Holding 11 over 100 million products, six new products will be added to the R & D acceleration of Lizhu group

On December 23, 2017, Lizhu group issued a notice that dantraline sodium for injection, which had been included in the priority review earlier, was approved by CFDA for clinical application; on December 30, Lizhu group again issued a notice that the product was approved for clinical application This time, it was approved for recombinant all human anti RANKL monoclonal antibody injection At the same time, Lizhu issued a notice in mid December, in which jiankangyuan, the company and shareholder, indirectly increased 306 million yuan and 294 million yuan to Lizhu McAb through overseas SPV respectively (keeping the shareholding ratio unchanged), which will help accelerate the research and development of McAb products and the listing process Some securities companies predict that the company's first McAb product, TNF - α McAb, is expected to be listed in 2020, and occupy a certain market share with a high cost-effective positioning The follow-up product line is rich, and CD20, HER2, PD-1 are approved for clinical use Follow up IL-6R and other varieties are expected to apply for clinical application in succession, forming a strong research and development team According to the announcement of listed companies and statistics of public information, including the above two products, there were 6 new products approved by Lizhu group in 2017 At present, the company has 11 over 100 million products, and the new products will surely bring good stimulation to the company's performance after coming into the market in the future   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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; "> R & D investment has increased year by year, and 6 new products have been approved in 2017 Figure 1: R & D investment of Lizhu group in 2013-2016 (unit: 100 million yuan) (data source: annual report of listed companies) According to the data in the annual report, in recent years, Lizhu group has been increasing its R & D efforts The R & D investment has increased from 233 million yuan in 2013 to 475 million yuan in 2016 The proportion of R & D investment in total operating revenue has also increased from 5.05% in 2013 to 6.20% in 2016 Table 1: the approved clinical products (non API) of Lizhu group in 2017 (source: announcement of listed companies, incomplete statistics) according to the announcement of listed companies and other public data statistics, in 2017, Lizhu group was approved 6 new clinical products, including the recently popular recombinant human anti-PD-1 monoclonal antibody for injection in the world and Recombinant all human anti RANKL monoclonal antibody injection High purity urotropin is a kind of gonadotropin preparation which is extracted from nature Its purity can reach the level of recombinant single component preparation It is a high tolerance and easy to use high purity product At present, the high purity urotropin for injection in the market is the import product of Huiling medicine According to the data of mienei.com, urotropin for injection ranked ninth in the top 20 of terminal chemical hormone and reproductive system regulator products in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) in 2016, with sales exceeding 280 million yuan Paclitaxel polymer micelles for injection, independently developed by the company, is a broad-spectrum anti-tumor drug Compared with ordinary injections, as a drug delivery system, the micelles have the characteristics of small particle size, strong drug delivery capacity, and reduce the pain caused by injection At present, there is no paclitaxel micelles on the domestic market According to the data of mienei.com, paclitaxel ranked first among the top 20 chemical anti-tumor drugs in public medical institutions of China in 2016, with a sales volume of more than 4.9 billion yuan Triptorelin acetate microsphere for injection is a kind of gonadotropin releasing hormone agonist injected once a month by muscle Compared with ordinary triptorelin acetate injection, it has the characteristics of long onset time, reducing the number of times of medication, etc., which can reduce the pain and burden of patients, improve the tolerance and accessibility of medication According to the data of mienei.com, among the top 20 end-user chemical endocrine therapy products of public medical institutions in China in 2016, triptoreline acetate for injection ranked seventh, with a sales volume of more than 600 million yuan, and triptoreline acetate injection ranked tenth, with a sales volume close to 259 million yuan Dantraline sodium for injection is independently developed by the company for the treatment of malignant high fever, which is a rare disease In order to solve the current domestic drug availability, CDE released the announcement of drug registration application to be included in the priority review procedure (the 13th batch) on February 28, 2017, and the product has obtained the qualification of priority review and approval At present, only capsule is approved for dantraline sodium The recombinant all human anti RANKL monoclonal antibody injection line Lizhu first submitted the clinical trial application on April 20, 2017, which was approved by CFDA about half a year ago, and it is preliminarily expected to take 4-6 years to complete the clinical trial The indications of anti RANKL monoclonal antibody are women's osteoporosis and solid tumor bone metastasis The original research product is denosumab (trade name: Prolia ® and xgeva ®), which was approved by FDA in 2010 and sold for more than 3 billion US dollars in 2016 At present, there are no similar products on the market in China There are 7 manufacturers including Lizhu, which have been approved to be clinically targeted at "RANKL"   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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; "> in 2016, Lizhu group achieved an operating revenue of 7.652 billion yuan, including 41.84% for western medicine, 27.91% for traditional Chinese medicine, 22.79% for APIs and intermediates, and 7.46% for diagnostic reagents and equipment Table 2: Sales of more than 100 million products of Lizhu group in China's public medical institutions in 2016 (unit: 10000 yuan) (data source: minernet China's public medical institutions terminal competition pattern) Figure 2: Sales of Shenqi Fuzheng Injection in China's public medical institutions in 2013-2016 (unit: 10000 yuan) Shenqi Fuzheng injection is the exclusive product of Lizhu group Limin pharmaceutical factory It is used for the treatment of fatigue of spirit caused by deficiency of lung and spleen qi, lack of breath, laziness, and self perspiration vertigo Lung cancer and gastric cancer are the auxiliary treatment of the above symptoms In 2016, the product ranked the second in the top 20 of Chinese proprietary medicine for tumor diseases in public medical institutions in China, with a sales volume of more than 2.8 billion yuan It is a veritable large variety of traditional Chinese medicine Figure 3: Sales of urofollicle stimulating hormone for injection in China's public medical institutions in 2013-2016 (unit: 10000 yuan) (data source: M-net China's public medical institutions terminal competition pattern) The trade name of urofollicle stimulating hormone for injection produced by Lizhu pharmaceutical factory of Lizhu group is lishenbao, which is used to treat those who are anovulatory (including polycystic ovary syndrome) and have no effect on clomiphene citrate treatment, and those who are superovulated by assisted reproductive technology In 2016, the product ranked third in the top 20 chemical hormone and reproductive system regulator products of public medical institutions in China, with a sales volume of more than 500 million yuan Figure 4: Sales of iprazole enteric coated tablets in China's public medical institutions in 2013-2016 (unit: 10000 yuan) (data source: minernet China's public medical institutions terminal competition pattern) Another blockbuster drug of Lizhu group is iprazole enteric coated tablets, with the trade name of Elian, which is the company's exclusive product In 2016, the product ranked 15th among the top 20 chemical antacids and drugs for peptic ulcer and flatulence in public medical institutions in China, with sales volume exceeding 300 million yuan Eprazole enteric coated tablets were approved for marketing in December 2007, and its indication was duodenal ulcer In September 2017, Lizhu group issued a notice saying that it received the approval of CFDA for drug registration and approved to increase the indications for the treatment of reflux esophagitis Lizhu group said that after the new indications of the product, the clinical users could be expanded, and the sales volume of the product is expected to increase 。   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; 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Im portant; "> the performance is growing steadily The latest data in the future shows that the operating revenue of Lizhu group in the first three quarters of 2017 is 6.522 billion yuan, and the net profit is 4.246 billion yuan It is estimated that the net profit of 2017 will be between 4.322 billion yuan and 4.475 billion yuan According to Lizhu group, the company's performance in 2017 rose in the same direction as that of the same period of last year, mainly due to the transfer of 100% equity of its subsidiary Zhuhai Weixing Industrial Co., Ltd., which increased the company's net profit attributable to shareholders of listed companies by about 3.498 billion yuan, and the stable growth of business sales in other areas of the company In addition, 2017 is the last year of the company's last equity incentive assessment Recently, the company launched a new option incentive scheme The net profit of the performance assessment target is not less than RMB 992 million, RMB 1141 million and RMB 1312 million, respectively, from 2018 to 2020, reflecting the confidence in the long-term and stable growth of future performance It will take a while to wait for the above new products to come into the market, but judging from the current products on sale in the market and the R & D Progress of new products under research, the overall development trend of Lizhu group is relatively positive What new surprises will Lizhu group bring us in 2018? We will wait and see Source: announcement of listed companies, Internet database, Chinanet