Securities code: 600380 Securities abbreviation: Joincare Announcement No.: Lin 2022-019
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in this announcement, and Take individual and joint responsibility for the authenticity, accuracy and completeness of its content.
Recently, Livzon Pharmaceutical Group Co., Ltd. (hereinafter referred to as: Livzon Group), a holding subsidiary of Joincare Pharmaceutical Group Co., Ltd. The “Notice of Approval for Clinical Trials of Drugs” (Notice No.: 2022LP00260, 2022LP00261) issued by the Food and Drug Administration (NMPA), approved the company’s LZ001 tablets to carry out clinical trials. The relevant details are hereby announced as follows:
I. Main content of the notice
Drug name (code): LZ001
Dosage form: tablet
Specifications: 10mg, 40mg
Application: Clinical Trial Application
Registration Category: Chemical Class 1
Applicant: Livzon Pharmaceutical Group Co., Ltd. Co., Ltd.
Approval conclusion: According to the “Pharmaceutical Administration Law of the People’s Republic of China” and relevant regulations, after review, the LZ001 tablets accepted on December 16, 2021 meet the relevant requirements for drug registration, and it is agreed that this product will be launched in the late stage Solid Tumor Clinical Trials.
II. Drug R&D and related information
LZ001 tablet is a new generation of anti-drug ROS1/NTRK/ALK jointly developed by Livzon Group and Zhejiang Tongyuankang Pharmaceutical Co., Ltd. Multi-target inhibitors, as a new generation of tyrosine kinase inhibitors, show excellent activity on multiple targets such as ROS1/NTRK/ALK, can effectively inhibit various drug resistance gene mutations, overcome G2032R, G595R, G667C, Drug resistance caused by G623R, G696A, G1202R, etc. and potential double mutations can effectively solve many unmet clinical needs. LZ001 tablets are mainly used to treat solid tumors with ROS1/NTRK/ALK multi-target mutations, mainly non-small cell lung cancer.
As of the disclosure date of this announcement, the cumulative direct investment in research and development expenses of LZ001 was RMB 32.226 million.
III. Market situation of drugs
According to the Food and Drug Administration and related databases, as of the disclosure date of this announcement, there are no multi-targeted chemicals of the same type as LZ001 in China. The products are listed, 1 is in the stage of import registration and application, and 2 have been approved for clinical trials (including Livzon Group).
IV. Approval procedures still to be performed for product listing
After Livzon Group obtains the clinical trial approval document, it needs to conduct clinical research in accordance with the content of the approval document, and then submit an application for production and marketing The application can only be listed after approval.
V. Risk warning
LZ001 is the research and development of Livzon Group and Zhejiang Tongyuankang Pharmaceutical Co., Ltd., the intellectual property rights, research and development fees and milestone funds formed during the research and development process Relevant matters are implemented in accordance with the “Patent Transfer and Technology Exclusive License Agreement” signed by the two parties. For details of the above agreement, please refer to the “Livzon Group” published by Livzon Group on cninfo.com.cn on September 1, 2020. Announcement of Zhuzhou Pharmaceutical Group Co., Ltd. on Signing the Patent Transfer and Technology Exclusive License Agreement (Announcement No.: 2020-094).
Due to the particularity of drug research and development, the period from clinical trials to production and marketing is long and many links are involved, and it is easily affected by many unpredictable factors. There are many clinical trials progress and results and future product market competition. Uncertainty, the company will perform its information disclosure obligations in a timely manner based on the progress of research and development. Investors are advised to pay attention to investment risks.
It is hereby announced.
Joincare Pharmaceutical Group Co., Ltd.
February 25, 2022