NMPA approved 31 new drugs in the first half of the year with a minimum time of 139 days!

TextAccording to The Insight database, The NMPA approved 212 pharmaceutical batches in the first half of 2020, involving 146 varieties, with 85% of chemicals by variety ingredient category, followed by monospecificy antibodies accounting for about 4%from the corporate dimension, in the first half of the year approved more than 3 varieties of enterprises have 11, of which Qilu Pharmaceuticals has a total of 9 generic drugs approved for listing, ranked firstQilu Pharmaceuticals can be said to be one of the leading domestic generic drug enterprises, not only generic batch harvest big man, but also generic drug consistency evaluation big man, there are currently 33 varieties of evaluation, leading the domestic generic drug enterprisesthe first half of 2020 approved more varieties of enterprise generic drugs are still the main domestic, the first half of the chemical generic drugs approved a total of 175 (according to varieties and enterprise statistics), of which more than 4 approved enterprises are injection varieties, and most of them are approved according to the old 6 categories, only a few are newly registered category 4 approvedof the 175 genericdrugs approved, only 26 were included in the priority review and approval, with an average listing review duration of 677 days (as of natural days, the same below);overall, the average review time for new registered classified generics included in priority reviews is about 2 months faster than that of generic genericsnoteworthy, during the new crown outbreak, the State Drug Administration approved a generic drug in just 27 days, namely, Shanghai Huilun Jiangsu Pharmaceuticals injected sodium sesame, a neutrophil etusinase inhibitor that can be used to improve acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) with systemic inflammatory response syndromebecame emergency drugs during the New Crown outbreaknew drug is the hot word in china in recent years, according to Insight database statistics, the first half of 2020 domestic approved a total of 31 imports and domestic new drugs (according to the registration classification 1, domestic first approved imported drugs, new Chinese medicine, and biological products declared in accordance with the new drug procedures 2, 15 categories statistics);31 new drugs with an average review duration of 511 days, of which the shortest-time tablets of thyceobutanine benzodiazepines were approved for market in just 139 days, the drug used to treat the rare disease Huntington's disease, is the country's published clinically urgently needed new drug varieties, enjoy ingested review policy channelsas a whole, most of the imported new drugs have clinical advantages, or are used in special patient groups and have been approved abroad, the review time is shorter than domestic new drugs11 new drugs approved in the first half of the year were new drugs for chemical drugs, including 4 domestically produced class 1 new drugs, from Hausen's mthsulfonate ometinib tablets, Thesain-Shenzhou's Zambutini capsules, Cain Technology's KW-136 capsules and Silver Valley Pharmaceuticals' benzene-brominated ammonium nasal spray, Haussen Pharmaceuticals' amatinib is china's first domestically approved three-generation EGFR-TKI inhibitor, Bazi Shenzhou's Zebutini is the first approved original research BTK inhibitor, Cain Technology's Colopavir is the second domestic 1 new type of hepatitis C drug approved after Gorida Norevir, Silver Valley Pharmaceuticals benzene cyclomine brominamide nasal spray is also a new type of new drug developed in Chinadomestic biological drugs in the first half of the harvest is also full, Sansheng Pharmaceutical's initomonotag is the use of its own platform technology independent research and development of anti-HER2 treatment of an "imitation combination" of anti-HER2 monotonica; The biosimilars of bevanzumab, the first domestically produced winter insulin analogue, and the recombinant TB fusion protein (EC, commodity name Yika) of Chifei bio-organisms are a new class of 1 drug developed in China for screening for TB infectionin addition to the above-approved drugs, in the first half of 2020 there are a number of new drugs approved in China new indications: however, in the first half of 2020 the field of indications expansion is the most notable pD-1/L1 monoantisay, Hengrui Pharmaceuticals' Carelli Zhusing was approved for 3 new indications, that is, second-line treatment of liver cancer lung cancer and esophageal cancer; The second-line treatment of peinous skin cancer in the second line of the terreiju monosuphertic in Baiji Shenzhou; Odivo was approved for the treatment of gastric or gastroesophageal connectivity adenocarcinoma; Koda was approved for second-line treatment of esophageal squamous cancer; and Tai Sanqi was approved for first-line treatment of a wide range of small cell lung cancerdomestic listed PD-1/L1 has been approved for indications.