HAIXI PHARMA(02637.HK): Phase III Clinical Trial of C019199 Tablets for Osteosarcoma Initiated

NewTimeSpace · 2026/07/09 16:42 · By Boyuan Chen

NewTimeSpace News: Fujian Haixi Pharmaceuticals Co., Ltd. (02637.HK) announced that the Phase III clinical trial (CTR20261818) of self-developed first-in-class multi-target tumour immune modulator C019199 tablets has officially been initiated for osteosarcoma patients who failed at least two prior lines of treatment. Approximately 120 subjects are planned to be recruited across multiple clinical centres nationwide.

NewTimeSpace News: Fujian Haixi Pharmaceuticals Co., Ltd. (02637.HK) released a voluntary announcement dated 9 July 2026, disclosing that the Phase III clinical trial of its in-house developed C019199 tablets has formally kicked off for patients with osteosarcoma who have failed at least two lines of prior therapy.

This randomised, controlled, open-label, multicentre Phase III study (Protocol No.: HXP019-CTPIII-02) is designed to evaluate the efficacy and safety of C019199 tablets versus gemcitabine combined with docetaxel in osteosarcoma patients progressing after at least two prior treatment lines, with around 120 subjects expected to be enrolled. The primary endpoint is progression-free survival (PFS) assessed by a blinded independent review committee (BIRC). Multiple secondary endpoints including overall survival (OS) and objective response rate (ORR) will also be evaluated.

C019199 tablets are a first-in-class multi-target tumour immune modulator developed by Haixi Pharma based on its proprietary MultiSel-Opt small-molecule innovative drug discovery platform. Osteosarcoma is a common malignant bone tumour predominantly affecting adolescents and young adults. Patients with recurrent or metastatic disease who fail second-line treatment face poor prognosis, representing a substantial unmet clinical need.

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HAIXI PHARMA 02637.HK Clinical Trial