First review of valsartan capsule of Lepu subsidiary

5 billion varieties, the first to be evaluated On the evening of November 20, Lepu announced that Lepu hengjiuyuan Pharmaceutical Co., Ltd., a subsidiary holding shares of Lepu, had received the approval document of drug supplement application on "valsartan capsule" approved and issued by the State Drug Administration, which passed the consistency evaluation of quality and efficacy of generic drugs At present, lepuheng is the first enterprise in China to pass the consistency evaluation According to the public information, the original preparation of valsartan capsule (80mg) is Novartis "Daiwen", and the indication is to treat mild and moderate essential hypertension It is reported that the drug belongs to the heavyweight type of antihypertensive drug of angiotensin Ⅱ receptor antagonists, which is one of the most widely used antihypertensive drugs in the domestic market at present It is listed as class a medicine of medical insurance in the new version of national basic medical insurance, industrial injury insurance and maternity insurance drug catalog released in August 2019 According to Lepu's assessment, the total domestic sales of valsartan is 3-5 billion yuan, of which the proportion of Novartis in Switzerland is about 75% According to the data of minenet, in 2018, the sales volume of valsartan capsule 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) reached 3.723 billion yuan, with the main manufacturers including Novartis, Changzhou siyao pharmaceutical, China Resources SECCO pharmaceutical, Lizhu pharmaceutical of Lizhu group, etc However, in recent years, the substitution effect of generic drugs has appeared, and Novartis' market share has declined, from 75.07% in 2013 to 66.81% in 2018 According to the public information, Lepu Hengyuan started the consistency evaluation of "valsartan capsule" in September 2016, after more than three years, and finally had a review According to Lepu half year report 2019, the progress of Lepu's consistency evaluation is as follows: Two antihypertensive drugs, amlodipine besylate and valsartan, have been evaluated recently; the antilipidemic drugs, atorvastatin calcium and clopidogrel bisulfate, are the second enterprises in China to pass the national drug quality and efficacy consistency evaluation; the hypoglycemic drugs, acarbose and betahistine hydrochloride, have completed the drug quality and efficacy consistency evaluation test, and have Application for CDE is under review In the second half of 2019, it is planned to complete the consistency evaluation test of quality and efficacy of tegrilol and losartan potassium hydrochlorothiazide, and apply for CDE; meanwhile, many of Lepu's second tier drugs begin to enter the pharmaceutical research stage, and in the future, it is planned to complete the be research of a series of varieties such as rosuvastatin calcium, apixaban, rivaroxaban and tenofovir dipivoxil It can be seen from Lepu semi annual report that Lepu has the ability of integration of APIs In addition to three overweight varieties with huge market capacity, such as atorvastatin calcium, clopidogrel bisulfate and insulin glargine, valsartan, acarbose, amlodipine besylate and betahistine hydrochloride are also its heavyweight varieties The cost control ability of API preparation integration and the steady evaluation of consistency according to the weight of varieties are important factors for many pharmaceutical enterprises to take the lead in the centralized drug procurement organized by the state For example, Lepu successfully won the bid of atorvastatin calcium and clopidogrel bisulfate in the 4 + 7 expansion On the same day, Shandong Luoxin Pharmaceutical Co., Ltd announced that Cefradine capsule (0.25g) was approved by the State Drug Administration and passed the conformity evaluation of quality and efficacy of generic drugs It is reported that this is the third product under rohin pharmaceutical industry after ambroxol hydrochloride tablets and Cefalexin Capsules that has passed the consistency evaluation of quality and efficacy of generic drugs At the same time, rohin pharmaceutical is also the third pharmaceutical enterprise that has passed the consistency evaluation of cefradine capsules According to the information of Luoxin pharmaceutical industry, the other 10 products of Luoxin pharmaceutical industry, such as Lansoprazole for injection, have completed the declaration of quality and efficacy consistency of generic drugs, and it is expected that nearly 30 varieties will complete the declaration by the end of 2020 According to the public information, the original Cefradine capsule is the first generation cephalosporin developed by Bristol Myers Squibb, which belongs to β - lactam antibiotics The drug can be used to treat acute pharyngitis, tonsillitis, otitis media, bronchitis, pneumonia and other respiratory tract infections, urogenital tract infections and skin and soft tissue infections caused by sensitive bacteria According to some data, the global sales of cefradine in 2018 is nearly 70 million US dollars At present, cefradine capsules produced by a number of pharmaceutical enterprises in China have been listed, including famous pharmaceutical enterprises such as Yangzi River, Shandong Lukang Pharmaceutical and Hunan Kelun pharmaceutical In addition to Roxin pharmaceutical, cefradine capsules of Xinhua Pharmaceutical and Yangzijiang pharmaceutical have passed the consistency evaluation successively So far, there are three enterprises that have passed the evaluation of cefradine capsules.