First domestic PD-1 price announced, only 30 yuan / mg

On December 17, 2018, tuoyi, the first anti-PD-1 monoclonal antibody independently developed in China, was approved by the State Drug Administration for listing On January 7, 2019, monarch biology officially announced its pricing The company benefits Chinese cancer patients' families with high quality and high price, and fulfills the solemn commitment of new era innovative Biomedical Company to "healthy China" Tuoyi (treprizumab injection) was approved for the treatment of local progression or metastatic melanoma that had previously failed to receive standard treatment According to Guo Jun, vice president of Peking University Cancer Hospital and Secretary General of CSCO, there are about 20000 new cases in China every year The results show that tuoyi single drug has a significant clinical effect Objective remission rate (ORR) was 17.3%, disease control rate (DCR) was 57.5%, and 1-year survival rate was 69.3% in patients with unresectable or metastatic melanoma who had previously received systemic treatment failure Professor Guo Jun said that tuoyi's approval gives Chinese patients the opportunity to obtain the most advanced level of tumor immunotherapy in the world As the first anti-PD-1 monoclonal antibody with independent intellectual property rights in China, Junshi biology sets the price of tuoyi as 7200 yuan / 240mg (piece) Meanwhile, the "benefit accompanied by benefit -- Bethune tuoyi public welfare donation project" initiated by Beijing Bethune public welfare foundation will also be carried out nationwide See the announcement of the foundation for specific programs Han Jing, deputy general manager of business marketing of Junshi biology, said: "tuoyi is the crystallization of the wisdom of China's high-level innovative drug R & D team, and also the result of the promotion of the national" healthy China "strategy and the reform of the national drug review and approval system The company hopes to repay the families of Chinese patients with high-quality innovation, reduce economic burden and fulfill social responsibility Use Chinese technology to benefit the world and make cancer patients happy and healthy " At present, Junshi biological Suzhou Wujiang production base has actively carried out research to explore the therapeutic effect of tuoyi on indications such as nasopharyngeal carcinoma, non-small cell lung cancer, gastric cancer, esophageal cancer, urothelial cancer, liver cancer and Sanyin breast cancer, so as to benefit more patients as soon as possible At present, the research focus of tumor immunotherapy is mainly on the anti programmed death-1, PD-1) receptor and other immune checkpoint inhibitors, it is different from the traditional chemotherapy and targeted treatment, mainly through overcoming the immunosuppression in patients, reactivating patients' own immune cells to kill the tumor, is a new anti-tumor treatment concept The approved tuoyi (trepril mAb injection) is a new type of recombinant human anti-PD-1 mAb developed by Junshi biology It can block the binding of PD-1 of T-lymphocytes with PD-L1 on the surface of tumor cells, relieve the immunosuppression of tumor cells on immune cells, and enable immune cells to play the anti-tumor immune role again and kill tumor cells Melanoma melanoma has been increasing rapidly in recent years in China It is one of the fastest growing malignant tumors with incidence rate of about 20000 cases The mortality rate is increasing rapidly year by year It has become one of the diseases that seriously endanger the health of our people In terms of treatment, there is a lack of effective standard treatment for melanoma patients who fail in the first-line treatment As the first domestic monoclonal antibody drug with PD-1 as the target, tuoyi (trepril mAb injection) was approved to be listed in China, and obtained the support of major national science and technology projects Since the beginning of 2016, clinical research and development of this product has been started, and so far, more than 20 clinical trials are in progress, including those in the United States In March 2018, the State Drug Administration officially accepted the listing registration application of this product, and included it in the priority review and approval varieties to speed up the review and approval The clinical trial results showed that the objective remission rate, disease control rate and 1-year survival rate of patients with unresectable or metastatic melanoma who had previously failed to receive systemic therapy were 17.3%, 57.5% and 69.3%, respectively The approval of this product on the market is of positive significance to the choice of clinical medication for cancer patients in China About Junshi biology, Junshi Biology (neeq: 833330, HKEx: 01877) was founded in December 2012 by a team of well-known universities graduated from China and the United States with rich experience in the transformation of transnational scientific and technological achievements and industry Junshi biology focuses on the development and industrialization of monoclonal antibody drugs and other therapeutic protein drugs At present, it has a wealth of product pipelines under research, including 12 innovative drugs and 1 biological analogue It is the first Chinese company to submit ind application and NDA to nmpa on anti PD-1 monoclonal antibody, and the first Chinese company to obtain ind application approval of nmpa on anti PCSK9 monoclonal antibody and anti BLyS monoclonal antibody in China At present, it has more than 500 employees in the world, which are located in San Francisco and Maryland, Shanghai, Suzhou and Beijing, China.