The R & D investment of Shanghai Pharmaceutical Co., Ltd. has reached a new high repeatedly, focusing on the development of these seven new drugs in 2018

On March 23, SHP released its 2017 annual report (hereinafter referred to as the annual report): the company's revenue was 130.847 billion yuan, an increase of 8.35% year on year; the net profit attributable to shareholders of the listed company was 3.521 billion yuan, an increase of 10.14% year on year Field focus + key product strategy to drive industrial growth Shanghai Pharmaceutical is a large pharmaceutical industry group listed in Shanghai and Hong Kong Its main business covers pharmaceutical industry, distribution and retail During the reporting period, the sales revenue of the pharmaceutical industry was 14.987 billion yuan, up 20.71% year on year; the sales revenue of the pharmaceutical distribution business was 116.150 billion yuan, up 6.93% year on year; the sales revenue of the pharmaceutical retail business was 5.640 billion yuan, up 9.44% year on year It can be seen from this that although pharmaceutical distribution is the main source of pharmaceutical revenue in Shanghai, and pharmaceutical industry only accounts for a small part of the total revenue, from the perspective of development, pharmaceutical industry has a strong growth momentum In addition, the annual report shows that of the 3.521 billion yuan of the net profit attributable to the shareholders of listed companies, 1.442 billion yuan (nearly half) comes from the pharmaceutical industry, which can also be seen as a considerable profit The considerable industrial profits can not be separated from the promotion of domain focus and key product focus strategy Shanghai pharmaceutical products mainly focus on digestive system and immune metabolism, cardiovascular, systemic anti infection, mental nerve and anti-tumor five treatment areas In 2017, its business income in the field of cardiovascular system was relatively high, reaching nearly 3.1 billion yuan, with a year-on-year growth of 8.26% Its income in the field of digestion and metabolism was nearly 1.8 billion yuan, with a relatively large growth rate of 24.20% compared with last year, with a considerable development prospect (the income in various fields in 2017 is shown in the figure below) Note: according to the "basic information of the company's main industrial manufacturing business by treatment field" in the annual report, the business income in the figure is sorted out In 2017, the sales revenue of 60 key varieties reached 7.979 billion yuan, an increase of 14.42% year-on-year Among them, 37 varieties were higher than or equal to the growth of the same kind of varieties The annual sales revenue of over 100 million products reached 28, an increase of 2 It is estimated that the sales volume of Shenmai injection, hydroxychloroquine sulfate, Bifidobacterium sanlianhuo, sodium tanshinone Ⅱ a sulfonate injection and cefotiam hydrochloride for injection in the centralized bidding has exceeded 3 billion yuan (see the figure below for the centralized procurement sales volume of five major products in 2017) Note: the sales volume in the figure is estimated according to the annual report of "winning the bid in centralized drug bidding procurement" The calculation formula is: sales volume = (lowest bidding price + highest bidding price) / 2 * procurement volume Among them, the sales volume of sodium tanshinone Ⅱ a sulfonate injection is the highest, nearly 1 billion yuan It is reported that the drug is used for auxiliary treatment of coronary heart disease, angina pectoris and myocardial infarction At present, only Shanghai medicine has obtained the production approval in China In addition, hydroxychloroquine sulfate tablets are also the exclusive variety of Shanghai Pharmaceutical Only Shanghai Shangyao and Jincheng Haisi pharmaceutical have obtained the approval for Bifidobacterium triple viable bacteria R & D investment has repeatedly reached a new high While ensuring the sales volume of existing products in the market, we can see from the R & D investment that Shanghai Pharmaceutical attaches more importance to drug development During the reporting period, its R & D expenditure was 836.06 million yuan (including R & D investment and capitalized R & D investment), a year-on-year increase of 24.68%, a new five-year high, and the fastest year-on-year increase (R & D investment in the past five years is shown in the figure below) Note: the data in the figure comes from Shanghai Pharmaceutical annual report 2013-2017 In 2017, Shanghai Pharmaceutical R & D investment totaled 790350000 yuan, an increase of 20.79% year on year Among them, 21.14% went to the research and development of innovative drugs, 22.59% to the research and development of generic drugs, 35.43% to the secondary development of existing products, and 20.84% to the consistency evaluation of quality and efficacy of generic drugs According to the annual report, in 2017, there were only two kinds of Shanghai Pharmaceutical for consistency evaluation: Fluoxetine Hydrochloride capsule and captopril It can also be seen that the cost of consistency evaluation is huge In addition to the two varieties of consistency evaluation, in 2017, there were 12 drugs (including different product specifications, the same below) submitted to the regulatory authorities for approval, including 6 clinical approval documents and 6 production approval documents (the application in 2017 is shown in the figure below) Note: the data in the figure is sorted out according to the "14 drugs (including different drug regulations) submitted to the regulatory authorities for approval" in the annual report It is worth mentioning that in 2017, the three varieties of clinical application of Shanghai Pharmaceutical were innovative drugs According to the data, sph3348 (special approved variety) is independently developed by Shanghai Pharmaceutical and has full intellectual property rights At present, there is no similar product listed and sold at home and abroad Hydroxytriptolide (special approved variety) is a derivative of triptolide, which was declared as "rheumatoid arthritis" in 2008, and obtained the approval document of clinical trial in 2009 At present, phase I clinical research has been completed, and phase III clinical application will be started in 2018 This declaration increases the new indications of the drug in the treatment of AIDS chronic abnormal immune activation At present, the same kind of research at home and abroad are in the stage of clinical exploration, and there are no products for chronic abnormal immune activation in the treatment of AIDS on the market The recombinant anti HER2 humanized monoclonal antibody mcc-dm1 coupling agent for injection of biological products is declared by Shanghai cross linked drug research and Development Co., Ltd (a wholly-owned subsidiary of Shanghai Pharmaceutical) Kadcyla has been listed as the same target drug at home and abroad The total overseas sales of kadcyla in 2016 was 843 million US dollars In 2018, these seven drugs will be laid out In 2017, in addition to the clinical application records of the above three drugs, according to the registration and acceptance database of smart drugs, the recombinant anti-HER2 humanized monoclonal antibody composition for injection was also submitted for clinical application on February 13, 2017, only on September 27, 2017, the clinical approval document was obtained (see the following figure for details of application) Note: the data in the figure is from the registration and acceptance database of smart drugs It is reported that the recombinant anti HER2 humanized monoclonal antibody composition for injection has independent intellectual property rights At present, there is no same product listed in China, and there is no registration application The same target drugs at home and abroad include trastuzumab and patozumab of Roche pharmaceutical According to Roche's annual report, in 2015, the global sales of trastuzumab was about 44.8 billion yuan, and the global sales of its new drug patozumab was about 9.9 billion yuan According to the annual report, as one of the important R & D projects in 2018, the drug has also launched phase 1 clinical research Up to now, its R & D cost has accumulated nearly 100 million yuan, which shows that Shanghai Pharmaceutical attaches great importance to this drug In addition to the recombinant anti HER2 humanized monoclonal antibody composition for injection, the important research and development projects in 2018 also include: dotipofen, sph3127, sph1188, TNFa receptor Fc fusion protein, recombinant anti-CD20 humanized monoclonal antibody injection, and leitengshu (the details of the important research and development projects in 2018 are as follows) Note: the data in the figure is sorted out according to the "basic situation of main R & D projects and important R & D projects carried out in the new year" in the annual report The cumulative investment of recombinant anti-CD20 humanized monoclonal antibody injection has exceeded 100 million yuan The drug was applied for clinical application on May 12, 2014 and approved on August 23, 2016 (see the following figure for details of application) Phase 1 clinical research will be launched in 2018 Note: the data in the figure is from the registration and acceptance database of smart drugs It is reported that the same target drugs listed at home and abroad include rituximab of Roche pharmaceutical, offatumumab of GlaxoSmithKline and obinutuzumab of Roche pharmaceutical According to Thomson Reuters data, the sales of the three drugs in 2015 were $7.24 billion, $75 million and $130 million respectively In addition, nearly 100 million yuan has been invested in sph3127, which is a major special variety and special review variety It was applied for clinical application on June 3, 2015 and approved on May 4, 2016 (see the following figure for details of application) Clinical phase 2 clinical research will be launched in 2018 Note: the data in the figure is from the registration and acceptance database of smart drugs It is reported that sph3127 is jointly developed by Shanghai Pharmaceutical Co., Ltd and Japan's tambian Mitsubishi Pharmaceutical Co., Ltd., both of which have intellectual property rights The company has submitted the compound patent application for the product to 14 countries / regions, such as the United States, Japan, Europe, Australia, South Korea, the Philippines and China, and has obtained the authorization in China, the United States, Japan and Australia.