News about "NMPA"

China Grants Priority Review to Leqembi Subcutaneous BLA

The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.

NMPA | 11/02/2026 | By News Bureau

China's NMPA Accepts Akeso's Gumukimab sNDa for Ankylosing Spondylitis

China’s NMPA gives approval to Akeso’s gumokimab for the treatment of active ankylosing spondylitis, supported by Phase III data showing significant symptom relief and functional improvement.

NMPA | 20/01/2026 | By News Bureau |  121

China's NMPA Approves Sanofi-Licensed Myqorzo and Redemplo for Rare Cardiac and Lipid Disorders

Myqorzo and Redemplo approvals by NMPA expand treatment options for obstructive hypertrophic cardiomyopathy and familial chylomicronaemia syndrome in adult patients across Greater China.

NMPA | 17/01/2026 | By News Bureau |  154

China Updates Ivonescimab Label After NSCLC Survival Gains

China’s drug regulator has approved a label update for Akeso’s ivonescimab, citing Phase III data showing significant improvements in progression-free and overall survival in EGFR-TKI-resistant non-small cell lung cancer patients.<br />

NMPA | 07/01/2026 | By News Bureau |  283

China Approves Nucala from GSK for Adult COPD Treatment

China has approved Nucala (mepolizumab) for adult COPD, supported by phase-III MATINEE and METREX trials showing reduced exacerbations in patients with blood eosinophil counts from 150 cells/µL.

NMPA | 06/01/2026 | By News Bureau |  192

China Approves Azstarys for ADHD Treatment

ArkBio secures NMPA nod for once-daily ADHD treatment in China.

NMPA | 06/01/2026 | By News Bureau |  188

Glenmark Secures Exclusive Multi-Region Rights to Aumolertinib from Hansoh Pharma

Glenmark has entered into an exclusive licensing agreement with Hansoh Pharma to commercialise aumolertinib, a third-generation EGFR-TKI approved by the MHRA and China’s NMPA, across multiple international markets, reinforcing the company’s oncology portfolio and expansion strategy in high-growth regions.

NMPA | 17/12/2025 | By News Bureau |  103

Ronovo Surgical Closes Series D Financing

Ronovo Surgical secures USD 67 million in Series D funding led by JJDC, raising over USD 100 million in 2025 to advance minimally invasive surgery.

NMPA | 06/09/2025 | By Dineshwori |  164

Innovent's DOVBLERON Secures Second NMPA Approval for ROS1-Positive NSCLC

China's National Medical Products Administration (NMPA) has approved the second New Drug Application (NDA) of DOVBLERON®, a next-generation ROS1 tyrosine kinase inhibitor (TKI).

NMPA | 03/01/2025 | By Abha |  270

Gufic receives approval from NMPA, China for Prilocaine API

Gufic receives approval from NMPA, China for Prilocaine API

NMPA | 19/06/2023 | By Sudeep Soparkar |  621