China's first domestic western medicine injection was FDA certified in the United States

The U.S. Food and Drug Administration (FDA) Beijing Office confirmed on the 29th that the antitumor drug irinotecan injection manufactured by Jiangsu Hengrui Pharmaceutical Co., Ltd. has passed the FDA U.S. generic drug registration certification, becoming the first domestically-produced western drug through this certification. injection.

FDA spokesperson Pat Elsinavi said that irinotecan injections approved by Hengrui are generic drugs (general drugs) and that there are two doses of products listed on the FDA's generic name list of prescription drugs.

According to Yu Mingde, president of the Chinese Pharmaceutical Enterprise Management Association, this is the first time that Western medicine injections produced by Chinese pharmaceutical companies have received FDA generic drug certification. Obtaining this certification means that the injection product can be formally marketed in the United States, and also opens the door to other overseas markets that reference FDA standards. The FDA certification of domestic injections is a milestone in the implementation of China's pharmaceutical outbound strategy and is a great encouragement to the development of China's pharmaceutical industry.

Sun Feiyang, chairman of Jiangsu Hengrui Pharmaceutical, introduced that the company began to apply for the development of the formulation and product registration for the US market in early 2006. In June 2008, Hengrui Pharmaceutical submitted irinotecan injection registration application to FDA. After five years of efforts, this homemade western medicine injection was officially approved by the FDA in December 2011.

Irinotecan injections were first developed by Pfizer Pharmaceuticals in the United States and were used by Western medicine in the treatment of metastatic colorectal cancer in adults and in adjuvant therapy for patients with chemotherapy failure. Patents patented by Pfizer Inc. in the United States expired in August 2007.

The common name drug is the same as or similar to the original research drug in terms of raw materials, formulas, etc., and it is far less effective than the price of the original study drug. According to the data from the International Monetary Fund, with the large number of patents for in-study drugs that have matured in recent years, the global market for generic drugs has exceeded US$50 billion.