Securities code: 002019 securities abbreviation: Yifan Pharmaceutical Co.Ltd(002019) Announcement No.: 2022-013 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 the application for domestic registration and listing license of deoxyepinephrine hydrochloride injection issued by the State Drug Administration (hereinafter referred to as the “drug administration”) on February 16, 2022. The relevant information is hereby announced as follows:
1、 Basic information of drugs applied for registration
Acceptance No.: cyhs2200329
Drug name: deoxyepinephrine hydrochloride injection
Application item: registration and marketing license of domestically produced drugs
Drug registration classification: chemical drugs category 3
Specification: 1ml: 10mg
Applicant: Hefei Yifan biopharmaceutical Co., Ltd
2、 Product related information
Deoxyepinephrine hydrochloride injection is suitable for the treatment of hypotension caused by vasodilation under anesthesia. Deoxyepinephrine hydrochloride injection was first developed by avaedl legacy and first listed in the United States in 1954. The company submitted its listing application to the food and Drug Administration in January 2022 and was accepted on February 16, 2022.
As of the disclosure date of this report, only Shanghai Hefeng Pharmaceutical Co., Ltd. has been listed for sale of deoxyepinephrine injection. Guangdong Zhongrun Pharmaceutical Co., Ltd. / Guangdong Xinghao Pharmaceutical Co., Ltd. (Joint Declaration), Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) and three enterprises including the company have reported three types of imitation according to the consistency evaluation standard, and no enterprise has passed or deemed to have passed the consistency evaluation.
According to the data of Intranet, the sales of deoxyepinephrine injection in China was 68.35 million yuan in 2020 and 41.08 million yuan in the first half of 2021.
As of January 2022, the company has invested 2.06 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 February 18, 2022
