Medicine network on July 31 - elimination, shuffling - this is the most in the industry for two years ago the July 22 data verification storm "and the" combination "policy consistency evaluation policy will do industry of the impact of the prophecy.
Now in the past two years, the state food and drug supervision and administration bureau announced recently the most strict verification storm early curative effect, from the point of data, in China a significant percentage of clinical data on suspicion of fraud.
Now, companies involved in the withdrawal of more than 1,300 species are faced with the fact that drug research and development costs are difficult to recover in the short term, and those who have been found to have been found to be fraudulent are not allowed to apply for clinical treatment again within three years. In the a-share market, more than half the number of pharmaceutical listed companies, have been affected, poor even worse capital, research and development strength of thousands of small generics firms, data verification and evaluation of the double tube of the storm's consistency, let the past homogeneity, lack of market share of small and medium-sized generics companies live hard, nearly 5000 pharmaceutical enterprises in China, this type of enterprises account for A third.
Two years ago, perhaps these firms are also looking forward to able to survive through the form of merger and acquisition, transfer, but now, many in the industry for the first financial journalist said, by the big mergers and acquisitions of expectations may be dashed, if not this, these valuable enterprise could end up with only scattered in the workshop and cheap pharmaceutical equipment.
One-third of pharmaceutical companies face elimination
According to the lunar eclipse July drug safety administration of the latest report of the clinical trial data verification second anniversary of the data, by the end of June 2017, the administration decided to report 2033 has been the production or import pending drug registration application for drug clinical trial data check, among them, 1316 pending drugs were the applicant voluntarily withdraw, 64.7% of the total, 313 in the rest of the verification of drug registration application, there are 38 registration of clinical trial data on suspicion of fraud.
Since 2015, in fact, China's pharmaceutical market regulatory policy is frequently punch, clinical trial data audits and inspections generics consistency evaluation as a "combination", intended to purge from the sources of drug quality, promote the development of Chinese pharmaceutical market from generics powers for generic power, under such demands, no core competitiveness, and capital strength of small and medium-sized pharmaceutical enterprise is inevitable.
But out in the form of how to become an issue of concern, for small and medium-sized enterprise managers, if be big mergers and acquisitions, they still have a respite, managers also can have the clearing out points on a piece of good, but I'm afraid that reality cruel than expected.
"The two policy influence must be consolidation for a long time, but at present, large pharmaceutical companies can most attention is the knock-out product of its own through consistency evaluation, and didn't have the energy to take care of mergers and acquisitions." Roland berger pharmaceutical and medical industry partners Lin Jianghan said in an interview with the financial journalist, "small businesses want to through mergers and acquisitions to fetch a good price also needs to have worthy of large companies to buy, if the enterprise data, money is not up to standard, so for large pharmaceutical companies don't have the value of mergers and acquisitions."
Almost 5000 in Lin Jianghan point of view, the current domestic pharmaceutical enterprise basic or on generic drug manufacturing, under such fierce competition environment, really make money only in niche areas in the top 10% ~ 20% of these enterprises. If not, these uncompetitive small and medium-sized generics firms will struggle to survive.
"For example, under the threshold of consistency evaluation to improve the status quo of the enterprises who don't make money, what is worth paying money to assess the consistency is faced with the cost-benefit considerations, do it, is likely to cost close not come back, but not to be, enterprise can't production, will eventually phase out." "Said Mr Lin.
With "generic" for the specialty of China's small and medium-sized pharmaceutical enterprises in the real stage, not only because two years ago the most strict data consistency check storms and evaluation policy launched intensive, lead to small and medium-sized pharmaceutical enterprise in product quality and capital on sad "screen off", on the other hand, according to a new version of GMP certification, in December 31, 2016 by the latest version of the most stringent production certification of pharmaceutical enterprise also can't again for pharmaceutical production.
According to the public information, Japan's policy towards the end of the 1990 consensus assessment policy reached 20 per cent. And Lin Jianghan told reporters, the first finance and economics in the face of the current domestic the policy of "combination", the industry of common cognitive is to eliminate a third of the pharmaceutical companies, at least one or two thousands of pharmaceutical enterprises will be hard to survive.
Access to capital is a survival leverage
Whether or not the capital continues to be the key to the survival of thousands of small and medium-sized enterprises, whether or not the dominant variety becomes the most important condition for enterprises to gain the capital preference.
"Because consistency evaluation requires enterprise during the reporting all process to go again, when each drug is to apply for a document number, our internal estimate declare it will take at least one or two years time, and money spent each varieties you need at least 3 million." Earlier, tian zhoushan, vice President of cp group co., told the first financial reporter.
Zhengda shine is between 2006 ~ 2007 one of the enterprise to obtain a large number of drug approval number, in fact, that time is also a lot of domestic pharmaceutical enterprises from the "weak" "strong" critical period, the approval document how many directly linked to the strength of enterprises, is now in front of the application for cost millions of dollars, capital can be said to be a lot of small and medium-sized enterprises can be life-saving straws.
"There is no special varieties of enterprise survival is lower, so to speak, and if there is a characteristic of varieties of enterprise, to survive, need now is money to raise their quality system, to assess the consistency." "Said Lin.
The way he think whether through strategic agreement to negotiate cooperation with large enterprises or to raise funds by the government, private, for these are high quality varieties of small and medium-sized enterprise is the most important core or have the advantage of drug varieties, this is a large enterprise, investors feel the real value.
"Actually big drug firms in China now has the demand of the transformation, in the past China's pharmaceutical companies don't pay attention to research and development, but now include qilu, hengrui, green leaves are by cooperation with external methods to complete the transformation of itself, including to buy domestic and overseas research and development of varieties and the team. So if there are variety and research and development strength of small and medium-sized enterprises, so it will be for these large pharmaceutical companies produce value." "Said Lin.
Canaan ji medicine, for example, its core product is still in the clinical trials of CM082 new drugs in the synchronous development of China and the United States, Canaan, the company has the new drugs in China's exclusive patent authorization, and carry out for multiple indications of patients with clinical research in China. Registered its own research and development and ability to access, however, to afford the huge cost for a long time, as the data verification, etc to the requirement of clinical drug promotion, enterprise trapped in a single product line and clinical access to the great pressure.
In June 2017, baida pharmaceutical completed a 100% equity purchase of kananji medicine with a total of 480 million yuan. The core reason is to further improve the overall layout of bayda pharmaceutical in the field of tumor immune medicine.
