Where has the global R & D wave come to be the first choice for overseas clinical trial bases of Chinese pharmaceutical enterprises?

Source: e drug manager 2018-06-04 the emergence of immunotherapy targeting the programmed death receptor-1 / ligand-1 (PD-1 / PD-L1) pathway has had a devastating impact on the strategies of all pharmaceutical companies As the industry feels, the release of every new data may mean the reorganization of enterprises, the birth of new partners and the transformation of global development plans China's booming biotechnology industry is at an appropriate time, and has the ability to participate in and influence this development wave China's pharmaceutical industry policies are changing rapidly, and some policies that are conducive to new drug developers have been implemented One of the significant changes is that before the company had to wait for 1-2 years or even longer to obtain clinical trial approval, now the State Food and Drug Administration (CFDA) has proposed to shorten the review period of ind to 60 working days (equivalent to 3 months) With the reform and opening up of the policy, the biomedical industry is more and more favored by investors No matter for the start-up biotech companies established by returnees or the mature pharmaceutical companies, there are more and more financing opportunities for enterprises, and the stock price is also rising As a virtuous circle, more and more high-quality drugs begin to be born in China, because domestic biotechnology companies with sufficient funds are more likely to attract world-class scientists 1 The proven anti-tumor potential of R & D wave PD-1 / PD-L1 pathway in a variety of cancer types has made it an irresistible R & D target of China's emerging biotechnology companies According to GBI source data, since the first clinical trial of PD-1 antibody drug (Shanghai Junshi Biology) was approved in December 2015, as of March 30, 2018, there have been 16 PD-1 / PD-L1 antibody drugs approved by domestic companies in clinical trials in China, and 5 applications are under review In addition to the public data, some industry figures believe that at least 50 Chinese companies are currently developing PD-1 / PD-L1 antibody drugs Since the beginning of November 2017, BMS has been the first to submit the listing application of its PD-1 antibody drug nivolumab in China As of March 30, 2018, four enterprises have successively submitted the listing application of PD-1 antibody drug in China The other three enterprises are Cinda bio, MSD and Junshi bio In addition to Cinda biological said that its application for the indication of recurrent / refractory Hodgkin's lymphoma, the other three enterprises did not disclose specific indications According to the Chinese drug clinical trial registration and information publicity platform, up to now, MSD has carried out 8 clinical trials on pembrolizumab in China The indications include non-small cell lung cancer, liver cell cancer, esophageal cancer, gastric cancer, melanoma and other indications Junshi biology is carrying out 16 clinical trials of its PD-1 candidate drug js001 in China, covering more than 10 indications such as melanoma, NPC, gastric cancer, lung cancer, esophageal cancer and urothelial cancer According to people familiar with the matter, both the indications of mosadong and Junshi biological application are melanoma As for BMS, according to its clinical trials in China, the indication is likely to be non-small cell lung cancer (NSCLC), because the phase III clinical trials for NSCLC patients, including first-line / second-line treatment, are the fastest growing in BMS In addition, among the first echelon of PD-1 / L1 research and development of domestic enterprises, Jiangsu Hengrui's PD-1 drug shr-1210 is more prominent According to the Chinese drug clinical trial registration and information publicity platform, Hengrui currently conducts 20 clinical trials related to the drug, including 4 phase III or phase II / III studies, with NSCLC, advanced esophageal cancer and advanced liver cell cancer (HCC) as indications Zou Jianjun, chief medical officer and vice president of clinical research and development of Hengrui pharmaceutical, said at the China trials 10 forum held in 2017 that he expected enterprises to develop different indications according to their specific advantages: "I hope that each company can have different concerns and solve more tumor types If there are already 4-5 listed companies in the market, the opportunities for the latter companies are less and less " NSCLC is the most crowded field in terms of clinical trials being carried out by various companies, but considering that there are more than 700000 newly diagnosed patients in China every year, this clustering phenomenon is not difficult to understand Hengrui is combining shr-1210 with chemotherapy (pemetrexed and carboplatin) for the first-line treatment of NSCLC In addition, PD-1 inhibitors of Cinda and Baiji Shenzhou have also entered the key research stage in NSCLC indications, and both of them are carrying out second-line treatment, in which Cinda focuses on non squamous NSCLC patients in the late stage (IIIB / IV) 2 Before the first overseas human trial CFDA, the reform on accepting overseas clinical trial data is not only beneficial to multinational companies, but also beneficial to domestic enterprises Industry insiders in China's biopharmaceutical industry say they also welcome this change and plan to take full advantage of it The development of PD-1 / L1 antibody drugs is a good example These local companies usually focus on tumors related to Chinese patients at first, but they usually conduct early clinical trials overseas before returning to China for follow-up research Australia and the United States are the preferred overseas clinical trial sites for Chinese companies Of the 10 PD-1 / L1 molecules that have been disclosed in clinical trials, 5 are in early clinical studies overseas Among them, kangfang biological selection carried out the research of PD-1 antibody drug ak104 in Australia, and kangningjeri / thingdi, Lizhu medicine and Fosun medicine selection first carried out clinical trials in the United States Bgb-a317 of Baiji Shenzhou is on the global R & D route The company is conducting an international multi center clinical trial in the United States, Australia, Taiwan, South Korea and New Zealand Although Hengrui is mainly engaged in the research and development of PD-1 monoclonal antibody SHR-1210 in China, the company still decided to select Australia as the first human trial site for the later PD-L1 candidate drug SHR-1316 Australia and the United States have become the first choice for early clinical research, mainly due to their relatively fast and transparent management and processing capabilities, as well as the lack of professional first human body testing institutions in China As far as Australia is concerned, the government will give tax credits to biotechnology companies in any country invested in the country, ranging from 38.5% to 43.5% For small companies with turnover less than $20 million, they can also choose to directly get cash back However, in China, the current preferential treatment and subsidies are mostly limited to the new companies established by "returnees" A broader and open R & D incentive mechanism still needs to be implemented to further encourage the research and development of innovative drugs.