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Can the implementation of the Chinese Medicine Law incite the market of trillions?
The "Chinese Medicine Law", which has been brewing for 30 years, was officially implemented on July 1 this year. The classic name can avoid a series of favorable policies such as the clinical trials and the social strength of the Chinese medical institutions that can enjoy the same rights as the government, so that the investment in the Chinese medicine industry will be heard early and continue to heat up. Only this year, nearly 50 listed companies have taken or completed the acquisition of Chinese medicine assets, and they have rushed to the scale of Chinese medicine health services such as Chinese herbal medicines, Chinese patent medicines, Chinese medicine hospitals and Chinese medicine clinics. Market.
However, industry insiders pointed out that many of the provisions in the "Traditional Chinese Medicine Law" have yet to be implemented, and the core issue of the industry - quality issues are also urgently to be resolved. It will take time for the Chinese medicine industry to usher in the development of spring.
Social capital to run a doctor "songkou"
The Chinese Medicine Law enjoys the same rights for Chinese medicine medical institutions organized by the society and Chinese medicine medical institutions organized by the government in terms of access, practice, basic medical insurance, scientific research and teaching, and evaluation of medical staff titles. At the same time, the Chinese medicine clinic has changed to a record-keeping system and simplified the process of learning Chinese medicine practitioners to obtain the qualifications of Chinese medicine practitioners by means of teacher-training. It is also a great encouragement for doctors.
"The "Traditional Chinese Medicine Law" is a great promotion to us. The key is that the social status of private institutions has improved, and doctors have a sense of identity." Shareholders of Beijing Bazhentang Technology Co., Ltd., Beijing Bazhentang Hospital Chang Haoguang said that the favorable policy has given him the intention to expand investment. "Some investors come to consult, and some foreign investors have to enter the field of Chinese medicine, including running hospitals." But Hao Zhaoguang also pointed out that the industry is highly professional and chaotic. "Songkou" cannot be "relaxed". The government departments should issue more detailed supervision and review rules, including the review of employees, the audit of investors, and the review of projects. The Chinese medicine practitioners should also be severely punished.
In fact, this step is already underway.
At the end of June, the National Health and Family Planning Commission issued the Interim Measures for the Administration of Recording of Chinese Medicine Clinics (Draft for Comment). In terms of supervision and management, the competent department of Chinese medicine at the county level was required to establish a system of bad practice for Chinese medicine clinics, and to conduct bad practices in Chinese medicine clinics. Recording and scoring for random charges and false exaggeration of publicity, the results serve as an important basis for the supervision and management of Chinese medicine clinics.
Secondary development of Chinese medicine or mainstream
Affected by favorable policies, according to incomplete statistics, nearly 50 listed companies such as Tongjitang, Kunming Pharmaceutical Group, Luyan Medicine and Hongri Pharmaceutical have successively taken out or completed the acquisition of Chinese medicine assets. For example, on May 10, Zhejiang Kangenbei Pharmaceutical signed a Letter of Intent for Share Transfer with Jiangxi Pharmaceutical Group Co., Ltd., intending to participate in the bidding for 41% of Jiangxi Tianshikang Chinese Medicine Co., Ltd. held by Jiangyao Group. On July 7, Hainan listed company Xinlong Holdings announced that it will acquire Chinese medicine injection company Huawei Pharmaceutical and Chinese medicine decoction enterprise Dechang Pharmaceutical for 832 million yuan, and enter the Chinese medicine market as a foreign company.
In the industry's view, the "secondary development" of traditional Chinese medicine will become the choice of more enterprises, or use their own brands to go deeper into the direction of big health and treatment, or to make evidence-oriented medicine and clinical data. . For example, Yiling Pharmaceutical uses modern medical methods to conduct research on its related Chinese patent medicines, and proves the efficacy of medicines such as “Qianqiangxin Capsule” and “Lianhua Qinglan Capsule” through evidence-based medicine.
In order to meet the needs of the international market, Tasly uses the modern medical means to deeply develop its self-developed "Composite Danshen Dripping Pills", making it the world's first complete FDA Phase III randomized, double-blind, global multi-center large-sample clinical trial. The compound of modern Chinese medicine preparations. According to the relevant person in charge of Tasly, focusing on the unmet clinical needs, Tasly chose to develop classics such as senile diseases, women's and children's medications and complex diseases, and to study the pharmacodynamic basis, quality control and compatibility of the classic prescriptions. Key issues such as sex and innovative Chinese medicine varieties.
Industry insiders predict that the targeted Chinese patent medicines such as Compound Danshen, Ejiao, Danhong and Xiaoke Pill will be greatly improved, and it is expected to become the leader in the product group with a single company output exceeding 1 billion yuan in the future.
The classic name is free of clinical details yet to be released
All along, Chinese medicine has to be developed into a drug that needs to be evaluated for efficacy, and an animal model is established to allow the mouse to "nod" to pass. "It is not scientific to review Chinese medicine with the idea of western medicine. This has led to a low rate of Chinese medicine in the development review process. Coupled with large investment and long cycle, many enterprises are deterred from the research and development of Chinese medicine." Lecturer of Health Law, Beijing University of Chinese Medicine Deng Yong said.
According to the "2016 Drug Evaluation Report" issued by the State Food and Drug Administration, among the 206 new drugs approved for listing in 2016, there were only 2 Chinese medicines, and only 83 of the 3,666 drug clinical trial registration applications were approved.
Therefore, the classic name prescription proposed by the Chinese Medicine Law can avoid widespread clinical attention.
"Clinical research is the most expensive part of the money. If it can be avoided, it is not a good thing, but the catalogue of classic names has not been introduced. Enterprises are not afraid to move. Only a few enterprises are participating in the classic and related projects of major national special projects." Guangzhou Baiyun Mountain The relevant person in charge of the Pharmaceutical General Institute of Pharmaceutical Research said to the Beijing News reporter that for enterprises, technology is not a problem, but if the selected party is not listed in the catalogue, it is difficult to go through the approval process of new drugs, and they can only give up.
On March 8 this year, the State Administration of Traditional Chinese Medicine issued the "Notice on Soliciting Opinions on the Selection Scope and Selection Principles of the Ancient Classics Catalogue," which defines the scope of the selection of the ancient classics to be released, and proposes The specific principles of selection.
"How to define the classic Chinese medicine prescription is the key, but there is no supporting tracking or supervision mechanism that will cause industrial confusion." Deng Yong suggested that in addition to the "Chinese Medicine Law," the provinces can also promote the adoption of local planning and policies. Standardize the development of the classic real estate industry.
Yan Haitao, vice president of Tianqi Pharmaceutical Group, said that he is not very optimistic: "Industry chaos, peer competition is serious. Previously, the classics such as Liuwei Dihuang Wan, Zhibai Dihuang Wan, etc., domestically produced enterprises are few hundred There are more than a thousand." In Yan Haitao's view, drug production is very dogmatic, and it is difficult to break through innovation. The classic name is not as easy as it is.
The problem of Chinese medicine quality frequently needs to be solved urgently
"The pharmaceutical industry capital is following the policy, the future expectation is good, but the core problem - the quality problem is not solved, the industry development will be limited." Faced with the heat of social capital, the third-party medical service platform Maxcon Founder Shi Lichen hit the nail on the head. In recent years, the problems in the field of traditional Chinese medicine production have been frequent, and the Chinese medicine decoction pieces have become the “hardest hit areas” for drug flying inspections. Some well-known enterprises have also been named, such as Yunnan Baiyao and Kangmei Pharmaceutical.
In the first five months of this year, Yunnan Baiyao entered the blacklist three times in the drug sampling report of the State Food and Drug Administration. In January, Huanglian, produced by Yunnan Baiyao Group Co., Ltd. Chinese Herbal Medicine Pieces Branch, detected goldamine O and had dyeing problems. On April 20th, the chrysanthemums of Yunnan Baiyao were named by the State Food and Drug Administration because of their unqualified traits. For the same reason, the chrysanthemums of Kangmei Pharmaceutical were also named. On May 18, the soil mites produced by Yunnan Baiyao Group Co., Ltd. Chinese Herbal Pieces Branch were named because of their unqualified traits.
The 2016 Drug Inspection Report showed that 172 GMP (Good Manufacturing Practice) certificates were recovered in 2016. Among them, there are 81 pieces of traditional Chinese medicine decoction pieces, accounting for up to 47.6%. According to the 2016 National Drug Quality Test, the overall pass rate of Chinese herbal medicines and decoction pieces was 77%, less than 80%.
Wang Guoqiang, deputy director of the State Health Planning Commission and director of the State Administration of Traditional Chinese Medicine, also publicly stated that “Chinese medicine may be destroyed on Chinese medicine”. The quality of Chinese medicine and the sustainable resources of Chinese medicine will have an impact on the development of Chinese medicine.
Recently, the Chinese Medicine Association of China established the Traditional Chinese Medicine Traceability Professional Committee to undertake the construction of the traceability system of Chinese medicine enterprises and create a “reliable Chinese medicine”. Yan Haitao, vice president of Tianqi Pharmaceutical Group, pointed out that the country has been laying down the source system a few years ago, and is also paving the way for the standardized management of the next medicinal materials. However, detailed implementation of the implementation of the regulations is required.
"The protection of traditional Chinese medicine by the "Traditional Chinese Medicine Law" will help enterprises strengthen the layout of upstream Chinese herbal medicines, clean up development obstacles, strengthen management, and control the quality of Chinese medicine, and the industry can enter the formal development state." Shi Lichen said.