These 36 varieties will pass the consistency evaluation first! The generic market has changed

As of October 15, 2017, at least 35 be tests have been completed, more than 30 varieties have been submitted to CDE for acceptance, and the first wave of beach grabber is coming in the wave of consistency evaluation The battle started, and the future of the generic drug market has long been clear Both the brave and the temporarily frustrated giver have caught the flavor of change from it This paper is compiled from the Research Report of Guotai Junan Securities special research report on the consistency evaluation of generic drugs source: as of October 29, 2017, CFDA has uniformly accepted 18 consistency evaluation applications for changing process prescriptions, 8 applications for not changing the prescription process or applications for exemption from the consistency evaluation In addition, before the unified acceptance of the General Administration, eight varieties have been submitted to the General Administration for acceptance through the verification of the Provincial Bureau, and these varieties are expected to pass the consistency evaluation in the first batch On August 25, 2017, CFDA issued the announcement on the issues related to the consistency evaluation of quality and efficacy of generic drugs, which optimized and adjusted all aspects of the consistency evaluation Requirements: the review shall be completed within 120 working days after acceptance At this speed, the first batch of varieties that pass the consistency evaluation will be released soon Table: 36 varieties are expected to be the first batch to pass the consistency evaluation The "leftover" is Wang's generic consistency evaluation, which is the most important change in China's pharmaceutical industry in 2018 On March 5, 2016, the general office of the State Council issued the opinions on the evaluation of the consistency of quality and efficacy of generic drugs It is required that the consistency evaluation of the chemical generic oral solid preparations approved for marketing before October 1, 2007 should be completed by the end of 2018, marking the comprehensive launch of the consistency evaluation of generic drugs in China The "left" is the king According to the national policy, the total number of generic drug approvals is about 116000 By the end of 2018, 289 basic drug varieties and 17740 approvals need to be evaluated, involving 1859 manufacturing enterprises Time is tight, task is heavy, enterprise must decisively arrange resources, rational choice The period of consistency evaluation is about 20-28 months The two key steps are to determine the reference preparation and to carry out be test With the State Administration of industry and Commerce continuously issuing detailed rules and documents to solve these two key problems, the competition, which was initially hesitated and waited by enterprises, has entered a hot state As of October 20, 2017, the Chinese Academy of inspection has disclosed 5009 pieces of reference preparation information, covering most of the generic drug varieties filed by enterprises, of which 659 generic drug enterprises have filed 4271 reference preparations Most reference preparations of 289 base drug varieties have also been published According to the data, Shanghai Pharmaceutical has the largest number of registered product regulations (88), followed by Fu Ren Pharmaceutical (82); amoxicillin has the largest number of registered enterprises (112), followed by ceftriaxone capsule (72) With the release of qualified clinical trial institutions by the General Administration, from December 2016, the speed of be trials has been significantly accelerated, and the number of be trials passing the ethical consistency assessment has increased significantly every month, with the highest number being 21 in May 2017 As of October 15, 2017, there were 135 be items belonging to the consistency evaluation The most active pharmaceutical industry in Yangtze River has carried out 21 be tests Of the 135 be tests, 35 have been completed, and the smoke of be test is getting thicker The pharmaceutical industry is ushering in the peak of be test 2 Look at the trend of large varieties Those varieties that have passed the consistency evaluation will enjoy preferential purchase, medical insurance payment, financial support and other policy support However, since the time limit is the end of 2018, it is wise for small and medium-sized enterprises to give up related varieties and save time, and use the funds for the varieties that have made rapid progress and are most likely to compete for the market At present, Jiangsu Province, Shanxi Province, Zhejiang Province and Anhui Province have announced that they plan to give up the evaluation of varieties CFDA has analyzed all 289 varieties evaluation progress information, and variety selection is the general trend of the industry According to the conformity evaluation of 289 varieties published by CFDA as of May 23, 2017, 57% of the enterprises do not give up the evaluation, but only 26% of the enterprises have carried out the evaluation It is estimated that some enterprises have to give up due to time reasons Finally, the evaluation rate of 289 varieties can be stable at about 40% The remaining high-quality domestic generic drugs will use the bidding rules to gradually impact the original research drugs and accelerate the import substitution Among them, diabetes, cardiovascular disease, tumor, respiratory disease, hepatitis B and other fields, due to the huge market scale and the current market is mostly occupied by the original research drugs, will become the first target to be impacted after the consistency evaluation of generic drugs
In the field of oral hypoglycemic drugs, Huadong pharmaceutical is conducting the be test of acarbose, leading in the progress of consistency evaluation, which will compress Bayer, the original manufacturer, and seize the market share of Baoguang pharmaceutical; Yangzi River has completed the be test of glimepiride, which will impact Sanofi, who holds 90% of the market share; yuekang pharmaceutical and Boya biology have completed the be test of metformin, but at present The market share of 82% belongs to Squibb; for DPP-4 inhibitors, domestic enterprises have not yet listed, and Kelun pharmaceutical and Tonghua Dongbao are conducting research and development of gliptin generic drugs and actively conducting be test Amoxicillin capsule, which has the most reference preparations on record, is more competitive At present, UL, Sinopharm and conerby have completed be test and reported to CDE for acceptance, which is expected to pass first Risuvastatin calcium of AstraZeneca is also a key product to be imitated There are 6 domestic enterprises producing their generic drugs and 5 enterprises filing be tests Among them, Beijing new biology takes the lead, nearly 5 months ahead of the second place Table: progress of consistency evaluation of generic drugs of top 20 oral solid preparations in market scale (as of November 7, 2017) consistency evaluation is the supply side reform of China's pharmaceutical industry, accelerating the de production of China's pharmaceutical industry and optimizing the competition pattern The pharmaceutical industry will usher in the next long cycle, and pharmaceutical enterprises with excellent therapeutic varieties will eventually benefit 3 The breakthrough of generic drugs has brought about changes In this wave of waves, a new group of "star enterprises" will be born in the market For example, with the "Dongfeng" of consistency evaluation, the federal pharmaceutical company that arranges Amoxicillin Capsules has a strong breakthrough by relying on the large-scale variety market, the small share of original research, the large number of domestic enterprises, but the lack of absolute leading large-scale generic varieties; the clopidogrel of Lepu medical is the representative of the large-scale market, but the original research drug is dominant and the competition pattern is good, and it has a preemption by virtue of consistency evaluation The market share of the original research is to realize the counterattack of the weak; for the varieties of which the original research medicine is dominant and there are many competitors, rosuvastatin calcium of Beijing new pharmaceutical industry is the representative who takes the initiative and stands out in the fierce competition Considering the variety competition pattern, R & D basis, international resources and other factors, the three ways to achieve breakthrough of high-quality generic drugs have been gradually clear
Most of the stock varieties need to actively carry out variety mathematics and physics, carry out pharmaceutical research, seize be resources, and complete the consistency evaluation of generic drugs in a good and fast manner to make up for the "old historical account"; for the enterprise varieties with good industrial foundation and strong international ability, the domestic listing will be accelerated with the policy encouragement of priority evaluation and domestic application for approval after foreign market transfer, Realize overtaking in curve; actively withdraw and re declare varieties to conduct research according to the consistency standard with the original research drug, obtain the policy advantage of priority approval, and speed up the listing For example, enterprises with a large number of industrial varieties represented by Shanghai Pharmaceutical will continue to promote consistency evaluation through multiple core varieties to win by quantity The pharmaceutical export-oriented enterprises represented by Huahai Pharmaceutical Co., Ltd have achieved the goal of overtaking by turning export into domestic sales At present, Shanghai Pharmaceutical has 15 products in be clinical stage, Huahai pharmaceutical has 42 anda approvals, and azithromycin for injection of Puli pharmaceutical has become the first approved export to internal type in China.