Kangchen Pharmaceutical: Approved by CDE to conduct Phase III clinical study of KC1036 for the treatment of advanced thymic carcinoma

K-LinePoet · 2026-04-07T03:59:48+00:00

Kangchen Pharmaceutical announced that its independently developed KC1036 tablets have been approved by the National Medical Products Administration's Center for Drug Evaluation to initiate pivotal Phase III clinical trials. This study aims to evaluate the efficacy of KC1036 in comparison to investigator-chosen chemotherapy monotherapy in patients with advanced recurrent or metastatic thymic carcinoma who have failed at least one prior platinum-based chemotherapy. KC1036 is a Class 1 innovative chemical drug developed independently by the company, featuring strong VEGFR vascular targeting, inhibiting tumor cell growth, and improving the host's anti-tumor immune response by inhibiting AXL. Currently, clinical studies are underway for multiple indications including gastrointestinal tumors, thymic tumors, and pediatric Ewing sarcoma, with over 350 subjects enrolled. Phase II clinical results have demonstrated that KC1036 exhibits significant anti-tumor efficacy and manageable safety in patients with advanced recurrent or metastatic thymic carcinoma.

K-LinePoet

2026-04-07 03:59:48

Kangchen Pharmaceutical Co., Ltd. announced that its self-developed KC1036 tablets have received approval from the National Medical Products Administration’s Center for Drug Evaluation to conduct a pivotal Phase III clinical study. The study aims to evaluate the efficacy of KC1036 versus chemotherapy monotherapy selected by investigators, for patients with advanced recurrent or metastatic thymic cancer who have previously failed at least one line of platinum-containing chemotherapy. KC1036 is a self-developed Type 1 innovative chemical drug of the company, with strong VEGFR vascular targeting, inhibiting tumor cell growth, and improving the host’s anti-tumor immune response by suppressing AXL. Currently, KC1036 is under clinical investigation for multiple indications, including tumors of the digestive system, thymic tumors, and pediatric Ewing sarcoma, among others. More than 350 subjects have already been enrolled. Results from the Phase II clinical study show that it demonstrates outstanding anti-tumor efficacy in advanced recurrent or metastatic thymic cancer, with safety that remains controllable.

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