Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Shots: The NMPA has accepted BLA of Everest's Lerochol (lerodalcibep; SC, QM) as an adjunct to diet & exercise to reduce LDL-C in adults with hypercholesterolemia, incl. heterozygous familial hypercholesterolemia; regulatory review is ongoing in the EU The BLA was supported by multiple global trials & a P-III China study, where in global trials, Lerochol…

ByRidhi Rastogi4 days ago

NEWS

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…

ByRidhi RastogiJune 12, 2026

NEWS

NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Shots: The NMPA has accepted IND application for HBM7004 for the treatment of advanced solid tumors HBM7004, developed using Harbour’s HBICE platform, is a novel B7H4×CD3 bispecific antibody that is designed to enhance cancer immunotherapy, aiming to improve both efficacy & safety through targeted immune activation In preclinical studies, HBM7004 induced B7H4-dependent T-cell activation within…

ByRidhi RastogiJune 10, 2026

NEWS

Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots: The Chinese NMPA has approved Zai lab's Tivdak for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after CT Approval was backed by the global P-III (innovaTV 301) trial evaluating Tivdak vs CT alone, which met its 1EP of improved OS in the IIT population In the…

ByRidhi RastogiJune 9, 2026

NEWS

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma

Shots: Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…

ByRidhi RastogiJune 4, 2026

NEWS

Haisco Pharmaceutical Secures US FDA Approval of Cypsedo for Adult General Anesthesia Prior to Surgery

Shots: The US FDA has approved Cypsedo (Cipepofol) to induce general anesthesia in adults undergoing surgery Cipepofol (Chinese trade name: Sishuning) is China's first domestically developed Class 1 innovative intravenous anesthetic with global IP rights. It is approved in China for procedural sedation, induction and maintenance of general anesthesia, and ICU sedation during mechanical ventilation In Dec 2020, Cipepofol, approved…

ByDipanshu DixitMay 29, 2026

NEWS

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The NMPA has granted conditional approval to Hernexeos (zongertinib) for initial treatment of adults with unresectable, locally advanced, or metastatic NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations Approval was based on the data from a treatment-naïve cohort (N=74) of P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75.7% (10.8%…

ByRidhi RastogiMay 22, 2026

NEWS

Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management

Shots: Vincentage Pharma has reported topline P-III trial results evaluating VCT220 (120 0r 160mg, QD, PO) vs PBO for 52wks. in 840 Chinese adults with obesity or overweight with ≥1 weight-related comorbidity The trial met its 1EP, showing mean body weight reduction of -12.2% and -12.4% in the 120 & 160mg groups, respectively, vs -1.3% for…

ByRidhi RastogiMay 19, 2026

NEWS

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots: The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…

ByRidhi RastogiApril 29, 2026

NEWS

Mabwell Reports NMPA’s sBLA Acceptance of Maiweijian (Biosimilar, Xgeva)

Shots: The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may…

ByDipanshu DixitApril 15, 2026

Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma

Haisco Pharmaceutical Secures US FDA Approval of Cypsedo for Adult General Anesthesia Prior to Surgery

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Mabwell Reports NMPA’s sBLA Acceptance of Maiweijian (Biosimilar, Xgeva)

Contact US

FOLLOW US