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Simcere Received IND Approval for Two Immuno-oncology Bi-specific Antibodies from NMPA

Release time:2022-12-30

Dec 29, 2022, Simcere Pharmaceutical Group (2096.HK) announced that the company has received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for two immune-oncology bi-specific antibodies (SIM0348, SIM0237). Both molecules were developed in-house by utilizing Simcere’s protein engineering platform.


SIM0348 is intended to be used in clinical trials for the treatment of advanced malignant solid tumors. SIM0237 is intended to be used in the treatment of locally advanced unresectable or metastatic solid tumors.


In addition, the U.S. Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application on October 27, 2022.


Up to now, Simcere has 18 innovative pipeline projects at clinical stage or has obtained clinical approval, among which two projects have been approved to carry out clinical trial both in China and the United States.



SIM0348 is a humanized TIGIT/PVRIG bi-specific antibody injection intended for clinical trials for 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. In April, preclinical data of SIM0348 was presented at the American Association for Cancer Research (AACR) Annual Meeting.


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 enhance the secretion of IFN-γ factor by antigen-specific CD8 + T cells, with higher efficacy than that of PVRIG and TIGIT monotherapy. The combination of SIM0348 with anti-PD-L1 antibody showed a good synergy effect, higher than that of either single-target monotherapy or the combination of three single-target therapies.


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.



SIM0237 is an anti-PD-L1/IL-15 bi-specific antibody injection designed for the treatment of patients with advanced solid tumors.


IL-15 is an immune-activating cytokine that promotes the expansion and activation of NK cells and CD8 + T cells. Previous research has revealed that IL-15 when combined with anti-PD-L1/PD-1 antibodies showed good clinical benefits in patients with advanced malignancies, including patients who have failed or relapsed after immune checkpoint inhibitor treatment. Therefore, bi-specific antibody targeting both IL-15 and PD-1/PD-L1 may have good clinical antitumor efficacy in relapsed/refractory patients after immunotherapy.


SIM0237 is a fusion protein that combines the functions of both PD-L1 antibody and IL-15, resulting in immune activation by dual pathways. In an attempt to optimize the combination of such functions, the IL-15 end of the molecule is specifically engineered to reduce the activity, therefore creates potentially superior efficacy and safety than other similar molecules as it increases the tolerability and exposure to anti-PD-L1 antibodies.



About Simcere


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 forward-looking vision toward disease areas that may have significant clinical needs in the future,aiming to achieve the mission of “providing today’s patients with medicines of the future.” Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Driven by its in-house R&D efforts and synergistic innovation, the Company has established strategic cooperation partnerships with many innovative companies and research institutes. 


PR contact: simcere.mediarelations@simcere.com