The new GMP near end of Chinese medicine yinpian accelerate reshuffle

http://www.pharmacy.hc360.com

08:52 September 7, 2015

Source: netease finance T | T

Beijing ding automobil pharmaceutical industry network 】 【 I medical consultation center director Shi Lichen pointed to the reporter, traditional Chinese medicine formula particles pilot qualifications of have debate for many years, and as the country's emphasis on the development of modern Chinese medicine, Chinese medicine formula particles pilot qualifications let go is a trend, there will be more companies share the market.

With the development of the new GMP certification and deadline approaches, the industry think that the pharmaceutical industry, especially Chinese medicine yinpian enterprise or will have an opportunity to reshuffle. According to incomplete statistics, as of September 5, 64 drug firms be retrieved GMP certificate, Chinese medicine yinpian enterprise for more than half.

Zhang Jili wide hair negotiable securities analyst believes that in spite of 2015 years is the years of the new GMP certification mark yinpian enterprise, at present only 20% of the enterprises through certification, industry barriers greatly improve, but the most is still the boom of medicine yinpian industry sector, because the drugs cancel plus Chinese medicine yinpian 25% bonus rate will not cancel, do not need to worry about health insurance fee.

And the traditional Chinese medicine formula particles as a substitute for traditional Chinese medicine yinpian, growth is in gold. Industry forecasts, according to a report in the next few years the traditional Chinese medicine formula particles will remain around 30% growth. We have learned, at present in traditional Chinese medicine formula particles only six production enterprises.

However, the Beijing minister medical consultation center director Shi Lichen pointed to the reporter, traditional Chinese medicine formula particles pilot qualifications have debate for many years, as the country's emphasis on the development of modern Chinese medicine, Chinese medicine formula particles pilot qualifications let go is a trend, there will be more companies share the market, such as Buddha goodness pharmaceutical (002644 SZ) and other related enterprises are layout.

Chinese medicine yinpian accelerate realignment

Chinese medicine yinpian, as a industry chain is an important part of traditional Chinese medicine industry, since 2010, both in the scale of production and production capacity, has high value of the record.

2015-2020 "issued by the industry information network of China, Chinese medicine yinpian processing industry market evaluation and investment strategy consulting report, according to Chinese medicine yinpian capacity of 332 tons from 2010 to 2010, 450 tons, and annual output from 2010 tonnes in 175 up to 2014 tonnes in 315. Another according to the ministry, 2014, Chinese medicine yinpian revenue of 2014 yuan, up 15.72% from a year earlier, higher than that of chemical drugs and biological drugs.

However, from the Angle of profit margins, Chinese medicine yinpian only 7% profit margin, and chemical and biological agents also has the very big disparity compared to more than 10% of the profit margin. And, according to Chinese medicine yinpian has also been facing the problem of excess production capacity, such as the 2014 to 300 tons, domestic demand for Chinese medicine yinpian output is 315 tons.

At the same time, industry analysts believe that with the development of the new GMP certification and deadline approaching, Chinese medicine yinpian enterprise or will face reshuffle.

According to the drug production quality management standard 2010 edition certification requirements, Chinese medicine yinpian production enterprises in December 31, 2015, must through the new state GMP certification, otherwise may continue to production.

21st century business herald reporters from the state food and drug administration of the relevant data query, currently has GMP Chinese medicine yinpian certification scope of a total of 2203 enterprises, Chinese medicine yinpian drug manufacturers a total of 1318. Otherwise, according to the data of wide hair negotiable securities only 20% enterprises through certification.

In all previous "flight check" (that is, without prior notice by examination enterprise for its rapid on-site inspection, hereinafter referred to as the "flying inspection"), Chinese medicine yinpian enterprise also is not optimistic. According to a report in the 21st century economy reporters incomplete statistics, as of September 2, 2015, a total of 15 provinces 64 drug firms be retrieved GMP certificate, there are 47 drug firms is the Chinese medicine yinpian enterprise, accounting for 74.6% of the charge card companies.

At the national food administration of drug safety notice "fly check" projects, key goal is Chinese medicine yinpian and traditional Chinese medicine enterprise. According to the state food and drug administration officials had introduced to the media, Chinese medicine yinpian GMP certification inspection project a total of 111 items, including 18 key projects, production procedures and key process, toxic medicinal materials production, storage and packaging, Chinese medicine yinpian processing standards, production water quality standards, Chinese medicine yinpian review record before release, etc are included in the key projects.

And we have learned, be retrieved the cause of the GMP certificate, including the Chinese and western medicine production alternating collinear, fabricating false inspection reports, Chinese herbal medicine mildew, suspected of making fake Chinese medicine yinpian, suspected of OEM Chinese medicine yinpian, allegedly lend packaging materials and production sites, etc. Part in severe cases, all case investigation.

"Our Chinese medicine yinpian product quality the good and bad are intermingled, mainly because of the current standardization and standardization work has just started, also in accelerating industrial upgrading, enterprise innovation also in further practice." Taizhou, a Chinese medicine yinpian, head of corporate sales to economic reporter analysis pointed out that in the 21st century.

The head pointed out that the hope of an orderly market evolution, reshuffle is inevitable trend. "In Chinese medicine yinpian, informal and formal Chinese herbal medicine processing factory has been very competitive and sometimes even bad money after bad money. Informal Chinese medicine processing enterprises to produce Chinese herbal medicine yinpian rely on low-cost flooding the market, making formal enterprise survival is threatened, and even the whole Chinese medicine yinpian industry is difficult to guarantee product quality."

In the bohai securities medical biological analyst Wang Wen view, many ministries jointly issued during the first half of the protected traditional Chinese medicinal materials and the development plan (2015-2020), to have been in the production of "small, scattered and disorderly" mill yinpian industrial chain made the standard and requirements, combined with many slices companies GMP certificate be retrieved, during the first half of the future of the integration of industry is expected to gain market share.

Rapid growth in Chinese traditional medicine formula particles

Although Chinese medicine yinpian industry all kinds of problems, but in Zhang Jili wide hair negotiable securities analyst's view, is still the boom of medicine yinpian industry the highest subsectors, because drug cancel plus Chinese medicine yinpian 25% bonus rate will not cancel, do not need to worry about health insurance fee.

The bohai securities medicine Wang Wen biological analyst thinks, compulsory certification of GMP is about to expire at the end of 2015, the merger integration and policy out the ascension will lead to industry concentration, including traditional Chinese medicine formula particles in Chinese medicine market segments will be the focus. "On the one hand, the market is expected to open space, is now only 3 armour hospital can use formula particles. If this restriction canceled, demand side will open, broad market space."

Traditional Chinese medicine formula particles, also known as "single taste traditional Chinese medicine (TCM) condensed particles", "Chinese medicine new granular yinpian", "no Fried slices", etc., is based on the traditional Chinese medicine yinpian which conform to the process for raw material, extracted by modern technology, concentration, drying, granulating new kind of refined products. It ensures that all characteristics of the original Chinese medicine yinpian, can satisfy the physician to syndrome differentiation and treatment, in the add and subtract, powerful, high efficacy; And don't need decoction, direct blunt, little dose and effect quickly, composition, curative effect, safety and hygiene, carry save completely is convenient and easy modulation and suitable for industrial production and many other advantages.

According to the related study, traditional Chinese medicine formula particles the size of the market growth in 2006 from 2006 to 228 million in 4.2 billion, the compound growth rate as high as 51.6%. Market growth is far more than other category in the traditional Chinese medicine industry. Compared with traditional Chinese medicine yinpian nearly billions of market scale at present, traditional Chinese medicine formula particles market is still small.

But the traditional Chinese medicine formula particles as a substitute for traditional Chinese medicine yinpian, growth is in gold. Industry forecasts, according to a report in the next few years the traditional Chinese medicine formula particles will remain around 30% growth, by 2016 the market overall scale is expected to exceed 11 billion yuan, to a rapid rise in 2018 to 18.8 billion yuan.

Previously, in addition to parts of some hospitals, Chinese medicine formula particles at his own expense category, but with the use of traditional Chinese medicine formula particles more and more, into the call for health care is becoming more and more high.

On August 24, zhejiang, shaanxi provinces for traditional Chinese medicine formula particles released a statement on the same day, Chinese traditional medicine formula particles into the trial of basic medical insurance to pay limits in zhejiang province for advice; Shaanxi limit pharmaceutical retail enterprise management sales rights of traditional Chinese medicine formula particles.

For advice, according to zhejiang province on September 1, after the traditional Chinese medicine formula particles into the scope of coverage, but the traditional Chinese medicine formula particles reimbursement scope will be limited to traditional Chinese medicine formula particles into the scope of the trial of basic medical insurance limit above province level 3 hospital of traditional Chinese medicine (including combine traditional Chinese and western medicine hospital), pay varieties, use management and for JiaChaLv according to Chinese medicine yinpian related management regulations.

In wang jun, an analyst at boc securities pharmaceutical industry point of view, the pilot is a milestone in Chinese traditional medicine formula particles sales promotion event.

"At present, only a few cities such as Qingdao and hangzhou will Chinese traditional medicine formula particles into the local coverage. In some areas, the traditional Chinese medicine formula particles only as part of the Chinese medicine yinpian were included in the local health care, such as some of Beijing's high-end hospital. Zhejiang is the first Chinese medicine formula particles as independent drug, not the other part of the related products to included in the province of local coverage. Patients taking these drugs daily cost isn't cheap, chronic diseases needs 50 to 60 yuan, cough take 10 to 15 yuan, believe in zhejiang province, the pilot will create more sales promotion opportunity for traditional Chinese medicine formula particles, there will be more patients to choose this kind of medicine." Mr. Wang said.

Drug companies rushed to layout of TCM formula granules

Although Chinese medicine granule growth quickly, the size of the market has reached billions, but in the size of the Chinese medicine yinpian, the proportion is still low single digits. This is one of the historical reasons.

In July 2001, the state food and drug administration issued the "traditional Chinese medicine formula particles management interim provisions", clear the category of traditional Chinese medicine formula particles should be brought into the Chinese medicine yinpian management. But due to its production process is not unified, enterprise quality standard is inconsistent, clinical studies are still some problems such as limitations, for a long time, state food and drug administration of pilot production enterprise qualification strictly controls, only approved the six pilot production of enterprises, in order to formulate unified industry standards.

On June 26, 2013, the state food and drug administration issued a "about Chinese medicine yinpian processing specification strictly and traditional Chinese medicine formula particles pilot study management and other related matters notice, require strict management of traditional Chinese medicine formula particles pilot, before the new rules, the provinces may not approved by the name of any Chinese medicine formula particles.

At present, with traditional Chinese medicine formula particles pilot production enterprise qualification of only six companies, jiangyin day jiang pharmaceutical, red sun pharmaceutical co. (300026 SZ) subsidiary Kang Rentang, CRC san-jiu (000999 SZ), guangdong side, empower pharmaceutical and new green pharmaceutical industry in sichuan province. Among them, the day jiang pharmaceutical has day river in jiangsu and guangdong party two pilot license. Anhui others pharmaceutical, JiLinLi source pharmaceutical only province pilot qualifications.

According to the head of the enterprise, traditional Chinese medicine formula particles industry international standards has been discussed by the world federation of Chinese medicine, in the process of establishing national standard are also, and nearly a year or two have liberalised expected production qualification.

"Traditional Chinese medicine formula particles the size of the market in the past ten years of rapid growth, the average annual compound growth rate of nearly 50%. Even so, traditional Chinese medicine formula particles in proprietary Chinese medicine market in China accounted for less than 2%, there is a huge room to improve. In addition, the traditional Chinese medicine formula particles technical threshold is not high, and the average gross profit margin is as high as 70%, Chinese medicine formula particles such a wide market prospect, with the advent of open qualification, other enterprises is certainly don't want to miss it." Shi Lichen analysis said.

Buddha goodness pharmaceutical June 25th noon announcement, the transferee by lanzhou compound traditional Chinese medicine formula particles secret technology. In southwest securities analyst Zhu Guoguang view, the layout of the Buddha goodness pharmaceutical seize market opportunities, the current northwest of TCM formula granules market is still blank, market development is relatively weak, Buddha goodness pharmaceutical are expected to lead to the northwest market relying on geographical advantages, and radiation throughout the country.

Pharmaceutical (600518. SH), in addition, the sig essence pharmaceutical (002349 SZ) listed drug firms are also active layout. Sig pharmaceutical in phase ii of the Chinese medicine yinpian factory reserve, the expansion of the traditional Chinese medicine formula granules production automation and quality of online monitoring technology reform project, according to the card appellation for several years ago in the preparation of this technology, at present is ready; Essence pharmaceutical, says its subsidiary essence pharmaceutical bozhou kombucha co., LTD., has the Chinese medicine yinpian production workshop, after the opening policy, the factory will gradually into the production of traditional Chinese medicine formula particles; According to understand, xiangxue pharmacy (300147 SZ) also have a plan to related merger into the idea of traditional Chinese medicine formula particles.