China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC).
Phase III Study Data Supports NDA Filing
The filing is supported by data from the Phase III ALTN-AK105-III-02 study, which successfully reached its pre-set endpoints in August 2024. The study demonstrated that the combination therapy achieved a median progression-free survival (PFS) of 6.9 months, compared to 2.8 months in the control group, significantly reducing the risk of disease progression or death by 47%. Additionally, the median overall survival (OS) in the experimental group was 16.5 months, versus 13.2 months in the control group, significantly reducing the risk of death by 31%.
Background on Anlotinib and Penpulimab
Anlotinib, a multi-target tyrosine kinase inhibitor (TKI), was licensed to Sino Bio by Advenchen Laboratories and obtained marketing approval in China in May 2018 for the treatment of previously treated advanced non-small cell lung cancer (NSCLC). Penpulimab, a PD-1 inhibitor co-developed by Sino Bio and Akeso Biopharma (HKG: 9926), was approved in China in August 2021 as a third-line treatment for relapsed/refractory classic Hodgkin lymphoma (cHL). The approval of this new indication would mark the 10th for anlotinib and the 5th for penpulimab in China.-Fineline Info & Tech
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