Doxorubicin Hydrochloride for Injection, with annual sales of US $600 million, has been approved by Haizheng pharmaceutical in the United States

Just now, Haizheng pharmaceutical released an enterprise announcement that its holding subsidiary Haizheng Pharmaceutical (Hangzhou) Co., Ltd (hereinafter referred to as "Haizheng Hangzhou company") received a notice from the U.S Food and Drug Administration (hereinafter referred to as "FDA"), and Haizheng Hangzhou company applied to the U.S FDA for the brief application for new drug of doxorubicin hydrochloride for injection (anda, i.e the U.S generic application) Please obtain FDA review approval, which means that the applicant can produce and sell the product in the U.S market) Basic information of drug name: doxorubicin hydrochloride for injection anda No.: 206062 dosage form: injection specification: 20mg / bottle application item: anda applicant: doxorubicin hydrochloride for injection of Haizheng Pharmaceutical (Hangzhou) Co., Ltd is mainly applicable to the treatment of breast cancer postoperative adjuvant treatment and other malignant tumor diseases The original research drug adriamycin injection USP, 20mg / vial, is developed by Pharmacia & Upjohn company The domestic and foreign manufacturers and sales manufacturers mainly include west-ward pharmaceuticals int, amneal pharmaceuticals, Shenzhen Wanle Pharmaceutical Co., Ltd., Shanxi Pude Pharmaceutical Co., Ltd., etc According to statistics, the global sales volume of doxorubicin hydrochloride for injection in 2017 is about 560038200 US dollars, including 187367900 US dollars in the U.S market; 573099900 US dollars in 2018, including 163.9778 US dollars in the U.S market (data source: IMS) Up to now, the company has invested about 15.7 million yuan in the R & D project of doxorubicin hydrochloride for injection The FDA approval of doxorubicin hydrochloride anda for injection marks that the company has the qualification to sell the product in the U.S market, which has a positive impact on the company's expansion of the U.S market.