The products of 29 pharmaceutical companies "going abroad" are bright and bright

Under a series of policies, R & D innovation and internationalization have become the main direction of the development of pharmaceutical enterprises According to the data of minenet, 29 pharmaceutical enterprises have obtained 96 anda application numbers in the United States in 2019 (94 varieties in total, calculated by drug name + dosage form + enterprise), a slight decline compared with last year "Main force" dongyangyao, humanwell pharmaceutical and Huahai pharmaceutical have been out of business, while Fosun and Nantong Lianya have made outstanding achievements 17 of 94 varieties have been listed in China, 6 of them have been evaluated, 10 of them have been included in the priority evaluation through co production, and 56 of them are to be transferred to China Table 1: the Anda approved by the FDA by Chinese pharmaceutical enterprises in 2019 note: with * is provisional approval; the R & D investment statistics as of the approved announcement date, / indicates not published According to the data of the global drug database of minenet, in recent years, the Anda number (including the data after purchasing and purchasing companies) approved by the FDA of Chinese pharmaceutical enterprises has shown an overall upward trend, reaching the highest value in 2018 and slightly declining in 2019 A total of 29 pharmaceutical enterprises have obtained FDA approved anda, involving 199 product regulations and 96 application numbers According to the announcement of the listed company, 26 varieties have announced R & D investment, 14 varieties have more than 10 million R & D investment, and Nanjing Jianyou's enoxaparin sodium injection USP has the highest R & D investment, with a total investment of about 123 million yuan; Haizheng's cladribine injection has the most "money saving" with a total R & D investment of 3.2053 million yuan The main force is "out of business", the star is shining, and six new faces are born Table 2: the approval of Anda of Chinese pharmaceutical enterprises in 2018-2019 (unit: Unit): Note: the first approval with * is based on the application number In 2019, 29 pharmaceutical companies "went abroad" In 2018, dongyangyao, humanwell pharmaceutical and Huahai pharmaceutical, the top 3 enterprises approved by anda application number, dropped their products in 2019 Dongyangyao dropped from 15 to 7, humanwell from 13 to 4, Huahai from 11 to 4 In the first half of 2019, the performance of dongyangguang pharmaceutical was still outstanding, leading by 6 anda numbers, which decreased sharply in the second half of 2019, only apixaban was approved; humanwell pharmaceutical gained multiple anda by purchasing epicpharma, but its performance was weak in 2019, only contributing 1 anda; the number of Anda of Huahai pharmaceutical industry reached a record high in 2017, and its anda decreased year by year after the emergence of the event of Shatan API in 2018 Fosun Pharmaceutical and Nantong Lianya showed outstanding performance, with Jingfeng pharmaceutical, Haizheng pharmaceutical, Nanjing Jianyou and Shiyao group all showing significant growth year on year By virtue of the acquired brand and subsidiary Chongqing Yaoyou, Fosun Pharmaceutical leads with 18 anda numbers, an increase of 9 compared with last year, followed by Nantong Lianya, which has gained 12 andas, an increase of 8 compared with last year In 2019, six new faces have been added to the internationalization path of Chinese pharmaceutical enterprises, including Beijing Taide, Borui pharmaceutical, East China pharmaceutical, pulo pharmaceutical, Shanghai anbisheng and Yongtai technology 17 varieties have been listed in China, and 25 varieties want to disrupt the market of more than 30 billion Table 3: varieties declared to be listed in China after the introduction of new registration classification Before the new registration and classification, 10 varieties have been approved for listing, including doxorubicin hydrochloride for injection, doxorubicin hydrochloride injection, doxorubicin hydrochloride for injection, actinomycin D for injection, cladribine injection, heparin sodium injection and enoxaparin sodium injection of Nanjing Jianyou, pantoprazole sodium injection of East China, and rosuvasta of Lunan pharmaceutical Ting calcium tablet, azithromycin tablet of Shiyao group In addition to pantoprazole sodium for injection of Huadong pharmaceutical and azithromycin tablets of Shiyao group, the other varieties have not yet been declared for conformity evaluation Pantoprazole sodium for injection is the first anda approved by Huadong Pharmaceutical Co., Ltd at present, there is no product evaluation of other enterprises in the domestic market Huadong Pharmaceutical Co., Ltd., Yangzijiang Pharmaceutical Co., Ltd., aosaikang Pharmaceutical Co., Ltd., Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., China Resources Shuanghe Pharmaceutical Co., Ltd and Hunan Theron Pharmaceutical Co., Ltd have submitted supplementary application for consistency evaluation Azithromycin tablets of Petrochemicals Group have passed the consistency evaluation At present, the company has 20 varieties Pass or deemed to pass conformity assessment Three varieties submitted clinical application / listing application before the introduction of new registration classification Fengomode and prasugrel of dongyangyao applied for clinical application with new drug category 3.1 At present, these two varieties are still in a blank state in the domestic market The competition for prasugrel is fierce Including dongyangyao, there are 17 domestic pharmaceutical enterprises and 1 multinational pharmaceutical enterprise in China approved prasugrel hydrochloride tablets We have approved the production of datormycin for injection, and the supplementary application for consistency evaluation has been accepted by CDE in November 2019 25 varieties submitted for listing after the introduction of new registration classification In 2018, the total terminal sales of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) exceeded 30 billion yuan (in common name) Six varieties have been approved for production, and five of them are deemed to have passed the consistency evaluation Among the 19 varieties under review, nifedipine sustained-release tablets of Nantong Lianya, duloxetine hydrochloride enteric sol capsule of Baiyang pharmaceutical, propafenone hydrochloride sustained-release capsule and posaconazole enteric coated tablets of xuantai pharmaceutical, Napol of humanwell, nifedipine sustained-release tablets of Nantong Lianya Shengna tablet is expected to be the first to pass the evaluation 56 varieties to be transferred to China, 3 varieties "promising" Table 4: included in the priority review varieties After the introduction of the new registration classification, 10 of the 25 varieties submitted for listing were included in the priority review The reason for inclusion is "generic drugs produced in the same production line, listed in the EU / us, and applying for domestic listing" The inclusion of the priority review process helps to accelerate the product listing process, and the way of foreign reporting to domestic has become one of the thrust of the review Table 4: domestic anda varieties to be transferred without evaluation on layout consistency of domestic enterprises note: * represents unknown dosage form; sales volume is less than 30 million symbols - Represents 56 anda varieties have not yet applied for listing or clinical application in China At present, only azithromycin for injection, which has been evaluated by enterprises, has applied for supplementary application according to the consistency evaluation and passed the consistency evaluation Other injections have applied for listing according to the new registration classification and passed the consistency evaluation after being approved Among the 56 varieties to be transferred to China, 16 are injections These injections can be transferred to China through new registration classification Once approved for production, they will be deemed to have passed the conformity assessment 46 varieties have not been evaluated by enterprises in China, of which 26 varieties have not been evaluated for consistency of enterprise layout In 2018, the terminal sales of three varieties of cytarabine for injection, buspirone hydrochloride tablet and fenofibrate capsule in public medical institutions in China exceeded 100 million yuan Source: minenet database, announcement of listed companies note: review data statistics as of January 15, if there are omissions, welcome to correct! Original title: 29 pharmaceutical companies, 96 andas! Three kinds of products have made great achievements, Fuxing is bright, dongyangguang, Qilu.. Want to disrupt the market of more than 30 billion