Do Chinese medicine rely on the "new" breakout difficult? Listen to what the representatives of the two councils say...

"Three-drug three-way" in the new crown of pneumonia, the clinical effectiveness of Chinese medicine has been confirmed.
the "China Programme" has made remarkable achievements in the prevention and control of the epidemic, so that the general public has seen the country's traditional medicine and modern medicine in close cooperation to combat the epidemic has made important achievements.
is the two sessions, the national representatives, members have proposed the innovation and development of Chinese medicine, "new" is the mainstream word of the pharmaceutical market at the moment, Chinese medicine breakthrough must also rely on "new drugs", but for the time being, China's traditional Chinese medicine is still not enough innovation, next, we will do a simple combing introduction of new Chinese medicine.... The status of new Chinese medicine Chinese medicine New Drug approval less Since 2015, China has initiated drug approval reform, accelerating the speed of new drug market.
in the application of new Chinese medicine, according to the data query, the National CDE accepted a total of 24 applications for Chinese medicine NDA in 2015, affected by the "722" incident, 0 in 2016, 1 in 2017, 2018 8 cases, 3 in 2019, the specific status of the following figure: And in the approval of new Chinese medicine, from 2016 to date, drug data query, approved only 10 new Chinese medicine, in contrast to the same period of Western medicine new drugs, approved 532.
Sangzhi total alkaloid tablets - nearly 10 years of the first new drug of diabetes, the approval of the drug, changed the oral sugar-lowering drug market has been dominated by chemical drugs.
Five and Boao Pharmaceuticals said that Sangzhi total alkaloid tablets are a natural heavyweight drug to create independent innovation, as an exclusive patented product, the annual post-partum sales are expected to exceed 1 billion yuan.
The Golden Flower Clear Particles - In 2009 in response to influenza A(H1N1), domestic Chinese medicine experts jointly formed a Beijing research group to screen and evaluate effective Chinese medicine effective groups.
was approved for listing in 2016 and has been recommended by the National Health and Planning Commission for the Release of influenza Diagnosis and Treatment Program (2018 Edition) and has been shortlisted for the Report on the Scientific Competitiveness of Chinese Medicine Strains (2018 and 2019 editions).
the outbreak, the National Health and Welfare Commission and the State Administration of Traditional Chinese Medicine jointly issued the "new coronavirus infection of pneumonia diagnosis and treatment program" from the fourth edition of the recommended jinhua clear particles used in the observation period.
stop-stopping particles, or hemp-stop-spasm particles, were given priority review in September 2018 as "innovative drugs with obvious therapeutic advantages and medicines for children" and were approved for listing in December 2019.
compared with Tiberi, the efficacy is comparable, the side effects are less, there is a certain competitive advantage in the market.
this two sessions of the National People's Congress, the National People's Congress representative, Yangzijiang Pharmaceutical Group Chairman Xu Mirrorren said that the inheritance and innovation of Chinese medicine, the need to be guided by clinical needs, to maintain the characteristics of traditional Chinese medicine and the Chinese medicine system.
it is worth noting that most of the Chinese medicines approved in recent years reflect this.
there are no particularly prominent clinical advantages in these areas, and the approval of these new Chinese medicines can effectively meet clinical needs.
this is also a trend of new Chinese medicine in the future.
low investment in research and development of new Chinese medicine according to the query, with the Huashun pharmaceutical bio-chinese medicine plate a total of 68 listed enterprises, 67 published the 2019 annual report, from the annual report, the investment in Chinese medicine research and development is low to let people tongue-in-cheek.
2019, only two Chinese medicine companies will invest more than 10% of their revenue in research and development (Longjin Pharmaceuticals and Kangyuan Pharmaceuticals).
32 were below 3.28% (the median investment in Chinese medicine research and development in 2019). Among the
, Baiyunshan, Dali Pharmaceuticals, Tai'antang, Yunnan White Pharmaceuticals, Xinbang Pharmaceuticals, Guofa shares of research and development investment accounted for no more than 1% of revenue.
the general low investment in research and development of Chinese medicine, first of all, from the above-approved new Chinese medicine, the research and development cycle is longer, the audit uncertainty is large, it is difficult for enterprises to make a decision.
secondly, although in recent years, China's new Chinese medicine approval concept change, has been trending from advanced technology methods to clinical needs as the core, but a large number of Chinese medicine enterprises still stay in the past cognition, so the general research and development of new Chinese medicine is still in the wait-and-see stage.
the development of Traditional Chinese Medicine" Chinese medicine is a traditional medicine scientific and technological resources with original advantages, but the difficulty of reviewing chinese medicine and the difficulty of Chinese medicine science and technology innovation are difficult to export, which is the key constraint to the development of the Chinese medicine industry.
" 2019 National People's Congress representative, Hunan Times Sunshine Pharmaceutical Co., Ltd. executive director Tang Chunyu pointed out: the existing Chinese medicine registration classification model does not fully reflect the advantages and characteristics of Chinese medicine itself, with reference to even the use of Western medicine or international natural drug research models and requirements, too much emphasis on drug composition, mechanism of action, not enough attention to clinical research.
also experts pointed out that, because traditional Chinese medicine does not force clinical trials, Chinese medicine injections, Chinese and Western compound serums, although to do after the market clinical evaluation, but did not really land.
many Chinese medicine enterprises believe that enterprises do not need to invest too much in research and development, as long as the ancient side, inspection of the development of products can be.
many of the chinese medicine products listed at present are lack of clinical trials, which leads to many products safety, effectiveness is not clear.
long research and development cycle, complex registration supervision, clinical trials, policy impact and so on are leading to the current situation of new Chinese medicine is not optimistic factors, but with this year's performance in the outbreak of Chinese medicine, as well as the country has issued a series of good policies of Chinese medicine, I believe will lead Chinese medicine to a new era.
National Favorable Policy for Chinese Medicine In October 2019, the Central Committee of the Communist Party of China and the State Council issued the Opinions on Promoting the Innovation and Development of Chinese Medicine Heritage and Development, which put forward new requirements for the development of Chinese medicine heritage and innovation and industrial development. The new version of the Drug Administration Law, which was officially implemented by the
on December 1, 2019, also puts forward new requirements for the registration and administration of Chinese medicine.
the end of 2019, the "Measures for the Administration of Drug Registration" was published in the draft, put forward the basic requirements for the administration of drug registration, and made it clear that the registration management of Chinese medicine will be in line with the characteristics of Chinese medicine.
January 7, 2020, the National Drug Administration issued the "Guidelines (Trial) on Real World Evidence Support drug Development and Review", which is the first guidance document on real-world evidence to support drug development and review, and is a "milestone" in the evaluation of new drug development in China, i.e., for certain rare and life-threatening major diseases that lack effective treatment measures, or the development of innovative Chinese medicines, based on real-world research to obtain the effects and safety information.
the MAH system, which began piloting in 2016, has benefited a number of new Chinese medicine varieties, and under the impetus of this system, scientific research institutions have truly shared the benefits of their scientific research results.
the above approved new Chinese medicine, gram wart toxic ointment, Danlong oral solution and gold granules of pharmaceutical companies have benefited from the MAH system.
at the end of March this year, Zhangzhou City issued a number of policies to support drug research and development and production and operation, and said that innovative drugs (including Chinese medicine, chemicals and biological products) research and development, has entered the stage of clinical research, committed to drug market licensing holders, production, sales registration and full-caliber statistical settlement in the city, according to 50% of the cost of research and development to support, the total amount of support for individual varieties not more than 120 million yuan.
at present, the cost of research and development of Chinese medicine, the state has support, clinical data on Chinese medicine, real-world evidence support, future benefits of Chinese medicine, MAH support.... With the future requirements further clear, the implementation of a series of policies, it can be foreseen that with a wealth of clinical practice application of prescription drugs, in the development of new Chinese medicine, in addition to reducing the cost of research and development, there will be a series of high efficiency channels and huge future profit margins, including control of research and development risks, shorten the research and development cycle, intellectual property rights and so on.
, therefore, adhere to the clinical demand-oriented and Chinese medicine characteristics of enterprises ushered in their new products to market a great opportunity.
Chinese medicine has also reached the biggest turning point.
on Chinese medicine, the representatives of the two sessions of the two sessions of the proposal summary in the national two sessions of the occasion, on how to better serve the public health services of Chinese medicine and how to promote the development of the industry, a number of representatives of the two national conferences also put forward relevant recommendations.
national people's congress representative Zhang Boli said that if from the system, system, mechanism to integrate Chinese medicine into the system of infectious disease prevention and treatment system and the entire major disease treatment system, the development of Chinese medicine will be more active, it is recommended that the relevant content of Chinese medicine into the "Infectious Disease Prevention and Control Law." Lu Chuanjian, a member of the Chinese People's Political Consultative Conference (CPPCC) of
and vice president of the Guangdong Provincial Academy of Medicine, said that Chinese medicine has a unique advantage in the prevention and treatment of infectious diseases, and in the long run, it is recommended that traditional Chinese medicine be integrated into the national infectious disease prevention and control system, so that the treasure of Chinese medicine plays a greater role.
in addition, Lu Chuanjian suggested that the state issue guidelines, including the establishment of a special Chinese medicine management department and Chinese medicine research room at the national, provincial and municipal CDC; Xu Mirrorren, a representative of the National People's Congress of
and chairman of Yangzijiang Pharmaceutical Group, said that the observation and reflection of the past year had been written into a proposal, and at the same time put forward, to guide and support the construction of the chinese medicine information, intelligent manufacturing system, from the cultivation of medicinal materials, harvesting, processing, preparation production, quality inspection, storage and transportation, etc. , the overall implementation of intelligent upgrading, improve the overall quality control level of Chinese medicine, promote the Chinese medicine industry to green manufacturing, intelligent manufacturing upgrade. Xiao Wei, a representative of the National People's Congress of
and chairman of Jiangsu Kangyuan Pharmaceutical Co., Ltd., said that at this year's "two sessions" of the National People's Congress, he will put forward four proposals, including "Recommendations on the comprehensive construction of a system of prevention and control of Chinese medicine to deal with major public health events based on the "Wuhan model" and "Recommendations on accelerating the development of innovative drugs to prevent and control major viral infections in Chinese medicine."
representative of the National People's Congress, Shi Fuchun, said that at the upcoming National People's Congress, "recommendations on the establishment and improvement of The System of Prevention of The Prevention of The Epidemic of Chinese Medicine" "Recommendations on the integration of Chinese medicine into the ecological protection and high-quality development plans of the Yellow River Basin" and the submission of more than a dozen recommendations to strengthen scientific and technological innovation in Chinese medicine, anti-viral research in Chinese medicine and so on. Tang Chunyu, a representative of the National People's Congress of the
, said that this year will continue to focus on the construction of transportation facilities, the promotion of the cause of Chinese medicine, the development of the Chinese medicine industry to make suggestions. Zhang Zhilong, a representative of the National People's Congress of
and deputy head of the expert group on the prevention and treatment of Chinese medicine for xinguan pneumonia in Tianjin, called for the speedy revision of the Emergency Regulations on Public Health Emergencies, the addition of relevant provisions to play the role of Chinese medicine, in order to better implement the Chinese Medicine Law, to smooth the channels for Chinese medicine to participate in disease prevention and emergency emergency response, in order to play the prevention and emergency disposal of Chinese medicine, to provide human, financial and material institutional protection. Zeng Fang, a member of the
National Committee of the Chinese People's Political Consultative Conference (CPPCC) and dean of the Acupuncture Pusher College of Chengdu University of Traditional Chinese Medicine, said that during the two sessions she will focus on the path of innovation and development of Chinese medicine, the transformation and upgrading of Chinese medicine higher education and other topics.
in her view, with the growing influence of Chinese medicine in the world, how to follow the law of the development of Chinese medicine, in the inheritance of the essence at the same time to keep the right innovation is a long-term issue.
the proposal of representatives of the two national conferences has not yet been fully announced, but the development and inheritance of Chinese medicine has become a trend... Responsible Editor: Meng Meng.