Drug companies secretly formula particles, standard lead crisis

The announcement of the State Food and Drug Administration concerning the solicitation of opinions on the “Measures for the Administration of Chinese Herbal Formula Granules (Draft for Comment)” (hereinafter referred to as the “Draft for Soliciting Opinions”) is more than a month away from the deadline of March 1st. Kangmei Pharmaceutical shares Co., Ltd. (hereinafter referred to as "Kangmei Pharmaceutical") disclosed that the company has begun to lay out the market for traditional Chinese medicine formula granules. Industry insiders believe that Kangmei Pharmaceutical's move is a sign that the battle for the Chinese herbal formula granule market has started. With the gradual liberalization of the country’s market and the increase in the area where the Chinese herbal granules market has been incorporated into the medical insurance category, Chinese granules production represented by the original six major pilot manufacturing companies, such as China Resources Sanjiu, Tianjiang Pharmaceutical, and Kangrentang Pharmaceutical, has increased. Sites will face re-division.

Production competition scramble kicks off

On January 22, Kang Mei Pharmaceutical announced that it plans to invest 650 million yuan in the construction of traditional Chinese medicine formula granules in Puning, Guangdong Province. The total land area of ​​the project is approximately 12,000 square meters and the construction period is planned for 18 months. The project will build 12 new production lines with an annual extraction capacity of approximately 6,000 tons of traditional Chinese medicine. It is expected to develop and produce about 450 kinds of traditional Chinese medicinal granules such as licorice, wolfberry, Chinese angelica, and white peony, with an annual output of approximately 2.4 billion bales to meet the company's business requirements. Product requirements.

It is understood that Li Congxuan, the general manager of OTC Division of Kangmei Pharmaceuticals, stated in the article “Prediction of the Trend of Chinese Herbal Pieces Market in 2016” that China’s traditional Chinese medicine formula granules only had six production licenses, and this year’s policy has continued to be liberalized. It is rumored that many traditional Chinese medicine and proprietary Chinese medicine manufacturers, including Kangmei Pharmaceutical and Shenwei, have completed the preparation of traditional Chinese medicine formula granule production lines, production plants, and technology, and immediately established national production licenses after the release of national policies.

In addition, Essence Pharmaceuticals stated that its subsidiary subsidiary, Essence Pharmaceuticals (Cangzhou Kangpu) Co., Ltd., has a production workshop for Chinese Herbal Pieces. After the policy is opened, the plant will gradually enter the production of traditional Chinese medicine formula granules. The news shows that Xiangxue Pharmaceutical also has the idea of ​​expanding in this area. “Hendar Data” also disclosed that there are currently 628 manufacturers that possess both extraction and granules GMP (ie, product quality control specifications). Benefiting from restrictions on release, these companies will be eligible to apply for the production of traditional Chinese medicine formula granules.

According to professional analysis, with the advancement of the reform of public hospitals, the hospital will gradually cancel the addition of drugs, and the pressure on hospital revenues will increase. Formula particles will perform a 25% bonus on traditional Chinese medicines. This will accelerate the enthusiasm of hospitals to use TCM formula granules. TCM formula granules will maintain a growth rate of around 30% in the next three years. By 2016, the overall market size is expected to exceed 10 billion yuan, and by 2018 it will increase to 20 billion yuan. This is also one of the main reasons why the policy has once opened up, causing the group to enter the field of traditional Chinese medicine granule production.

In this regard, Shi Lichen, head of Beijing Dingchen Pharmaceutical Management Consulting Center, told the Beijing Commercial Daily reporter that although many companies can apply for the production of traditional Chinese medicine formula granules, it is not easy to really invest in production. “If you want to produce traditional Chinese medicine formula granules, you must re-establish the production line, and the cheapest line for this production line is about 10 million yuan. If you want to fully lay out the production costs, you will even have to spend 100 million yuan. Such a fee is for general enterprises. It's very difficult to get it out. For example, traditional Chinese medicine companies that have not passed the new GMP certification will find it difficult to enter the Chinese herbal formula granules market. Of course, there are also many companies like Shenwei and Tasly that aim at traditional Chinese medicine formula granules. Cake.com America's investment in traditional Chinese medicine formula granules project is actually the first shot of the market battle, and then there will be a large number of companies into the traditional Chinese medicine formula granule market to compete for market share." Shi Lichen frankly.

The six elders said frankly that there is no pressure

According to public information, the market size of TCM granules in 2013 was approximately RMB 5 billion, and the compound growth rate in the last five years was 40%-50%. According to this estimate, it should reach 8.2 billion yuan in 2015. By 2016, the annual sales volume of TCM granules will reach 10 billion yuan.

It is understood that due to the inconsistency of the traditional Chinese medicine formula granules process and the unclear effect and side effects, from 2001 to the present, in the past 15 years, the pilot production of traditional Chinese medicine formula granules has always been only six companies. Currently, about 60% of the six pilot companies in circulation of traditional Chinese medicine formula granules are produced, which has a very high market share. This is mainly due to the production constraints that make the competitive pressure of the TCM granule market less, and to some extent protect the monopoly position of the six companies in the TCM granule market.

According to industry experts, the National Food and Drug Administration's opportunity to pilot the six companies that year is to form a set of standards and quality standards for traditional Chinese medicine formulation granules that can be used for reference by all Chinese companies. However, after more than 10 years, the above-mentioned The enterprises rely on the status of pilot status to make a lot of money in a boring voice, and they are governing themselves in the standardization of their own. The government’s publication of the “Draft for Solicitation of Comments” also aims to form a unified standard.

Then, is the “Draft for Soliciting Opinions” issued for the six pilot production enterprises threatened? For this, the Beijing Business Daily reporter contacted Peili (Nanning) Pharmaceutical Co., Ltd., the company’s relevant personnel said, “Consultation Draft” The introduction of this product will certainly have a certain impact on the production of traditional Chinese medicine formula granules, but it will not have a decisive impact. "We have core technology and we have our own R&D team, so we are not too worried."

Although Prairie (Nanning) Pharmaceuticals stated that it possesses core technologies and R&D teams, it does not worry that other companies will give birth to the market. However, these cannot represent several other senior-level companies to maintain their market position. “After years, a large number of companies, such as Shenwei and Tasly, will enter the Chinese herbal formula granule market. By then, the six companies will not rule out that they will be overtaken by other companies and may even be squeezed out of the market for the intrinsic formula. In my opinion, these six years Businesses are too comfortable, have no competitive pressure, and waste a very good opportunity, that is, six companies do not make standards in terms of formula particles. In other words, if the industry standards can be made in the production process, quality, etc. Even if the policy is liberalized, these six companies can firmly occupy the market share. Therefore, once the policy is liberalized and companies are flooding into the market, the market share of the six companies will be divided immediately, Shi Lichen said.

Crisis of standards causes crisis

According to public information, Japan, South Korea, China Taiwan and other places began to develop granules in the 1970s and won the international market with traditional Chinese medicine formula granules. Authoritative sources revealed that in the international Chinese medicine market, about 98% of the market share was occupied by Japan and China Taiwan. Although there is information that China has experienced more than 20 years of independent research and development, in 2001 by the China Food and Drug Administration officially named traditional Chinese medicine granules, by 2010, has completed the production of more than 600 flavors of traditional Chinese medicine formula granules. However, people in the industry believe that traditional Chinese medicine formula granules can certainly bring considerable benefits to production companies. However, pilot companies have been unable to promulgate industry standards and have doubted the quality of Chinese medicine granule preparations. It is precisely for this reason that a group of Chinese Herbal Pieces companies want to participate in the delivery of this “big cake”.

At the same time, the reporter found out that the data has found that China has not published a document on the quality of Chinese herbal formula particle production process standards.

Although in the “Draft for Comment”, it is clearly stipulated that the National Pharmacopoeia Committee shall organize the formulation and revision of the uniform drug standards for Chinese herbal formula granules, and at the same time, the emphasis shall be placed on the requirements for the formulation of TCM formula granules: “Comparative study with standard decoction should be sufficient. Considering the consistency of the basic attributes of Chinese Herbal Medicine Pieces and the specificity of lack of traits, fully consider the factors affecting quality in various aspects such as the origin of medicinal materials, preparation of decoction pieces, production and use of traditional Chinese medicinal formula granules, and strengthen the identification of specificity and multi-component and overall quality control. It fully reflects the advanced level and quality of the drug quality control at the present stage stems from the concept of design. The format and terminology of drug standards should closely follow the 2015 edition of the “Chinese Pharmacopoeia.” However, the quality standards for traditional Chinese medicine formula granules have not been published.

Shi Lichen said that at present, China's traditional Chinese medicine formula granules are faced with an urgent need to solve the problem, that is, the current domestic Chinese herbal formula granules generally have a quality but not close. This also reflects the disadvantages of the country's failure to harmonize production process quality standards at another level. Now that the country has liberalized the production of traditional Chinese medicine formula granules, companies want a share of the pie. However, they do not have a market access standard and production process quality standards. As such, the market's quality of Chinese herbal formula granules is more difficult to control.

In addition, China has not yet mastered the core technology of traditional Chinese medicine formula granules, which means that domestic companies wanting to produce traditional Chinese medicine formula granules need to purchase technology abroad, or hire foreign aid, even if six senior-level companies are not all Master core production technology. Therefore, if the production of traditional Chinese medicine formula granules is opened, it is not ruled out that newly entering enterprises will compete for a place in the existing market of the original pilot enterprises.