echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > New drugs enter the market and sit on the bench for five years

    New drugs enter the market and sit on the bench for five years

    • Last Update: 2015-03-12
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: from March 12, 2015, Securities Daily: "last October, an expert of the thousand talents plan for entrepreneurship in Suzhou came to me to complain He came back in 2006 and started his business It took eight years and 80 million yuan to invest He developed a product for the treatment of liver cancer In 2014, the sales volume was only over 1.7 million yuan, which was not enough for the interest of these years This is not a case I have made a survey The best innovative drugs sold in these years are more than 60 million yuan I remember when the new anticancer drug developed by our company went on the market, one of my peers poured cold water on me, saying don't be too happy first, and don't expect this product to make money in five years In foreign countries, some new drugs can reach billions or even tens of billions of dollars of sales in the year when they go on the market What is the reason for such a big gap? The main factor is that there are too many bottlenecks in China's market access and the approval process is too long " Ding liming, deputy to the National People's Congress and chairman of Beida Pharmaceutical Co., Ltd., told reporters in an exclusive interview with Securities Daily At the same time, he also said, "in foreign countries, new drugs may be bought in hospitals in a few hours, but in China, it may be several years after the completion of provincial bidding, hospital approval and other processes." Based on these pain points of the industry, in this year's "two sessions", Ding Liming put forward the proposal again, and put forward his own suggestions to solve the problems existing in the bottleneck of new drug industrialization According to Ding lieming's analysis in the proposal, it has been nearly 15 years since the government led centralized bidding for drugs was implemented in China The original intention of this system is to purchase drugs with high quality and low price through market competition, but there are many deviations in the actual implementation process Recently, due to the policy of "only low price is to take", the bid price of many drugs is falsely low, which has seriously affected the supply and quality Hundreds of drug companies have been aroused to write jointly in various places, which has aroused heated public opinion The interests of patients are ignored, and the enthusiasm of R & D and production of pharmaceutical industry is suppressed This kind of bidding can not achieve the goal of "protecting people's health and reducing the growth of medical expenses", but it has more obvious counteraction to the pharmaceutical innovation in China "There is no uniform regulation on the bidding period, which affects the timeliness of new drugs; at the same time, the current bidding system has unreasonable requirements on drug prices This is the two outstanding manifestations of the negative effects of the current bidding system on pharmaceutical innovation " According to Ding Liming At present, many provinces have not invited bids for more than three years, including Beijing, Tianjin, Jiangsu and Zhejiang, which are economically developed provinces and cities The longest one has not invited bids for nearly five years Due to the uncertainty of bidding period, nearly one-third of new drugs in our country still can not enter the provinces for sale two years after being put on the market In the first year, more than half of the drugs could not be sold in hospitals This means that innovative drugs can not be used for clinical use in time New drugs become old drugs, which not only affects the further improvement of medical quality, but also seriously frustrates the innovation enthusiasm of Chinese pharmaceutical enterprises just in the initial stage of new drug research and development Compared with the performance of innovative drugs at home and abroad, it can be found that the annual sales of new drugs at home and abroad are always in the tens of millions and tens of millions of dollars within a few years after the market, while the sales of new drugs in Europe and the United States are often in the first year of the market, which is closely related to the restriction of the current bidding system Such a result is extremely unfavorable for Chinese patients who are eager to get the latest treatment methods, or for Chinese pharmaceutical enterprises that are committed to innovation In fact, the state franchises the independent pricing of class 1.1 innovative drugs There is no similar drug in the market for price comparison, and bidding itself is meaningless In many provinces, there is no clear scientific basis for price negotiation The bid inviter determines the final price according to the price quoted by each bidder and the price reduction range according to the drug classification However, innovative drugs are unique and incomparable In practice, the pricing of bidding is not objective and can not truly reflect the value of innovative drugs At the same time, in the process of hospital price negotiation, most experts come from doctors or pharmacy staff of different departments, who often don't know much about innovative drugs with special effects, and the price limit (benchmark price) or negotiation price given is often determined arbitrarily in a one size fits all manner, which leads to the unacceptability of enterprises Administrative price reduction instead of bidding procurement has become a means of political achievements, which violates the market rules and the basic principles of the state to encourage new drug innovation In order to deal with the preparation of various documents and procedures in the bidding process and the personnel energy involved, the complexity is no less than the price approval again, which is almost empty talk for the price protection of innovative drugs Since the implementation of the "thousand talents plan", one quarter of the talents returning to China have been active in the fields of biomedicine and life science After years of overseas accumulation, these people are the backbone of their respective fields After returning to China, many people choose innovation and entrepreneurship They reflect that the most prominent constraint (the development of the industry) is that the approval process is too long However, they have to go abroad to apply for clinical research curve to save the country, which is obviously not conducive to the development of the industry, but also contrary to the original intention of the thousand people plan to introduce talents " Ding told Securities Daily "There are 7000 new drug projects waiting to be approved every year in China, and the new approved projects need to wait eight months before someone opens the materials for review," Ding said In general, not all of these approved drugs are fundamentally innovative drugs, many of which are imitations There are many reasons for this situation, including the shortage of examination and approval personnel and the low examination and approval expenses, which make many enterprises blindly declare with the mentality of "first reporting and then saying" and occupy a lot of examination and approval time and human cost Therefore, we suggest that the standard of examination and approval fees should be raised, and the declared projects should be prioritized, instead of being crowded into one lane by ox cart, carriage and car, and a positive guidance and diversion should be formed " It can be seen from the past data that, in the previous two sessions, Ding Liming has put forward relevant proposals on the new drug approval process To this day, what are the reasons for the long-standing unresolved issues? Ding explained, "this appeal still works We can see that through your suggestions, there are some improvements at present, but this is a long process, which needs continuous efforts." In this year's "two sessions" proposal, Ding Liming put forward three suggestions to solve the bottleneck of new drug industrialization, including improving the new drug pricing mechanism, standardizing the bidding cycle and innovating the bidding system "For a real class of new drugs with independent intellectual property rights, patents should be protected and supported to varying degrees in terms of pricing mechanism to ensure that innovative drugs can recover their R & D costs and obtain reasonable profits through the market; Nowadays, the application of various new technologies is accelerating and new drugs are emerging in an endless stream The birth of a new drug may mean the birth of a new treatment method, which should enable Chinese patients to enjoy the benefits of scientific and technological progress in a timely manner Therefore, it is suggested that the government should directly enter the market in the aspect of no bidding for class 1.1 new drugs If bidding is required, it shall be specified once a year During this period, the drugs on the market can be recorded and purchased at any time, so as to ensure the clinical drug demand, benefit the vast number of patients as soon as possible, and stimulate the power of continuous innovation of enterprises " Ding said in the proposal In addition to solving the factors of approval process, Ding believes that the current problems of small but scattered, weak innovation in the industry are also the ceiling restricting the development of the industry "In recent years, the enthusiasm of enterprise innovation has greatly improved A gratifying phenomenon is that a large number of overseas talents have joined the army of domestic innovation and entrepreneurship However, at present, due to the large investment and high risk factors of innovative drugs, innovation is still an unspeakable pain in the industry It used to be said that innovation is dying " Ding liming was helpless "To ensure the enthusiasm of introducing talents, we need to improve the back-end supporting measures of the industry If the innovation results are not applied in time, innovation is meaningless." In addition to the back-end supporting policies, Ding Liming proposed that, in the capital market, can we also introduce some policies to support R & D-oriented companies? "In foreign countries, R & D investment of pharmaceutical enterprises can account for 30% of the revenue, but in China, it can account for 7% and 8% Even if it's good, there are many factors that cause this situation, such as the long time of input-output and the inability to realize in the R & D approval process Our national pharmaceutical enterprises are small and scattered, unable to achieve scale effect, and it is difficult to invest heavily in R & D of new products, which in turn restricts the development of enterprises In this case, it's difficult for venture capital to intervene if the enterprises can't meet the profit requirements if they want to be listed Can we give some active support to the enterprises in the stage of R & D with the help of the reform of capital market, so that the early potential R & D companies can be strengthened with the help of capital "  
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.