Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022016 Shanghai Junshi Biosciences Co.Ltd(688180)
Announcement on voluntary disclosure of approval notice of js001sc injection for drug clinical trial
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, Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as “the company”) received the notice of approval for clinical trial of drugs approved and issued by the State Drug Administration, and the clinical trial application of js001sc injection (project code “js001sc”) was approved. 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、 Basic information of drugs
Drug name: js001sc injection
Application item: clinical trial of domestic drug registration
Acceptance No.: cxsl2101506
Applicant: Shanghai Junshi Biosciences Co.Ltd(688180)
Examination and approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, the js001sc injection accepted on December 22, 2021 meets the relevant requirements of drug registration, and it is agreed to carry out the clinical trial for the treatment of advanced nasopharyngeal carcinoma.
2、 Other relevant information of drugs
Js001sc injection is the company’s listed product treprizumab injection (trade name: tuoyi ®， Product Code: js001). Js001sc takes human PD-1 as the target, binds PD-1 with high affinity, and selectively blocks the binding of PD-1 with ligands PD-L1 and PD-L2, so as to activate T lymphocytes and improve lymphocyte proliferation and cytokine secretion. Preclinical in vivo pharmacodynamic test showed that js001sc showed significant antitumor effect in animal model by subcutaneous injection. At the dose level of 0.3mg/kg, the antitumor effect of js001sc administered subcutaneously was equivalent to that of treprizumab administered intravenously, and there was no significant difference. In addition, the animals had good tolerance to js001sc.
With the gradual popularization of the concept of “chronic disease management” of tumor immunotherapy, shorter subcutaneous injection is more attractive than frequent going to the hospital for several hours of intravenous injection. At the same time, subcutaneous injection can avoid infusion related adverse reactions caused by intravenous administration, benefit patients as a whole and reduce medical costs. Upon inquiry of public information, as of the disclosure date of this announcement, among the more than ten kinds of PD – (L) 1 antibodies listed worldwide, only envolimab injection (trade name: envida ®） It is subcutaneous injection, and other products are intravenous injection.
3、 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 about the company shall be subject to the announcements published by the designated disclosure media of the company, such as China Securities News, Shanghai Securities News, securities times, securities daily and the website of Shanghai Stock Exchange. It is hereby announced.
Shanghai Junshi Biosciences Co.Ltd(688180) board of directors March 8, 2022
