This luxury product line R & D company with ten new class 1 drugs has made progress again

Recently, Sihuan pharmaceutical announced that pirocinib, a class 1 innovative drug developed by Sihuan pharmaceutical, has obtained the approval document of phase I-III clinical trial issued by CFDA Sihuan Pharmaceutical Co., Ltd is a pharmaceutical enterprise with cardiovascular and cerebrovascular prescription drugs as the main market In 2016, its share in cardiovascular market reached 11.9%, ranking first among cardiovascular pharmaceutical enterprises At present, the products are mainly distributed in five fields: cardio cerebrovascular system, central nervous system, metabolism of new town, tumor and anti infection Although relying on fist products, Sihuan medicine seems to have become the leader in cardiovascular field But it still seems dissatisfied with the development in a certain field After purchasing Shandong xuanzhu in 2008, Sihuan pharmaceutical transferred part of its focus to the research and development of new drugs According to its annual report, in 2016, its R & D expenses reached 254 million yuan, accounting for 8% of the total revenue, an increase of 4.9% compared with 2015 Looking at the 11 innovative drug product lines released on the website of Sihuan pharmaceutical company, 10 of them are in the research of class 1.1 new drugs Most of the innovative drug research focuses on the clinical phase I to II, with at least 3-5 years to go on the market Figure 1 four ring pharmaceutical innovation product line (from the company's official website), among which, the key products are eglitaine hydrochloride, pirocinib, pirotinib, fudanafil and other varieties 1 Phenacyronyl chloride, a new drug of class 1.3, is an over-the-counter drug against vertigo, which is mainly used to prevent carsickness (ship and airplane) According to PDB, Beijing HuaSu Pharmaceutical Co., Ltd is the only one in the market to produce phenacyronyl ester 2 New drug of eglitaine hydrochloride 1.1 Eglitaine hydrochloride is an oral antidiabetic drug of DPP-4 inhibitors It is a new type II diabetes treatment drug It is clinically used to enhance the role of endogenous insulin to improve blood glucose control, and long-term administration can improve the function of β - cells of islets of Langerhans On July 27, 2016, it obtained the approval document of phase II / III clinical trial issued by CFDA The new drug has been patented in China and the United States, and has successfully completed phase I clinical trials (IA, IB, IC), and phase II clinical trials have been launched The results showed that once a day administration of eglitaine hydrochloride could effectively inhibit DPP-4 for a long time, and improve the glucose tolerance function of type II diabetic patients Its advantages would provide favorable market potential for eglitaine hydrochloride Table 1 global DPP-4 inhibitor market situation 3 Anaprazole sodium anaprazole sodium is the fifth class of innovative drugs approved by clinical trials of tetracycline medicine, which has applied for patent rights in China, the United States, Japan and Europe The phase I clinical trial of anaprazole sodium has been completed, the preparation of phase II / III clinical trial samples is in progress, and the application for phase II / III clinical trial is being prepared As a new generation of proton pump inhibitors ("PPIs") drugs, it can effectively and rapidly cure ulcer by inhibiting gastric acid secretion and clearing Helicobacter pylori Preclinical studies have shown that its antacid effect and time are significantly better than PPIs and traditional H2 receptor antagonists and antacids on the market, which can effectively treat various gastric acid related diseases 4 Benapenem is the third innovative drug of Sihuan pharmaceutical which has obtained clinical trial approval Benapenem is a carbapenem antibiotic, which is a broad-spectrum antibiotic commonly used in clinic Clinically, it is used for infection resistant to β - lactam antibiotics and complicated infection in hospital The preclinical data showed that BNP had good in vivo and in vitro activity and safety, long half-life, met the requirement of once a day administration, and the predicted clinical dosage was lower, which was significantly better than that of the same product meropenem (three times a day and a large dose); meanwhile, BNP had good chemical stability, simple production and storage conditions, which could reduce production costs and reduce production costs The cost of treatment will benefit the patients in the future, which is superior to the similar product ertapenem Currently, the main manufacturer of ertapenem in China is MSD Figure 2 national key city hospital MSD 2011-2016 ertapenem market 5 Telodipine is a chemical 1.1 class of Innovative Patent antihypertensive drug, and an L / T-type calcium double channel inhibitor class antihypertensive drug At present, the drugs on the market mainly control blood pressure by inhibiting L-type calcium channel, but they are easy to produce side effects of peripheral edema In the domestic market, the competition of calcium antagonists is also very fierce Table 2 domestic calcium antagonists manufacturers 6 Pirotinib is a new generation of broad-spectrum, irreversible tyrosine kinase target inhibitor for EGFR family, which will be used to study and treat lung cancer, gastric cancer and other major clinical needs of cancer Pirotinib completed the clinical application (category 1.1) in CFDA on September 13, 2013, and obtained the letter from FDA of the United States on November 26, 2014, and was officially approved to enter the clinical trial in the United States At present, the phase I clinical trial of pirotinib has been carried out in three well-known cancer research centers in the United States At present, patients taking pirotinib have shown good pharmacokinetic characteristics and preliminary efficacy response, and no serious adverse reactions have been found 7 As a new type of SGLT2 inhibitor, gliclazine 1.1 is used in the treatment of type II diabetes In 2014, Sihuan pharmaceutical submitted its clinical trial application to CFDA and was accepted According to the information in the annual report, the ethics of phase I clinical trial has passed, and phase I clinical trial was officially launched recently At present, SGLT2 inhibitor drugs on the market mainly include: invokana of Johnson & Johnson, farxiga of AstraZeneca / Bristol Myers Squibb, jardiance of bringer ingelham / Lilly, suglat of anstar, deberza of Sanofi, rugreen of Dazheng pharmaceutical, etc In China, henagliflozin, independently developed by Hengrui pharmaceutical, is in the front Who will become the first batch of SGLT2 inhibitor drug manufacturers in China? It is unclear whether Sihuan pharmaceutical or Hengrui pharmaceutical or other companies will take the lead 8 Sirotinib is a new generation of irreversible pan her inhibitor Sirotinib is the second new anti-cancer drug independently developed by Sihuan pharmaceutical, which is used to treat esophageal cancer, gastric cancer, lung cancer and other advanced cancers 9 A new class 1.1 drug, fudanafil In December 2016, CFDA's phase I / II / III clinical trial approval was obtained The indications were bph-luts and ed Fudanafil is a new generation of highly selective PDE5 inhibitor, which overcomes the adverse reactions of the same kind of drugs on the market Table 3 market situation of PDE5 inhibitors in domestic key city hospitals 10 Pirociclib (xzp-3287) is a class 1 innovative drug developed by Jilin Sihuan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Sihuan pharmaceutical, and Shandong xuanzhu Pharmaceutical Technology Co., Ltd In November 2016, as a new anti-tumor drug, the application for new drug clinical trial was submitted to CFDA and accepted According to the announcement released by Sihuan medicine, the product is a highly selective CDK4 / 6 (cell cycle dependent kinase 4 and 6) inhibitor, which is intended to be used for the treatment of breast cancer, malignant brain cancer and other solid tumors At present, only Pfizer's palbociclib (ibrance) and Lilly's kisquali (ribocicli) are listed as CDK4 / 6 inhibitors, and the indications are breast cancer In China, Hengrui medicine is also at the forefront of research and development Table 4 list of global CDK4 / 6 inhibitor drugs: the Internet is not listed in China at present, and the same type of drugs are not listed If pirocinib's advantages are confirmed by clinical trials and successfully listed, it will have a huge market potential and become another breakthrough in the research and development of Sihuan medicine in the field of cancer.