Securities code: 000513, 01513 securities abbreviation: Livzon Pharmaceutical Group Inc(000513) , Lizhu pharmaceutical Announcement No.: 2022-006 Livzon Pharmaceutical Group Inc(000513)
Announcement on obtaining the notice of approval for drug clinical trial
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
On February 22, 2022, Livzon Pharmaceutical Group Inc(000513) (hereinafter referred to as “the company”) received the notice of approval of drug clinical trial (Notice No.: 2022lp00260, 2022lp00261) issued by the State Drug Administration (hereinafter referred to as “the drug administration”), and agreed to carry out the clinical trial of lz001 tablets. The details are hereby announced as follows:
1、 Main contents of the notice
Drug name (code): lz001
Dosage form: tablet
Specification: 10mg, 40mg
Application for clinical trial
Registration classification: Class 1 chemical products
Applicant: Livzon Pharmaceutical Group Inc(000513)
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, after examination, lz001 tablets accepted on December 16, 2021 meet the relevant requirements of drug registration, and it is agreed to carry out the clinical trial of advanced solid tumor.
2、 Drug research and development and related information
Lz001 tablet is a new generation of multi-target inhibitor against drug resistance ros1 / ntrk / ALK developed by our company in cooperation with Zhejiang cognate Kang Pharmaceutical Co., Ltd. as a new generation of tyrosine kinase inhibitor, it shows excellent activity against multiple targets such as ros1 / ntrk / ALK, can effectively inhibit the mutation of various drug resistance genes, and overcome g2032r, g595r, g667c, g623r G696a, g1202r and other potential double mutations can effectively solve many unmet clinical needs. Lz001 tablets are mainly used to treat solid tumors with multi-target mutations of ros1 / ntrk / ALK, mainly non-small cell lung cancer.
As of the disclosure date of this announcement, the accumulated R & D expenses directly invested by lz001 are RMB 32.226 million. 3、 Market situation of drugs
According to the FDA and relevant databases, as of the disclosure date of this announcement, lz001 similar multi-target chemicals with drug resistance have not been listed in China, one is in the stage of import registration and application, and two have been approved for clinical trials (including the company).
4、 Approval procedures to be performed for product listing
After obtaining the approval document of clinical trial, the company shall conduct clinical research according to the contents of the approval document, and submit the application for production and listing after the period, which can be listed only after being approved.
5、 Risk tips
Lz001 is developed by the company in cooperation with Zhejiang cognate Kang Pharmaceutical Co., Ltd. the intellectual property rights, R & D fees, milestone payments and other related matters formed in the process of R & D shall be implemented in accordance with the patent transfer and technology exclusive license agreement signed by both parties, For details of the above agreement, please refer to the announcement of Livzon Pharmaceutical Group Inc(000513) on signing patent transfer and technology exclusive license agreement (Announcement No.: 2020-094) issued by the company on September 1, 2020.
Due to the particularity of drug research and development, the cycle from clinical trial to production and listing is long and there are many links, which are vulnerable to many unpredictable factors. There are many uncertainties in the progress and results of clinical trial and the future product market competition situation. The company will timely fulfill the obligation of information disclosure according to the progress of research and development. Please pay attention to the investment risks.
It is hereby announced.
Livzon Pharmaceutical Group Inc(000513) board of directors February 25, 2022
