Corning Jerry Pharmaceutical-B (09966): JSKN033 received approval from CDE to conduct a phase III clinical study to treat cervical cancer

Zhitong Finance App News, Corning Jerry Pharmaceutical-B (09966) issued an announcement. JSKN033 (a high-concentration subcutaneous compound formulation composed of human epidermal growth factor receptor 2 (“HER2”) bispecific antibody conjugate drug (“ADC (s)”) and a programmed death ligand 1 (“PD-L1”) immune checkpoint inhibitor) has obtained approval from the China National Drug Administration (“State Drug Administration”) Drug Evaluation Center (“CDE”) to carry out a single drug treatment containing platinum-containing chemotherapy and D-1/P D-L1 inhibitor treatment failed Phase III clinical study of recurrent or metastatic cervical cancer (Study ID: JSKN033-301).

Globally, cervical cancer is the most common gynecologic malignant tumor and the fourth leading cause of cancer death in women. Locally advanced and high-risk early-stage patients are prone to recurrence and metastasis after treatment, and the 5-year survival rate of advanced patients is less than 20%. Immunotherapy combined with platinum-containing dual-drug chemotherapy (with or without bevacizumab) is the first-line standard plan recommended by authoritative domestic and foreign guidelines, but most patients will still develop disease progression due to drug resistance. There is currently no effective treatment other than chemotherapy for cervical cancer patients who have failed first-line platinum-containing chemotherapy and PD-1/PD-L1 inhibitors.

JSKN033-301 is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of JSKN033 versus investigator-selected chemotherapy in patients with recurrent or metastatic cervical cancer who failed platinum-containing chemotherapy and PD-1/PD-L1 inhibitors.