Stock abbreviation: Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) Stock Code: Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) Announcement No.: Lin 2022033 bond abbreviation: Huahai convertible bond bond bond Code: 110076
Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521)
Announcement on the temporary approval number of apixaban tablets obtained by FDA
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 individual and joint liabilities for the authenticity, accuracy and completeness of its contents. Recently, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) (hereinafter referred to as “the company”) received a notice from the US Food and Drug Administration (hereinafter referred to as “FDA”), The brief application for new drug of apixaban tablets (anda, i.e. American generic drug application) declared by the company to the FDA has obtained provisional approval (provisional approval refers to a form of approval given by the FDA because the FDA has completed all the review requirements of generic drugs but the patent right or monopoly right has not expired). The relevant information is hereby announced as follows:
1、 Basic drugs
1. Drug name: apixaban tablets
2. Anda No.: 210133
3. Dosage form: tablet
4. Specification: 2.5 mg, 5mg
5. Application item: anda (brief application for new drugs in the United States)
6. Applicant: Prinston pharmaceutical, Inc
2、 Other relevant information about drugs
Apixaban tablets are mainly used to reduce the risk of stroke and systemic embolism. Apixaban tablets was developed by BMS and was listed in the United States in January 2013. Because the drug is still in the patent protection period, at present, only the original research products are on the market in the United States. In 2021, the sales volume of the drug in the U.S. market was about 158230618 million US dollars (data from IMS database).
Up to now, the company has invested about 7.78 million yuan in the R & D cost of apixaban tablets. Apixaban tablets have obtained the temporary approval number of FDA, which indicates that the product has passed all the evaluation requirements of generic drugs. However, the product can be sold in the U.S. market only after the patent right expires and the final approval of FDA. The temporary approval of apixaban tablets by FDA will help the company strengthen the product supply chain, enrich the product echelon, improve the market competitiveness of the company’s products, and have a positive impact on the company’s expansion of the U.S. market.
Please invest rationally and pay attention to investment risks.
It is hereby announced.
Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) board of directors
April 13, 2022
