Oral liquid consistency evaluation takes a high-end line! 3 products have been evaluated and 16 challenges have been imitated for the first time

According to the data of minenet, in November 2019, 39 products (involving 51 approvals) passed or deemed to have passed the consistency evaluation, including 25 tablets (involving 33 approvals), 10 capsules (involving 14 approvals), 2 injections (involving 2 approvals), 1 granule (involving 1 approval), 1 oral liquid (involving 1 approval) Since the implementation of the consistency evaluation, the over evaluation progress of oral regular release dosage forms such as tablets and capsules has been keeping a good momentum The over evaluation of injections is expected to speed up after the State Food and Drug Administration recently released the technical and application documents, while the over evaluation of oral liquid agents has gradually entered people's vision With the approval of calcium zinc gluconate oral liquid according to the new classification, it is deemed as over evaluation Three oral liquid agents have been evaluated before In 2018, the market size of oral liquid medicine in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal chemical medicine market exceeded 18 billion yuan, ranking the fifth in 17 categories, with market share rising from 1.64% in 2013 to 1.76% in 2018 For children and the elderly, it is very convenient to take oral liquid preparation, and because the drug is absorbed in a dissolved state, the drug in the solution can be immediately absorbed in the gastrointestinal tract, so the absorption of the solution is much faster and more efficient than that of the same dose of tablets or capsules With the effect of aging and the second birth era, the market demand for oral liquid agents is growing According to the data of minenet, up to now, three products have been approved according to the new classification and passed the consistency evaluation, among which aripiprazole oral liquid is the first one in China In 2018, the terminal sales volume of calcium zinc gluconate oral solution in China's public medical institutions was 364 million yuan, and the market shares of Aonuo (China) pharmaceutical, Hubei noon pharmaceutical and Hubei Furen Jinshen pharmaceutical were 70.11%, 15% and 14.88% respectively After the calcium zinc gluconate oral solution of Hebei renheyikang pharmaceutical was approved to enter the market according to the new classification, it is expected to break the tripartite situation In 2018, the sales volume of aripiprazole in China's public medical institutions was 1.078 billion yuan In terms of dosage forms, tablets accounted for 95.72% of the market share, while capsules only accounted for 4.28% The proportion of aripiprazole orally disintegrating tablets of Chengdu Kanghong Pharmaceutical Group is 32.57% At present, the product has passed the consistency evaluation; the aripiprazole oral liquid of Yibin pharmaceutical of China National Pharmaceutical Group is the first imitation in China, and its market potential is worth looking forward to In 2018, the sales volume of levetiracetam in China's public medical institutions was 1.039 billion yuan In terms of dosage form, tablets accounted for 88.9%, oral liquid accounted for 11.05%, and injection accounted for 0.05% Leading enterprise youshibi pharmaceutical included tablets, oral liquid and injection, with a total market share of 95.69% Among the ordinary tablets, four kinds of imitations of China Resources SECCO Pharmaceutical Co., Ltd and Zhejiang puluokangyu Pharmaceutical Co., Ltd were deemed to have passed the consistency evaluation, while the supplementary applications of xinlitai and Jingxin Pharmaceutical Co., Ltd were approved; the sustained-release tablets were deemed to have passed the consistency evaluation by xinlitai as per three kinds of imitations; the injection was deemed to have passed the consistency evaluation by four kinds of imitations of Hebei renheyikang Pharmaceutical Co., Ltd.; the oral liquid was deemed to have passed the consistency evaluation by Chongqing shenghuaxi Pharmaceutical Co., Ltd The approval of industry 4 imitation is deemed to have passed the consistency evaluation At present, the original research of this product has been evaluated in all dosage forms listed in China, and the situation of high-end imitation replacing the original research will be launched in succession According to the data of medchina drug review database 2.0, up to now, there are no enterprises applying for the consistency evaluation of oral liquid agents, but there are a lot of listing applications for class 3 and 4 imitations There are 23 products in the review and approval, 14 of which are products that are not imported in the domestic market and have no domestic approval, while there are only products in the market with no domestic approval There are two of them Entecavir and polyethylene glycol electrolyte are two kinds of more than 1 billion oral liquid In 2018, the sales volume of entecavir in China's public medical institutions was 8.771 billion yuan In terms of dosage form, the market share of tablets was 91.95%, while that of capsules was only 8.05% Among the ordinary tablets, Xintai Pharmaceutical (Suzhou), Beijing Baiao Pharmaceutical Co., Ltd and Chongqing Yaoyou Pharmaceutical Co., Ltd were approved according to four types of imitations; among the scattered tablets, the supplementary applications of Anhui Baker bio Pharmaceutical Co., Ltd., Suzhou Dongrui Pharmaceutical Co., Ltd., Jiangxi Qingfeng Pharmaceutical Co., Ltd and Zhengda Tianqing pharmaceutical group were approved through the consistency evaluation; among the capsules, Fujian guangshengtang Pharmaceutical Co., Ltd., Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd and Sichuan Haisi Pharmaceutical Co., Ltd The supplementary applications of Kefeng and Jiangxi Qingfeng were also approved and passed the consistency evaluation At present, there is no import or domestic approval for entecavir oral liquid in the market Stard Pharmaceutical (Beijing), together with Beijing newbio Pharmaceutical Technology Co., Ltd and Jiangsu Pharmaceutical Co., Ltd of Yangtze River Pharmaceutical Group, have participated in the competition for the first copy Who will be the winner? In the first round of centralized procurement, entecavir dispersible tablets of Zhengda Tianqing Pharmaceutical Group won the bid 4 + 7, entecavir dispersible tablets of Suzhou Dongrui pharmaceutical, entecavir tablets of Beijing Baiao pharmaceutical, entecavir capsules of Fujian guangshengtang Pharmaceutical Co., Ltd won the bid in 25 provinces and regions The industry was impressed by the intensity of the process If the first copy of the new dosage form was approved and deemed as having been evaluated, what will the market usher in Great change? We will continue to observe At present, the compound polyethylene glycol electrolyte in the market only has powder In 2018, the terminal sales in public medical institutions in China reached 1.176 billion yuan Shutaishen (Beijing) biopharmaceuticals accounted for more than 30% of the leading enterprises, Shenzhen Wanhe Pharmaceutical Co., Ltd and Jiangxi Hengkang Pharmaceutical Co., Ltd accounted for 28.20% and 27.98% respectively, and France yipusheng Pharmaceutical Co., Ltd accounted for 10.60% The three domestic enterprises were close to each other, but no enterprise had ever commented If the compound polyethylene glycol electrolyte oral liquid is approved for the first time and deemed as having been evaluated, it will have the opportunity to help shutaishen to open up the distance with the other two domestic enterprises after entering the market, and hold the dominant position of the product At the end of 2013, the national health and Family Planning Commission and other departments jointly formulated ten core information of rational drug use, which proposed that "drug use should follow the principle of" no need if you can use it less, no use if you can use it less; no intramuscular injection if you can take it orally, no infusion if you can intramuscular injection " After the policy of limited transfusion, limited resistance and other policies fell, the injection market entered a cold winter Since 2017, the conformity assessment work has been officially launched At the beginning of the work, it is mainly aimed at oral dosage forms Only in October 2019, the State Food and Drug Administration issued the conformity assessment technology and application documents for injection, and the market contraction faced by injection is also expected Among the varieties involved in the application for listing of class 3 and class 4 of the oral liquid agents under review, more than three over 100 million varieties currently account for more than 50% of the end injections in China's public medical institutions, but few enterprises apply for the injection consistency evaluation At present, only the tablet consistency evaluation of Shanghai Zhaohui Pharmaceutical Co., Ltd and Tianjin Lisheng Pharmaceutical Co., Ltd is in the review and approval In addition, the application for listing of three kinds of oral liquid medicines imitated by Jiangsu Yabang Shengyuan Pharmaceutical Co., Ltd and Nanjing zeheng pharmaceutical technology is under review According to the acceptance time of CDE, it is expected that the furosemide tablets of Tianjin Lisheng pharmaceutical will pass the evaluation as soon as possible The proportion of midazolam injection is up to 97% At present, only Jiangsu Enhua Pharmaceutical Co., Ltd and Yichang humanwell Pharmaceutical Co., Ltd have supplementary application for consistency evaluation, and Langfang Branch of State Pharmaceutical Group has 4 types of generic listing application Yichang humanwell Pharmaceutical Co., Ltd has also applied for 3 types of generic listing application for oral liquid agents, which are under review and approval In addition, Jinsheng Pharmaceutical Co., Ltd of Jilin Province has applied for buccal mucosa Three types of imitative listing application for solution (external liquid agent) "certificate preparation completed - to be approved" will be approved soon At present, there are only three kinds of imitations of Jiangsu Hengrui Pharmaceutical Co., Ltd of oral liquid agent for nimodipine on the market If they are approved successfully, they will become the first imitations At present, all national policies follow the principle of "can take orally without injection" The general direction of injection affected is expected to remain unchanged for a long time Many pharmaceutical enterprises mainly engaged in injection business are constantly seeking transformation Developing new oral products has become an important strategy Especially for generic drugs, there are many competitors for oral regular release dosage forms such as tablets and capsules, and the advantages are difficult to highlight From the current review of oral liquid agents, the number of high-end generic products is increasing gradually After entering the market, the impact on low-end generic drugs is obvious Coupled with the effect of social aging, the future market potential needs to be explored.