Xinuovi: Announcement on the approval notice of drug clinical trial obtained by its holding subsidiary SYS6041
Securities code: 300765 Securities abbreviation: Xinnuowei Announcement number: 2026-050
CSPC Innovative Pharmaceutical Co., Ltd.
About the holding subsidiary SYS6041
Announcement of Obtaining Drug Clinical Trial Approval Notice
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.
1. Overview
CSPC Jushi Biopharmaceutical Co., Ltd. (hereinafter referred to as "Jushi Bio"), a controlling subsidiary of CSPC Innovative Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), has recently received the approval and issuance of the "Drug Clinical Trial Approval Notice" for SYS6041 (folic acid receptor ADC) from the National Medical Products Administration, and will launch clinical trials in the near future. The relevant information is now announced as follows:
2. Basic information about drugs
Drug name: SYS6041
Dosage form: injection
Registration Category: Biological Products for Therapeutic Use Class 1
Application Matters: Clinical Trial
Acceptance number: CXSL2600381
Applicant: CSPC Jushi Biopharmaceutical Co., Ltd.
Approval conclusion: In accordance with the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the SYS6041 clinical trial application accepted on April 7, 2026 complied with the relevant requirements for drug registration, and it was agreed that this product should carry out clinical trials of SYS6041 combination for the treatment of ovarian cancer.
3. Other related information about drugs
SYS6041 is an antibody-drug conjugate targeting folate receptor alpha (FRα). The FRα antibody part binds to FRα on the surface of tumor cells. After entering the tumor cells through endocytosis, the linker is specifically cleaved by cathepsin to release a small molecule toxin - a topoisomerase I inhibitor, thereby killing tumor cells. It can also exert a bystander effect to non-specifically kill surrounding tumor tissue cells. Potential indications for SYS6041 are solid tumors such as gynecological tumors and lung cancer. Available data from Phase I clinical trials show that SYS6041 is competitive among similar products. The approved clinical trial exploration study of SYS6041 combination drug will further expand the clinical application scenarios of SYS6041.
4. Risk warning
According to the laws and regulations related to national drug registration, after a drug obtains the "Drug Clinical Trial Approval Notice", it still needs to conduct clinical trials and obtain approval from the national regulatory authorities before it can be marketed and sold.
Drug research and development is characterized by high investment, high risk, and long cycle. There are risks such as clinical trial results not being as good as expected, failure to obtain approval from relevant competent authorities, launch time being later than planned, or post-market sales not being as expected. It will not have a significant impact on Jushi Biotech and the company's performance in the short term.
The company will promptly fulfill its information disclosure obligations based on subsequent research and development progress, and investors are advised to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of CSPC Innovation Pharmaceutical Co., Ltd.
June 15, 2026