Junshi Bio: Junshi Bio voluntarily disclosed the announcement of the notice of approval of the drug clinical trial of the JS010 injection.
DATE:  Mar 18 2023

Stock code: 688180 Stock abbreviation: Junshi Biological Announcement No.: Pro 2023-015.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

VOLUNTARY DISCLOSURE ABOUT JS010 INJECTION ACQUISITION

Announcement of Drug Clinical Trial Approval Notice

the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.

Recently, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company") received the "Drug Clinical Trial Approval Notice" approved and issued by the State Drug Administration, and the clinical trial application of JS010 Injection (project code "JS010") was approved. Due to the long R & D cycle and many approval links of drugs, they are easily affected by some uncertain factors. Investors are requested to make cautious decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:

Basic information of 1. drugs

Drug Name: JS010 Injection

Application: Domestic production of drug registration clinical trials

Accepted number: CXSL2200629

Applicant: Shanghai Junshi Biomedical Technology Co., Ltd.

Approval conclusion: According to the the People's Republic of China and Drug Administration Law and relevant provisions, after examination, 2022

The JS010 injection accepted on December 30, 2010 met the relevant requirements for drug registration and agreed to carry out clinical treatment with this product.

Test. Indications for application: Prophylactic treatment of migraine.

Other information related to 2. drugs

JS010 is a recombinant humanized anti-CGRP monoclonal antibody injection developed by the company, which is mainly used

Prophylactic treatment of migraine in adults. CGRP is a neuropeptide consisting of 37 amino acids, expressed in the central and peripheral nervous systems of mammals, which are generally divided into two subtypes: α-CGRP and β-CGRP. CGRP peptide levels increase during migraine attacks and can be ameliorated by CGRP antagonist therapy

Symptoms of pain. Preclinical study results show that JS010 can bind human α-CGRP and β-CGRP with high affinity

and cell biological activity studies based on the reporter gene system show that JS010 can effectively bind α-

CGRP or β-CGRP polypeptide, blocking its binding to the receptor, thereby inhibiting the intracellular cAMP signaling pathway,

And then play a role in the prevention of migraine. Pre-clinical in vivo pharmacodynamic data showed that JS010 had a significant inhibitory effect on vasodilation. In addition, the animals tolerated JS010 well, with no significant abnormalities seen in all animals during the study. As of the disclosure date of this announcement, a total of 8 products targeting CGRP or its receptor have been approved for listing in the world, and no similar target products have been approved for listing in China.

3. Risk Alert

As pharmaceutical products have the characteristics of high technology, high risk and high added value, the early research and development of drugs and the long cycle and many links from development, clinical trial approval to production of products are easily affected by some uncertain factors. Please be cautious in making decisions and pay attention to preventing investment risks.

The company will actively promote the above research and development projects, and in strict accordance with the relevant provisions of the follow-up progress of the project to fulfill the obligation of information disclosure. The relevant company information shall be subject to the announcements published in the company's designated disclosure media "China Securities Journal", "Shanghai Securities News", "Securities Times", "Securities Daily" and the website of the Shanghai Stock Exchange.

It is hereby announced.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

Board of Directors

March 18, 2023

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