Will Chinese medicine be a good business?

On February 9, 2021, the General Office of the State Council issued "Several Policy Measures on Speeding Up the Development of Chinese Medicine Characteristics", which is a very good policy for the domestic Chinese medicine industry.
with the relevant policies issued so far, where is the development direction of Chinese medicine-related manufacturing enterprises, this paper will analyze the new investment opportunities and listed Chinese medicine in both directions.
new investment opportunities to analyze the new Chinese medicine will have a wave of approval? Policy background: "On accelerating the development of Chinese medicine characteristics of a number of policy measures" for chinese medicine investment in new drugs, the main policy initiatives are the following parts: to speed up the reform of the Chinese medicine review and approval mechanism, the establishment of science and technology, medical, Chinese medicine and other departments to recommend qualified new Chinese medicine into the rapid review and approval channel of the effective mechanism.
To the qualified innovative Chinese medicine, Chinese medicine improved new drugs, ancient classics, the same name prescription, etc., to study the implementation of exemption from non-clinical safety research and part of the clinical trial management mechanism in accordance with the law.
actively explore the establishment of real-world research evidence system of Chinese medicine.
to optimize the registration and approval of ancient classic prescription Chinese medicine compound preparations.
system of technical research guidelines for quality control of the whole process of chinese medicine.
to build national key laboratories around key areas such as Chinese medicine theory, Chinese medicine resources, Chinese medicine innovation and evaluation of the efficacy of Chinese medicine.
Relying on high-level research institutions, institutions of higher learning, Chinese medicine hospitals and innovative enterprises of traditional Chinese medicine, we will build a number of incubation and transformation bases for Chinese medicine research and scientific and technological achievements representing the national level, solve the major scientific and technological problems that restrict the development of Chinese medicine, formulate a number of chinese medicine specialty diagnosis and treatment programs, and transform them into a group of advanced chinese medicine equipment and new Chinese medicine medicine.
February 10, 2021, the State Drug Administration issued a notice on the "Technical Requirements for the Quality Control and Standard-Setting of Chinese Medicine Formula Particles" (No. 16 of 2021), the Chinese medicine formula particle varieties to implement the record management, not to implement the approval number management, before the market by the production enterprises reported to the provincial drug regulatory department for the record, Chinese medicine formula particles for up to 20 years of the pilot has finally ended.
In December 2020, the State Drug Administration's implementation opinion on promoting the innovation and development of traditional Chinese medicine heritage was noted in addition to the following good policies: exploring the introduction of real-world evidence to support the registration and listing of new Chinese medicines.
new tools, new methods, new technologies and new standards for the evaluation of the efficacy of traditional Chinese medicine.
to formulate relevant technical requirements for the research of new drugs of Chinese medicine improvement, and to support the use of new technologies, new processes and new dosage forms that reflect the advantages and characteristics of clinical application.
support the development of the same prescription drug of the same name and promote the quality competition between the listed Chinese medicine and the variety.
the material basis as the basis for dividing the registration category, opening up a registration declaration path with Chinese medicine characteristics.
the application for new Chinese medicines with clear clinical orientation and obvious clinical value for major diseases, prevention and treatment of rare diseases, clinical urgent needs and market shortages, or for new Chinese medicines that belong to children's medicines shall be reviewed and approved on a priority level.
If the treatment of a seriously life-threatening disease and there is no effective treatment means, as well as the department in charge of health and health or Chinese medicine under the State Council, is determined to be an urgent need for Chinese medicine, the clinical trial of the drug has data or high-quality Chinese medicine human experience evidence shows efficacy and can predict its clinical value, it may be approved with conditions.
Amend the Regulations on the Protection of Chinese Medicine Species, integrate the protection system of Chinese medicine species with the patent protection system, and incorporate it into the whole life cycle registration management of Chinese medicine, and give full play to its protective role in the protection of Chinese medicine varieties such as innovative Chinese medicine, chinese medicine improved new medicine and ancient classic Chinese medicine compound preparations.
Evaluation: According to the above-mentioned policy, the overall registration difficulty factor of Chinese medicine is decreasing, the clinical research requirements of Chinese medicine imitation, improvement and research and development of new drugs are decreasing, and the liberalization of prescription particles of Chinese medicine can become the investment direction of Traditional Chinese medicine.
imitation of Chinese medicine: the same party of the same name need to wait for the Pharmacopoeia Commission will develop the relevant list, according to the ancient classic party's publication process, this can wait more than a year.
How to evaluate the consistency of Chinese medicine, if the original research if there is a fingerprint map, often fingerprint map has a 20-year patent, if the original research does not have a fingerprint map, in case the differences between the original research batches are very broken.
: Oral modified injections are still not expected to be released, and the improvement of this dosage form is limited to improvements in swallowing of children's and geriatric drugs, or the change of toxic herbs from oral to external medicines.
if it's just an improvement between oral medications.
centralized procurement involves differential prices, similar products unified group bidding, hospital terminal market prices do not support such improvements, unless the first target is the pharmacy market.
new Chinese medicine: natural medicine extraction is still the fastest path, but human experience is gone.
even if someone with experience, phase three clinical or not exempt, biological products of the third phase of clinical failure, chinese medicine phase three clinical success is too difficult.
corresponding, Chinese medicine projects that have completed relevant clinical studies are worth investing in.
Natural medicine extraction purification and improved active ingredients of Chinese medicine if the blood absorption is the fastest and most effective, safe and controllable circumstances, should be appropriately liberalized the registration restrictions of Chinese medicine injections, all should be handed over to the results of clinical phase III to make a final judgment.
The development of Traditional Chinese medicine can be developed in theory of Traditional Chinese medicine, but it can also allow the development direction of Western medicine to follow the path of the development of modern medicine, at present, on the grounds that ancient Chinese medicine does not have Chinese medicine injections, all anti-natural medicine injections are a bit over-corrected.
In danfang did not develop the era, Chinese medicine only soup is not conducive to convenience, the development of Chinese medicine should be like the development of Danfang as with the times, drug market standards still have to follow the premise of safety and effectiveness to ensure the maximum benefit of patients.
Ancient classic prescription Chinese medicine compound preparation: ancient classic prescriptions are large prescriptions, the amount of medicinal herbs are quite a lot, if completely in accordance with the usage of the amount, the daily price can be 30 or higher, Chinese traditional medicine oral medicine pricing is so high, the health care sector is willing to support it? Chinese medicine prescription particles: the use of the scene can only be in the hospital, the current hospital terminal market access is the biggest threshold, which is the advantage of the old player field.
Most of the old players have developed 300 common herbs, new competitors can consider choosing existing players did not study the medicinal herbs to overcome, local Chinese medicine enterprises can consider the development of local unique herbs.
the future policy background of Chinese medicine, which has been listed on the market: gradually promote the "mechanism, team, measure and effective" combination of Chinese and Western medicine in general hospitals, infectious disease hospitals, specialized hospitals, etc.
the necessary continuing education in Chinese medicine for the clinical, oral and public health categories.
research and implementation of Western medicine to learn Chinese medicine major special, with 10 to 15 years time, training a considerable number of high-level Combination of Chinese and Western medicine talent and can provide Chinese and Western medicine combined services of general practitioners.
to carry out major difficult diseases, infectious diseases, chronic diseases and other Chinese and Western medicine joint attack.
establish the evaluation criteria of Chinese and Western medicine combined with clinical efficacy, and select and form a directory of superior diseases.
pilot demonstration, and strive to use 5 years to form about 100 Chinese and Western medicine combined diagnosis and treatment programs.
strongly support the inclusion of Chinese medicine medical service items with advantages in efficacy and cost into the scope of payment of basic medical insurance, taking into account such factors as effectiveness and economy, and reasonably determining the classification of catalog A and B in accordance with the provisions.
to explore the characteristics of Chinese medicine in line with the payment methods of medical insurance, the release of the advantages of Chinese medicine diseases, to encourage the implementation of Chinese and Western medicine with the same effect of the same price.
general Chinese medicine treatment programs continue to pay per item.
Explore conditional places to relax the proportion of special needs medical services for public Chinese medicine medical institutions that perform well in public welfare services, and allow public Chinese medicine medical institutions to set up their own international medical departments within the scope of the policy, independently determine the volume, projects and prices of international medical services, and the balance of income and expenditure is mainly used to improve the treatment of workers, strengthen the construction of specialties and the development of hospitals.
the Implementation Opinions of the State Drug Administration on Promoting the Innovation and Development of Chinese Medicine Heritage includes: optimizing the technical requirements related to the change of listed Chinese medicine.
to guide drug market licensing holders to take the initiative to carry out post-market research and post-market evaluation of Chinese medicine.
establish a safety evaluation method and standard system that conforms to the characteristics of Traditional Chinese medicine, and establish a classification and evaluation strategy of Chinese medicine safety based on the clinical orientation of Chinese medicine.
to implement special approval for the increased functional treatment of listed Chinese medicines required for emergencies in major public health emergencies.
evaluation: Chinese medicine injections: Chinese medicine injections are likely to be reborn through post-market research and post-market evaluation of Chinese medicine, the main challenge in the future is the centralized procurement of provinces and access to chinese and Western medicine combined treatment programs.
Chinese medicine oral medicine: chronic diseases have a great effect, the focus is to enter the combination of Chinese and Western medicine treatment program, but in the short term, Chinese and Western medicine combined diagnosis and treatment program can not be implemented immediately.
Some Chinese medicine has not been sold can take a high-quality route, especially combined with the advantages of diseases, special needs medical services and the needs of the International Ministry of Medical Services of Chinese medicine, the price can be relatively flexible, in the short term, such as good Tongren Tongren Tongli has a historical background and quality assurance of the old Chinese medicine enterprises.
small conclusion in the short term exclusive Chinese medicine approval, has completed clinical research of Chinese medicine production approval trade will be a good business can be seen.
In the long run, who really master the demand of the market terminal is a good business, that is, the price of Chinese medicine recognized by medical insurance / commercial insurance and access to the advantages of diseases, about 100 Chinese and Western medicine combined treatment program list of Chinese medicine, will be a sustainable development of good business.