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Akesobio
NEWS

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Shots: The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS) sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…
January 20, 2026

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Sanofi
NEWS

Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Shots: China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…
January 15, 2026

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NEWS

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin) 

 Shots:  The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab)  BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity  Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…
January 13, 2026

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Arrowhead Pharmaceuticals
NEWS

Arrowhead Pharmaceuticals Receives the NMPA Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The Chinese NMPA has approved Redemplo to reduce triglycerides (TGs) in adults with FCS; regulatory review is ongoing in other regions Redemplo will be commercialized by Sanofi in Greater China under an agreement with Arrowhead, with NMPA approval triggering a $10M milestone payment from Sanofi to Arrowhead’s subsidiary Visirna Therapeutics Redemplo is an siRNA…
January 8, 2026

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NEWS

GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…
January 5, 2026

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Hutchmed
NEWS

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Savolitinib for Gastric Cancer Patients with MET Amplification

Shots: The Chinese NMPA has accepted NDA & granted priority review to savolitinib for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments NDA was supported by the P-II trial of savolitinib in gastric cancer pts with MET amplification in China, which met its 1EP of improved ORR by…
December 30, 2025

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