The declaration of volume purchase will be closed! 8 billion new competitors

In early November, the "4 + 7 urban drug centralized procurement document" was released to the public, and the volume procurement officially entered the sprint stage The total purchase quantity of 31 varieties is more than 1.6 billion tablets (10000 bags) of oral dosage form and more than 6.9 million injections It is mentioned in the application requirements that the application varieties can be the original research drugs and reference preparations and generic drugs issued by the State Food and drug administration, which must pass the consistency evaluation or deemed to pass the consistency evaluation At present, the deadline for submission of application materials is closer and closer to December 6, 2018 Can some varieties that are about to complete the review process catch up with this train? 8 billion varieties add competitors On November 23, hispec announced that it received the approval document of drug supplement application on entecavir capsule approved and issued by the State Food and drug administration, and passed the consistency evaluation of quality and efficacy of generic drugs According to the latest news, entecavir capsule (0.5mg) of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd has also passed the consistency evaluation and has been included in the list of drugs listed in China On November 27, Dongrui pharmaceutical announced that entecavir dispersible tablet (0.5mg) of Suzhou Dongrui Pharmaceutical Co., Ltd., a subsidiary of the group, was the third one approved to pass the consistency evaluation in China Figure 1: Sales of entecavir in China's public medical institutions in 2013-2017 (unit: 10000 yuan) (source: China's public medical institutions' terminal competition pattern in minenet) According to meter data, in 2017, the total sales of entecavir (tablets and capsules) 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) terminals exceeded 8.4 billion yuan, of which the market share of tablets was 93.38% (0.5mg accounted for 99.03%, 1mg for 0.97%), and the market share of capsules was 6.62% (0.5mg) Figure 2: in 2017, the enterprise structure (unit: 10000 yuan) of entecavir (0.5mg) in China's public medical institutions terminal (source: minernet China's public medical institutions terminal competition pattern) is currently 0.5mg in the market The market share of market leader Zhengda Tianqing Pharmaceutical Group is 47.27%, and the former research enterprise Shiguibao ranks second with 34.54% Table 1: compliance assessment of entecavir formulations (source: minenet database) According to the minenet database, as of November 27, 2018, the enterprises that have passed the consistency evaluation of entecavir dispersible tablets (0.5mg) are Zhengda Tianqing pharmaceutical, Jiangxi Qingfeng pharmaceutical, Suzhou Dongrui pharmaceutical; while the enterprises that have passed the consistency evaluation of entecavir capsule (0.5mg) are Jiangxi Qingfeng pharmaceutical, Sichuan HISCO pharmaceutical and Nanjing Zhengda Tianqing pharmaceutical Table 2: supplementary application for consistency evaluation of entecavir in review (source: Med China drug review database 2.0 on minenet) At present, the enterprises under review and approval of entecavir capsule are Fujian guangshengtang Pharmaceutical Co., Ltd., with the product specification of 0.5mg, and the enterprises under review and approval of entecavir dispersible tablets are Anhui Baker biopharmaceutical Co., Ltd., with the product specification of 0.5mg Table 3: centralized purchase quantity of drugs in 4 + 7 cities (unit: 10000 tablets) (source: centralized purchase document of drugs in 4 + 7 cities) In the centralized purchase document of drugs in 4 + 7 cities, it is determined that the specification for purchasing entecavir oral regular release dosage form is 0.5mg, and the agreed purchase quantity is 41.3351 million tablets According to the document application requirements, the enterprises that are qualified to submit the application materials at present include the original research enterprises Shiguibao, Zhengda Tianqing, Jiangxi Qingfeng, hisic and Dongrui pharmaceutical Who will be the final one? We'll see R & D accounts for more than Hengrui's revenue In 2018, Hisense has approved a class 1 new drug clinical chart 3: performance of Hisense in 2014-2017 (unit: 100 million yuan) (source: annual report of listed companies) Hisense is a diversified medical and health group listed company integrating new drug R & D, manufacturing, sales and other businesses In 2017, the operating revenue was 1.856 billion yuan, the net profit was 238 million yuan, and the R & D investment was 245 million yuan, accounting for 13.19% of the revenue Hengrui Pharmaceutical Co., Ltd., a domestic R & D group, is a member of the "10 billion revenue club" From 2014 to 2017, the R & D investment accounted for 8.75%, 9.57%, 10.68% and 12.71% of the operating revenue respectively So it seems that Hisense's investment in R & D is a match with Hengrui In recent years, innovation has become an important development goal of all walks of life, and new documents in the field of medicine have given more support and dividends to innovative drugs Table 4: the latest development of products under research of HISCO and its subsidiaries in 2018 (source: meed China drug review database 2.0), no pains, no gains In 2018, HISCO has a class 1 new drug approved for clinical use The indications of hsk16149 capsule are diabetic peripheral neuralgia and post bullous neuralgia The preclinical study shows that hsk16149 has the characteristics of strong analgesic effect, long-term analgesic effect and little central side effect In the future, hsk16149 may have the advantages of more significant efficacy and better safety in clinical application, and it is expected to replace pregabalin and gabapentin, and has the potential to become the first choice for chronic neuropathic pain In addition, hispec also has 6 generic drugs approved for production, two of which are 1 billion varieties: palonosetron hydrochloride injection has a market scale of more than 1.6 billion yuan at the end of China's public medical institutions in 2017; esmeralazole sodium for injection has a market scale of more than 2.3 billion yuan at the end of China's public medical institutions in 2017 In terms of consistency evaluation, in addition to the approval of entecavir capsule, the supplementary application for consistency evaluation of flupentixoxime tablets of HISCO has been accepted The product is a non 289 variety, and its market scale in China's public medical institutions in 2017 was close to 1 billion yuan At present, only the supplementary application of consistency evaluation from hisilico has been accepted, and Chongqing Zhien Pharmaceutical Co., Ltd has completed the be test of the product.