Stock abbreviation: Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) Stock Code: Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) Announcement No.: Lin 2022031
Bond abbreviation: Huahai convertible bond bond Code: 110076
Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521)
Announcement on obtaining FDA approval number for preparation products
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") that the company's brief application for new drug of nabilol tablets (anda, i.e. US generic drug application, which is reviewed and approved by the US FDA, which means that the applicant can produce and sell the product in the US market) has been approved. Now the relevant information is announced as follows:
1、 Basic information of drugs
1. Drug name: nabilol tablets
2. Anda No.: 212682
3. Dosage form: tablet
4. Specification: 2.5 mg, 5 mg, 10 mg, 20 mg
5. Application item: anda (brief application for new drugs in the United States)
6. Applicant: Prinston pharmaceutical, Inc
2、 Other relevant information of drugs
Nebirol tablets are mainly used to treat hypertension. Nabilol tablets were developed by Allergan and first listed in the United States in 2008. At present, the main manufacturers of nabilol tablets in the United States include ani, ascend, camber, etc. In 2021, the sales volume of the drug in the U.S. market was about US $23.671 million (data from IMS database). Up to now, the company has invested about RMB 1.073 million in the R & D project of luonaier.
The approval of the Anda number of nabilol tablets indicates that the company has the qualification to sell the product in the U.S. market. The acquisition of the Anda number of the product is conducive to the company's continuous expansion of U.S. market sales, strengthening the product supply chain, enriching the product echelon, improving the market competitiveness of the company's products, and having a positive impact on the company's business performance.
Please invest rationally and pay attention to investment risks.
It is hereby announced.
Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) board of directors
April 10, 2022
