Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022033 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntary disclosure of anti-cd112r monoclonal antibody injection
Announcement of FDA approval of clinical trial application
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
Recently, topalliance Biosciences, Inc., a wholly-owned subsidiary of Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as “the company”), received a notice from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) that the clinical trial application of anti-cd112r monoclonal antibody injection (project code “tab009 / js009”) for the treatment of advanced solid tumors was approved by FDA. Due to the long R & D cycle and many approval links of drugs, they are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:
1、 Drug related information
Tab009 / js009 is a recombinant humanized IgG4 monoclonal antibody targeting cd112r independently developed by the company, which is used for the treatment of advanced malignant tumors. Cd112r, also known as pvrig (poliovirus receptor related immunoglobulin domain), is a new immune checkpoint pathway discovered by the company. Dr. Shengyao, executive director, deputy general manager and core technician of the company, is one of the discoverers of this new pathway. Cd112r is a single transmembrane protein of PVR family. It is mainly expressed on T cells and NK cells, and its expression is significantly up-regulated after cell activation. CD112, the common ligand of cd112r and tigit, is expressed on the surface of antigen-presenting cells and some tumor cells. The combination of cd112r and ligand can inhibit the antitumor effect of T cells and NK cells. Tab009 / js009 can bind cd112r with high affinity and specificity, effectively block the signal pathway of cd112r and its ligand CD112, promote the activation and proliferation of T cells and NK cells, and enhance the ability of the immune system to kill tumor cells. As of the disclosure date of this announcement, no products targeting cd112r have been approved for listing outside China.
Tigit is another immunosuppressive target of PVR family. Its ligands are PVR and CD112, and its binding site to CD112 is different from cd112r. Tab009 / js009 can cooperate with tigit antibody to promote T cell activation. Preclinical in vivo efficacy experiments showed that the combination of tab009 / js009 and the specific anti tigit monoclonal antibody injection independently developed by the company (project code “tab006 / js006”) showed significant synergistic antitumor effect. As of the disclosure date of this announcement, the clinical trial application of tab006 / js006 has been approved by the State Drug Administration and FDA.
In addition, the combination of tab009 / js009, tab006 / js006 and the company’s commercial product treprizumab injection (trade name: tuoyi, product code: js001) can further promote T cell activation and improve clinical treatment effect. The company will actively explore the combination of drugs to maximize the synergistic anti-tumor effect of self-developed products.
2、 Risk tips
Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the early research and development of drugs and the long cycle and many links of products from research and development, clinical trial approval to production are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks.
The company will actively promote the above R & D projects and fulfill the obligation of information disclosure on the follow-up progress of the project in strict accordance with relevant regulations. The information disclosed by the Shanghai Securities Times and the website of the Shanghai Securities Times shall be subject to the announcement of the company. It is hereby announced.
Shanghai Junshi Biosciences Co.Ltd(688180) board of directors April 6, 2022
