Securities code: 603087 Securities abbreviation: Gan & Lee Pharmacy Announcement No.: 2022-010
The board of directors and all directors of the company warrant that there are no false records, misleading statements or major omissions in the contents of this announcement, and will not Individual and joint responsibility for the authenticity, accuracy and completeness of its content.
GZR18 independently developed by Gan & Lee Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”, “Gan & Lee Pharmaceutical”) is currently undergoing Phase I clinical trials in the United States, and the first subject has been successfully enrolled recently. The relevant information is hereby announced as follows:
1. Basic information of GZR18
GZR18 is a weekly injection of glucagon-like peptide-1 (hereinafter referred to as “GLP-1” ) receptor agonist drugs, the clinical trial is planned to develop the indication for type 2 diabetes.
Glucagon-like peptide-1 (GLP-1) can regulate the secretion of various glucose-regulating hormones, promote insulin secretion and inhibit glucagon release in a glucose-dependent manner, and these impaired in patients with type 2 diabetes. Compared with insulin injections, GLP-1 receptor agonist (GLP-1RA) hypoglycemic agents can reduce the incidence of hypoglycemia compared with insulin injections because GLP-1 promotes insulin secretion in a glucose concentration-dependent manner.
2. The research and development status and progress of GZR18
The product was approved by the US Food and Drug Administration for Phase I clinical trials in December 2021, and the company will conduct double-blind clinical trials. , randomized, placebo-controlled, sequential, single ascending dose clinical phase I trial, mainly to investigate the safety and tolerability of GZR18 in healthy subjects, and the secondary goal is to evaluate GZR18 in healthy subjects. Pharmacokinetic (PK) parameters. The drug research is currently progressing smoothly, and the first subject enrollment has been successfully completed recently.
As of September 30, 2021, Gan & Lee Pharmaceuticals has invested a total of RMB 58.12 million in research and development expenses in this project.
III. Risk warning
Due to the high-tech, high-risk, and high-value-added characteristics of pharmaceutical products, the early stage of drug development and the cycle from product development, clinical trial approval to production It is long and has many links, and is easily affected by some uncertain factors. The company will actively promote the above-mentioned R&D projects in accordance with the relevant national regulations, and fulfill the obligation of information disclosure on the follow-up progress of the projects in a timely manner. Investors are advised to make decisions with caution and pay attention to preventing investment risks.
It is hereby announced.
Gan & Lee Pharmaceutical Co., Ltd.
Board of Directors
March 11, 2022