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Vcanbio’s Stem Cell Therapy VUM02 Gets NMPA Approval for Systemic Sclerosis Clinical Trial
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645), a biotechnology company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 therapeutic biologic product, VUM02. This product, derived from human umbilical cord mesenchymal stem cells, is designed…
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Insilico Medicine Partners with Inimmune Corporation to Utilize AI for Immunotherapy Innovation
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Insilico Medicine, a leading artificial intelligence-driven drug discovery company based in China, has announced a strategic research collaboration agreement with Inimmune Corporation, a U.S. biotechnology firm specializing in immunotherapy and vaccine innovation. Under the terms of the agreement, Inimmune will utilize Insilico’s proprietary generative AI platform, Chemistry42, to accelerate the…
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NHC Releases Updated List of Pediatric Drugs for Research and Development Incentives
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The National Health Commission (NHC) has issued a notification regarding the fifth batch of pediatric drugs encouraged for research and development. The list includes 15 varieties, encompassing systemic anti-infective drugs, respiratory system medications, anti-tumor drugs, and immune modulators. This edition features 25 specifications and 8 dosage forms, and is notable…
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Innovent Biologics’ Dupert Demonstrates Positive Results in Phase II NSCLC Trial
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial results for Dupert (fulzerasib) have been selected for an oral presentation at the 2024 World Conference on Lung Cancer (WCLC). The study, known as HARMONi-2 (AK112-303), focuses on the treatment…
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China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
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The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released a draft proposal titled “Questions and Answers on Pharmaceutical Similarity Research of Biosimilars,” seeking public feedback until October 9th. This document, applicable to Category 3.3 biologics, provides clarity on common issues and technical requirements for…
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Tigermed Partners with Purpose Africa to Boost Clinical Research and Healthcare Cooperation
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Tigermed (SHE: 300347), a leading Contract Research Organization (CRO) in China, has entered into a strategic partnership with Purpose Africa, a Rwanda-based platform organization comprised of experts from African academia and industry. The collaboration aims to enhance China-Africa cooperation in the realms of clinical research and digital platform development, thereby…
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China’s 2024 Negative List Eases Restrictions on Foreign Investment in TCM and Biotechnology
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The National Development and Reform Commission (NDRC) of China has announced the release of the Special Administrative Measures for Foreign Investment Access (Negative List) for the year 2024, which will come into effect on November 1, 2024, rendering the previous 2021 version obsolete. This updated Negative List reflects a continued…
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China’s NMPA Proposes Inclusion of Cochlear Implants in Volume-Based Procurement Plans
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The National Medical Products Administration (NMPA) has disclosed plans to expand the scope of its volume-based procurement (VBP) tendering to include high-value medical consumables such as cochlear implants during an inspection visit to the Medical Purchasing Center and associated medical institutions in Tianjin. The administration intends to tailor the procurement…
