CSPC PHARMA (01093.HK): Phase I Data for SYS6002 in Advanced Cervical Cancer; Confirmed ORR Up to 35.9%

NewTimeSpace News: On 8 October 2026, CSPC Pharmaceutical Group Limited (the "Company") voluntarily announced that the Group presented Phase I clinical study data for SYS6002 monotherapy in advanced cervical cancer in a rapid oral presentation at the 2026 IGCS Annual Global Meeting (IGCS 2026). The study is a multi-centre Phase I trial in China evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6002 in patients with advanced solid tumours; at the meeting the Group presented results of SYS6002 monotherapy in previously treated advanced cervical cancer.

The announcement disclosed that, as of 8 May 2026, 82 patients were enrolled and assigned to two dose groups: 39 in the 2.4 mg/kg once every two weeks group and 43 in the 3.6 mg/kg once every three weeks group, with a median follow-up of 16.1 months. On safety, both dose groups were generally manageable, with treatment-related adverse events mostly Grade 1-2; ocular-related events were the most common but no Grade 3 or above events occurred and none led to discontinuation; the incidence of interstitial lung disease and non-infectious pneumonitis was low (2.4%); treatment-related rash occurred at a low incidence and grade (any grade: 20.7%; Grade 3 or above: 1.2%); no Stevens-Johnson syndrome or toxic epidermal necrolysis occurred; peripheral neuropathy was also low (12.2%, all Grade 1-2); and no treatment-related deaths occurred.

The Company stated that on efficacy, both regimens showed preliminary efficacy: the confirmed objective response rate was 35.9% in the 2.4 mg/kg Q2W group and 28.6% in the 3.6 mg/kg Q3W group; median duration of response for confirmed responders was 8.2 and 10.3 months; median progression-free survival 4.1 and 4.3 months; and median overall survival 15.1 and 11.5 months. The 2.4 mg/kg Q2W regimen for immunotherapy-treated advanced cervical cancer has entered a Phase III trial (NCT07230626). SYS6002 is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4, using enzyme-catalysed site-specific conjugation to direct the potent mitotic inhibitor MMAE to Nectin-4-expressing cancer cells; its stable linker design helps deliver high concentrations of MMAE to tumours while reducing systemic exposure to the toxin to lower toxicity.

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