Securities code: 688266 securities abbreviation: Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) Announcement No.: 2022-008 Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266)
Application for voluntary disclosure of clinical trial of zg19018 tablets
FDA approved announcement
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal liabilities for the authenticity, accuracy and integrity of its contents according to law.
Important content tips:
On January 22, 2022, Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) (hereinafter referred to as “the company”) applied for the clinical trial of zg19018 tablets, which was under development, and was approved by the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) for the treatment of advanced malignant solid tumors with KRAS G12C mutation.
The application for clinical trial of zg19018 tablets has been approved by FDA, which will not have a significant impact on the company’s recent performance. Due to the long R & D cycle, many approval links and large R & D investment, drugs are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks.
The relevant information is hereby announced as follows:
1、 Basic information of drugs
Drug name: zg19018 tablets
Dosage form tablet
No. ind 159912
Indications: advanced malignant solid tumor with KRAS G12C mutation
2、 Drug related information
Zg19018 is a selective covalent inhibitor of KRAS G12C independently developed by the company, with global intellectual property rights. At present, only one drug with similar mechanism has been approved to market all over the world. Sotorasib (amg510), a KRAS G12C covalent inhibitor of Amgen, was accelerated by FDA in May 2021 for the treatment of non-small cell lung cancer (NSCLC) carrying KRAS G12C mutation. In addition, monotherapy or combination of KRASG12C inhibitors also showed good efficacy and safety in KRAS G12C mutation of advanced colorectal cancer and advanced pancreatic cancer. The results of preclinical studies show that zg19018 has a significant pharmacodynamic effect of inhibiting KRAS G12C mutant tumor growth and cell proliferation, has long drug half-life and high oral bioavailability, and has high drug concentration in tumor and brain tissue. Zg19018 is expected to become an innovative drug for the treatment of KRAS G12C mutant tumors.
3、 Risk tips
The application for clinical trial of zg19018 tablets has been approved by FDA, which will not have a significant impact on the company’s recent performance. Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the long cycle and many links of early drug R & D and products from development, clinical trial, approval to production are vulnerable to some uncertain factors. The company will actively promote the above R & D projects in accordance with the provisions of relevant laws and regulations, and fulfill the obligation of information disclosure on the follow-up progress of the project in time. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) board of directors January 24, 2022
