China Sino Biopharm (01177.HK) announced that the Phase III clinical trial (ALTN-AK105-III-02) of the self-developed Class 1 innovative drug Anlotinib Hydrochloride Capsules in combination with Apatinib Injection for first-line treatment of advanced liver hepatocellular carcinoma has completed the pre-specified interim analysis of the protocol. The Independent Data Monitoring Committee (IDMC) determined that both the primary endpoint of progression-free survival (PFS) and overall survival (OS) have reached the predefined superior boundary values of the protocol. Based on this positive outcome, the group has recently submitted a new indication marketing application to China's National Medical Products Administration Drug Evaluation Center (CDE) and has received acceptance.
The company stated that first-line treatment for advanced liver hepatocellular carcinoma is the 10th indication for the application of Anlotinib Hydrochloride Capsules for marketing, which is expected to provide a safer and more convenient treatment option for patients with advanced liver hepatocellular carcinoma. With the continuous investment in innovative research and development by the group, innovative products are constantly achieving new breakthroughs.
The innovative pipeline has entered a harvest period with continuous breakthroughs and achievements in innovation.