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…
Where biopharma's biggest deals take shape!
Qyuns Therapeutics Out‑Licenses TL1A × IL‑17 Bispecific Program to Caldera Therapeutics – USD 30 Million Upfront with Up to USD 750 Million in Milestones
Qyuns Therapeutics (HKG: 2509) announced that it has entered into an out‑license agreement with Caldera Therapeutics, Inc. covering a preclinical‑stage bispecific antibody program targeting TL1A and IL‑17 (specifically IL‑17A and…
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…
