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Simcere Zaiming Doses First Patient in Phase 1 Trial of SIM0348, a TIGIT/PVRIG Bi-specific Antibody

Release time:2023-04-03

-The molecule binds with two novel immune checkpoint proteins with unique Fc-mediated effector function


On April 03, 2023, Simcere Zaiming, an innovative oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group, (the “Company”) announced today that a Phase 1 clinical study of Simcere Zaiming’s humanized TIGIT/PVRIG bi-specific antibody, SIM0348, has successfully enrolled and dosed the first patient (FPI) with advanced solid tumors in Sun Yet-sen University Cancer Center in China.


This first-in-human, open-label, dose-escalation phase 1 clinical trial (NCT05718219) led by Professor Li Zhang from Sun Yat-sen University Cancer Center, aims to enroll approximately 68 adult patients with advanced solid tumors to evaluate the safety, pharmacokinetic/pharmacodynamics, tolerability profile as well as preliminary antitumor activity of SIM0348.


The study received IND approval from the National Medical Products Administration (NMPA) of China in December 2022. Preclinical studies have shown that SIM0348 can promote the killing of NK cells on human colorectal cancer cells and human leukemia cells, while also significantly enhances the secretion of IFN-γ factor by antigen-specific CD8 + T cells, with higher efficacy than that of PVRIG or TIGIT monotherapy. The combination of SIM0348 with an anti-PD-L1 antibody demonstrated strong efficacy, higher than that of either single-target monotherapy or the combination of three single-target therapies in preclinical models. A summary of the preclinical data of SIM0348 was presented at the 2022 American Association for Cancer Research (AACR) Annual Meeting(abstract #5203).



About SIM0348

SIM0348 is a humanized TIGIT/PVRIG bi-specific antibody injection intended for clinical trials in the treatment of advanced malignancies. The IgG1-based protein can specifically bind with two novel immune checkpoint proteins, TIGIT and PVRIG, which will block the interaction between CD155/TIGIT and CD112/PVRIG, and consequently enhance the anti-tumor activity of immune cells. Compared with other investigational bi-specific antibodies targeting TIGIT/PVRIG, SIM0348 has potentially higher tumor killing ability due to its unique Fc-mediated effector function, which can kill immunosuppressive Treg cells with high TIGIT expression or Tregs that are high in both TIGIT and PVRIG expression.



About Simcere Zaiming

Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited. Founded in 2023, the Company is committed to developing disruptive therapies that have the potential to address unmet clinical needs for cancer patients around the world. Simcere Zaiming has built an innovative R&D pipeline, with differentiated clinical assets. Several products of Simcere Zaiming are commercially available in China, which include COSELA®, Endostar®, and Envafolimab. Simcere Zaiming strives to bring potentially breakthrough treatment options to cancer patients worldwide through in-house R&D, manufacturing and commercialization, as well as collaborations with global partners of innovative cancer therapeutics.

Media contact: pr@zaiming.com



About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a vision toward disease areas that may have significant clinical needs in the future. and a mission of "providing today's patients with medicines of the future." Simcere has built a market-leading product portfolio in China. The company’s vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world-leading innovative companies and research institutes.

Media contact:  simcere.mediarelations@simcere.com