China’s NHC Issues Working Procedures for Rare Disease Catalogue (2026 Edition) – Expanded Inclusion Criteria and Faster Update Cycle Reshape Drug Access Landscape
China's National Health Commission (NHC) issued the Working Procedures for Formulating the Rare Disease Catalogue (2026 Edition) on 4 Nov 2026, a policy revision designed to strengthen rare disease management,…
NMPA Grants Priority Review to Hengrui’s Trastuzumab Rezetecan NDA for First‑Line HER2‑Positive Breast Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for a new indication of Trastuzumab rezetecan, with priority review granted. The application seeks approval for…
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Synmosa Biopharma Inks Exclusive Licensing Deal with Nxera Pharma for Insomnia Therapy Quviviq – Daridorexant Expansion Across Eight Asia‑Pacific Territories
Synmosa Biopharma (TPE: 4114) announced that it has signed an exclusive licensing, supply, and commercialization agreement with Nxera Pharma Japan, a subsidiary of Japan's Nxera Pharma, for the insomnia therapy…
NMPA Proposes Drug Market Exclusivity Framework – Up to Seven Years for Rare Disease Therapies and Two Years for Pediatric Drugs
The Comprehensive Department of China's National Medical Products Administration (NMPA) has released the Measures for the Implementation of Drug Market Exclusivity (Draft for Comment), proposing a unified exclusivity regime that…
