Is it wise or helpless for Huahai and Kangenbei to give up the consistency evaluation of 160 varieties? Who is the future king of generics?

The consistency evaluation of generic drugs has been carried out for one and a half years, and the competition is over half, and the fierce competition has begun After Zhejiang Province and Jiangsu Province announced that some enterprises in the province, such as Yangzi River and Jingxin pharmaceutical industry, have nearly completed the consistency evaluation of some varieties, there are new trends on the track recently This time, the key words are: give up Recently, the food and Drug Administration of Zhejiang Province released the variety information of consistency evaluation on quality and efficacy of generic drugs not to be carried out in Zhejiang Province, among which 160 drug plans of 32 pharmaceutical companies are not to carry out consistency evaluation on generic drugs For most pharmaceutical companies, The consistency evaluation work is time-consuming and expensive, so it is difficult to carry out the consistency evaluation for all varieties in hand However, these 160 varieties have been abandoned by these enterprises, which means that in more than one year since the work was carried out, each enterprise has a clearer understanding of the situation and promotion degree of its own work, and has made a more realistic decision Guotai Junan Securities analysis pointed out that according to the end of 2018, it is wise for small and medium-sized enterprises to choose to give up relevant varieties, save time and money for fast progress and most promising market varieties At the same time, the 160 varieties that the pharmaceutical enterprises intend to give up to carry out consistency evaluation must be the result of weighing, evaluation and comprehensive consideration by the enterprise management This is the first province in China to release the list of planned abandonment, and other provinces may follow up This way is convenient for enterprises to select varieties more rationally, and also conducive to enterprises to make rational choices, and accelerate the progress of generic drug consistency evaluation as a whole 1 pharmaceutical enterprises: as a whole, there are 32 enterprises that give up most varieties Zhejiang Jutai Pharmaceutical Co., Ltd under Puluo Pharmaceutical Co., Ltd is the company with the largest number of varieties to be given up, with a total of 35 varieties However, there are 12 pharmaceutical enterprises with the number of varieties to be abandoned greater than or equal to 5 According to the merger of subsidiaries of listed companies, many listed companies, such as Kangenbei, Sansheng pharmaceutical, Xinguang pharmaceutical, Haizheng pharmaceutical and Huahai pharmaceutical, have announced to give up the consistency evaluation Even some enterprises intend to give up the number of varieties has accounted for more than half of the total number of varieties Taking Puluo pharmaceutical as an example, Zhejiang Jutai Pharmaceutical Co., Ltd., a subsidiary of Puluo Pharmaceutical Co., Ltd., as of the end of July 2017, has obtained approval documents of 41 varieties of "Guoyao Zhuzi" This time, it is planned to give up the consistent evaluation of 35 varieties, and only keep cefixime dispersible tablets, amoxicillin potassium clavulanate capsules (2 specifications), sterile crystalline sulfanilamide, vitamin E nicotinate ester and other varieties It is reported that cefixime dispersible tablets and amoxicillin and clavulanate potassium capsules are the main products of the pharmaceutical industry of Puluo Their market share has been steadily increased in the first half of 2017 At present, reference preparations have been filed and be test is about to start Taking Xinguang pharmaceutical industry as an example, the consistency evaluation of 7 chemicals is to be abandoned It is understood that the company is mainly engaged in Chinese patent medicine business, and the company's leading products Huangqi Shengmai Yin, Shenjindan Capsule and American ginseng oral liquid accounted for 98.5% of the total revenue in 2016 Therefore, the industry is expected to give up the consistency evaluation of seven chemicals, which has little impact on the company's future performance as a whole Guotai Junan Securities analysis pointed out that from the current progress of consistency evaluation, the be test is mainly led by large-scale pharmaceutical enterprises with abundant funds and strong R & D strength, such as Shiyao group, Shanghai pharmaceutical, UL, etc small and medium-sized pharmaceutical enterprises are unable to compete with their own related varieties and choose to give up directly, It is wise to save money for the consistency evaluation of varieties that have made rapid progress and are most likely to occupy the market Varieties: from the perspective of abandoned varieties, the common point of the whole varieties to be abandoned announced by Zhejiang Province is that the competition is fierce and the varieties are non core varieties of these enterprises According to the analysis of Guotai Junan Securities Research Report, the 160 varieties to be abandoned have a large number of existing approvals and fierce competition, the vast majority of which have been put on record by many enterprises in the Institute For example, five enterprises of Cefalexin capsule (in common name) announced to give up the consistency evaluation Cefalexin capsule is one of the first batch of basic drugs in the "289" catalogue, and it is also the second variety in the total number of reference preparations reported by the Chinese Academy of inspection At the same time, Norfloxacin Capsules, ranitidine hydrochloride capsules, metformin hydrochloride tablets and other varieties abandoned by many enterprises also ranked in the top 10 in the total number of reference preparations reported by the Central Inspection Institute It is reported that the number of approvals for the above four varieties has exceeded 100, and the number of production enterprises is large and the competition is fierce In addition, there are Amoxicillin Capsules, metformin hydrochloride tablets and other varieties that have been tested by large pharmaceutical enterprises such as stone Pharmaceutical Group and Fosun Pharmaceutical According to the data, as of July 24, 2017, CIIS has disclosed about 4000 reference preparations filed by 629 generic pharmaceutical enterprises, 2294 of which are related to 289 drug base directories, accounting for 57%; 223 of 289 drug base varieties have been filed by enterprises, accounting for 77% As of August 4, 2017, there are about 5 kinds of be test records in the 160 list of varieties to be abandoned (121 varieties after weight removal), which are amoxicillin capsule, azithromycin capsule, metformin hydrochloride tablet, clindamycin hydrochloride capsule and captopril tablet Except captopril tablet, the other four varieties have been tested According to the opinions on the evaluation of the consistency of quality and efficacy of generic drugs issued by the general office of the State Council in March 2016, it is required that "among the national generic drugs, the generic oral solid preparations of chemical drugs approved for marketing before October 1, 2007 shall be completed by the end of 2018, and those not completed within the time limit shall not be registered again" And "if there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, no more varieties that have failed the consistency evaluation will be selected in the centralized purchase of drugs." Therefore, these enterprises give up the evaluation work of these varieties, which means that their document number will be cancelled, and the enterprises will not be able to sell the varieties and lose the current market share of the varieties However, these varieties to be abandoned are non core varieties of each listed company, and the sales of these varieties account for a relatively low proportion of corporate income The analysis shows that in the long run, the enterprises choose to give up the overall impact on future sales revenue is small 3 in the future, the "leftover" is Wang's consistency evaluation Up to now, both the regulatory authorities and the enterprises have a clear and profound understanding of the importance of this reform task, and they are increasingly holding an open and time effective attitude The next year will be the key period of consistency evaluation It is expected that some varieties will pass the consistency evaluation one after another, The reshuffle of Chinese pharmaceutical industry officially began On June 28, Zhejiang food and Drug Administration announced that it had completed the preliminary review of the consistency evaluation of risuvastatin calcium tablets of Zhejiang Jingxin Pharmaceutical Co., Ltd and reported it to the State Administration Then, according to the article "food and Drug Administration of Jiangsu Province vigorously promotes the consistency evaluation of quality and efficacy of generic drugs" issued by Taizhou food and Drug Administration of Jiangsu Province, as of the middle of June, Jiangsu Province has completed the consistency evaluation of 6 specifications of 4 enterprises including Yangzijiang Pharmaceutical Group, and applied to the provincial administration Now, Zhejiang Province once again announced the relevant progress, which can be said to be in the forefront of reform Guotai Junan Securities pointed out that with the promotion of consistency evaluation, the spring of supply side reform of China's chemical pharmaceutical industry will come, in which the "leftover" is the king and the market competition pattern is optimized, and the pharmaceutical industry will enter a new starting point of a long cycle In particular, the excellent therapeutic pharmaceutical enterprises with solid industrial foundation, certain profit volume, large number of varieties, and emphasis on consistency evaluation will eventually benefit from the structural opportunities of industry transformation Although in the short term, the varieties that do not conduct consistency evaluation will gradually withdraw from the market, and the enterprise will face the downward risk of profit brought by the reduction of sales varieties However, if we can make use of the material and financial resources saved from the consistency evaluation of non dominant varieties to promote the consistency evaluation of our own core dominant varieties quickly and strive to pass as soon as possible, we are expected to seize new market share and achieve overtaking at the corner The consistency evaluation work has been continuously promoted, and variety compression has been the industry trend for a long time After the elimination of small varieties, the rest will be the most representative large varieties of pharmaceutical enterprises Pharmaceutical enterprises with excellent varieties will eventually benefit from the changes in the industry Although the power of generic drug consistency evaluation may not really play out for the time being, but with more and more varieties completing the evaluation, the time left for many enterprises is really not much! (this paper is compiled and collated from Guotai Junan Securities Research Report "targeted, accelerated promotion of consistency evaluation - new trend of consistency evaluation in Zhejiang: 160 varieties to be abandoned", see the report for details of 160 varieties.)