Hengrui pharmaceutical PD-1 project sr1210 gains US $25 million before entering clinical practice

On September 3, Hengrui pharmaceutical announced that it would license the PD-1 monoclonal antibody project (sr1210) for tumor immunotherapy with its own intellectual property rights to Incyte company in the United States for compensation, and Incyte company would obtain the global exclusive clinical development and marketing rights except for mainland China, Hong Kong, Macao and Taiwan The announcement also said that within 30 days after the signing of the agreement and receiving the receipt from Hengrui, Incyte company of the United States will make a down payment of US $25 million to Hengrui In addition, the two parties agreed to pay milestone payment in three steps After the successful listing of sr1210 in Europe, America and Japan, Incyte company will pay Hengrui a milestone payment of no more than 90 million US dollars in total In the payment terms of Clinical Excellence milestone, shr1210 achieved excellent results in foreign clinical trials, Incyte company in the United States paid Hengrui 150 million US dollars and sales performance milestone In the payment terms, after shr1210's sales reached different targets, Incyte company of the United States paid Hengrui a milestone payment of no more than 530 million dollars in total In addition, both parties also agreed on the sales commission, that is, after the listing of shr1210 abroad, Hengrui will commission from its annual sales according to the agreed proportion Incyte will prepare to conduct clinical trials after signing the agreement Both sides work together to fully promote the development and listing of the project PD-1 monoclonal antibody has always been a hot spot in immunotherapy, and it is also the front position of competition among pharmaceutical giants In recent years, PD-1 products have been listed in foreign countries, and investors have given high expectations In 2014, the most popular antibodies were opdivo of Bristol Myers Squibb and keytruda of mosadong, which were mainly used for the treatment of melanoma E valuepharma said that the market sales of opdivo in 2020 is expected to be US $6.201 billion, Keytruda's global sales will reach US $3922 million by 2020 In the past two years, the most exciting clinical trial of the annual meeting of clinical oncology in the United States is probably the Black Whirlwind brought by PD-1 anti-cancer antibody The clinical anticancer effect of PD-1 antibody is unprecedented It can control the cancer progression of 50% of skin cancer patients and cure about 10% of skin cancer patients For stubborn non-small cell lung cancer patients, there has been no medical solution for many years PD-1 antibody also has clinical control effect on 24% of patients Because of its broad-spectrum anticancer effect, the clinical efficacy of renal cancer, gastric cancer, breast cancer, bladder cancer, blood cancer, head and neck cancer, colorectal cancer and brain cancer is also in the clinical phase II or phase III trials   According to Zhou Feng, an expert in product and solution of Thomson Reuters, the current tumor immunotherapy represented by PD-1 has also triggered an investment boom According to the statistics of transaction database of Thomson Reuters, the heavyweight transactions on tumor immunity have occurred frequently in recent years, and the vast majority of them are related to multinational companies, such as Pfizer and Merck xuelano, who jointly develop the cooperative transaction value of PD-L1 drugs 2 US $850 million shows the enthusiasm of multinational companies in this direction It is estimated that the market size of tumor immunotherapy, including PD-1, will reach US $35 billion, with a compound annual growth of more than 20% In March 2014, the national health and Family Planning Commission published the "2015 key content direction of major new drug development science and technology projects", which clearly listed tumor immunotherapy as the support focus, fully reflecting the national level's concern for tumor immunity It is understood that at present, only Hengrui medicine and Junshi biology have applied for PD-1 inhibitors in China, and they are both in the clinical application stage The PD-1 inhibitor monoclonal antibody (shr-1210) of Hengrui medicine has been listed in the priority review varieties (the major special recommendation of national major new drug creation technology), and is expected to take the lead in the domestic market The recombinant humanized anti-PD-1 monoclonal antibody (js001, preclinical research stage) of monarch is the first clinical application of PD-1 monoclonal antibody in China In addition, the enterprises that are developing PD-1 inhibitors include Baiji Shenzhou, etc.