Mass purchase of Chinese medicine has been put on the agenda. With the normalization of the country's centralized and volume procurement, the scope of drugs included in volume procurement continues to expand, and the field of traditional Chinese medicine is no longer just a "bystander". The reporter of "Economic Information Daily" learned that the inclusion of the Chinese medicine industry in centralized procurement has been determined, which may open a real pattern of reshaping the Chinese medicine market based on quality. However, due to the complex compatibility of traditional Chinese medicine, the complicated processing methods, and the special characteristics such as the difficulty of uniform quality of raw materials, it is difficult to collect pieces such as decoctions. Some Chinese patent medicines and formula granules that have established unified standards may be included first. However, many people in the industry said that in formulating policies for centralized procurement of proprietary Chinese medicines, consideration should be given to the particularity of Chinese medicinal materials to prevent the simple pursuit of low prices, which would lead to the phenomenon of “bad money driving out good money”.
The focus is on pilot projects in many places with high prices and large quantities
A few days ago, the National Medical Insurance Bureau publicly responded to the “recommendations for accelerating the inclusion of proprietary Chinese medicines and formula granules into centralized procurement” and pointed out that there are policy arrangements and preliminary explorations. The National Medical Insurance Administration will work with relevant departments to improve the quality evaluation standards of Chinese patent medicines and formula granules, adhere to quality priority, be clinically demand-oriented, start with high-priced and large-volume varieties, and scientifically and steadily promote the centralized procurement of Chinese patent medicines and formula granules. reform.
Earlier this year, at the State Council’s regular policy briefing, Chen Jinfu, deputy director of the National Medical Insurance Administration, pointed out that the inclusion of large varieties of biosimilar drugs, including proprietary Chinese medicines, into centralized procurement is an institutional requirement, but the rules will be more optimized and updated. Pertinence and quality are more in line with the attributes of the medicine itself. At present, Qinghai Province, Jinhua, Zhejiang, Puyang, Henan and other places have carried out centralized procurement exploration for some Chinese patent medicines that are in high demand and high in value, and have achieved positive results.
At the end of July 2020, Qinghai announced the results of the planned selection of drug purchases by public medical institutions. Among the 59 varieties collected, Xueshuantong injection, Xuesaitong for injection (freeze-dried), Xiyanping injection, and blood Larger varieties such as Saitong capsules are listed impressively. For Jinhua, the second batch of drugs will be purchased in June 2020. Among the 274 drugs, there are 180 proprietary Chinese medicines, accounting for 66%. Including compound Yuxingcao mixture, Niuhuang Shangqing Capsules, Qingkailing Granules, Shufeng Jiedu Capsules, Shenmai Injection, Strong Loquat Dew, Bailing Capsules, Liuwei Dihuang Pills, Anshen Bu Nao Liquid and many other large varieties.
In addition to the above-mentioned regional pilot projects, recently, industry insiders revealed that Hubei Province initiated my country's first centralized procurement of proprietary Chinese medicines. According to the "Letter from Hubei Provincial Medical Security Bureau on Inviting Participation in Centralized Procurement of Proprietary Chinese Patent Medicines in Provincial Cross-Regional Alliances", in order to expand the scale of centralized procurement, give full play to the advantages of volume-price linkage and volume-for-price. To deepen the important role in the reform of the supply side of medical services, and to promote the high-quality development of traditional Chinese medicine inheritance, innovation, Hubei Province plans to build a regional and national drug procurement alliance to carry out centralized procurement of Chinese patent medicines.
Zhang Tingjie, the founder of Fengyun Yaotan and an expert in the pharmaceutical industry, said in an interview with a reporter from the Economic Information Daily that with full competition, large quantities of varieties or the first to be included, the market for Chinese patent medicines with a scale of over 300 billion yuan will officially enter with the purchase of quantities. "Shuffle" stage.
Zhang Tingjie believes that this time Hubei plans to select 17 groups of Chinese patent medicines, which are divided into oral and injection groups according to the route of administration, a total of 74 varieties, with a market size of nearly 20 billion yuan, involving 292 companies. "The main types of purchases are cardio-cerebrovascular. For example, Xuesaitong, Xueshuantong, and Ginkgo biloba are the best-selling products in the field of cardio-cerebrovascular diseases."
According to data from Minai.com, the sales of Xuesaitong and Xueshuantong in 2019 were 6.683 billion yuan and 6.53 billion yuan, respectively, and their sales far exceeded other drugs. In addition, Ginkgo biloba extract injection will rise by more than 30% in 2020. In 2020, the sales of public medical institutions in China will exceed 2 billion yuan for the first time, a year-on-year increase of 38.58%.
Difficulty in unifying standards is still the biggest obstacle to the centralized procurement of Chinese medicine
It is worth noting that, compared with Western medicines with relatively single action, the overall treatment characteristics of Chinese patent medicines with "multi-targets and multiple effects" have certain advantages in the prevention and treatment of some diseases. However, it must be admitted that most Chinese medicine products only It can be defined by the treatment site or the treatment field. There is no standard "fixing" such as a generic name, and the standards for proprietary Chinese medicines are more complicated.
In addition, specialties need to be considered in the centralized procurement of Chinese patent medicines. Zhang Tingjie said that there are no clear reference standards for Chinese patent medicines in terms of raw materials, processing methods, indications, grouping, scoring, and merging. In addition, the treatment characteristics of Chinese patent medicines are "clear and individual." Lu Qingguo, the founder of Chenguang Biotechnology Group Co., Ltd., also said that in terms of raw materials, traditional Chinese medicine is much more complicated than chemical medicine. For example, Moutan bark is divided into "Chuandan bark" and "Fengdan bark", which are all authentic medicinal materials. How to use modern evaluation mechanism for evaluation requires a lot of work to refine and clarify.
In addition, “For the traditional Chinese medicine industry, it is difficult to unify the planting standards of medicinal materials in the place of origin, resulting in huge differences in the cost and quality of downstream preparations. Even affected by the environment and weather, the quality of different batches of the same manufacturer may be different. Take Codonopsis for example. There is a certain price difference between large, medium and small strips, but they all meet the standards of the pharmacopoeia. When selecting raw materials, Chinese patent medicine manufacturers may choose small strips if they only refer to the price, but this is contrary to the demand for quality.” Lu Qingguo Frankly.
"The obvious difficulty in the centralized procurement of Chinese patent medicines is that it is difficult to have a unified product standard." Shanghai Securities Pharmaceutical Manufacturing analyst Ji Lijun said that this year the standard of Chinese medicine formula granules is being customized in stages, and the pace of centralized procurement of Chinese medicine formula granules may be faster than that of Chinese patent medicines.
Lu Qingguo said that improving the standard system and taking the lead in incorporating Chinese medicine formula granules into the drug centralized bidding procurement system will promote the better development of Chinese medicine formula granules.
In fact, in April this year, the National Medical Insurance Administration approved and promulgated the first batch of 160 Chinese medicine formula granules national drug standards, which were officially implemented on November 1.
According to data, at the beginning of this year, my country's 20-year-long pilot work of traditional Chinese medicine formula granules officially ended. At present, the number of pharmaceutical companies with production qualifications approved by the State Food and Drug Administration has grown from the original six pharmaceutical companies including China Resources Sanjiu, Hongri Pharmaceutical, and Guangdong Yifang Pharmaceutical to more than 60. In addition, more than 30 listed companies, including Jilin Aodong, Jinghua Pharmaceutical, Taiji Group, Zuoli Pharmaceutical, and Xiangxue Pharmaceutical, have clearly laid out granular preparations.
In the context of the gradual increase in market acceptance, the sales volume of traditional Chinese medicine formula granules continues to increase. According to data released by the Ministry of Industry and Information Technology, the main business revenue of Chinese herbal medicine decoction pieces in 2019 is about 193.25 billion yuan, and the sales revenue of Chinese medicine formula granules accounted for about 26.01% of the proportion of traditional Chinese medicine decoction pieces. The market size is about 50.259 billion yuan. The market size is expected to reach 53.3 billion yuan in 2020.
The industry reshuffle should consider the particularity of Chinese medicine
Lu Qingguo predicts that the inclusion of proprietary Chinese medicines in centralized procurement will intensify market competition and industry reshuffle is inevitable. In the context of the concentration of industry resources, it can effectively promote the large-scale production and operation of traditional Chinese medicine companies, reduce the cost of traditional Chinese medicine, pay more attention to clinical value, and promote the healthy development of the traditional Chinese medicine industry.
Lu Qingguo pointed out that there are currently many companies and drug numbers in the traditional Chinese medicine industry. Each company produces relatively small amounts of drugs, and the industry is relatively disordered.
According to the report of Flint Research Institute, as of the end of 2020, there were 2,160 companies producing Chinese patent medicines, accounting for 28% of the national pharmaceutical industry companies, and 4357 companies producing Chinese medicines (including decoction pieces), accounting for 57% of the national pharmaceutical companies. Small businesses account for about 80% of the entire Chinese medicine industry.
"Accelerate the standardization upgrade of Chinese medicine enterprises, the survival of the fittest, the industry resources tend to be concentrated, and the industry reshuffle is imminent." Lu Qingguo said that the current research and development power of Chinese medicine enterprises is still insufficient. He believes that for traditional Chinese medicine companies, like chemical medicine companies, accelerating innovation and R&D is an inevitable choice. With the continuous advancement of reforms in various aspects such as centralized procurement, profits are constantly being squeezed, and companies that light R&D will inevitably be eliminated.
According to a report by Great Wall Guorui Securities, in 2020, 22 of the nearly 70 A-share Chinese medicine companies will achieve positive growth in total revenue, and 42 will achieve positive growth in net profit. However, from the perspective of R&D investment, only 23 Chinese medicine companies have R&D expenses. More than 100 million yuan.
Unlike chemical medicine, which has a "consistency evaluation" tool, the problem of standardization of Chinese patent medicines has not been solved. A number of industry insiders interviewed stated that the formulation of a policy for centralized procurement of proprietary Chinese medicines should take into account the particularity of Chinese herbal medicines to prevent the simple pursuit of low prices, which would lead to the phenomenon of "bad money driving out good money". On the enterprise side, it should also reasonably estimate the corresponding space from a cost perspective.
Chinese patent medicines face the problem of unpredictable costs. The prices of some Chinese medicinal materials, especially wild Chinese medicinal materials, fluctuate greatly. Droughts, floods, wind, frost, rain and snow, epidemics, etc. will all affect the supply and demand of Chinese medicinal materials. Therefore, with a one-year cycle, the participation of downstream preparation companies in bidding will cause corresponding problems.
Affected by the epidemic, starting from 2020, the prices of Chinese patent medicine raw materials and Chinese medicinal materials have seen a "full-scale rise". According to the Cyblan Blue report, taking honeysuckle as an example, affected by the epidemic, the market volume quickly climbed from 140 yuan per kilogram to 270 yuan per kilogram. At the same time, affected by imports, the prices of some medicinal materials that need to be imported to supplement the market, such as Caulis spatholobi, dog's spine, red peony root, atractylodes, and Wei Lingxian, have even doubled due to the obstruction of their sources.
In addition, some insiders pointed out that attention should be paid to the impact of changes in regulatory policies on prices. For example, with the implementation of the 2020 edition of the Pharmacopoeia, Chinese medicine companies will face high standards for heavy metal and pesticide residue inspection, and related inspection costs have risen sharply.