China's first overseas authorization of innovative biological drugs

Source: Science and technology daily 2015-09-21 (correspondent Zhang Suya) recently, Jiangsu Hengrui Pharmaceutical Co., Ltd., with a down payment of US $25 million plus a total amount of US $770 million, sold the foreign equity of PD-1 antibody SHR-1210 with independent intellectual property rights to us Incyte The company has realized the first transfer of innovative biological drugs by Chinese enterprises, adding a touch of bright color to the international development of China's pharmaceutical industry The transferee, Incyte, is mainly engaged in the R & D and sales of tumor treatment and inflammatory treatment products with independent intellectual property rights In 2015, it ranked the third in the biomedical field in Forbes magazine's "the most innovative company in the world" In addition to mainland China, Hong Kong, Macao and Taiwan, Incyte will be granted the right of exclusive clinical development and marketing It is reported that PD-1 is one of the most popular new drug projects in the world in the past five years, which can effectively improve human anti-tumor immunity Hengrui medicine has been engaged in the research and development of PD-1 monoclonal antibody since 2012 At present, it has applied for the domestic patent of shr-1210 and the international patent of PCT In December last year, the company was the first in China to submit a clinical application for new drugs, which is currently in the clinical stage to be approved As a forerunner of the internationalization of Chinese pharmaceutical preparations, Hengrui pharmaceutical has continuously strengthened international cooperation in recent years to promote innovation and research, development and promotion of high-quality drugs, and accelerated transformation and upgrading Since 2011, the company has "irinotecan injection", "oxaliplatin for injection", "letrozole tablets", "cyclophosphamide for injection" and other preparation products, including injection, successively listed in the United States, the European Union or Japan, among which cyclophosphamide injection won FDA at the end of 2014 Approved for marketing in the United States, the first half of this year alone accounted for 45% of the drug's market share in the United States In August this year, the company reached an agreement with American tesaro company to introduce rolapitant, a patent antiemetic drug used by tesaro company for tumor adjuvant treatment, to carry out clinical development, registration and marketing in China In addition, the company also has several innovative drugs such as pyrrolidine to carry out clinical research in the United States The cooperation with Incyte in the United States will help speed up the development of shr1210 in the world, provide better treatment for cancer patients in the world after its listing, further enhance the company's innovative brand, and accelerate the internationalization process of innovative drugs.