Simcere Receives NMPA Clearance for SIM0348 Clinical Study

China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0348, a bispecific antibody (BsAb) targeting TIGIT and PVRIG in advanced malignant solid tumors.

Mechanism of Action and Design
SIM0348 is designed to block the interaction between CD155/TIGIT and CD112/PVRIG, thereby enhancing the anti-tumor activity of immune cells. The antibody possesses Fc-mediated effector functions, enabling it to kill immunosuppressive Treg cells with high expression of TIGIT and dual expression of TIGIT and PVRIG. Additionally, SIM0348 can better mediate the activation and killing functions of NK cells, positioning it as a promising candidate for the treatment of advanced malignant solid tumors.

Future Prospects and Clinical Development
The clearance from the NMPA marks a significant milestone in the development of SIM0348. Simcere Pharmaceutical Group’s commitment to advancing this innovative bispecific antibody underscores its dedication to addressing significant unmet medical needs in oncology. The upcoming clinical study will provide valuable insights into the safety and efficacy of SIM0348, potentially paving the way for new treatment options for patients with advanced malignant solid tumors.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry