In depth interpretation of "36", these five directions are worth betting!

Source: on October 8, 2017, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (hereinafter referred to as "Article 36"), which caused the industry shock Some insiders even said that this was the most important policy for the pharmaceutical industry after the founding of the people's Republic of China Based on the policy content, the following five key points are drawn from the professional perspective of the industry for the benefit of readers New drug market acceleration In Article 36, the first and second parts mainly focus on accelerating the speed of new drug marketing: reforming the clinical trial management, accelerating the clinical links of drugs from GCP filing, Ind filing, improving the efficiency of ethical review, opening the bottleneck of production capacity of clinical trial institutions, and promoting the efficiency of overall research and development; accelerating the review and approval of listing, and giving more attention to the drugs urgently needed and rare diseases Policy tilt, put forward a number of measures to speed up the approval, drug and pharmaceutical raw and auxiliary materials and packaging materials related approval, optimize the industrial supply structure Article 36 and No.44 document issued by the State Council in 2015 on the reform of drug and medical device review and approval system are important documents in the process of drug review system reform in China The state's intention in encouraging innovation and accelerating the listing of new drugs is very clear The development of innovative drugs has been greatly encouraged by the opening of the bottleneck of clinical trial resources, the opening of priority review channels, the addition of patent term compensation, and the timely inclusion of medical insurance and other policies In addition, generic drugs will be included in the list of drugs on the market with the help of consistency evaluation, while medical insurance and drug collection will also be included in the list in time After the arrival of "Article 36", China's leading innovative pharmaceutical and generic pharmaceutical enterprises with strong strength will be the biggest winners Representative of leading innovative pharmaceutical and generic pharmaceutical enterprises: Hengrui pharmaceutical: Hengrui pharmaceutical is the only pharmaceutical enterprise selected as "the first batch of national top 100 innovative enterprise pilot enterprises" in 2016 In the past 17 years of listing, except for a slight decrease of 2.17% in 2002, the net profit has achieved a positive growth in the remaining 16 years, with an annual compound growth rate of 25.94%; in the last 10 years, the return on net assets has been maintained at more than 21%, and the profitability is very eye-catching Hengrui medicine has applied for more than 400 invention patents, and the innovative drugs arexib and apatinib have been approved for listing In 2017, there were 24 innovative drugs under clinical development In the development of innovative drugs, Hengrui medicine has basically formed a benign development trend of applying for clinical innovative drugs every year and listing innovative drugs every 2-3 years Huadong pharmaceutical: Huadong pharmaceutical is a leading enterprise in the field of generic medicine in China It takes the development route with high-end generic medicine as the main and innovative medicine as the auxiliary Its product line has rich echelons and its performance growth rate is sustainable Acarbose, the main product of East China medicine, mainly relies on the fermentation of actinomycetes, and cannot be synthesized by chemical means The high barrier of production technology, coupled with the pharmaceutical commercial advantages of East China medicine, accounts for 24.24% of the domestic market share of acarbose Traditional Chinese medicine injection industry faces shuffle Article 11 and Article 25 of Article 36 indicate the attitude of the state to strictly review and approve drug injection: in the future, if the oral preparation can meet the clinical needs, the injection preparation will not be approved for listing; if the intramuscular injection preparation can meet the clinical needs, the injection preparation will not be approved for listing; in addition, it will strive to use 5-10 years to re evaluate the drug injection that has been listed Price For this, the industry believes that it will have a great impact on the injection industry, especially the traditional Chinese medicine injection industry Wu Zhen, deputy director of the State Food and drug administration, said, "we need to reevaluate the safety of traditional Chinese medicine injections We have preliminarily formed this reevaluation plan, but it is still under discussion in the industry, and we may seek opinions in the near future." On October 10, Bi Jingquan, director of the State Administration of food and drug administration, emphasized once again that the injection was in the evaluation work at the teleconference of the national drug administration system, "the injection, especially the intravenous injection, belongs to the high-risk dosage form and must be strictly supervised" In recent years, there are many disputes about traditional Chinese medicine injections The excellent characteristics of high gross margin attract many Chinese patent medicine enterprises to set foot in one after another However, the frequent quality crisis and high adverse reaction rate are also indisputable facts in the industry With the coming of Article 36, it has become an inevitable trend to strictly review and approve drug injections in the future The traditional Chinese medicine injections with frequent quality crisis will face the arrival of industry reshuffle, the high-quality products will return to a healthy growth state, the products with no advantages in quality and sales will gradually weaken, and the products with poor quality and serious homogenization competition will gradually be eliminated However, the state's support bonus for traditional Chinese medicine with national characteristics will continue to be released As one of the products of the modernization of traditional Chinese medicine, traditional Chinese medicine injection has become one of the sub industries with strong growth in the future due to its innovation and efficiency Therefore, the strong traditional Chinese medicine injection with strong strength and exclusive varieties will enjoy the benefits of broad market and policy dividend after the industry shuffle, and become the ultimate beneficiary Representative of traditional Chinese medicine injection enterprise: Zhongheng group: Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd., the main subsidiary of Zhongheng group, is the leading pharmaceutical manufacturer in Guangxi and the largest traditional Chinese medicine injection manufacturer in South China Its main products are Xueshuantong (freeze-dried), Zhonghua Dieda pill, Fuyanjing capsule, shishitong tablet, Hedan Chuanbei liquid, etc According to the data of Zhongkang CMH, Xueshuantong for injection (Guangxi Wuzhou pharmaceutical) is the brand with the highest market share of traditional Chinese medicine injection for four consecutive years, with a market share of 7.43% in 2016 Step pharmaceutical: step pharmaceutical is a pharmaceutical enterprise with patent Chinese patent as its core and committed to the modernization of traditional Chinese medicine Its main products are Naoxintong capsule, Wenxin Granules, Danhong injection and Guhong injection, which are four exclusive patent varieties Its treatment range covers common cardiovascular and cerebrovascular diseases such as stroke, arrhythmia, insufficient blood supply and ischemic infarction According to the data of Zhongkang CMH, Danhong injection (step length) ranked second in the injection market share for five consecutive years, accounting for 6.59% of the market share in 2016 Increase of medical device support In Article 36, medical devices and drugs are put at the same level for clinical trial institutions to record management, strengthen clinical trial incentive system, optimize review procedures, recognize qualified overseas clinical trial data, speed up review and approval for clinical urgent needs and rare diseases, which means that good policies for innovative drugs will be transformed into innovative medical devices In terms of equipment, the policy support for innovative medical devices has been enhanced In addition, Article 36 puts forward that the system of medical device listing license holder will be promoted, and the second type of medical device evaluation standard will be unified and standardized, and the national unified evaluation will be gradually realized in the future Compared with hundreds of millions of R & D investment in the pharmaceutical field, the R & D cost of medical devices is relatively low, and the risk is also lower The improvement of policy favorable degree is expected to better promote the development of innovation and R & D of medical devices, and stimulate the potential of R & D of medical devices Therefore, the medical device leader with strong R & D ability and rich product reserve under research will benefit better from the policy dividend Representatives of leading medical device enterprises: Yuyue medical: Yuyue medical is a company mainly engaged in providing domestic medical devices, medical clinical devices and internet medical services, while R & D, manufacturing and sales of medical device products are its current core business Yuyue medical products started from oxygen generator, sphygmomanometer, etc after being put on the market, the product line has been greatly expanded by integrating Suzhou medical supplies factory, youyue optics, Shanghai Machinery Group, Zhongyou medical, etc at present, it has hundreds of product types, of which, the medical product line has covered almost all the surgical instruments and disinfection and health materials in the clinical departments, while in the home field, it focuses on respiratory system and painstaking efforts Tube and endocrine diseases have developed star products such as oxygen generator, sphygmomanometer and blood glucose meter In addition, through the integration of R & D resources of M & A enterprises, the company launched new products such as double-level ventilator, medical electronic sphygmomanometer, indwelling needle, etc., and constantly improved the competitiveness of the company's products Perfect patent system and MAH system There are also a lot of references in Article 36 to the improvement of patent system and MAH system, such as the establishment of a list of listed drugs, the exploration of the establishment of drug patent link system, the pilot of drug patent term compensation system, the improvement and implementation of drug test data protection system, the promotion of drug imitation production, the play of the innovative main role of enterprises, and the support of clinical application of new drugs The system of listing license holder shall be fully implemented, the legal liability of listing license holder shall be implemented, the system of directly reporting adverse reactions and adverse events by listing license holder shall be established, the re evaluation of drug injection shall be carried out, the re evaluation system of medical devices shall be improved, and the academic promotion of drugs shall be standardized With the coming of Article 36, the patent protection system and MAH system will be further improved, which will greatly stimulate the innovation of pharmaceutical enterprises, research institutions and individuals This is undoubtedly a great advantage for small and medium-sized R & D innovation enterprises and CMO enterprises in China After obtaining the drug listing license, small and medium-sized enterprises can entrust CMO enterprises to produce on their behalf, so as to avoid the company holding the advanced drugs in China and even in the world However, the product project can only make a living by "selling approval documents", and it is expected to share the profits brought by the successful marketing of drugs CMO enterprise representative: kelleying: kelleying is one of the leading enterprises of cdmo (Pharmaceutical contract customized R & D and production) enterprises in China It is mainly committed to the technological innovation and commercial application of global pharmaceutical technology, and provides one-stop CMC services for large and medium-sized pharmaceutical enterprises and biotechnology enterprises at home and abroad At present, kelleying has deep embedded cooperation with large and medium-sized pharmaceutical companies in the world, such as Merck, Pfizer, Bristol Myers Squibb, Ai Bowei and Lilly It mainly provides integrated services from clinical phase I, phase II and phase III to post marketing phases Its service products include hepatitis C, anti diabetes, anti-tumor, cystic fibrosis, prostate cancer, myeloma, soft tissue sarcoma, leukemia, some new drugs for rare diseases and Cefalexin, the third line antibiotics, penem, antilipidemic statins, hypoglycemic gliptin Some of them have become breakthrough new drugs in the world Article 13 of Article 36 of the simplified review and approval of classical famous prescriptions clearly points out that to support the inheritance and innovation of traditional Chinese medicine, the review and approval of classical famous prescriptions shall be in accordance with the simplified standards, and the application for production of classical famous prescriptions that meet the requirements shall be made clear Only the pharmaceutical and non clinical safety research data can be provided, and the pharmacodynamic research and clinical trial data are exempted On October 9, CFDA website released the management regulations on simplified registration and approval of traditional Chinese medicine and famous formula compound preparation (Draft for comments) (hereinafter referred to as draft for comments) and the opinions on application materials (Draft for comments), which became the first supporting document for the implementation of Article 36 In China, it is always difficult to apply for approval of traditional Chinese medicine According to the 2016 drug review report released by CFDA, only 2 of 206 new drugs approved for marketing in 2016, accounting for 0.97% After the implementation of Article 36, the traditional Chinese medicine industry, especially the traditional Chinese medicine enterprises, will also get good results The varieties researched and developed based on the classic formula can save a lot of time and money costs for the related enterprises in the research and development of new drugs Representatives of traditional Chinese medicine enterprises: Tongrentang: Tongrentang as a senior of traditional Chinese Medicine