Securities code: 002019 securities abbreviation: Yifan Pharmaceutical Co.Ltd(002019) Announcement No.: 2022-009 Yifan Pharmaceutical Co.Ltd(002019)
Announcement on the receipt of drug registration acceptance notice by wholly-owned subsidiaries
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.
Liaoning Yifan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical Co.Ltd(002019) (hereinafter referred to as “the company”), received the acceptance notice of tirofiban hydrochloride injection application for domestic registration and listing license issued by the State Drug Administration (hereinafter referred to as “the drug administration”) on January 24, 2022. The relevant information is hereby announced as follows:
1、 Basic information of drugs applied for registration
Acceptance No.: cyhs2200182
Drug name: tirofiban hydrochloride injection
Application item: registration and marketing license of domestically produced drugs
Drug registration classification: chemical drugs category 4
Specification: 50ml: 12.5mg (calculated by c22h36n2o5s)
Applicant: Liaoning Yifan Pharmaceutical Co., Ltd
2、 Product related information
Tirofiban hydrochloride injection is suitable for adult patients with non ST segment elevation acute coronary syndrome (NSTE-ACS) with ECG changes and / or elevated myocardial enzymes within 12 hours of the last onset of chest pain to prevent early myocardial infarction. The patients most likely to benefit are those with a higher risk of myocardial infarction in the first 3-4 days after the onset of acute angina symptoms, including those who may undergo early percutaneous coronary intervention (PCI). It is used to plan patients with acute myocardial infarction (STEMI) for direct PCI to reduce the occurrence of major cardiovascular events. This product should be used with unfractionated heparin and aspirin.
Tirofiban hydrochloride injection was first developed by MSD sharp & Dohme GmbH and was first listed in the United States in 1998. The company completed the pharmaceutical research of tirofiban hydrochloride injection in June 2021, submitted the listing application to the food and Drug Administration in January 2022, and was accepted on January 24, 2022.
As of the disclosure date of this report, the main manufacturers of tirofiban hydrochloride injection in China are lunambert Pharmaceutical Co., Ltd., Yuanda Pharmaceutical (China) Co., Ltd. and Guizhou Jingfeng injection Co., Ltd. several enterprises have applied according to the consistency evaluation standard, of which 7 enterprises have passed or deemed to have passed the consistency evaluation, and 1 enterprise has obtained the implied license of clinical trial.
According to the data of Intranet, the Chinese market sales of tirofiban hydrochloride injection in 2020 was about 434 million yuan.
As of the disclosure date of this report, the company has invested 3.9079 million yuan in R & D of this project.
3、 Risk tips
According to the requirements of laws and regulations related to national drug registration, the above drugs will be transferred to the drug evaluation center of the Drug Administration for review and approval after the application for registration and marketing license of the drug administration is accepted. The completion time, approval results and specific sales situation of the drugs after approval are uncertain. The company will timely perform the obligation of information disclosure on the follow-up progress of the above drugs in accordance with relevant regulations. Please make careful decisions and pay attention to preventing investment risks.
4、 Filing documents
Acceptance notice
It is hereby announced.
Yifan Pharmaceutical Co.Ltd(002019) board of directors January 26, 2022
