Heavy! 84 varieties were given priority review, Hengrui, Baiji Shenzhou, Zhengda Qing, Roche...

Introduction: According to the data of pharmaceutical intelligence, up to now in 2020, a total of 140 acceptance numbers (84 varieties) have been given priority review qualification, due to the impact of the new crown epidemic, april to June, the speed of drug review slowed slightly, the current outbreak is basically under control, the efficiency of the review in July improved, 20 acceptance number 12 varieties were included in the priority review.
to accelerate the marketing of new and clinically urgently needed generic drugs, the State Bureau has played a series of combinations, in which the priority review and approval of drugs plays a very important role.
no doubt that, in accordance with the relevant national policies, the inclusion of drugs in the priority review sequence means that the review and approval time for drug market will be shortened, thereby accelerating the introduction of drugs, welfare-related patients at the same time, but also conducive to enterprises to seize the market.
According to the 2019 Drug Review Report released recently by the State Drug Administration, the Drug Review Center in 2019 included 253 applications for registration (139 varieties in the common name) in the priority review process, a decrease of 19.2% year-on-year, of which 52 were for children and rare diseases.
in addition, 143 registration applications (82 varieties in general name) in 2019 were approved for listing through the priority review process, such as Agaglyse beta for the injection of toluene sulfonate and glylute sodium capsules for the injection of the first class of innovative drugs developed in China.
, 2020 has reached the "Dangui fragrance, autumn wind send cool" August, according to drug data statistics, 2020 so far, a total of 140 acceptance numbers (84 varieties) have been given priority review eligibility, due to the impact of the new crown epidemic, April to June, the drug review speed slightly slowed, the current epidemic is basically under control, the July review efficiency increased, there are 20 12 varieties received priority review.
9 class 1 new drugs and 20 class 5 primary import priority review, Hengrui pharmaceutical market shortage, urgent need for drugs, in accordance with the relevant policy requirements of priority review and approval, new drugs with obvious clinical value, innovative drugs with obvious therapeutic advantages into the priority review process.
, since 2020, a total of 9 1 innovative drugs have been given priority review status, including the FDA-granted Roche Pharmaceutical Orphan Medicine and Fast Track qualification risdiplam oral solution powder;
, it is worth noting that all 8 drugs are in the NDA phase, except for Roche Pharmaceuticals' Risdiplam oral solution powder IND stage.
the first class of new drugs included in the priority review in 2020 is also notable for hengrui Pharmaceuticals subsidiary Chengdu Shengdi Pharmaceutical's hefluoroprostorus eye drops, his fluoroprostorin eye drops are a new type of antiseptic-free prostaglandin analogue (PGA) eye drops, clinically used to reduce the risk of intra-eye pressure in patients with open-angle glaucoma or high eye pressure.
currently in addition to Japan's Santian Pharmaceuticals of his fluorine prostaglandin eye drops listed in china, has not yet had his fluorine prostagluoratic eye drops generic drug approved for listing in China, the layout of this variety of producers are fewer, only Santi Pharmaceuticals and Sichuan Collon two companies, this time Shengdi Pharmaceuticals' application for listing of his fluoropronosinineye drops is to be included in the priority review, which means that the drug is expected to accelerate the approval of the market, and Chengdu Shengdi Pharmaceutical's application for listing of his fluoropronosinineye drops to be included in the priority review for the clinically urgent need, market shortage of drug registration application.
in addition, five types of imported chemical drugs, in particular the 5.1 primary drug, were clearly included in the priority review by virtue of the therapeutic advantage of the drug.
2020 to date, a total of 5.1 class of imported drugs have been included in the priority review of 31 receiving number 20 varieties, 5.2 imported drugs have 8 acceptance number 5 varieties into the priority review, the details are as follows: 2. Four new types of modified drugs (preparations for new indications containing known active ingredients) were also prioritized, namely AstraZeneca's Dagre net tablets, Reding Pharmaceuticals' methyl sulfonate nirapali capsules, Baiji Shenzhou's linamine capsules, and the alomyel aroscane capsules.
11 biological products included in the priority review, 8 for mono-antitherapy biological products are anti-tumor hot-spot drugs in recent years, especially mono-anti-drugs, is the focus of research and development drugs, but also clinically proven anti-tumor effect of better biological drugs, 2020 up to the present cumulative Eleven biological products were included in the priority review, eight of which were mono-resistant biological products, such as Roche's Attilizumab, Jiahe's Jano sing-ininjection, GlaxoSmithKline's injections, and other heavy-weight varieties. Among the biological products that will be included in the priority review by 2020
are Roche's Satralizumab injections and Fosun Kate's Ikilirunsai injections.
Satralizumab injection is a human-derived anti-alcotoxyle 6 receptor (IL-6R) monoclonal antibody and is currently being developed for the treatment of the optic neurospinal itis spectrum disorder (NMOSD), a rare disease.
in the United States, the FDA granted satralizumab a breakthrough drug for NMOSD in December 2018.
in the United States, the European Union, Japan, satralizumab has also been granted orphan medicine qualification.
the domestic inclusion of priority review sand in the rapid approval, the domestic rare disease patients ushered in the gospel.
Iquillade injection (proposed), codenamed FKC876, is foe's Target CD19 self-made CAR-T cell therapy product, introduced YESCARTA ® (Acabta Cilleucel) from Kite Pharma in the United States and authorized to produce locally in China.
is the first CAR-T cell therapy product in China to be accepted as a listing application.
35 generic drugs were included in the priority review; The first generic drugs in the first generic review were successfully obtained by the Zilu sulfonate resagilan tablets, mostly because of innovative drugs with obvious therapeutic advantages, but, although generic drugs have been listed overseas, domestic and foreign generic drugs have also been included in the priority review, in addition to clinically urgently needed drugs;
the list of generic stakes to be included in the priority review in 2020, with particular attention to the positive fluorium injections and Ziru Pharmaceuticals' mesulfonate resaguillan tablets.
fluorovir group injections are estrogen receptor (ER) dispensings that are clinically used for recurrence after or during anti-estrogen-assisted therapy, or postmenopausal ER-plus locally advanced or metastatic breast cancer that progresses in anti-estrogen therapy.
acompany, with global sales of $892 million in 2019.
October 2019, fluorovenom injections were included in one of the 33 varieties of the First List of Encouraging Generic Drugs, and it is worth mentioning that AstraZeneca was left out of the 2019 health-care renewal negotiations because of a price reduction.
According to the drug registration and acceptance database shows that at present only Haussen and Zhengda Qing domestic layout of fluoroweis group injection, Zhengda Qing has been given priority review, quickly approved is expected to break the original research barriers, divide the billions of market.
fluves group injection declaration registration details form sasulcane resagilan tablets developed by Denmark's Lingbei And Teva is a Treatment of Parkinson's Disease (PD), a second-generation monoamine oxidation-B (MAO-B) inhibitor.
was approved by the European Union in February 2005, approved by the FDA for listing in the United States in May 2006, submitted a listing application in January 2014, and was officially approved by NMPA in June 2017.
According to the drug registration and acceptance data show that there are Chongqing Huasen, Shanghai Sino-Western Pharmaceutical, Qilu Pharmaceutical and Changzhou four drug reports, but before the enterprises have withdrawn, 2019 Qilu and Changzhou four drugs again declared for listing acceptance, early this year was included in the priority review, accelerated review of the listing, the first Qilu Pharmaceutical stake in the recent topic showed as a shipment, or has been through the priority review of the first successful imitation.
the listing details of the listed sheet of the mesosulfothane Resagilan tablets Source: Pharmaceutical Intelligence Data, CDE.