Junshi Biosciences: Junshi Biosciences voluntarily disclosed the announcement on the approval of JS125 for drug clinical trials
DATE:  Sep 27 2024

Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2024-060

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure Regarding JS125 Access to Drug Clinical Trials

Announcement of the Notice of Approval

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

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 National Medical Products Administration, and the clinical trial application of WJ47156 tablets (project code "JS125") was approved. Due to the long R&D cycle of drugs and many approval links, they are easily affected by some uncertain factors, so investors are advised to make prudent decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:

First, the basic situation of drugs

Name of Drug: WJ47156 tablets

Application matters: registration and clinical trials of domestically produced drugs

Acceptance number: CXHL2400678, CXHL2400680

Applicant: Shanghai Junshi Biomedical Technology Co., Ltd

Approval conclusion: According to the "People's Republic of China Drug Administration Law" and relevant regulations, after review, 2024

The WJ47156 tablets accepted on July 9 met the relevant requirements of drug registration, and it was agreed that this product was a single drug in the advanced stage

Clinical trials in patients with malignant tumors.

2. Other relevant conditions of drugs

JS125 is a targeted histone deacetylase (hereinafter referred to as "HDACs") inhibitor, developed by the company in conjunction with

Jointly developed by Weijing Biomedical Technology (Shanghai) Co., Ltd., it is intended for the treatment of malignant tumors and belongs to the category of epigenetic regulators. HDACs are involved in the regulation of the homeostasis of histone and non-histone lysine residues, and their expression is known to be closely related to the occurrence and development of a variety of malignancies.

HDACs have a variety of subtypes, JS125 can selectively inhibit HDAC1, HDAC2, HDAC3,

It also induces cell cycle arrest, inhibits angiogenesis, regulates immune response and promotes cancer cell senescence and apoptosis to inhibit tumors and achieve the purpose of tumor treatment.

3. Risk Warning

Due to the characteristics of high-tech, high-risk and high value-added of pharmaceutical products, the pre-research and development of drugs and the cycle of products from development, clinical trial approval to production are long and linked, and they are easily affected by some uncertain factors. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

The company will actively promote the above-mentioned R&D projects, and fulfill the obligation of information disclosure on the follow-up progress of the project in a timely manner in strict accordance with relevant regulations. The relevant company information is subject to the announcements published on the company's designated disclosure media, "China Securities Journal", "Shanghai Securities News", "Securities Times" and the website of the Shanghai Stock Exchange.

The announcement is hereby made.

Shanghai Junshi Biomedical Technology Co., Ltd

board of directors

September 27, 2024

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