April 8 2026, Simcere Zaiming announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIM0505, for the treatment of platinum-resistant ovarian cancer.
SIM0505 is an investigational antibody drug conjugate (ADC) developed by Simcere Zaiming. Comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload, the ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.
In June 2025, Simcere Zaiming and Nextcure entered into a strategic partnership for co-development of SIM0505. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan, which are retained by Simcere Zaiming.
SIM0505 is being evaluated in an open-label, global Phase 1 study (ClinicalTrials.gov) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum-resistant ovarian cancer. The dose escalation data of this study will be presented at ASCO 2026.
Drug candidates that receive Fast Track Designation are eligible for more frequent meetings and written interactions with the FDA, rolling review and priority review if supported by clinical data at the time of Biologics License Application(BLA), potentially accelerating the process of bringing this innovative therapy to patients worldwide.