Medical network on December 23 - December 31, 2016, national "about to speed up the implementation of the new revised drug production quality management standard for upgrading the pharmaceutical industry related issues notice" a new version of GMP "(Jane) landing on the arrival of the last barrier known as proprietary Chinese medicine" monosodium glutamate "bezoar also a clampdown on speed of the market.
Recently, local governments at all levels, including gansu, jilin, etc, to accelerate the fall to the ground "about strengthening your fine herbs containing bezoar and so on proprietary Chinese medicine supervision and inspection of the notice, bezoar this neglected Chinese herbal medicine market, is becoming a new hot spot.
Bezoar can be divided into natural, cultivation, breeding and artificial bezoar in vitro, price difference is very big, from hundreds of yuan to hundreds of thousands of yuan per kilogram. In the raw material source, factors such as market access and spreads, artificial bezoar still accounted for more than 90%, "and the production of artificial bezoar is not standard, the phenomenon such as OEM a lot." An industry to discuss, now national renovation market, bezoar facing the industry reshuffle.
Artificial bezoar
Bezoar is liver of gallstones in the gallbladder says "bravery yellow" or "egg yolk", the bile ducts to the say "yellow", as a result of hepatic duct say "yellow" liver. Can be used in antipyretic, detoxification, arresting convulsion, can add in a variety of proprietary Chinese medicine.
The core indexes of the bezoar medicinal value is bilirubin, natural bezoar bilirubin content of 18% - 18%, yield is not high. "National natural bezoar may be less than six hundred kilograms." Zhou Ruguan chief executive of the wuhan jianmin dapeng pharmaceutical co., LTD., said the main reason is that risk of gallstones in only a few parts per thousand, and only scalpers have gallstones, plus now cattle is very little, and basic it is fine to feed, reduces the risk.
According to incomplete statistics, now more than two thousand kinds of proprietary Chinese medicine used in bezoar there are more than six hundred, the great demand of natural bezoar, scarcity raises prices, "the natural bezoar can sell for 200000 yuan per kilogram." Zhou Ruguan said, in short supply, began to appear the artificial bezoar in the 1970 s.
Artificial bezoar is simple to understand the several main ingredients made a combination of bezoar, Zhou Ruguan introduction, "artificial bezoar bilirubin content is only about seven over one thousand, not by the reaction of organism, not core effect."
Barriers to entry are low of artificial bezoar. Another artificial bezoar, head of the enterprise is, according to the previously lax supervision, obtain approval of artificial bezoar batch number 20-30, but which is used for the production of artificial bezoar manufacturer only 5 to 6, the rest of the document number in no document number small manufacturer factory OEM sales, even it is this increased regulation of important reasons.
Artificial bezoar price is very low, usually only about 500 yuan per kilogram." The sources, different from the medicine, proprietary Chinese medicine efficacy than its effect could not be determined by clinical trial data. And proprietary Chinese medicine in general is a variety of combinations, a single variety usage is not much, at present, artificial bezoar sales accounted for more than 90%, but the demand is only more than 200 tons a year.
In vitro cultivation of standardization
Earlier this year, the strategic plan for development of Chinese medicine (2016-2030) ", means will be included in the development of Chinese medicine are not national development strategy. As a broad spectrum of bezoar, a strategy that release the positive market signals.
On the efficacy of it, artificial bezoar as natural bezoar, particularly in clinical acute heavy conditions. Under this situation, between natural bezoar and artificial bezoar products concern.
In 2004, the state food administration of drug safety "about strengthening containing bezoar medicinal materials such as varieties of proprietary Chinese medicine supervision and management of notice in the clear, containing bezoar in prescription drug standards of clinical acute disease drug varieties and other dosage forms or specifications, the prescription of bezoar can be fixed by cultivating bezoar or in vitro cultivation bezoar equivalent replacement feeding is used, but not using artificial bezoar instead. In addition, the traditional mean that people can only use natural bezoar and in vitro cultivation bezoar.
The technology of "cultivating bezoar is very complex. The industry, it needs to live cattle do surgery twice, namely the cattle strains of gallbladder cut into first, again after a few months out, yield is low, and involves the non-humanitarian, almost no companies engaged in the technology.
In vitro cultivation bezoar market was open, but so far, only engaged in vitro cultivation bezoar domestic suppliers, namely wuhan jianmin dapeng pharmaceutical co., LTD.
"Originally, this is a patent of tongji hospital." Zhou Ruguan introduction, in 1999, jianmin dapeng will be used for commercial, after the patent purchase the technology principle of in vitro cultivation bezoar is to simulate ox-gall environment, in particular, ox gall bladder will have gallstones after a bacterial infection, inflammation, jianmin dapeng do steel gallbladder after entered the ox bile, ox-gall simulation environment, by bacterial fermentation cultivation bezoar.
Natural bezoar bilirubin content is high, but the individual content is very different, is not stable. Zhou Ruguan said the medicine prescribed by the state bezoar bilirubin content cannot be lower than 35%, stability control technology of in vitro cultivation bezoar can bilirubin content between 36% and 39%.
However, the market share of artificial bezoar still very less, "the bezoar annual demand is about more than four hundred tons, but natural bezoar only four tons, in vitro cultivation bezoar has more than 10% market share." Zhou Ruguan revealed that the in vitro cultivation bezoar price about 70000 yuan per kilogram.
Can't accept this price to market, "some proprietary Chinese medicine enterprises inadequate feeding." Another bezoar industry also explain, but it is difficult to regulation, in addition, some manufacturers did not replace artificial bezoar as required.
And the barriers to entry in vitro cultivation bezoar is also very high. "Market stability and technical requirements are high." Zhou Ruguan said, in addition, the country's new drug approval strictly, cycle is long, the general clinical observation for eight years, many companies don't do this. Limit the scale enlargement of the industry.
To break the ceiling of in vitro cultivation bezoar industry. Jianmin dapeng has to change, "in addition to the API, we set out to increase the materials and the added value of bezoar preparation including bezoar." Zhou Ruguan, according to the company plan to do a bezoar strategic alliances, in view of the bezoar related products to provide professional inspection system. In addition, to a third party is engaged in the bezoar, teams and companies to provide expert academic support. Jianmin dapeng, moreover, are also seeking to join the health insurance market to expand in vitro cultivation bezoar. |
