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Liaoning Chengda’s ACYW135 Meningococcal Vaccine Receives NMPA Clearance
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China’s Liaoning Chengda Biotechnology Co., Ltd (SHA: 688739) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its ACYW135 meningococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent epidemic cerebrospinal meningitis caused by Neisseria meningitidis of groups A, C, Y, and W135.…
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Zhaoke Ophthalmology Enrolls First Patients for ZKY001 in Phase II Trials
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) has announced the enrollment of the first patients for its ZKY001 in a Phase II clinical study in transepithelial photorefractive keratectomy (TPRK). The study will enroll 120 patients across 10 centers. Additionally, a separate Phase II clinical…
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CDE Seeks Public Feedback on New Drug Benefit-Risk Assessment Guidelines
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The Center for Drug Evaluation (CDE) has released the “New Drug Benefit-Risk Assessment Technical Guidelines,” which are open for public feedback for a one-month period. These guidelines are designed to determine whether a drug’s expected benefit outweighs the potential risks for the proposed indication. Draft Proposal BackgroundThe draft proposal is…
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Zhaoke Ophthalmology Licenses C&V Tech’s TONO-i Tonometer for Greater China
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a licensing agreement with South Korea’s C&V Tech, a glaucoma device firm. The agreement grants Zhaoke exclusive rights for registration, import, promotion, distribution, marketing, and sales of C&V Tech’s TONO-i tonometer in Greater China. No…
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CDE Releases Draft Guidelines on New Drug Benefit-Risk Assessment
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The Center for Drug Evaluation (CDE) has released the “New Drug Benefit-Risk Assessment Technical Guidelines,” soliciting public feedback for a one-month period. The guidelines aim to determine whether a drug’s expected benefit outweighs the potential risks for the proposed indication. Draft Proposal BackgroundThe draft proposal is based on several key…
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Insilico Medicine Partners with Sanofi for AI-Driven Drug Discovery
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Insilico Medicine, an artificial intelligence (AI)-driven drug discovery company based in Hong Kong, has announced a multi-year, multi-target strategic research collaboration with French pharmaceutical major Sanofi. The partnership aims to leverage Insilico Medicine’s AI platform, Pharma.AI, to advance drug development candidates for up to six new targets. Collaboration DetailsUnder the…
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CDE Releases Guidelines on Pediatric Anti-tumor Drug Development
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The Center for Drug Evaluation (CDE) has released a Technical Guidelines document focused on “Clinical R&D of Anti-tumor Drugs for Children.” The document is open for public feedback for a one-month period, aiming to gather insights and suggestions from stakeholders in the field of pediatric oncology. Pediatric vs. Adult Anti-tumor…
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Pfizer Partners with CARD, CSAF, and PingAn Good Doctor at CIIE
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The 5th China International Import Expo (CIIE) saw the announcement of a partnership between US-based Pfizer (NYSE: PFE), the Chinese Alliance for Rare Disease (CARD), China Social Assistance Foundation (CSAF), and Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as PingAn Good Doctor. The collaboration aims to…
