China's PD - (L) 1 antibody R & D echelon has been set. If we don't work hard this year, we will become the 18th tier!

In 2018, the approval and listing of PD - (L) 1 antibodies such as odivo, coreda, tuoyi and dabushu in China ushered in a new era of cancer immunotherapy in China, especially the successful development and commercialization of tuoyi and dabushu, which represents an important breakthrough in the field of pharmaceutical innovation in China and the infinite vitality of biomedicine On March 28, 2019, the second indication in China, namely, the combination of pemetrexed / platinum chemotherapy for the first-line treatment of EGFR - / ALK non squamous NSCLC patients, was harvested This is an indication of Coretta's overweight This year, there are still a number of progress in PD - (L) 1 antibody, which is worthy of attention In this paper, several important progress are briefly summarized and prospected Up to now, four PD - (L) 1 antibodies have been approved for listing in mainland China This is a typical case of drug review and approval reform of the State Drug Administration and innovation breakthrough of domestic enterprises, in which there is no need to elaborate the significance Table 1 at present, the four anti-PD - (L) 1 antibodies approved for listing in mainland China have been successfully commercialized, among which Shanghai Pharmaceutical has obtained the national general agent rights and interests of opdivo and keytruda According to the 2018 financial report of Shanghai pharmaceutical, odivo and coreda have become important drivers of the company's distribution revenue growth Junshi biological tuoyi and Xinda biological / Lilai dabeshu have also won the bid in Shanghai, Gansu, Jiangxi and other provinces and cities The innovation of domestic PD - (L) 1 antibody not only represents an important breakthrough in the development of domestic innovative drugs, but also impacts on the same kind of imported drugs to some extent Table 2 the pricing of 4 PD - (L) 1 antibodies approved for listing in mainland China is noteworthy that 4 PD - (L) 1 antibodies have corresponding rescue or assistance programs In 2019, Pd - (L) 1 antibody is still expected to be full In 2018, the approval of four PD - (L) 1 antibodies in China has ushered in a new era In 2019, there are still many noteworthy progress in the review and approval of PD - (L) 1 antibody Attention 1: AstraZeneca's "Pacific storm" is about to land in China On December 26, 2018, AstraZeneca PD-L1 McAb submitted an application for listing to nmpa In the 2018 financial report, it was approved that the indication of this listing application was unresectable three-stage NSCLC without progress after chemotherapy Pacific (nct02125461) confirmed that durvalumab could bring clinical benefits to patients with stage III NSCLC, which also became the main driving force for the rapid growth of durvalumab's market performance In 2019, the approval of durvalumab will bring more choices to patients with stage 3 non-small cell lung cancer in China Attention 2: the review progress of the technical review of karelizumab (trade name: Alito) is about to be completed, which has attracted the attention of the industry At present, the review cycle of karelizumab is significantly longer than that of the four PD-1 mAbs that have been listed According to the 2018 annual report of Hengrui medicine, carrizumab is one of the heavyweight products developed by Hengrui in recent years, and has invested nearly 400 million yuan in research and development At present, the technical review of cxss1800009 is completed, and the review sequence of supplementary information is still in progress The author expects that the administrative approval of alitol (carrizumab, acceptance No cxss1800009) will be launched in early April 2019, and it will be approved for listing within the month, and the review progress is worthy of continuous attention Table 3 application acceptance No for listing of PD - (L) 1 antibody (under review) attention 3: nafulizumab and pabolizumab will be approved for several new indications Pabolizumab has become an unstoppable leader in the market of PD - (L) 1 antibody due to its stable performance in the field of lung cancer and its sales volume has skyrocketed Therefore, the expansion of lung cancer indications also largely determines the performance of pablizumab in China On March 28, 2019, pabolizumab completed the first indication expansion and gained a super weight indication According to the clinical registration information of CDE, the clinical progress of pablizumab in lung cancer and esophageal cancer is leading, and the development of gastric cancer indications is suspended Therefore, the author speculates that the two acceptance numbers of pabolizumab in the review are still lung cancer indications, which are the first-line treatment for patients with squamous NSCLC combined with chemotherapy and the single drug for PD-L1 positive non-small cell lung cancer, which are expected to be approved in the second quarter of 2019 Table 4 PD - (L) 1 antibody indication extension acceptance No (under review) attention 4: compared with other PD - (L) 1 antibodies in China, the new listing application of Hengrui medicine karelizumab has a wide range of indications, among which, the progress of HCC, non-small cell lung cancer, nasopharyngeal carcinoma and so on is leading In 2019, the author speculates that carrizumab will submit at least one new application for marketing Attention 5: at present, Junshi biology, Xinda biology, Hengrui medicine and Baiji Shenzhou have taken the lead in the development of other indications of PD - (L) 1 monoclonal antibody in China and entered the first echelon of PD - (L) 1 monoclonal antibody At the same time, many enterprises are still in the late clinical stage The details are as follows: the first domestic PD-L1 mAb is expected to be produced in cornerstone pharmaceutical, Hengrui pharmaceutical and kangningjierui The product has entered phase 3 clinical trials, and there is no phase 3 clinical data published; The layout of products with Hodgkin's lymphoma indications, such as cs1001, ak105, tqb2450, kl-a167, gls-010, deserves special attention These products are likely to take the lead in completing the listing with Hodgkin's lymphoma indications, or the backbone of domestic application for listing of PD - (L) 1 monoclonal antibody in the next 1-2 years Therefore, who will enter the second largest listing echelon of PD - (L) 1 monoclonal antibody in China, and the follow-up product development progress of cornerstone pharmaceutical, Corning Jerry, Zhengda Tianqing, Jiahe biology, Kelun pharmaceutical, and Yaoming biology are most worthy of expectation Table 5 development of indications of PD - (L) 1 monoclonal antibody