Securities code: Haisco Pharmaceutical Group Co.Ltd(002653) securities abbreviation: Haisco Pharmaceutical Group Co.Ltd(002653) Announcement No.: 2022019 Haisco Pharmaceutical Group Co.Ltd(002653)
About obtaining hsk36273 for injection of innovative drugs
Announcement of notice of approval for clinical trials of drugs
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.
Haisco Pharmaceutical Group Co.Ltd(002653) (hereinafter referred to as “the company”) recently received the notice of approval of drug clinical trial issued by the State Drug Administration. The basic information is as follows:
1、 Basic information of drug application
Drug name dosage form specification acceptance number
Hsk36273 injection 125mg cxhl2200011 for injection
According to the drug administration law of the people’s Republic of China and relevant regulations, after review, hsk36273 for injection accepted in January 2022 meets the relevant requirements of drug registration, and it is agreed to carry out the clinical trial of “for hemodialysis and systemic anticoagulation of intraoperative patients”.
2、 Introduction to R & D projects
Hsk36273 for injection is an intravenous anticoagulant developed by our company. It is intended to be used in hemodialysis and systemic anticoagulation of patients during operation. Its main component hsk36273 was introduced by our company from American company exithera in 2019 (see the Announcement No. 2019038 disclosed by the company on April 2, 2019 for details). It is an efficient small molecule drug with fast onset and fast dissociation. It is a highly selective factor Xia inhibitor. Previous studies have shown that the curative effect is equivalent to that of heparin, but the safety is greatly improved. Its successful development has important clinical and social significance. 3、 Risk tips
At present, the phase I clinical trial of hsk36273 for injection is about to be carried out. In the later clinical research and application production process, there may be the risk of clinical trial failure, or the risk of research failure, supplement and withdrawal due to the project itself and the quality of application materials unable to meet the review requirements. Please make careful decisions and pay attention to preventing investment risks.
The board of directors of the company will pay close attention to the follow-up progress of the project and fulfill the obligation of information disclosure in time.
It is hereby announced.
Haisco Pharmaceutical Group Co.Ltd(002653) board of directors April 11, 2022
