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Results For "NMPA"

76 News Found

GSK’s Nucala approved in China for COPD with high eosinophils
Drug Approval | January 07, 2026

GSK’s Nucala approved in China for COPD with high eosinophils

Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL


Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China
Biopharma | January 07, 2026

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001


CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers
Clinical Trials | December 31, 2025

CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers

The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively


ENHERTU gains first-ever nod in China for metastatic breast cancer
Drug Approval | December 29, 2025

ENHERTU gains first-ever nod in China for metastatic breast cancer

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy


Sanofi secures two breakthrough nods in China for rare blood disorders
News | December 16, 2025

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia


Glenmark secures China approval for Ryaltris
Drug Approval | November 10, 2025

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline


Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment
News | September 24, 2025

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion


Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China
Drug Approval | September 15, 2025

Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China

This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis