedTech Completes Pilot Enrollment for OMNY-AF Study on Atrial Fibrillation Treatment
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US major Johnson & Johnson (J&J, NYSE: JNJ) MedTech has announced the completion of pilot phase enrollment for the OMNY-AF study, which is assessing the effect of its OMNY-AF platform in symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. The single-arm, multi-center study aims to enroll up…
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Innorna Co., Ltd Receives FDA Rare Pediatric Disease Designation for mRNA Drug IN015
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Shenzhen-based Innorna Co., Ltd has announced that it has received Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for its proprietary mRNA drug, IN015, developed for the treatment of progressive familial intrahepatic cholestasis (PFIC). Understanding PFIC and the Impact of IN015Progressive familial intrahepatic cholestasis (PFIC)…
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Teva Pharmaceutical Reports Positive Phase III Results for TEV-‘749 in Schizophrenia Trial
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Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has released new positive data on social functioning and quality of life from the Phase III Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial. The study assesses the efficacy of TEV-‘749 in adult patients diagnosed with schizophrenia. SOLARIS Study Design and TEV-‘749’s EfficacyThe SOLARIS…
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Neurodawn Pharmaceutical Secures Hundreds of Millions in Series C Financing
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Nanjing-based central nervous system (CNS) drug developer, Neurodawn Pharmaceutical Co., Ltd, has announced the successful completion of a Series C financing round, raising hundreds of millions of renminbi. The funding was led by Nanjing Jiangning High Tech Zone Science and Technology Entrepreneurship Investment Management Co., Ltd and Huaxing Kangping Pharmaceutical…
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Suzhou Basecare Medical’s BKA210 Receives Marketing Approval in Jiangsu Province
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China-based in vitro fertilization (IVF) specialist Suzhou Basecare Medical Co., Ltd (HKG: 2170) has announced that it has received marketing approval for its intelligent sperm quality analyzer, BKA210, in Jiangsu province. This marks the world’s first device capable of detecting unstained live sperm, offering a significant advancement in the field…
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Reprogenix Secures Over RMB100 Million in Series A Financing Led by China Venture Capital
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Hangzhou-based stem cell specialist Reprogenix has announced the successful completion of a Series A financing round, raising in excess of RMB100 million (USD14.04 million). The funding round was led by China Venture Capital, with participation from Betta Pharmaceuticals Co., Ltd (SHE: 300558) contributing RMB 20 million, Lenovo Capital and Incubator…
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Novo Nordisk’s Semaglutide Meets Primary Endpoints in ESSENCE Phase III Study for MASH
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Denmark-based pharmaceutical company Novo Nordisk (NYSE: NVO; CPH: Novo-B) has announced that part 1 of the Phase III ESSENCE study, a pivotal 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, has successfully reached its primary endpoints. The trial evaluated the efficacy…
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Jiuzhitang Co., Ltd Announces Clinical Clearance for Volagidemab in Type 1 Diabetes
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China-based traditional Chinese medicine (TCM) giant Jiuzhitang Co., Ltd (SHE: 000989) has announced that volagidemab (REMD-477), a Category 1 drug developed by Beijing CoSci-REMD Bio Med-Tech Co, Ltd (CoSci-REMD Bio), a subsidiary of U.S. biotech REMD Biotherapeutics Inc., has received clearance for clinical study in type 1 diabetes in China.…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its category 1 innovative drug, chiauranib. The study will evaluate chiauranib in combination with a programmed-death (PD)-(ligand) 1 monoclonal antibody and chemotherapy as a…
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Innovent Biologics Halts Subscription Agreement with Lostrancos Ventures
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the decision not to proceed with a subscription agreement between its wholly owned subsidiary, Fortvita, and Lostrancos Ventures Ltd. The agreement would have seen Lostrancos acquire a 20% stake in Fortvita for USD 20.5 million. Despite this setback, Innovent Biologics reaffirmed its…
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China’s CDE Releases 88th Batch of Reference Preparations for Generic Drug Evaluation
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The Center for Drug Evaluation (CDE) in China has announced its 88th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This selection is a critical step in ensuring the quality and efficacy of generic drugs within the Chinese market. Expansion and Refinement of Reference…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
