The shuffle of the 500 billion generic drug market is under pressure from multinational pharmaceutical companies

Wang Hesheng, director of the Medical Reform Office of the State Council and deputy director of the National Health and Family Planning Commission, pointed out that due to historical reasons, the situation of "many small scattered messes" in the pharmaceutical industry has not changed fundamentally, and problems such as uneven quality of medicines, disorderly circulation order, inflated prices and drug abuse are still prominent.
Times Weekly reporter noted that it is to seize this pain point, the new pharmaceutical policy "National 17" clear, from the quality and efficacy of the knife, proposed to strict drug market review and approval, new drug review highlights clinical value, generic drug review in strict accordance with the quality and efficacy of the principle of consistent with the original drug.
will bring about huge changes for Chinese generics companies. At present, China's overall generic drug market size reached about 500 billion yuan. According to data from the State Administration of Food and Drug Administration, at the end of 2015, China had 5,065 pharmaceutical manufacturers, which are the world's largest producers and exporters of API, and the world's largest producer of preparations, with 97% of its products generic, with serious drug homogenization and low-level duplication.
" before the standard of generic drugs is low relative to the original drug, this time specifically proposed that the future of the entire research and development, production, have to follow the standards of the original drug to go, in fact, the entire standard of the rule has been raised. "On February 20th, Shi Lichen, founder of the third-party pharmaceutical services platform Maxcomlai, told Time Weekly.
, the 2016 annual results of the major multinational pharmaceutical companies, it can be found that most of these companies last year's performance by generic competition and suffered a decline.Similar pharmaceutical companies increased the cost of
" Before the founding of New China, our country almost no modern pharmaceutical industry, after the establishment of our country from nothing, set up from the beginning, when the pharmaceutical industry mainly solved the problem of drug quantity safety, that is, we can eat medicine. Hu Yinglian, associate professor at the National School of Administration, said.
, depending on the level of innovation, drugs can be divided into two levels: innovative and generic. The so-called generic drugs, in layman's terms, are the imitation of the drugs that have been developed and marketed, the imitation of the production of drugs suitable for the treatment of diseases, as well as quality and safety, should be the same as the original drug research.
international practice, it is not illegal for other countries and pharmaceutical technology to replicate patented drugs after they have passed their protection period. Western developed countries such as the United States, developing countries such as India and China, are large generic countries.
, because most of the original drugs are very expensive, if the quality and efficacy of generic drugs can be developed, will greatly reduce the cost of medical treatment. However, due to historical reasons, most of China's generic drugs only reached the national set the line of failure, from the quality and efficacy of the original drug is still far from.
Times Weekly reporter noted that the new drug policy "Country 17" clearly proposed to strict drug market review and approval, new drug review highlights clinical value, generic drug review in strict accordance with the quality and efficacy of the original drug consistent principle.
the new policy, for domestic generic drug companies, there are higher requirements. "Before the data is not right, almost on the line, according to the original drug to go, there is basically no 'almost' this said, you have to basically meet the existing standards." Insiders told time weekly reporters, the future of enterprises to produce generic drugs, if in accordance with the original research drug go, research and development investment increased, the cycle becomes longer, the cost will increase.
" after such a work, a few years later, after the efforts of the whole social industry and regulatory authorities, when China's domestic generic drugs, can be with imported drugs to achieve clinically consistent quality and efficacy. "Some industry experts say that, in layman's terms, people (44.050, -0.21, -0.47%) can eat domestic drugs that are exactly consistent with the efficacy of imported drugs for less money.
fact, to solve the pain point of drug quality, it is not enough to improve the review standards alone, but also to speed up the reshuffle of pharmaceutical companies. At present, China's pharmaceutical production enterprises, the number of small-scale, low-level duplication of outstanding problems, many drug varieties have more than 100 enterprises at the same time production, quality is uneven.
" originally why I talk about supply-side structural adjustment, optimize our existing drug varieties, some small production enterprises, the original through low-cost investment agents, these must be reformed, the structure of production enterprises will change. Local medical reform sources in Fujian Province told the Times Weekly.
According to public information, there are 13,508 pharmaceutical wholesale enterprises, more than 453,000 retail enterprises, the market share of the top three pharmaceutical wholesale enterprises is only 33%, compared with the developed countries generally in more than 80% of the market share is far from the industry concentration is low, with modern pharmaceutical circulation conditions of only 1.75 percent of enterprises.
"National Article 17" also specifically mentioned the need to speed up the quality and efficacy of listed generic drugs consistent evaluation. For drugs that are evaluated through consistency, relevant information is promptly made available to the community and included in the catalogue of alternative medicines with the original drug.
In addition, more than 3 production enterprises with the same variety of drugs through consistency evaluation will no longer choose varieties that have not passed the consistent evaluation in the area of centralized drug procurement, and if there are no more than 3 varieties that have passed the consistent evaluation, priority will be given to the procurement and use of varieties that have passed the consistent evaluation. We will speed up the development of standards for payment of medical insurance drugs according to the common name, and form an incentive mechanism conducive to the consistent evaluation of the use of generic drugs as soon as possible.
" the quality of domestic generic drugs is uneven, the market presents a vicious competition situation, the follow-up industry integration is imperative, and generic consistent evaluation will accelerate the process. "There are medical researchers who think. Translical pharmaceutical companies hit
Recently, the world's major pharmaceutical companies in 2016 the company's annual report has been released, including Pfizer (PFE), Roche (RHHBY), Novarma (NVS) and AstraZeneta (AZN) four major multinational pharmaceutical companies with high annual revenue.
times weekly reporter combed its annual report and found that all four drug companies face market challenges from generics, as well as the pressure of the new U.S. administration's attempts to drive down drug prices.
, the world's largest pharmaceutical company, reported full-year revenue of $52.8 billion, up 11 percent, and Pfizer's independent operating income for the full year of 2016, excluding the former Hershey and former Medivation businesses, rose 5 percent to $48.1 billion. Revenue for the fourth quarter of 2016 was $13.6 billion, down 1 percent, due to a negative impact of four fewer U.S. sales days and three fewer international sales days than a year earlier, while Pfizer's independent revenue for the fourth quarter of 2016 was $12.3 billion, down 2 percent.
past 2016 has been extraordinary for Pfizer, a foreign drug company that has experienced significant headwinds from the expiration of product patents and a decline in U.S. revenue from 13-price adult vaccines, but still shows strong growth potential.
Frank D'Amelio, executive vice president and chief financial officer of Pfizer's business operations, said, "Based on the mid-point of the 2017 financial guidance, operating income is slightly higher than in 2016 and adjusted diluted earnings per share are up 6 percent from 2016. Of course, headwinds remain, and could lead to a total decrease of $4.5 billion in operating income - including an expected $2.4 billion decrease in generic competition, a $1.2 billion decrease in his infusion system for sale, and a $900 million decrease in adverse changes in foreign exchange rates since 2016.
also affected by generics was AstraZeneca, which reported full-year revenue of $23 billion on February 2, slightly below analysts' earlier forecasts of $23 billion and down 6.9 percent from $24.7 billion in 2015. Its core revenue was $6.72 billion, down 7 percent, while its core earnings per share were $4.31, down 5 percent. Pre-tax income was $3.55 billion, compared with $3.07 billion a year earlier and a full-year dividend of $2.80 per share.
of generic drugs led to a 57 per cent drop in sales of AstraZeneone's best-selling cholesterol-lowering drug Crestor and a 39 per cent drop in sales of Nexium, which treats stomach acid.
notably, AstraZeneone's revenues fell sharply, down 16 per cent in China, as a result of last June's price negotiations in China and competition for generics in the South Korean market.
times noted that Ginistinib's patents in China expired in April 2016 and that the drug is currently lying in the Chinese market with fierce generic competition.
as of August 31, 2016, 25 companies in China had applied for a copy of Gifeitinib. Among them are pharmaceutical giants such as Baiyunshan, Hengrui Pharmaceuticals and Peking University Pharmaceuticals.
February 18, by Qilu Pharmaceuticals successfully copied, domestic treatment of non-small cell lung cancer "heavy bomb-grade" first-line targeted special effects drug Gifettini (Ireco) listed, the industry said it will break the foreign pharmaceutical giants in the Chinese market monopoly pattern, greatly reducing the market price of products. (Time Weekly)