169 varieties have passed the consistency evaluation, and 30 enterprises have passed the evaluation

[pharmaceutical network industry trends] consistency evaluation, since the implementation of the policy, has gained a lot! Most of the mainstay varieties of enterprises have passed the evaluation or entered the application stage, and the quality of domestic imitated varieties has been increasing As of November 4, there were 1556 acceptance numbers of conformity assessment undertaken by the drug evaluation center of the State Food and drug administration, involving 327 varieties and 459 enterprises According to the statistics of a database of an organization, there are 169 varieties passing / deemed passing the consistency evaluation, involving 165 pharmaceutical enterprises, among which 4 enterprises have passed the consistency evaluation and the number of product specifications exceeds 20 Qilu pharmaceutical: at present, in the application work of consistency evaluation, Qilu pharmaceutical ranks first with 30 over evaluated varieties The first variety that passed the consistency evaluation was gefitinib tablets (obtained the supplementary application approval document for consistency evaluation on December 2017); subsequently, Qilu pharmaceutical varieties, such as tenofovir dipivoxil fumarate tablets, terbinafine hydrochloride tablets, solinacin Succinate Tablets, olanzapine tablets, olanzapine orally disintegrating tablets, levocetirizine hydrochloride tablets, passed the consistency evaluation one after another In the consistency evaluation, Qilu pharmaceutical has gained so much that it can not do without R & D innovation As of October 17, Qilu pharmaceutical has successively undertaken nearly 30 major national science and technology projects, won the second prize of four national science and technology progress awards in the past 10 years, and ranked the top three domestic pharmaceutical enterprises in terms of innovation capacity for many years At present, Qilu pharmaceutical is developing more than 200 new drug projects, of which more than 50 are innovative drug projects Fosun Pharmaceutical: at present, there are 28 reviewed varieties of Fosun Pharmaceutical, ranking second only to Qilu Pharmaceutical (30) As of August 2, the average R & D cost of each evaluated variety has reached 7.772 million yuan According to public information, in the first quarter report of 2019 released by Fosun Pharmaceutical, its R & D cost was 394 million yuan, an increase of 41.85% year on year With the acceleration of consistency evaluation, R & D cost of Fosun Pharmaceutical will continue to increase Thanks to continuous R & D and innovation, Fosun Pharmaceutical has made new progress in biological medicine and small molecule innovative medicine in recent years In the first half of 2019, hanlikang was approved as the first domestic biological similar drug Hlx02 (trastuzumab bioequivalent) has been declared for production acceptance in the first half of the year, and the clinical phase III has reached the preset end point It is expected that the product will be approved for market in the first half of 2020, becoming the first trastuzumab bioequivalent in China In addition, hlx11 is about to enter clinical practice, enriching the company's HER2 breast cancer product pipeline A number of small molecule innovative drugs have gradually entered the clinical stage, and their late development momentum is strong Shiyao group: 20 At present, the group has established a rich R & D pipeline, of which 18 small molecule innovative drugs have entered the clinical research stage, 4 are in the registration clinical stage; 13 large molecule innovative drugs have entered the clinical research stage, 3 are in the registration clinical stage; 9 new products are in the clinical stage, 4 are in the registration clinical stage The products have also covered many fields of treatment, such as tumor, mental nerve, cardiovascular and cerebrovascular, digestion and metabolism, anti infection, autoimmune and so on The construction of R & D system is perfect, and innovative drug products will enter the harvest period In the next three years, PetroChina group is expected to have a number of innovative drug products on the market, including amphotericin B complex, CD20 monoclonal antibody, mitoxantrone liposome, PI3K inhibitor, RANKL monoclonal antibody, irinotecan liposome, dbpr108 (DPP-4), rmx1002 (EP4 receptor antagonist), long-term GLP-1 and other products which are expected to be on the market in 2022 With the launch and volume of innovative pharmaceutical products, the group may have a number of heavy-duty varieties with sales exceeding 1 billion in the next five years Huahai pharmaceutical: 20 Huahai Pharmaceutical Co., Ltd has passed the consistency evaluation of losartan potassium tablets (December 2017), and the first declared variety is irbesartan hydrochlorothiazide tablets (August 2017); subsequently, 20 drugs such as irbesartan tablets, fosinopril sodium tablets, voriconazole tablets, donepezil hydrochloride tablets, valsartan tablets, risperidone tablets, nevirapine tablets, paroxetine hydrochloride tablets, lisinopril tablets have been evaluated Recently, Huahai pharmaceutical released the third quarter report, which showed that its operating revenue in the first three quarters of 2019 was 4.012 billion yuan, a year-on-year increase of 4.39%; net profit was 512 million yuan, a year-on-year increase of 100.4%; net profit after deduction was 373 million yuan, a year-on-year increase of 37.2% However, as irbesartan API and losartan potassium API of Huahai Pharmaceutical Co., Ltd are once again qualified for export to Europe, their future performance is generally optimistic.