Fuzhou, China—Haixi Pharma (Haixi Pharma, HKEX: 02637.HK, or the "Company") is pleased to announce that C019199 has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III pivotal clinical study for the treatment of osteosarcoma patients who have failed at least two prior lines of therapy.
The approved Phase III clinical study (HXP019-CTPIII-02) is a multicenter, randomized, open-label study designed to evaluate the efficacy and safety of C019199 tablets versus gemcitabine plus docetaxel in osteosarcoma patients who have failed at least two prior lines of therapy. This study will serve as the pivotal trial supporting the marketing application for C019199 tablets, marking a significant step forward for this program in the treatment of advanced osteosarcoma.
Ms. Feng Yan, Co-Founder, Executive Director and Deputy General Manager of the Company, stated:
"Osteosarcoma is a malignant tumor that poses a serious threat to the lives and health of adolescents and young patients. For patients with recurrent and metastatic disease in particular, there are currently no approved therapies available. As a clinical-need-driven innovative pharmaceutical company, we remain committed to developing novel treatment solutions that truly address patients' unmet needs.
The approval of C019199 to proceed into a Phase III clinical study represents an important milestone in the Company's innovative R&D strategy and reflects the Company's dedication to innovation-driven drug development. We look forward to further validating the clinical value of C019199 through rigorous, scientifically designed clinical research, and we hope to bring new treatment options and renewed hope to osteosarcoma patients as soon as possible."
About C019199
C019199 is an oral multi-target small-molecule anti-tumor drug discovered and developed by Haixi Pharma. By precisely targeting three key targets — CSF-1R, DDR1, and VEGFR2 — C019199 modulates the tumor microenvironment (TME), opening a new pathway for tumor treatment. Previously, the Phase Ib clinical study results of C019199 in osteosarcoma patients were selected for an oral presentation at the 2025 ASCO Annual Meeting.
About Haixi Pharma
Fujian Haixi Pharmaceutical Co., Ltd. (“Haixi Pharmaceutical”, 02637.HK) was founded in 2012 as a commercial-stage innovative pharmaceutical company covering the entire industrial chain of R&D, clinical research, manufacturing and commercialization. The company was successfully listed on the Main Board of The Stock Exchange of Hong Kong Limited on October 20, 2025, and was included in the Hong Kong Stock Connect on March 9, 2026.
Our company adheres to the development philosophy of “Generics empower innovation, innovation drives the future”, by generating stable cash flow through its generic drug consistency evaluation business, it continuously invests in the R&D of original innovative drugs to achieve sustainable development.
