Hengrui's innovative medicine is breaking out, another 1 billion varieties will be born?

Recently, Hengrui pharmaceutical announced that the company's Btk kinase inhibitor shr1459 has obtained the CFDA clinical trial approval and will carry out phase I clinical trial in the near future In addition, the company will recently carry out phase I / II clinical trial of bevacizumab injection and phase III clinical trial of rimazazolam toluene sulfonate for injection For Hengrui medicine, it is good news Btk is highly sought after by enterprises A total of 6 domestic pharmaceutical enterprises have been approved as clinical shr1459, which is a small molecule Btk inhibitor By selectively inhibiting Btk kinase, inhibiting B cell activation, proliferation and survival, and then inhibiting the growth of B cell lymphoma, it is intended to be used in the treatment of B cell lymphoma and rheumatoid arthritis On November 28, 2016, Hengrui pharmaceutical, Shanghai Hengrui Pharmaceutical Co., Ltd and Jiangsu Shengdi Pharmaceutical Co., Ltd submitted drug registration application to Jiangsu food and Drug Administration and was accepted Recently, Hengrui pharmaceutical announced that it has received the notice of approval opinions and approval documents of clinical trials on shr1459 raw materials and tablets approved and issued by CFDA, and will carry out phase I clinical trials in the near future Table 1: Btk inhibitors registered and declared in China are very promising targets for blood tumors and immune diseases, and Btk has been sought after by domestic enterprises So far, 6 Btk inhibitors have been approved in China Among them, Baiji Shenzhou, which has the fastest progress, has entered phase III clinical stage, and most of the others are in phase I clinical stage Ibrutinib, the only Btk inhibitor on the market in the world, was approved by the US FDA in 2013 for the treatment of B-cell lymphoma In early August, ibotinib was approved by the FDA as the only drug to treat adult chronic graft-versus-host disease Figure 1: Sales of ibtini in the world from 2015 to 2016 (unit: US $100 million) According to the annual report of relevant companies, sales of ibtini in the world increased significantly in 2016, reaching US $3.083 billion Compared with ibotinib, shr1459 developed by Hengrui pharmaceutical has the same efficacy in vitro and in vivo, good target specificity, strong selectivity for kinase, high oral bioavailability, which is expected to reduce or eliminate the adverse reactions of ibotinib in clinical, and play a therapeutic advantage in B-cell lymphoid cancer and rheumatoid arthritis Bevacizumab, with a sales volume of 6.783 billion Swiss francs in 2016, is a humanized anti VEGF monoclonal antibody It is the first anti angiogenic drug in the world It is developed by gene tech, a subsidiary of Roche, and Sino foreign pharmaceutical cooperation As early as 2004, the US FDA approved the marketing of injection The indication was metastatic colorectal cancer Later, it was approved for the treatment of non-small cell lung cancer, malignant glioma, metastatic renal cell carcinoma and other indications At present, it has been sold in many countries around the world Figure 2: global sales of bevacizumab Roche in 2014-2016 According to the data of minenet, the sales of bevacizumab Roche in the world showed an upward trend during 2014-2016 The growth rate slowed down in 2016, reaching 6.783 billion Swiss francs in sales, with a growth rate of 1.48% According to the inquiry, the domestic import of bevacizumab injection of Roche has been approved, and the trade name is Avastin At present, Shanghai Hengrui, Zhengda Tianqing and Hualan gene engineering have submitted the clinical registration application of bevacizumab injection Up to now, Hengrui pharmaceutical has invested about 19.62 million yuan in the R & D project Hold more than one billion varieties, who will be the next to break out? Hengrui medicine is one of the largest research and production bases of anti-tumor drugs, surgical drugs and contrast agents in China The company's products cover many fields, such as anti-tumor drugs, surgical anesthesia drugs, characteristic infusion, contrast agents, cardiovascular drugs, etc., and have formed a relatively complete product layout, among which the market share of anti-tumor, surgical anesthesia, contrast agents and other fields are among the best in the industry In 2016, the company's economic indicators grew steadily, with operating revenue of 11.094 billion yuan, a year-on-year increase of 19.08%; the net profit attributable to shareholders of the listed company was 2.589 billion yuan, a year-on-year increase of 19.22% Figure 3: Sales of Hengrui pharmaceutical star products in the chemical medicine pattern of public medical institutions in China (unit: 100 million yuan) According to the data of minenet, in 2016, Hengrui pharmaceutical had 5 products with sales of more than 1 billion in the chemical medicine pattern of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as "China's public medical institutions"), including docetaxel, shunatracurium, dextromethomidine, iodophor and oxaliplatin Among them, docetaxel, as an anti-tumor drug, has the highest sales volume, reaching 1.869 billion yuan, up 9.39% year on year It is also an anti-tumor drug Oxaliplatin is a new member of the company's "1 billion club" Its sales increased from RMB 0.99 billion in 2015 to RMB 1.116 billion in 2016, with a growth rate of more than 12% This time, the company's shr1459 obtained the CFDA clinical trial approval, and the company announced to carry out the phase I / II clinical trial of bevacizumab injection According to the relevant data, we can see that the above two products have a good market In addition, the company also announced to carry out the phase III clinical trial of rimazazolam mesylate for injection Remazolam is a short acting GABA-A receptor agonist developed by paion AG It is a super quick acting sedative / anesthetic drug It combines the safety of midazolam with the effectiveness of propofol and is used as an anesthetic for surgery The company develops the toluene sulfonate of remazolam, which has many satisfactory advantages in physical and chemical properties On the other hand, the toxicity of toluene sulfonate is lower than that of benzene sulfonate, which undoubtedly improves the safety for clinical patients Up to now, the company has invested about 33.96 million yuan in the R & D project of ramazolam toluene sulfonate for injection, and its prospect is worth looking forward to Once the above-mentioned products have passed the clinical trials and been put on the market, will Hengrui pharmaceutical produce another billion varieties? Conclusion in 2016, Hengrui pharmaceutical invested 1.18 billion yuan in R & D, an increase of 32.82% over the same period last year Kapofungin was approved for production at the beginning of the year; pyrrolidine continued to develop in the United States Phase II clinical trial: fondaparinux and gadolinium butoxide are in the stage of data supplement; on August 15, Hengrui medicine continued to issue a notice that the company will carry out phase II clinical trial of shr0302 tablets in the near future; in addition, the company has a number of anti-tumor targeted drugs, new diabetes drugs and immune disease macromolecular drugs in the stage of clinical research With the gradual listing of new products to contribute to performance and continue to expand the overseas market, Hengrui pharmaceutical is expected to maintain stable growth in the next few years Source: annual report and announcement of listed companies