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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Minghui Pharmaceutical Strikes Exclusive Japan License Deal with ASKA for MHB018A – $110 Million Upfront, Up to $330 Million in Milestones and Mid‑30 % Royalties for Thyroid Eye Disease Antibody
Minghui Pharmaceutical and ASKA Pharmaceutical Co., Ltd. jointly announced an exclusive licensing agreement for the development and commercialization of MHB018A in Japan. Under the terms, Minghui Pharmaceutical will receive an…
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…
