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Amoy Diagnostics and AstraZeneca Expand Partnership for Companion Diagnostic Development
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced an additional cooperation agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN), focusing on the development of a companion diagnostic (CDx). This collaboration builds upon a global strategic master collaboration agreement that was first signed at the end of 2021.…
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Vcanbio’s VUM02 Stem Cell Therapy Accepted for Review by China’s CDE for aGvHD Treatment
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the Center for Drug Evaluation (CDE) has accepted another clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) for review. The Category 1 therapeutic biologic product is under development as a treatment for acute…
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NMPA Updates List of Medical Devices Exempt from Clinical Evaluation in China
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The National Medical Products Administration (NMPA) has released an updated version of the “List of Medical Devices Exempted from Clinical Evaluation,” which is effective immediately. This list is a significant guide for medical device manufacturers, particularly regarding the clinical trial requirements for different classes of devices in China. Clinical Trial…
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Chinese Health Authorities Unveil Key Reform Tasks for Medical System in H2 2023
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The National Health Commission (NHC), National Development and Reform Commission (NDRC), Ministry of Finance (MoF), Ministry of Human Resources and Social Security, National Healthcare Security Administration (NHSA), and National Medical Products Administration (NMPA) have jointly released the “Key Tasks for Deepening the Reform of the Medical and Health System in…
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NHSA Releases Official Guidelines for Drug Negotiations and Bidding for NRDL Update
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The National Healthcare Security Administration (NHSA) has officially released the “Negotiation Drug Renewals” and “Non-exclusive Drug Bidding” guidelines for the annual update to the National Reimbursement Drug List (NRDL). These guidelines outline the processes for drug negotiations and bidding, ensuring transparency and efficiency in the management of drugs included in…
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Carbon Medical Technology Secures Over RMB 100 Million in Series A Financing for Interventional Therapy
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Shenzhen-based Carbon Medical Technology Co., Ltd has reportedly raised over RMB 100 million (USD 13.9 million) in a Series A financing round, led by Cowin Capital with contributions from returning investor Jinding Capital. The funds will be directed towards enhancing product pipeline research and development (R&D), clinical and commercial layout,…
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BeiGene’s Tislelizumab Receives Positive CHMP Opinion for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending a first market approval. The regulatory decision on whether to approve tislelizumab monotherapy for unresectable, locally…
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CanSino Biologics Granted Approval by Health Canada for Zoster Vaccine Candidate CS-2032
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China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has announced receiving approval from Health Canada to conduct a Phase I clinical study assessing the safety and preliminary immunogenicity of CS-2032, a recombinant vaccine candidate for the zoster virus. This adenovirus vector-based vaccine is co-developed with UK firm Vaccitech Ltd under…
