Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022031 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntary disclosure on the fourth generation EGFR inhibitor js113
Announcement on obtaining the acceptance notice of drug 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, Suzhou JunJing Biomedical Technology Co., Ltd., a holding subsidiary of Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as “the company”), received the acceptance notice approved and issued by the State Drug Administration, and the application for clinical test of the fourth generation EGFR inhibitor wj13404 tablets (project code “js113”) was accepted. Due to the long research and development cycle and many approval links of drugs, they are vulnerable to some uncertain factors. There is uncertainty about whether the application for clinical trial can be approved. 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: wj13404 tablets
Application item: clinical trial of domestic drug registration
Acceptance No.: cxhl2200202, cxhl2200203
Applicant: Suzhou JunJing Biotechnology Co., Ltd
Examination and approval conclusion: according to the provisions of Article 32 of the administrative license law of the people’s Republic of China, after examination, it is decided to accept it.
2、 Other relevant information of drugs
Js113 is a first in class fourth generation EGFR (epidermal growth factor receptor) inhibitor, which was developed by the company in cooperation with microenvironment biomedical technology (Shanghai) Co., Ltd. and is intended to be used in the treatment of EGFR mutant non-small cell lung cancer and other solid tumors. Js113 has a new molecular skeleton and unique biological activity. Preclinical data show that the drug molecule has good inhibitory activity against primary and acquired EGFR mutations (including del19 / T790M / c797s and L858R / T790M / c797s co mutations) that are not sensitive to the third generation EGFR inhibitors, as well as some TKI resistant bypass activation targets and immunosuppressive targets. At the same time, it is highly selective for wild-type EGFR.
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. There is uncertainty whether the application for clinical trial can be approved or not. 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 April 2, 2022
