Kangchen Pharmaceutical’s announcement that the pivotal phase III clinical study of KC1036 in the treatment of advanced thymic cancer has been approved by CDE
Securities code: 603590 Securities abbreviation: Kangchen Pharmaceutical Announcement number: Lin 2026-010
Beijing Kangchen Pharmaceutical Co., Ltd.
Pivotal Phase III Clinical Study of KC1036 in the Treatment of Advanced Thymic Cancer
Announcement of CDE Approval
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
KC1036 tablets ("KC1036") independently developed by Beijing Kangchen Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has been approved by the Center for Drug Evaluation of the State Food and Drug Administration (hereinafter referred to as the "CDE") to conduct a "randomized, open-label, multi-center phase III clinical study to evaluate KC1036 versus investigator-selected chemotherapy monotherapy for the treatment of advanced recurrent or metastatic thymic cancer that has failed at least one line of platinum-containing chemotherapy." The relevant situation is now announced as follows:
1. Basic information of this approval
Drug name: KC1036 tablets
Drug clinical trial approval numbers: CXHL1900362, CXHB2300116
Time to obtain clinical approval: January 2020, August 2023
Indications for application: advanced recurrent or metastatic thymic cancer that has failed at least one first-line platinum-containing chemotherapy
Review conclusion: CDE has completed the review of this product and agreed to carry out critical phase III clinical research.
2. Brief introduction to the main situation of KC1036
KC1036 is a Class 1 innovative chemical drug independently developed by the company. The company owns the global intellectual property rights of this product. KC1036 achieves anti-tumor activity by inhibiting VEGFR2, AXL and other multiple targets. KC1036 has strong VEGFR vascular targeting and inhibits tumor cell growth; by inhibiting AXL, it can improve the host's anti-tumor immune response, thereby avoiding tumor immune escape.
Currently, KC1036 is undergoing clinical research for multiple indications such as digestive system tumors, thymic tumors, and children's Ewing sarcoma. Up to now, more than 350 subjects have been enrolled in KC1036 clinical studies. The existing clinical study results show outstanding anti-tumor activity and safety.
Phase II clinical study results show that KC1036 exhibits outstanding anti-tumor efficacy and controllable safety in late-stage recurrent or metastatic thymic cancer. The company recently received CDE approval to conduct a pivotal Phase III clinical study of KC1036 in the treatment of advanced thymic cancer. This is the second indication for KC1036 to be approved for a pivotal Phase III clinical study following the Phase III clinical study of third-line treatment of advanced esophageal squamous cell carcinoma.
3. Risk warning
Medical innovation has the characteristics of "three highs and one long" - high investment, high risk, high return, and long cycle. From clinical trials to production and marketing, drugs are affected by many factors such as technology, approval, and policies. There are many uncertainties in the progress and results of clinical trials and future market competition. The progress of this research and development will not have a significant impact on the company's recent performance.
The company will actively promote the progress of drug research and development in accordance with relevant national regulations and promptly fulfill its information disclosure obligations based on the progress of research and development. Investors are advised to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Beijing Kangchen Pharmaceutical Co., Ltd.
March 19, 2026