HAIXI PHARMA (ASX: 02637) has announced the official commencement of a Phase III clinical trial (CTR20261818) for its self-developed C019199 tablets, targeting osteosarcoma patients who have failed at least two prior lines of therapy. Details of the trial are now public on the Chinese National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) clinical trial registration and information platform.

This randomized, controlled, open-label, multi-center Phase III study (Protocol Number: HXP019-CTPIII-02) is designed to evaluate the efficacy and safety of C019199 tablets compared to the combination of gemcitabine and docetaxel in the target patient population. The trial is expected to enroll approximately 120 subjects across multiple research centers nationwide.

The primary endpoint of the study is progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC). Secondary endpoints will include a comprehensive set of measures such as overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.

C019199 tablets are a first-in-class, multi-target tumor immune modulator developed by HAIXI PHARMA based on its proprietary MultiSel-Opt small molecule innovative drug R&D platform. Osteosarcoma is a common malignant bone tumor that threatens the lives and health of adolescents and young adults, with a poor prognosis following recurrence, metastasis, or failure of second-line therapy, representing a significant area of unmet clinical need.

The initiation of this Phase III clinical trial for C019199 marks a crucial step forward for the group's innovative pipeline in the field of advanced osteosarcoma treatment, offering the potential to provide patients with a new therapeutic option.