Consistency evaluation is a major favorable policy for the overall improvement of the pharmaceutical industry. The key aspects of general R&D implementation include “reference preparations-secondary development of prescription processes (pharmaceutical research)-BE filing-BE testing-on-site assessment-review by drug control institutes-consistent Application for sexual evaluation-CFDA approval”. At present, it takes about 20-28 months to complete the entire process of consistency evaluation.
Since the beginning of this year, the pharmaceutical industry in the secondary market has moved from raw materials at the beginning of the year to innovative drugs, and recent hype to pharmaceutical consumption. With the release of a series of programmatic documents in the pharmaceutical industry, innovative drugs and consistency evaluations are judged by pharmaceutical analysts to be the main direction of future pharmaceutical investment.
“Innovative drugs and consistency evaluation will be the future investment direction.” Relevant researchers bluntly stated in an interview with the Hong Kong Journal of Finance and Economics that consistency evaluation, as the most important supply-side reform policy in recent years, has been progressing in an orderly manner. For example, after the China Food and Drug Administration (CFDA) compiled and issued four drafts of “Encouraging Innovation” in May this year, the “Innovation Opinions” was officially released on October 1, and on October 23, CFDA further issued the “< “Drug Administration Law of the People’s Republic of China” Amendment (Draft for Soliciting Comments)” and the corresponding “Administrative Measures for Drug Registration (Revised Draft)” (Draft for Soliciting Comments). It can be seen from this series of actions that the state attaches great importance to the drug management mechanism.
“There are currently ‘289 varieties’ required to complete the consistency evaluation by the end of 2018”. The aforementioned researcher told the Hongkan Finance and Economics reporter. The current policy requires generic drugs to be evaluated for consistency in the category of generic drugs approved for marketing before the implementation of the new registration classification of chemical drugs (including domestic generic drugs, imported generic drugs, and localized original research drugs). The mandatory varieties are the chemical imitation oral solid preparations in the list of basic medicines approved before September 1, 2007. There are 289 varieties in total, which need to be completed by the end of 2018. After the other varieties have passed the consistency evaluation for the first time, other companies will complete the same variety within 3 years in principle, and they will not be registered if they are not completed. On August 21, 2017, the CFDA issued the “Basic Information on the Quality and Efficacy Consistency Evaluation of Generic Drugs in the 289 Catalogue by Enterprises”. As of May 23, 2017, the “289 varieties” of national pharmaceutical companies will not give up, give up, A summary report was made on the status of “to be determined and carried out”. The overall non-abandonment evaluation rate of 289 varieties is about 57%, but the evaluation rate is only 26%. It is expected that some companies have to give up due to time. It can be seen from the specific variety data. Some companies basically do not give up evaluation for products with a small number of manufacturers and a broad market space, such as clopidogrel bisulfate, acarbose tablets, glimepiride tablets, etc. Some manufacturers do not give up on products with more varieties About half of the companies evaluated. The varieties that have not yet been evaluated for consistency are mostly those that have not been published by the CFDA on the catalog of relevant reference preparations, such as metronidazole capsules, ferrous sulfate sustained-release tablets, and bucinazine hydrochloride tablets. As of 2017 On September 21, the BE filing platform recorded a total of 99 varieties with a total of 173 product specifications, involving 27 manufacturers. Among them, the varieties with the most repeated filings included amlodipine besylate tablets (11), amoxicillin capsules ( 8), cefuroxime axetil (6). Among them, there are 42 “289 varieties” with 88 grades.
The researcher pointed out that consistency evaluation is a heavyweight and favorable policy for the overall improvement of the pharmaceutical industry. The key aspects of general R&D implementation include “reference preparations-secondary development of prescription processes (pharmaceutical research)-BE filing-BE testing-on-site assessment- Drug Inspection Institute Review-Consistency Evaluation Application-CFDA Approval”. At present, it takes about 20-28 months to complete the entire process of consistency evaluation. With the first appearance of acceptance numbers starting with CYHB175 in CDE, it is predicted that subsequent acceptance numbers starting with CYHB174 will appear one after another. These two types of acceptance numbers respectively represent registration applications with and without changes in the prescription process. It marks that the progress of the consistency evaluation of generic drugs has officially entered the stage of public announcement, which is a big step forward.
However, the Hongkan Finance reporter found that since February 2017, four provinces including Jiangsu, Shanxi, Zhejiang, and Anhui have announced the information on the products they intend to abandon the evaluation. In this regard, the researcher pointed out: “Big pharmaceutical companies, especially the top domestic companies The 50 companies are in a leading position in terms of consistency evaluation, mainly because they have sufficient human, financial and material resources to promote. Therefore, the enterprise side will make some adjustments to the record information according to the brand, competition status, and sales status. And from the government side From a point of view, encouraging measures have been implemented, and various regions have also introduced relevant policies to encourage consistency evaluation. For example, companies in Jiangxi Province, Anhui Province and Harbin City, Heilongjiang Province have passed the highest one-time award of 1 million yuan, 3 million yuan and 3 million yuan”.
In short, judging from the evaluation progress information of all “289 varieties” given by the CFDA, the progress of the consistency evaluation work has been significantly accelerated, and it is expected that the next year will be a critical period for consistency evaluation.
Regarding the consistency evaluation of the pharmaceutical industry, Zhao Bing, chief analyst of the Shanghai Securities Pharmaceutical Industry, analyzed: “In the review period, innovation is accelerated, and special effects drugs are now needed to be in line with international standards. The development, approval, and production and marketing of drugs will occur. Drastic changes. The competitive landscape of the industry will be reshaped in the future, and the competitive advantages of companies focusing on the research and development of innovative drugs and improving the quality standards of generic drugs will become more prominent.”
Li Zhixin, an analyst in the pharmaceutical industry of Lianxun Securities, also said in an interview with a Hongkan Financial reporter that there is currently a surplus of generic drugs, and more than 90% of domestic pharmaceutical companies are generic drugs. To solve the problems of the pharmaceutical industry, there must be a consistency evaluation drug review system to monitor. In order to solve the supply-side model, my country’s drug registration management system is gradually integrating with the world’s advanced level represented by the United States. In the case of oral solid preparations of base drugs, the consistency evaluation needs to be completed before the end of 2018. According to the policy requirements of the “Opinions of the General Office of the State Council on Carrying out the Evaluation of the Quality and Efficacy Consistency of Generic Drugs”, the generic drugs approved for marketing before the implementation of the new registration classification of chemical drugs (March 2016) are not consistent with the quality and efficacy of the original drug. Approval in principle shall be subject to consistency evaluation. Among them, the oral solid formulations of generic chemical drugs approved for marketing before October 1, 2007 in the National Essential Drug List (2012 Edition) should be evaluated for consistency before the end of 2018.
From the perspective of investment opportunities, the Hong Kong Journal of Finance and Economics reporters learned that the pharmaceutical industry has entered a new starting point for a long-term cycle. Pharmaceutical companies with excellent therapeutic varieties will ultimately benefit from the structural opportunities of industry changes. Especially in the field of major diseases is expected to give birth to great opportunities. At present, diabetes, cardiovascular and cerebrovascular diseases, hepatitis B and other disease fields have a wide range of patients and a huge market scale. They continue to maintain stable growth under the driving factors of aging population, rising income levels, and rising health awareness. Although the mainstream therapeutic drugs in the field of these diseases have generic drugs on the market, the market share is still mainly occupied by original drugs. Under the industry changes brought about by consistency evaluation, high-quality domestic drugs that pass consistency evaluation are expected to rewrite the competitive landscape, and the large varieties corresponding to these large fields are expected to nurture new investment opportunities. In the general environment where the consistency evaluation of generic drugs continues to advance, product compression is an industry trend. After eliminating its own small varieties, what is left will be the most representative large varieties of pharmaceutical companies and pharmaceutical companies with excellent varieties. Eventually, they will benefit from changes in the industry. Pharmaceutical companies worth paying attention to include Tiger Pharmaceuticals, Hengrui Pharmaceuticals, Shanghai Pharmaceuticals, East China Pharmaceuticals, Lepu Medical, and Huahai Pharmaceuticals.
Specifically, Tigermed has more BE base resources in the industry, and BE business has begun to gradually increase its volume. In the latest CFDA opinion draft, it is proposed to change BE to the base filing system, and the company’s investment in Compaq Hospital will crack the company’s BE project. The company’s benefit in this round of consistency evaluation of generic drugs in 2018 will be more obvious. In the long run, in the context of the upgrading of my country’s pharmaceutical industry, domestic companies’ innovative drug R&D capabilities continue to increase, and the demand for high-end CRO services is correspondingly increased. As a leading domestic CRO company, the company has a very good clinical trial management capability. Will benefit from this in the long term.
Hengrui Medicine’s share price has repeatedly hit new highs recently. The company announced on November 6 that it had received a clinical trial approval for glycopyrrolate inhalation powder from the State Food and Drug Administration. Glycopyrronium bromide inhalation powder developed by Novartis is a long-acting muscarinic receptor antagonist (anticholinergic drug) for inhalation, used to relieve the symptoms of adult patients with chronic obstructive pulmonary disease (COPD) , Has been approved for listing in the UK, Germany, Norway, Denmark, Australia and Canada. Upon inquiry, glycopyrrolate inhalation powder mist is not on the domestic market. In 2016, the global sales of glycopyrrolate inhalation powder was approximately US$157 million. Up to now, the company has invested approximately 6.5 million yuan in research and development expenses in this research and development project.
Shanghai Pharmaceuticals issued an announcement stating that Chia Tai Qingchunbao Pharmaceutical Co., Ltd., a subsidiary of Shanghai Pharmaceuticals, recently received the “Drug GMP Certificate” issued by Zhejiang Food and Drug Administration, with the certificate number ZJ20170067. There are 3 certified workshops for the “Drug GMP Certificate”: eight pre-processing workshops, seven extraction workshops, and the second workshop of small-volume injection workshops, all of which are used to produce small-volume injections. Up to now, the accumulated investment in the production line is approximately RMB 46.87 million. In addition, CP Qingchunbao passed the GMP certification and obtained the new GMP certificate, which will not have a significant impact on the current and future operations of Shanghai Pharmaceuticals and its subsidiaries. Obtaining the new version of the drug GMP certificate is conducive to improving the company’s product quality and production capacity, and meeting market demand. Huahai Pharmaceutical also announced on November 1 that the company’s new drug application for fingolimod capsules declared to the US FDA has been temporarily approved. Obtained the US FDA provisional approval number, marking that the product has passed the safety and effectiveness review. However, the product needs to be approved for sale in the US market only after the patent right expires and the FDA finally approves it. According to statistics, in 2016, Fingolimod capsules sold approximately US$2.1 billion in the US market.
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