Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in combination with chemotherapy as a first-line treatment regimen for advanced unresectable or metastatic soft-tissue sarcoma, which would mark the ninth indication for the drug in China if approved.
Anlotinib, when combined with chemotherapy for first-line soft-tissue sarcoma, has already demonstrated potential efficacy and safety in the early exploratory stage. The Phase III ALTN-Ⅲ-04 study for this combination has reached the pre-set primary efficacy endpoint. ALTN-III-04, recognized as the world’s first pivotal Phase III study combining an anti-angiogenic drug with chemotherapy, highlights the targeted therapeutic potential of this combination for advanced soft tissue sarcoma.
Anlotinib obtained marketing approval to treat previously treated advanced non-small cell lung cancer (NSCLC) in China in May 2018, followed by additional indications in soft tissue sarcoma, small cell lung cancer, medullary thyroid carcinoma, and differentiated thyroid carcinoma. The drug is also awaiting regulatory decisions in China for use in combination with benmelstobart for recurrent or metastatic endometrial cancer, and for first-line advanced unresectable or metastatic renal cell carcinoma.
The continued expansion of indications for anlotinib underscores Sino Biopharmaceutical’s commitment to advancing targeted therapies and addressing significant unmet medical needs.- Flcube.com
