The first drug imitated by Haizheng Pharmaceutical Co., Ltd. tegrilol tablet was approved in the United States

On October 16, Zhejiang Haizheng Pharmaceutical Co., Ltd (hereinafter referred to as "the company") announced that its holding subsidiary, Haizheng Pharmaceutical (Hangzhou) Co., Ltd (hereinafter referred to as "Haizheng Hangzhou company"), had received a notice from the U.S Food and Drug Administration (hereinafter referred to as "the U.S FDA"), and Haizheng Hangzhou company applied to the U.S FDA for the brief application of tigrilol tablets (anda, U.S generic application) has obtained temporary approval (temporary approval: a form of approval given by FDA because it has completed all the review requirements of generic drugs, but the patent right or monopoly right has not expired) Basic information of the drug 1 Drug name: tegrilol tablet 2 Anda No.: 208575 3 Dosage form: tablet 4 Specification: 90mg 5 Application items: anda 6 Applicant: tegrilol tablet of Haizheng Pharmaceutical (Hangzhou) Co., Ltd is suitable for the treatment of acute coronary syndrome The original drug of tegrilol tablet was developed by AstraZeneca According to statistics, the global sales volume of tegrilol tablets in 2017 is about $1.247 billion, including $692 million in the U.S market; from January to June 2018, the global sales volume is about $772 million, including $435 million in the U.S market (data source: IMS) Up to now, the company has invested about 11 million yuan in the drug R & D project Tegrilol tablet (90mg) is the first copy application submitted by the company to the U.S FDA This time, tegrilol tablet obtained the U.S FDA temporary approval number, indicating that the product has passed all the review requirements of generic drugs However, the product can only be qualified for sale in the U.S market after the patent expires and the final approval of FDA The company will continue to pay attention to the follow-up progress and fulfill the obligation of information disclosure in a timely manner The temporary approval number of tegrilol tablets from FDA marks the further promotion of the company's business in the field of generic drugs, which has a positive impact on the company's expansion of the U.S market.