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News about "NMPA Approval "
Ivonescimab Plus Chemotherapy Approved in China for First-Line Squamous NSCLC
Ivonescimab plus chemotherapy has been approved in China for first-line squamous NSCLC, based on the HARMONi-6 Phase 3 trial and significant overall survival benefit.
NMPA Approval | 13/08/2026 | By News Bureau | 173
Innogen Wins PIC/S GMP Certification for Efsubaglutide Alfa
Innogen Pharmaceuticals has secured PIC/S GMP certification, validating its manufacturing quality and supporting the global expansion of efsubaglutide alfa.
NMPA Approval | 04/08/2026 | By News Bureau | 106
Argo Biopharma Doses First Patient in Phase 1 siRNA Trial
Argo Biopharma has dosed the first participant in the phase I trial of BW-41012, its Factor XI-targeting siRNA therapy for preventing thromboembolic diseases.
NMPA Approval | 22/07/2026 | By News Bureau | 157
HUTCHMED Secures NMPA Approval for ORPATHYS in Gastric Cancer
HUTCHMED has received NMPA approval for ORPATHYS, the first selective MET inhibitor in China for patients with MET-amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma.
NMPA Approval | 04/07/2026 | By News Bureau | 110
Mabwell's 9MW5211 Gains NMPA IND Clearance for Inflammatory Bowel Disease
Mabwell’s 9MW5211 has received IND clearance from China’s NMPA for the treatment of Inflammatory Bowel Disease (IBD). As the first drug candidate globally targeting this novel mechanism to enter clinical development, 9MW5211 represents a significant advancement in the search for innovative therapies for IBD patients.
NMPA Approval | 08/06/2026 | By News Bureau | 103
Mabwell Secures FDA Clearance for 9MW5211 Clinical Trial Application
Mabwell receives US Food and Drug Administration (FDA) IND clearance for 9MW5211, a novel antibody therapy being developed for Inflammatory Bowel Disease (IBD) clinical studies.
NMPA Approval | 11/05/2026 | By News Bureau | 158
National Medical Products Administration approves IND application for HBM7575/SKB575, a long-acting bispecific antibody developed by Harbour BioMed and Kelun-Biotech for treating atopic dermatitis.
NMPA Approval | 10/03/2026 | By News Bureau | 176
Mabwell Gets NMPA Approval for Clinical Trial of Nectin-4 Targeting ADC in TNBC
Mabwell has announced that its novel Nectin-4 targeting ADC has been approved by the NMPA to enter Phase II clinical trial as monotherapy or in combination with a PD-1 inhibitor for the treatment of triple-negative breast cancer (TNBC).
NMPA Approval | 16/07/2024 | By Aishwarya | 308
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