The pharmaceutical industry even received policy gift package innovative pharmaceutical companies still have two expectations

In August 2015, the State Council issued the Opinions on Reforming the Review and Approval System for Pharmaceutical Medical Devices, which was described by many participants as a "gift package" to the industry. And in early October this year issued "on deepening the review and approval system reform to encourage innovation in pharmaceutical medical devices", but also by many in the industry is to encourage the innovation and development of pharmaceutical medical devices "36."
recently held the 2nd China Pharmaceutical Innovation and Investment Conference, the industry hotly discussed the policy dividend brought about by the bright future. However, many participants said that the price of innovative drugs and the capital support obtained by innovative pharmaceutical companies remain two major problems that cannot be ignored in the future.Policy Dividend
According to Yang Sheng, Deputy Director of the Drug and Cosmetic Registration Administration Department of the State Food and Drug Administration, after the promulgation of this series of reform measures, in the chemical drug declaration, the number of generic drug declarations in 2016, 20 There has been a marked decline in 17 years: in 2013-2015 it was more than 2,000, up from 714 last year and less than 300 this year; There has been a marked increase, with more than half of the innovative and improved new drugs being accepted for new classification registration applications, improving the efficiency of review and approval in drug review and approval, and increasing the number of drug registration applications from a peak of 2.2 at the peak of the backlog in 2015 Reduced to nearly 4,000 cases, basically eliminating the backlog, improving the speed of approval of new drugs, giving priority to the listing of a number of new drugs, improving the quality of drugs, carrying out consistent evaluation of the quality and efficacy of generic drugs, improving the quality of clinical trials and improving the transparency of review and approval, A series of achievements have been achieved by carrying out the pilot work of the drug market licensing system.
Song Ruixuan, executive director of the China Association for the Promotion of Pharmaceutical Innovation, said that in the United States, for example, it can be in the pharmaceutical field advantage, relying on policy incentives rather than investment incentives, strengthening incentives for researchers greatly stimulate the transformation of patent results from research to development;innovation drug generics are facing opportunities
the development of generic drug consistency evaluation, the acceleration of drug approval, etc., all make pharmaceutical companies actively or passively choose innovation. Yin Jinqun, vice president of Kanghong Pharmaceuticals, said that without innovation, the future path to generic drugs will become narrower and narrower.
It is understood that now to do a generic drug consistency evaluation required to calculate the cost, it is better to do innovative drugs, and in a sense, "reverse" enterprises focus on innovative drugs, and the acceleration of the approval and review process has also brought great benefits to the development of innovative drugs.
Sun Xianze, deputy director of the State Food and Drug Administration, said that the State Food and Drug Administration will take the Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation as the basic platform for the reform of pharmaceutical medical devices, actively formulate a series of supporting policies and regulations and guidelines, and will actively promote and improve the resolution of bottlenecks in clinical trials, speed up the review of listed drugs, strengthen the management of the full life cycle of pharmaceutical medical devices, enhance technical support and improve the technical review system, and strengthen the implementation of drug innovation and other work.
The establishment of a catalogue of drug listings, the exploration of the establishment of a drug patent link system, the piloting of the drug patent term compensation system, the improvement and implementation of the trial data protection system, the promotion of drug imitation production, support for the clinical application of new drugs and the development of innovative role of enterprises will promote drug innovation and the development of generic drugs.
fact, not only innovative drugs, generic drugs in fact ushered in a new round of development opportunities. Yang Sheng said that on the one hand, to encourage innovation, from the system to protect the rights and interests of innovators, but also hope that generic companies can quickly keep up, thereby reducing drug prices.
, founder of McConley, a third-party pharmaceutical service, says the opportunity for generics under the new policy is largely due to the acceleration of approval reviews. However, domestic pharmaceutical companies will continue to face strong competition from multinational pharmaceutical companies. Yin Believes that a series of policies are good for the long term, promoting innovation and encouraging innovation, but in the short term Chinese pharmaceutical companies may face greater challenges. In the future, multinational pharmaceutical companies will greatly accelerate their entry into the Chinese market. Recently, some multinational pharmaceutical companies closed their research and development centers in China, and Cheng Jianxin, president of Ping An Bank's Healthcare Arts and Tourism Finance Division, believes that this is a matter of research and development capabilities and effectiveness, not a lack of confidence in the Chinese market.Two expectations of innovative pharmaceutical companies
although innovative pharmaceutical companies at the policy level have ushered in a "big gift package", but for them, there are still two points they feel lacking.
First, in terms of price, although the national drug price negotiations into the drug, the State Health and Planning Commission has issued a message stressing that 36 negotiated access varieties to implement the implementation of national negotiated prices, the implementation of direct network procurement, no longer organize separate negotiations. However, it is understood that at present, some places and hospitals of the second bargaining "one more cut" phenomenon still exists.Sun He, vice president of
Tiansli, said it was a challenge for companies to get their money back in the market, promoting innovation on the one hand and pricing it on the other, which may more or less limit the development of real innovation capabilities. Liu Templebo, chairman of Greenlee Pharmaceutical Group, also said that if the bidding and procurement, health care negotiations, secondary bargaining and other links can not be straightened out, the enthusiasm of enterprises may be affected.
said he hoped domestic drug pricing would be based on drug values rather than prices. Mr. Slichen said appropriate enterprise-owned pricing could be considered, such as three-year enterprise-owned pricing of first-class generic drugs. The other is in the secondary market. Xinda Bio Chairman Yan Dechao hopes that the domestic can have a better secondary market platform, like some not yet profitable innovative pharmaceutical companies can be listed in the United States to finance, if there are similar channels at home, so as to avoid some high-quality domestic innovation enterprise projects abroad. (China High-tech Industry Guide)