On December 30, the State Food and Drug Administration and other eight departments jointly issued the “14th five year plan” for national drug safety and promoting high-quality development.
The plan defines the main development objectives of drug safety and promoting high-quality development during China’s 14th Five Year Plan period, and formulates 10 main tasks, namely, implementing the supervision of the whole process of drug safety, supporting industrial upgrading and development, improving the drug safety management system, continuously deepening the reform of review and approval system, strict vaccine supervision, promoting the inheritance, innovation and development of traditional Chinese medicine Strengthen the construction of technical support capacity, professional talent team, intelligent supervision system and capacity, and emergency system and capacity.
The plan sets a long-term goal for 2035: China’s scientific, efficient and authoritative drug supervision system will be improved, and the drug supervision capacity will reach the international advanced level. The ability of drug safety risk management has been significantly improved, and laws, standards and systems covering the whole life cycle of drugs have been fully formed. The efficiency of drug review and approval was further improved, and the technical support capacity of drug supervision reached the international advanced level. The safety, effectiveness and accessibility of drugs have been significantly improved, effectively promoting the prevention of major infectious diseases and the treatment of refractory and rare diseases. Remarkable progress has been made in the high-quality development of the pharmaceutical industry, the industrial level has been significantly improved, the innovation and R & D capacity of drugs has reached the international advanced level, excellent leading industrial clusters have been basically formed, the inheritance and innovation development of traditional Chinese medicine has entered a new stage, and the leap from a large pharmaceutical country to a powerful pharmaceutical country has been basically realized.
innovative drugs are expected to usher in the harvest period
The plan proposes that at the end of the 14th Five Year Plan period, the regulatory environment supporting the high-quality development of the industry will be further optimized, the reform of the review and approval system will continue to deepen, a batch of innovative drugs urgently needed in clinic will be approved, the listing of innovative drugs with clinical value will be accelerated, and the global innovative drugs and Innovation Medical Management Co.Ltd(002173) devices applied in China will be listed in China as soon as possible, 2650 standards for drugs, medical devices and cosmetics were prepared and revised, and 480 guiding principles were added.
According to incomplete statistics by the reporter of China Securities Journal, since this year, a total of 39 innovative drugs have been approved for listing, many of which are products independently developed by China and have independent intellectual property rights. In the first half of the year alone, more than 20 class 1 innovative drugs were approved for listing, which has exceeded the number of 20 innovative drugs approved in 2020, and the approval speed of innovative drugs has been significantly accelerated.
Caixin Securities believes that with the joint efforts of policy support, capital assistance and pharmaceutical enterprise innovation, the number of listing applications and external licensing of innovative drugs in China have increased significantly, and the achievements of innovation and internationalization have initially appeared, which is expected to usher in the harvest period. It is suggested to pay attention to innovative pharmaceutical enterprises with rich product pipelines, strong differentiated innovation ability and strong internationalization ability.
Capital Securities believes that with the deepening of understanding of drug targets and the continuous maturity of new technologies, all kinds of new products around the world have gradually entered the clinical and listing stage. Combined with the strong support of the capital market, China’s innovative drugs have entered the harvest period since 2018. It is expected that more innovative drugs will be approved in the next 2-3 years.
the vaccine industry is expected to usher in a golden decade
The plan proposes that at the end of the 14th Five Year Plan period, vaccine supervision will reach the international advanced level. Through the evaluation of the national vaccine supervision system of the World Health Organization, we will actively promote that the provincial drug inspection institutions where vaccine manufacturers are located have the ability to batch issue the main varieties of vaccines within their jurisdiction.
According to the statistics of insight consulting, the scale of China’s vaccine market increased from about 25.1 billion yuan in 2015 to 64 billion yuan in 2020, with a compound annual growth rate of 20.59%. It is estimated that the vaccine market will exceed 200 billion yuan by 2030.
Citic Securities Company Limited(600030) said it was optimistic about China’s vaccine industry and suggested paying attention to leading enterprises with large varieties, abundant production capacity and standardized operation; Companies that are expected to bring flexibility; Companies with rich vaccine R & D pipeline reserves.
optimization of traditional Chinese medicine plate or welcome pattern
The plan proposes that at the end of the 14th Five Year Plan period, new steps will be taken in the inheritance, innovation and development of traditional Chinese medicine, a preliminary evaluation evidence system combining traditional Chinese medicine theory, human experience and clinical trials will be established, and gradually explore and establish safety evaluation methods and standard system in line with the characteristics of traditional Chinese medicine, so as to improve the modern supervision system of traditional Chinese medicine.
Since this year, innovative research and development of traditional Chinese medicine is rising rapidly. According to incomplete statistics by the reporter of China Securities Journal, up to now, a total of 11 new traditional Chinese medicine drugs approved by the State Food and drug administration have been listed, including Yinqiao Qingre tablet of Jiangsu Kanion Pharmaceutical Co.Ltd(600557) and Jieyu Chufan capsule of Yiling pharmaceutical, which has become the year with the most new traditional Chinese medicine approved in recent five years.
Since this year, heavy support policies have been frequently issued in the traditional Chinese medicine industry. In February 2021, the State Council issued several policies and measures on accelerating the development of characteristics of traditional Chinese medicine; On June 30, the National Health Commission and other ministries and commissions jointly formulated the opinions on Further Strengthening the work of traditional Chinese medicine in general hospitals and promoting the coordinated development of traditional Chinese and Western medicine; On July 7, the five departments jointly formulated the implementation plan for the dissemination of traditional Chinese medicine culture (2021-2025). In addition, the centralized collection of traditional Chinese medicine by local alliances concerned by the market is relatively mild.
Brokers believe that the traditional Chinese medicine sector continues to be encouraged by policies, or welcomes the optimization of the pattern. Traditional Chinese medicine varieties, brands and patent barriers are high, and exclusive products are scarce. In recent years, the internal operation and management of many traditional Chinese medicine enterprises have been improved, and the retail marketing reform and channel improvement have increased product sales performance. Since 2020, many listed companies of traditional Chinese medicine have issued equity incentive and employee stock ownership plans. The annual growth rate of performance is required to be concentrated at 10% – 20%. The development speed of the industry is guaranteed, the upward space is fully opened, and the valuation is expected to continue to improve.
Recently, the Chinese medicine sector has continued to heat up. On December 30, the traditional Chinese medicine sector was active again. As of the close, Gansu Longshenrongfa Pharmaceutical Industry Co.Ltd(300534) “20cm” rose by the limit, Tianjin Chase Sun Pharmaceutical Co.Ltd(300026) rose by more than 11%, and Jinghua Pharmaceutical Group Co.Ltd(002349) , Kunming Longjin Pharmaceutical Co.Ltd(002750) , Yabao Pharmaceutical Group Co.Ltd(600351) rose by the limit.
(China Securities Journal)
