Kangchen Pharmaceutical’s announcement that the KC1086 project has been approved by the FDA to conduct clinical trials
Securities code: 603590 Securities abbreviation: Kangchen Pharmaceutical Announcement number: Lin 2025-086
Beijing Kangchen Pharmaceutical Co., Ltd.
Announcement on the KC1086 Project Obtaining FDA Approval for Clinical Trials
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.
Recently, Beijing Kangchen Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received the "Study May Proceed" issued by the U.S. Food and Drug Administration (FDA), and the company's clinical trial application for KC1086 tablets was officially approved by the FDA.
The relevant situation is now announced as follows:
1. Basic information on drugs
Drug name: KC1086 tablets
Application Matters: New Drug Clinical Trial Application
Applicant: Beijing Kangchen Pharmaceutical Co., Ltd.
Approval conclusion: FDA has completed its evaluation of this application and agrees that this product can be carried out according to the proposed clinical research plan.
2. Other conditions of drugs
KC1086 is a potent and highly selective small molecule inhibitor of Lysine Acetyltransferase 6 (KAT6) with a new structure, completely independently developed by Beijing Kangchen Pharmaceutical Co., Ltd. It is intended to be used for the treatment of late-stage recurrent or metastatic solid tumors.
KAT6 belongs to the MYST family of histone acetylases and plays a critical role in regulating transcription, development, hematopoietic cell differentiation, cell cycle progression, and mitosis. Studies have found that KAT6 is abnormally highly expressed in various tumor types such as breast cancer, ovarian cancer, cervical cancer, lung adenocarcinoma, colon and rectal adenocarcinoma, and medulloblastoma, and is closely related to tumor occurrence, development, and poor prognosis. Inhibiting KAT6 can effectively inhibit the growth of tumor cells or tumors, and has potential clinical application value in reversing tumor drug resistance and tumor treatment.
KC1086 has demonstrated excellent in vivo efficacy in a variety of mouse transplanted tumor CDX/PDX models: in the ER+/HER2- breast cancer efficacy model, the tumor inhibition rate of KC1086 can exceed 90%, and has shown similar effects in other solid tumor efficacy models.
The KC1086 project received implicit clinical trial permission from the State Food and Drug Administration at the end of June 2025 to conduct the first human clinical study for patients with advanced solid tumors; in August 2025, the first subject was enrolled. Currently, clinical trials are progressing in an orderly manner.
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.
December 25, 2025