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China’s NMPA Issues Guidelines for Domestic Manufacturing of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification aimed at further clarifying the regulations surrounding the manufacturing of imported medical devices by companies within China. The document is open for public feedback until December 2, 2024. Requirements for Domestic Production of Certified Imported DevicesThe document stipulates that for…
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Legend Biotech Corporation Appoints Alan Bash as President of Carvykti
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China-based chimeric antigen receptor (CAR) T cell therapy specialist, Legend Biotech Corporation (NASDAQ: LEGN), has announced the appointment of Alan Bash as the President of Carvykti, a BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy. In this role, Mr. Bash will oversee the continued growth of Carvykti, managing Legend Biotech’s…
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Novo Nordisk Secures Global Licensing Agreement with Ascendis Pharma for TransCon Technology
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Denmark-based healthcare giant Novo Nordisk (NYSE: NVO; CPH: NOVO-B) has entered into a licensing agreement with compatriot firm Ascendis Pharma A/S (NASDAQ: ASND), a specialist in rare diseases. The collaboration grants Novo Nordisk exclusive rights to utilize Ascendis’ TransCon technology platform globally for the development, manufacturing, and commercialization of proprietary…
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Mirxes Holding Company Updates IPO Prospectus with 2024 Financials
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Mirxes Holding Company Ltd, a Singapore-based RNA technology company specializing in blood-based miRNA test kit products, has submitted an updated initial public offering (IPO) prospectus to the Hong Kong Stock Exchange. The document reveals the company’s financial performance as of June 2024. During the first half of the year, Mirxes…
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Insilico Medicine Secures Revolving Loan Facility with HSBC to Boost Drug Discovery Pipeline
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China-based artificial intelligence (AI) drug developer Insilico Medicine has announced the establishment of a Revolving Loan Facility of up to USD 100 million with HSBC, a leading global bank and financial services institution. This customized financing solution is designed to support the expansion of Insilico’s proprietary novel drug discovery pipeline…
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Shanghai HeartCare Medical Technology Receives NMPA Approval for Embolization Stent
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China’s National Medical Products Administration (NMPA) has granted marketing approval to Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609) for its innovative intracranial aneurysm embolization assisted stent. This product is now cleared for use in clinical standard interventional surgical settings for intravascular embolization and blood flow reconstruction in patients diagnosed…
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Boehringer Ingelheim Partners with Broad Institute for Mental Health Treatments
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Germany-based pharmaceutical major Boehringer Ingelheim has entered into a collaboration agreement with the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard. The joint project aims to address the urgent and unmet needs of individuals living with mental health conditions, with a specific focus on developing…
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HuidaGene Receives FDA Clinical Clearance for HG202 in Neovascular AMD Treatment
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its drug candidate HG202, an innovative treatment for neovascular age-related macular degeneration (nAMD). BRIGHT Study to Assess Safety and Tolerability of HG202The upcoming BRIGHT study, an open-label, multicenter dosage escalation…
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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…
