Almirall Reports the NMPA Approval of Seysara to Treat Acne

Shots: The Chinese NMPA has approved Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular mod. to sev. acne vulgaris in patients (≥9yrs.) Seysara’s efficacy was validated across multiple trials, with real-world evidence from the PROSES study & clinical studies in diverse patient populations in the US & China confirming its relevance across…

ByRidhi RastogiJanuary 29, 2026

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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…

ByRidhi RastogiJanuary 20, 2026

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…

ByDipanshu DixitJanuary 15, 2026

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…

ByDipanshu DixitJanuary 13, 2026

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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…

ByRidhi RastogiJanuary 8, 2026

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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…

ByRidhi RastogiJanuary 5, 2026

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…

ByRidhi RastogiDecember 30, 2025

NEWS

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

Shots: The Chinese NMPA has approved neffy 2mg for the emergency treatment of type I allergic reactions (anaphylaxis) in adults & children (≥30kg), with availability anticipated in the spring of 2026. Filing for neffy 1mg for children (15 to <30kg) to the NMPA is expected in the coming mos. In 2021, ARS Pharma licensed neffy…

ByRidhi RastogiDecember 30, 2025

NEWS

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Shots: The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapy NDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, …

ByRidhi RastogiDecember 29, 2025

NEWS

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Shots: Chinese NMPA received two IND applications for CT0596 to initiate P-Ib/II trials in r/r multiple myeloma (MM) & primary plasma cell leukemia (pPCL), respectively IIT in China showed favorable efficacy as of Aug 31, 2025, with 6/8 evaluable R/R MM pts achieving PR or better (3 CR/sCR, 1 VGPR, 2 PR) at an mFU…

ByRidhi RastogiDecember 29, 2025

Almirall Reports the NMPA Approval of Seysara to Treat Acne

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

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

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

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

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

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

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

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