CSPC Innovation Pharmaceutical Co.,Ltd. (300765.SZ) has announced that its controlling subsidiary, CSPC Group Giant Biogene Pharmaceutical Co., Ltd. ("Giant Biogene"), presented Phase I clinical study data for SYS6002 monotherapy in the treatment of advanced cervical cancer. The results were disclosed in a rapid oral presentation at the 2026 International Gynecologic Cancer Society Annual Global Meeting (IGCS Annual Global Meeting), held from October 1 to October 3 in Montreal, Canada.

SYS6002 is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4. The drug utilizes enzyme-catalyzed site-specific antibody conjugation technology to deliver the potent mitotic inhibitor MMAE directly to cancer cells expressing Nectin-4. Its stable linker design not only facilitates the delivery of high concentrations of MMAE to tumors but also reduces toxicity by lowering systemic exposure to the toxin.

The relevant safety and efficacy data are as follows: In terms of safety, the overall safety profile of the two dose groups was manageable, with treatment-related adverse events mostly of Grade 1-2. Ocular-related adverse events were the most common, but no Grade 3 or higher events were observed, and no patient discontinued treatment due to them. The incidence of interstitial lung disease and non-infectious pneumonitis was low (2.4%). The incidence and severity of treatment-related rash were low (any grade: 20.7%; Grade 3 or higher: 1.2%), with no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. The incidence and severity of peripheral neuropathy were also low (12.2%; all Grade 1-2). No treatment-related adverse events leading to death occurred.

In terms of efficacy, both dosing regimens demonstrated preliminary efficacy in the study population. The confirmed objective response rate was 35.9% for the 2.4 mg/kg every 2 weeks dosing group, and 28.6% for the 3.6 mg/kg every 3 weeks dosing group. The median duration of response for patients achieving confirmed response in the two groups was 8.2 months and 10.3 months, respectively; the median progression-free survival was 4.1 months and 4.3 months, respectively; and the median overall survival was 15.1 months and 11.5 months, respectively.