Fujian Haixi Pharmaceuticals Co., Ltd. (Haixi Pharmaceuticals) has formally commenced a multicenter, randomized, controlled, open-label Phase III clinical study (Protocol HXP019-CTPIII-02) to evaluate its proprietary C019199 tablets in patients with osteosarcoma who have failed at least two prior treatment lines.

The trial, registered under CTR20261818 with China’s Center for Drug Evaluation, plans to enroll approximately 120 participants nationwide. Progression-free survival assessed by a blinded independent review committee serves as the primary endpoint, while overall survival, objective response rate, disease control rate and safety constitute key secondary endpoints.

C019199 is described as a first-in-class, multi-target tumor immunomodulator derived from Haixi Pharmaceuticals’ MultiSel-Opt small-molecule R&D platform. Osteosarcoma, a malignant bone tumor prevalent among adolescents and young adults, has limited therapeutic options following relapse or metastasis, underscoring the clinical significance of the new trial.

The initiation of this Phase III study marks a pivotal milestone in Haixi Pharmaceuticals’ oncology pipeline, potentially advancing a novel therapeutic option for patients with advanced osteosarcoma. Investors and shareholders are advised to exercise caution when dealing in the company’s shares and to seek professional advice if in doubt.