FDA Approves the orphan drug qualification of Yisheng biological immunotherapy drugs in the field of liver cancer treatment

The US Food and Drug Administration (FDA) has officially approved ys-on-001 as an orphan drug for liver cancer treatment, the company said today The product is a macromolecular biological preparation independently developed by the researchers of living organisms, with independent intellectual property rights It can weaken the immunosuppressive effect of tumor microenvironment and improve the killing function of immune system on tumor cells, which is also a major discovery and breakthrough of Chinese scientists in the field of tumor immunity Zhang Yi, chairman and chief executive officer of Yisheng biology, said: "this innovative drug has obtained the orphan drug qualification granted by the US FDA, which is an important milestone in the company's R & D history, and a comprehensive scientific certification of the product in terms of drug composition, anti-cancer mechanism, cancer treatment effect, etc This recognition will greatly promote the R & D process of ys-on-001 and make it expected to be approved quickly In addition, once approved for listing, it will enjoy a 7-year US market monopoly period " "Ys-on-001 has a unique anti-tumor mechanism," said Zhang Yi, chairman of the board It regulates the patient's immune system by inducing the production of various cytokines, regulating the differentiation of NK cells, macrophages and T cells, which is different from the monoclonal antibody checkpoint inhibitors approved by FDA in recent years, such as PD-1 and PD-L1 Many animal experiments show that our products have more attractive broad-spectrum in anti-tumor This product shows excellent efficacy and safety in the treatment of breast cancer, lung cancer, liver cancer and other solid tumors, and its antitumor effect is no less than or even better than the first-line chemotherapy drugs and targeted drugs " Referring to the layout of clinical development, Zhang Yi pointed out that "in recent years, orphan drugs account for about 30% to 40% of all FDA approved innovative drugs At present, anti-cancer drugs in the United States are basically approved through orphan drug pathway with rare diseases as indications Our anticancer drug is to be developed clinically in many countries, including liver cancer, breast cancer, lung cancer and other indications Although liver cancer is a rare disease in the United States, the incidence of liver cancer in China accounts for 50% of the global population (according to statistics, in 2012, the incidence of liver cancer in the world is about 780000) It is the responsibility and mission of our biopharmaceutists to promote safe and effective anti liver cancer drugs to the market as soon as possible We will actively work closely with the FDA of the United States, regulators in China and other countries to accelerate the development process of this product and benefit cancer patients as soon as possible! " Orphan drug is a new kind of drug and biological preparation approved by FDA for safe and effective treatment, diagnosis and prevention of rare diseases / disorders Rare diseases are defined in the United States as diseases with fewer than 200000 patients in the United States Rare disease is a regional concept, which is defined as rare disease in the United States and common disease in other countries Therefore, orphan drugs developed in the United States may have a large potential market in other countries and regions, and drugs approved by the U.S FDA are relatively easy to enter other markets, For example, Article 7 of cfda140 document of the State Food and Drug Administration of China states that "for the drugs that the applicant applies for registration in the European Union and the United States drug approval agencies at the same time, separate queues shall be implemented to speed up the review and approval" Therefore, making use of the regional differences in the definition of orphan drugs is one of the strategies for the simultaneous development of globalization About ys-on-001 Ys-on-001 is a macromolecular drug with biological immune regulation function independently developed by Yisheng biology It has the functions of promoting Th-1 immune response, inducing the activation and proliferation of dendritic cells (DC), B cells and natural killer cells (NK), regulating the polarization of tumor-related macrophages from m2 to M1, and down regulating T cells It can achieve the goal of breaking the immunosuppressive state and improving immunity at the same time The killing function of epidemic system to tumor cells Ys-on-001 has shown a very good effect in many tumor model animal experiments, such as breast cancer, lung cancer, liver cancer and other malignant solid tumors In addition, the product showed good safety in preclinical toxicology research About Yisheng biopharmaceutical Co., Ltd Yisheng biopharmaceutical Co., Ltd is a biopharmaceutical company headquartered in Beijing, China It focuses on the research, development, manufacturing and sales of new immune drugs and vaccines It has about 1000 employees in China, the United States and Singapore.