"R & D first brother" change? Half a year's R & D investment is nearly 1.2 billion, and this pharmaceutical company may win the first car-t in China

Wonderful content recently, Fosun Pharmaceutical announced that its investment company Fosun Kate's car-t product fkc876 was officially approved by the clinical trial of the State Food and drug administration, and the product may become the first car-t cell drug approved for marketing in China In the first half of 2018, Fosun Pharmaceutical invested 1.188 billion yuan in R & D to catch up with Hengrui, 5 biopharmaceuticals were in clinical phase III, and rituximab was submitted for listing and was approved soon; during the reporting period, 3 heavyweight products of the company passed the consistency evaluation, and 10 products were in the application stage, making progress beyond most pharmaceutical companies Figure 1: R & D investment of Fosun Pharmaceutical in the same period of 2015-2018 (unit: 100 million yuan) (source: China Daily of listed companies) On August 28, Fosun Pharmaceutical released the 2018 semi annual report The company's operating revenue was 11.859 billion yuan, an increase of 41.97% over the same period of last year, and the net profit attributable to the parent company was 1.561 billion yuan, a decrease of 7.61% over the same period of last year One of the main reasons for the decrease in the net profit attributable to the parent company over the same period of last year was the impact of the increase in investment in innovative R & D and business layout During the reporting period, the R & D investment of the company was 1.188 billion yuan, an increase of 89.82% year-on-year, and the R & D expense was 709 million yuan, an increase of 53.69% year-on-year The pharmaceutical manufacturing and R & D business segment is the support point of the company's performance and the focus of the company's R & D investment In the first half of 2018, the company's R & D investment in pharmaceutical manufacturing and R & D business was 1.064 billion yuan, an increase of 100.9% year-on-year, and the R & D expense was 596 million yuan, an increase of 63.29% year-on-year   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; font-variant-numeric: normal; font-variant-east-asian: normal; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> it is the first car-t battle in China Fosun medicine later ranked in car-t, i.e chimeric antigen receptor T cell immunotherapy At present, it has shown good antitumor effect in the treatment of leukemia, lymphoma, melanoma, glioma and other malignant tumors Novartis, kite and other enterprises are in the leading position in the development of car-t products, and domestic enterprises have grasped the trend of this era, and car-t product research and development has been developing rapidly in China In terms of the current R & D Progress of car-t products of domestic pharmaceutical enterprises, sibyman, bosengji, heyikang, Nanjing legend, etc are at the forefront After 2015, Galaxy biology, Keji biology, Hengrui medicine and other companies have also made great efforts to layout car-t products, all of which have made progress to varying degrees Table 1: R & D Progress of some car-t products in China (source: global drug R & D base of mienei.com) According to data of global drug R & D base of mienei.com, car-t products such as cbm-c30.1, cbm-c19.1, cbm-egfr.1, etc of sibyman, such as pcar-019, anti-MUC1 car T-cell therapy, car PNK, etc of bosengi, have also been in clinical phase II; Car-t products, such as csg-egfr, csg-cd19 and so on, of Keji bio, a rising star, are all in clinical phase I It can be seen that Fosun Pharmaceutical's layout in car-t products is not so early, but the company is catching up with kite pharma At the beginning of 2017, the company established a joint venture with kite Pharma, Fosun Kate, to officially start the research and development of car-t products On September 6, 2018, Fosun Pharmaceutical announced that Fosun Kate's car-t product fkc876 was officially approved by the clinical trial of the State Food and drug administration Fkc876, the US trade name yescarta, was approved by the US FDA on October 18, 2017 It is the first car-t cell drug approved by the FDA for specific non Hodgkin's lymphoma On August 27, 2018, yescarta was approved by European EMA and became the first batch of car-t cell treatment products in Europe for the treatment of recurrent or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (pmbcl) Figure 2: fkc876 review timeline (click on the picture to enlarge) (source: medchina drug review database 2.0 on minenet) According to the data of medchina drug review database 2.0 of minenet, Fosun Kate fkc876's clinical application for the treatment of relapsed and refractory large B-cell lymphoma was accepted and undertaken by CDE on May 18, 2018 with the acceptance number of cxsl1800059 It took only 98 days (less than 70 working days) from the formal acceptance of CDE to the completion of technical review, which shows the efforts of the state in optimizing drug review and approval reform At the same time, it reflects CDE's recognition and affirmation of the quality of the company's application materials Previously, Yang Sheng, deputy director of the registration department of the State Food and drug administration, pointed out: "for the drugs that have been listed abroad, which are seriously life-threatening and have no effective means of treatment and rare diseases, and have been confirmed by research that there is no ethnic difference, the applicant does not need to apply for clinical trials, and can directly apply for listing with the data of overseas trials, and the time of drug listing will be accelerated by 1-2 years." Fosun Kate directly grafts the products that have passed the clinical trials in the United States and the European Union and have been put on the market Now the clinical trials have been approved, and it is expected to promote the clinical trials rapidly in China with the help of overseas data In theory, as long as it proves that there is no ethnic difference, Fosun Kate can directly apply for listing with the overseas test data, and realize the overtaking at a curve in the progress, or "capture" the domestic market First car-t product According to the global drug R & D Library of minenet, in addition to kit's yescarta, the car-t products that have been launched in the world include TIVA pharmaceutical's tisagenlecleucel-t (trade name kymriah), whose target is CD19 with Fosun Kate's fkc876, which is mainly used to treat children and young adults (2-25 years old) with acute lymphoblastic leukemia and adult relapse / refractory large B-cell lymphoma   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; font-variant-numeric: normal; font-variant-east-asian: normal; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> bet mAb biological medicine and rituximab are on the market soon According to the annual report and the mid-term report of Fosun medicine, the company invested 1.529 billion yuan in R & D in 2017 In the first half of 2018, only half a year, the R & D investment reached 1.188 billion yuan, which is almost the total R & D investment of last year The R & D layout of the company focuses on bio innovative drugs such as monoclonal antibodies, bio similar drugs and small molecule innovative drugs Table 2: some products under research of Fosun Pharmaceutical and its subsidiaries (source: Zhongbao of listed companies, minenet database) According to the data of Fosun Pharmaceutical Zhongbao, during the reporting period, the company's monoclonal antibody research and development was further accelerated By the end of the reporting period, the company had 9 monoclonal antibody products (4 biological innovative drugs), 13 indications approved for clinical trials in China, and 2 monoclonal antibody products and 1 combination therapy were accepted for clinical trials in China Trastuzumab, adamumumab and bevacizumab, among the biological analogues, and recombinant human mouse chimeric anti-CD20 monoclonal antibody injection of biological innovation drugs have entered phase III clinical practice, and are expected to successively submit the listing application; rituximab is applied for production and included in the priority review, and is expected to be approved for listing by the end of 2018 The company's biological innovative drug anti-PD-1 monoclonal antibody (hlx10) combined with bevacizumab biological similar drug (hlx04) for the treatment of advanced solid tumors was accepted by the clinical trial registration review of the State Food and drug administration This is the first domestic monoclonal antibody combination treatment scheme accepted by ind application in China This scheme is not only the further implementation of the company's combined treatment strategy, but also an important milestone in the field of domestic combined treatment To sum up, the clinical work of biological analogues for TNF α, VEGF, EGFR targets, and biological innovative drugs for VEGFR2 and EGFR targets are steadily advancing In addition, the three phases of clinical progress of recombinant lysine insulin, recombinant human insulin and recombinant insulin glargine are smooth; In terms of small molecule innovative drugs, fc-110 (furetinib diacid capsule) and PA-824 have entered clinical phase I, and fn-1501 and fcn-437 have been approved for clinical use   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; font-variant-numeric: normal; font-variant-east-asian: normal; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> three varieties have passed the consistency evaluation, and another 10 are on the way In terms of consistency evaluation, the company follows the current policy and promotes the consistency evaluation in an orderly manner During the reporting period, amlodipine besylate tablets (trade name: schlida), escitalopram oxalate tablets (trade name: departure) and alfacalcitol tablets (trade name: Liqing) of the company passed the consistency evaluation successfully Table 3: varieties passed the consistency evaluation of Fosun Pharmaceutical and its subsidiaries (source: minenet database) According to the data of mienei.com, at present, there are as many as 61 manufacturers with amlodipine besylate tablets production approval documents Fosun Pharmaceutical subsidiary is the first enterprise that has passed the consistency evaluation of the product, forming a "tripartite confrontation" with Shanghai haini Pharmaceutical Co., Ltd of Yangtze River and China Resources SECCO Pharmaceutical Co., Ltd that have passed the consistency evaluation According to the end competition pattern of amlodipine in China's public medical institutions in 2017, Pfizer, the original research manufacturer, accounts for more than half of the market share Although the market share of Jiangsu Yellow River Pharmaceutical industry is relatively low, it is expected to further seize the market through the follow-up policy dividend Table 4: application for conformity assessment of Fosun Pharmaceutical and its subsidiaries (source: Med China drug review database 2.0, data statistics as of September 12) According to the 2.0 data of MED China drug review database on minenet, as of September 12, 2018, Fosun Pharmaceutical and its subsidiaries had 17 application acceptance numbers for conformity assessment (excluding the acceptance number of conformity assessment passed, the same below), involving 10 varieties (excluding the varieties of conformity assessment passed, the same below), and the application for conformity assessment was second only to Qilu pharmaceutical, among which CDE was obtained during the reporting period There are 9 acceptance numbers of consistency evaluation applications, involving 6 varieties Source: minenet database, listed company China Daily and announcement