Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The NMPA has approved ciprocopan (NXP100, QD, PO) for the treatment of pts with PNH previously untreated with Complement inhibitors. Application for PNH pts previously treated with anti-C5 therapies is under review in China Approval was based on a P-III trial of ciprocopan vs Soliris in the above-mentioned pts, which met all 1 &…

ByRidhi RastogiJuly 24, 2026

NEWS

NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Shots: NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…

ByRidhi RastogiJuly 22, 2026

NEWS

SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Shots: The NMPA has approved iza-bren (izalontamab brengitecan) for the treatment of adult pts with recurrent or metastatic ESCC whose disease has progressed following prior Pt-based CT & PD-1/PD-L1 inhibitor therapy Approval was based on the P-III (PANKU-Esophagus01) trial assessing iza-bren vs CT in the above-mentioned pts (n=497) across China, which met its dual 1EP…

ByRidhi RastogiJuly 20, 2026

NEWS

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…

ByRidhi RastogiJuly 15, 2026

NEWS

Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

Shots: Hansoh has reported the P-III (ARTEMIS-008) trial results assessing risvutatug rezetecan (Ris-Rez/HS-20093) vs topotecan in pts with advanced or relapsed SCLC after prior Pt-based therapy Trial met its 1EP of improved OS in the interim analysis, with consistent benefit also observed across 2EPs, incl. PFS; data will be presented at an upcoming conference Based on…

ByRidhi RastogiJuly 10, 2026

NEWS

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 RastogiJune 26, 2026

NEWS

CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx)

Shots: The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…

ByDipanshu DixitJune 18, 2026

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

Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

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

CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx)

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

Contact US

FOLLOW US