Minutes of overseas authorized conference call of Hengrui pharmaceutical PD-1

The company has signed an agreement with Incyte company, the main content of which is: within 30 days after receiving the receipt from Hengrui, Incyte company of the United States will pay the down payment of US $25 million Milestone payment for listing: after the successful listing of shr1210 in the European Union, the United States and Japan, Incyte company of the United States paid a milestone payment of no more than 90 million US dollars to Hengrui; milestone payment for Clinical Excellence: shr1210 achieved excellent results in clinical trials abroad, and Incyte company of the United states paid 150 million US dollars to Hengrui; Milestone payment of sales performance: after the sales volume of shr1210 reached different targets, Incyte company of the United States paid Hengrui a milestone payment of no more than 530 million dollars in total After the overseas listing of shr1210, Hengrui will commission from its sales according to the agreed proportion Cooperation produces win-win benefits, and Hengrui's internationalization strategy is further promoted Incyte is a NASDAQ listed company with strong R & D capabilities, especially in rheumatoid arthritis projects, autoimmunity and tumor immunotherapy It cooperates with Roche, Merck, Squibb and other major manufacturers, and develops an independently developed tumor drug Ido (a compound in the field of small molecule tumor therapy) PD-1, PD-L1 and PD-1 are both in clinical development At present, PD-1 has been fully verified in clinical practice, and its preclinical data has certain advantages compared with the original research drug The trend of immunotherapy in the world is combination The combination of PD-1 and Ido is a promising treatment in the future For Incyte, having PD-1 will get great flexibility, and with the combination of IDO, a complete closed-loop treatment can be obtained For Hengrui, although the process of PD-1 single drug in the western market is relatively late, its associated combined therapy process is not lagging behind Because PD-1 is a relatively safe target, basically without side effects, it can be combined with many chemotherapy drugs, and more importantly, it can be combined with targeted drugs such as apatinib, which makes the clinical application of PD-1 more extensive Incyte is about to launch the overseas PD-1 clinical project Due to the relatively fast clinical time in the United States, the overseas market may be earlier than that in China Immunotherapy layout is perfect, relying on the product portfolio to consolidate the product line The company's immunotherapy layout started five years ago, storing more than ten relatively mature projects and potential projects in the future It is the layout of the whole product line, and it is expected that more products will be applied for clinical application in the next year At present, we have achieved good results: PD-1 overseas authorization + the first application in China, IL-17 clinical application in China, etc Tumor immunotherapy can not be solved by single drug and single antibody, but by multiple product combinations The company has a good combination of tumor immune program, targeted treatment and chemotherapy drugs, and has a strong foundation, which needs to be further applied in clinical The company actively explores the field of cell therapy Immunotherapy PD-1 still belongs to the category of monoclonal antibody products In the world, another major direction of individualized treatment is cell therapy, but the effect of cell therapy alone is limited Especially for the treatment of solid tumors, the transfer of cell immunotherapy to solid tumors needs to be studied and verified Hengrui is willing to cooperate with companies in the field of cell therapy It is expected that PD-1 and other antibodies will be used in the cooperation With the standardization of cell therapy in China, Hengrui will have a layout in the future The introduction of good technology will not be excluded The starting point should be from the efficacy of solid tumors Clinical data can be shared, and overseas clinical progress is expected to accelerate Incyte is in charge of clinical work outside of China for PD-1 Australian clinical work has been started The company and Incyte jointly manage clinical projects FDA of the United States recognizes Australian clinical data, and can directly use Australian phase I clinical data to do phase II and phase III clinical work in the United States The overseas clinical layout will be relatively accelerated Considering the problems of Chinese laws and regulations, it is unknown whether CFDA can approve the clinical data of Australia PD-1 product structure is completely innovative, the target is known, and the product is completely innovative with independent intellectual property rights The company strives to communicate with CFDA, obtain clinical approval documents in China, and try to make the clinical progress in China and overseas simultaneously Bio medicine is the development direction of the company, with an investment of more than 800 million for antibody production Biopharmaceutical technology is more difficult, and the foundation of Chinese pharmaceutical companies is relatively weak In terms of the company's biopharmaceutical layout, from the number of applications, we can see that Biopharmaceutics account for a considerable proportion The company has invested a lot, imported almost all of its equipment, and introduced quite a number of high-end talents An antibody workshop has been built in Shanghai, and it is planned to invest about 850 million in Suzhou for antibody production in the future The company's main scientists have the ability to extract effective information to form targets in the era of information equality, and use antibodies to improve biological drugs The internationalization path will continue to advance, and more products will be introduced in the future by taking advantage of the R & D advantages of overseas innovative drugs The cooperation between the company and tesaro started before the approval of FDA, so the price is more favorable The antiemetic is characterized by a longer-term and safer effect, which can meet the clinical needs of chemotherapy-induced vomiting Hengrui attaches great importance to the quality of its partners' products and has strict requirements on drug quality There are two directions for the internationalization of the company: first, to bring out the company's products, and second, to bring in good overseas products The company has the advantage of introducing a large number of plates, such as tumor and tumor adjuvant treatment field, the company should make a comprehensive layout based on the existing pipeline, and further improve the product line The number of innovative drugs in the post clinical application stage of the company is more than 20 in China, and the clinical progress of apatinib phase III liver cancer and lung cancer is smooth The safety and effectiveness of apatinib have been verified, and the company is more confident; the clinical effect of famitinib in the third phase treatment of colorectal cancer is better; pyrrolidine not only does clinical trials in China, but also starts clinical trials in the United States, and the tolerance of three patients in the United States is better, which is the product that the company attaches great importance to Incyte clinical registration application is more flexible, do not exclude the combination of IDO and PD-1 application Incyte has no difference to Hengrui's agreement contract whether it is single drug or combined drug The company is optimistic about the R & D capability of Incyte, and the clinical application and application of Incyte are also flexible It is possible for Incyte to do single drug phase I clinical treatment, and then to do phase II and phase III combined clinical treatment, which may speed up the application.