Circulate the announcement published by our Company on 9 July 2026.：
This announcement is made by Fujian Haixi Pharmaceuticals Co., Ltd. (the“Company”, together with its subsidiaries, the “Group” or “Haixi Pharmaceuticals”) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business updates of the Group. The Board of Directors (the “Board”) of the Company is pleased to announce that the Phase III clinical trial of C019199 tablets, an independently developed drug of the Company, has been officially initiated for the treatment of osteosarcoma after failure of at least two prior lines of therapy (CTR20261818). Relevant information has been published on the Drug Clinical Trial Registration and Information Disclosure Platform of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China.
This randomized, controlled, open-label, multicenter Phase III study (Protocol No.:HXP019-CTPIII-02) is designed to evaluate the efficacy and safety of C019199 tablets versus gemcitabine plus docetaxel in the target patients. A total of approximately 120 subjects are expected to be enrolled across multiple clinical research centers nationwide. Progression-free survival (PFS) as assessed by the blinded independent review committee (BIRC) will serve as the primary endpoint, and other multi-dimensional indicators including overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety, will serve as secondary endpoints.
About C019199 Tablets
C019199 tablets is a first-in-class, multi-target tumor immunomodulator developed by Haixi Pharmaceuticals based on its proprietary MultiSel-Opt small-molecule innovative drug R&D platform. As a common malignant bone tumor that threatens the lives and health of adolescents and young patients, steosarcoma has a poor prognosis following relapse, metastasis and second-line treatment failure, representing a significant unmet medical need in current clinical practice. The initiation of the Phase III clinical trial for C019199 tablets marks a critical milestone for the Group’s innovative pipeline in the treatment of advanced osteosarcoma and is expected to provide patients with a novel therapeutic option.
Shareholders and/or potential investors of the Company are advised to exercise caution when dealing in the shares of the Company and not to place any excessive reliance on the information disclosed herein. Any shareholder or potential investor who is in doubt is advised to seek advice from professional advisors.
