China's bio pharmaceutical industry in the direction of a major breakthrough

        - FDA approved orphan drug therapy according to the biological immune qualification in the treatment of liver cancer in the field

        Beijing, October 2016 24 / PRNewswire / -- Yisheng biopharmaceutical company limited today announced that the U.S. Food and Drug Administration (FDA) has officially approved its flagship product YS-ON-001 has orphan drug in the treatment of liver cancer qualification. The product is a mutualist researchers developed molecular biological agents with independent intellectual property rights, to weaken the tumor microenvironment immunosuppressive effect and cytotoxicity to tumor cells to enhance the immune system, which is a great discovery and breakthrough Chinese scientists in tumor immunology aspect.

The chairman of the mutualist CEO Zhang Yi said: "this new drug received orphan drug qualification awarded American FDA company research and development is an important milepost in the history of the products in the pharmaceutical composition, anticancer mechanism, cancer therapeutic effect of comprehensive scientific certification. This recognition will greatly promote the development process of YS-ON-001, and it is expected to quickly approved. In addition, once approved the listing, will enjoy 7 years of the U.S. market monopoly period."

Zhang Yi, chairman of the board, said: "YS-ON-001 has a unique anti tumor mechanism. It is to regulate the patient's own immune system by inducing a variety of cytokines, regulatory NK cells, macrophages and T cells differentiation pathway, and the monoclonal antibody immune checkpoint inhibitor recently approved by the FDA, such as PD-1, PD-L1, monoclonal antibody drugs are different. A number of animal experiments show that our products have a more attractive broad spectrum of resistance to solid tumors. This product in the breast cancer, lung cancer, liver cancer and other solid tumors show a good efficacy and safety, and its anti-tumor effect is not inferior to or even superior to first-line chemotherapy drugs and targeted drugs."

        Speaking on the layout of the clinical development, Zhang Yi pointed out: in recent years, the United States FDA approval of all innovative drugs in the orphan drugs accounted for about 30% to 40%. At present, the anticancer drug in the United States is basically the first through a rare disease as an orphan drug access to obtain approval. Our anticancer drug is intended to be developed in a number of countries, including liver cancer, breast cancer, lung cancer and other indications. Although hepatocellular carcinoma is a rare disease in the United States, but Chinese HCC patients accounted for 50% of the population worldwide incidence (according to statistics in 2012 the global incidence of liver cancer is about 780000), as soon as the safe and effective market of anti hepatoma drugs is our responsibility and mission for the biopharmaceutical people. We will actively cooperate with the United States FDA, China and other countries of the regulatory agencies to accelerate the development process of this product, as soon as possible to benefit cancer patients!"

Refers to the orphan drug approved by the FDA for new drugs and biologics is safe and effective for the treatment, diagnosis and prevention of rare diseases / disorders. The definition of rare disease in the United States is a disease that is less than 200 thousand people in the United States. A rare disease is a regional concept in the United States, defined as a rare disease, is a common disease in other countries may, therefore the potential market in the U.S. orphan drug development in other countries and regions may be large, drugs have been approved by the US FDA is relatively easy to enter other markets, such as the CFDA State Drug Administration China No. 140 the seventh statement of the applicant "in the European Union and the United States drug approval mechanism for synchronous application for registration of the drugs, the implementation of a separate queue, to speed up the review and approval". Therefore, the use of the geographical differences in the definition of orphan drugs, is one of the strategies for the development of globalization.