Securities code: 002019 securities abbreviation: Yifan Pharmaceutical Co.Ltd(002019) Announcement No.: 2022-007 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.
Hefei Yifan biopharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical Co.Ltd(002019) (hereinafter referred to as "the company"), received the acceptance notice of domestic registration and listing license application for dopamine hydrochloride injection issued by the State Drug Administration (hereinafter referred to as "the drug administration") on January 11, 2022. The relevant information is hereby announced as follows:
1、 Basic information of drugs applied for registration
Acceptance No.: cyhs2200063
Drug name: dopamine hydrochloride injection
Application item: registration and marketing license for domestically produced drugs
Drug registration classification: Category 3
Specification: 5ml: 100mg
Applicant: Hefei Yifan biopharmaceutical Co., Ltd
Acceptance Description: according to the provisions of Article 32 of the administrative license law of the people's Republic of China, after examination, it is decided to accept it.
2、 Product related information
Dopamine hydrochloride injection is suitable for acute circulatory insufficiency (cardiogenic shock and hemorrhagic shock), mainly including: (1) no urine, oliguria or ineffective diuretics; (2) Increase pulse rate; (3) When other cardiac / pressor agents are intolerable or ineffective, they are used for clinical first aid, such as the treatment of shock, heart failure, acute renal injury and perioperative blood pressure maintenance.
Dopamine hydrochloride injection was first developed by Hospira Inc and approved by FDA in February 1974. The company completed the pharmaceutical research of dopamine hydrochloride injection in May 2021, submitted the listing application to the food and Drug Administration in December 2021, and was accepted on January 11, 2022.
As of the disclosure date of this report, the main manufacturers of dopamine hydrochloride injection in China include Shanghai Hefeng Pharmaceutical Co., Ltd., Yuanda Pharmaceutical (China) Co., Ltd., Yabang Pharmaceutical Co., Ltd. and Guangzhou Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited(600332) Mingxing Pharmaceutical Co., Ltd., with specifications of 5ml: 200mg and 2ml: 20mg, and there is no 5ml: 100mg generic drug product on the market; At present, there are 6 manufacturers applying according to the consistency evaluation standard in China, and 1 enterprise has applied for clinical supplementary application.
According to the data of Intranet, the sales volume of dopamine hydrochloride injection in China will be about 440 million yuan in 2020. As of the disclosure date of this report, the company has invested 2.94 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 according to 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 13, 2022
