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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…

