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    Home > Medical News > Latest Medical News > Complex preparations are opportunities for Chinese pharmaceutical innovation

    Complex preparations are opportunities for Chinese pharmaceutical innovation

    • Last Update: 2020-07-28
    • Source: Internet
    • Author: User
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    The 3rd Clinical Drug Treatment Conference, organized by the Beijing Pharmaceutical Society and the Journal of Clinical Drug Treatment, took this as the theme of the Deputy Director of the Cppcc National Committee of the Chinese People's Political Consultative Conference (CPPCC), Sun Xianze Military Academy of Chinese Academy of Engineering, Chen Wei, Director of the China Academy of Engineering, Andrei, Director of the Beijing Municipal Institute of Health and Physical Administration, and Zhang Wei, former Secretary General of the National Pharmaceutical Congress of the Beijing Pharmaceutical Society, Jin Shaohong, a researcher at Beijing Concord Hospital, and the president of Beijing's major hospitals attended the conference and held high-end academic exchanges with representatives of clinical pharmaceutical researchers, research institutes and the pharmaceutical industry from across the country in the form of online and offlineThe sub-forum "New Advances in Medicines - Promoting Clinical Accessibility of Complex Preparations" organized by the Industry Technology Alliance for Excellence in Development has attracted wide attentionAt present, the development and clinical application of complex preparations for the development of "Technical Guidelines for Clinical Trials of Chemical Lycouted New Drugs" has become a hot topic of discussion at this conferenceIt is reported that the forum also launched a complex formulation of clinical accessibility of research topicsClinical advantages obviously difficult to develop In the current Chinese pharmaceutical innovation complex preparations because of its obvious clinical value, good safety, product life cycle and so on become a hot research and development, but whether it is improved new drugs or generic drugs have technical difficulties"The development of complex formulations is not only a technical issue but also a question of whether the availability of these drugs can be reliably guaranteed"Li Dakui is an analysis of the importance of complex formulation research and approval for listingHe points out that the purpose of research and development of complex formulations is to pursue better clinical value, better safety and effectiveness, and address the need for clinical lyingChina's complex preparations rely heavily on imports This is the root cause of the state to encourage the development of complex preparations, including improved new drugs and generic drugsIt is reported that by the high technical barriers, original patent protection, key accessories and equipment constraints and other factors, even europe and Japan and other countries approved complex preparations generic drugs are very limitedAlthough there are very few complex preparations in China, generic drugs such as bright pro-polyrin microspheres, poly-phonosis liposomes, etcare faced with the problem of generic consistency evaluation"The fundamental solution to the clinical accessibility of complex preparations is to encourage and accelerate the development and marketing of domestic preparationsThere are two paths to consider in the future: one is the new drug, the second, the genericDue to the very difficulty of imitation of complex preparations, it is recommended that priority be encouraged to develop improved new drugs to allow new drugs with improved complex formulations to achieve biological equivalents or non-poor efficacy of the original research drug can be approved to increase drug selection and meet clinical drug accessibilityZhang Wei is callingMulti-point breakthrough innovation research and development force to encourage enterprises with the ability to do complex preparations to develop complex preparations early service clinically in line with the basic national conditions "Special injections are an important branch of complex formulations," Li said in his special report Special injections such as liposomes and microspheres are the evergreen trees of the global pharmaceutical industry because of their unique clinical advantages market effect is no less than new drugs The development of this kind of product should be improved new drugs as a breakthrough to find a differentiated market positioning to carry out international registration and clinical green leaf pharmaceutical has a number of special injection-improved new drugs in the United States, Europe and Japan to carry out simultaneous clinical research He also pointed out that the clinical requirements of new drugs for complex formulations in Europe and the United States are based on the principle that does not require clinical advantages at the same time because different productcountries require different enterprises to take the initiative to communicate with the drug regulatory departments to clarify the relevant technical requirements Zhou Jianping pointed out that "the transdermal patch is another creative therapy it has many advantages such as the long release of drugs to avoid oral administration caused by the peak and valley phenomenon to avoid the first effect of the liver adverse reactions can be interrupted at any time." However, at present, the current lack of transdermal paste related technical guidelines related to the requirements are gradually standardized Inhalation of preparations at the meeting also became a direction to be explored "This is a combination of high-end formulations of the formulation of inhalation preparations local administration has become the preferred treatment for chronic respiratory diseases Such as the first inhalation of the antibiotic drug tubmycin inhalation solution it solves the needs of bronchodilators "Kim believes that the development of complex preparations tests the strength of research and development High-end interview: Optimizing innovative ecology to promote improved new drugs better service Clinical afternoon in the "New Progress in Medicines - Promoting Clinical Access of Complex Preparations" experts generally reflected the need to encourage the development of new drugs for complex formulations to promote clinical accessibility from the establishment of review standards, improve approval efficiency, improve market access and evaluation of clinical value and other aspects of clinical accessibility system construction In this regard, "Pharmaceutical Economics" interviewed some authoritative experts for this advice Guest: Zhou Jianping (Professor of Chinese Pharmaceutical Sciences University) Yang Yue (Professor of Shenyang Pharmaceutical University) Chen Yu (Professor of Neurology, Xuanwu Hospital, Beijing) Qu Hengyan (Director of clinical research at the Fifth Medical Center of the PLA General Hospital) Li Hexin (President of Global Research and Development of Green Leaf Pharmaceutical Group) Improved new drugs is a strategic fulcrum Reporter: What is the significance of encouraging the development of high-end formulations to promote the steps of China's pharmaceutical industry? Yang Yue Yang Yue, a professor at Shenyang Pharmaceutical University, said: China's leap into pharmaceutical power has to foster more and more new drugs with independent intellectual property rights to support it The cultivation of these new drugs not only means that the original new drug improvement new drug is equally important and more in line with the current development of China's pharmaceutical industry Improved innovation is a successful experience of the Japanese pharmaceutical industry Japanese regulators are encouraging companies to develop new, improved drugs and give longer market-only incentives to encourage companies to be fully mobilized, but this encouragement is not blind but only more clinical value can be encouraged Domestic enterprises that can really do a kind of original innovation are rarely improved to the listed products to make it more clinically valuable will be the main battleground of future drug innovation Reporter: What are the innovative advantages of high-end preparations? Chen Wei, Professor of Neurology, Xuanwu Hospital, Beijing: The new formulation focuses on solving the unmet needs of the clinic China's drug research and development is still in the "catch-up" stage through the preparation innovation can break through the monopoly of primary research and this innovative model can effectively improve drug efficacy, reduce toxic side effects or improve patient compliance To some extent, improved new drugs have an advantage over those already on the market and even offer some leading opportunities Such as the new dosage form can bring drugs into the blood-brain barrier and cells and other special functions of microspheres, nanoparticles, etc are new directions Simplifying the approval process focus on institutional innovation Journalist: How can guidelines for improved new drugs be developed at the review and approval process to improve efficiency? Qu Hengyan Qu Hengyan, Director of Clinical Research Department of the Fifth Medical Center of the PLA General Hospital: The review and approval of complex preparations also requires accumulated experience Clinically we find that we can not fully copy the european and American guidelines so that special points and key points in the design of the design to communicate with positive communication in a timely manner so that enterprise research and development will not take a lot of detours Improved new drugs can be done step by step if the previous data found problems and then additional tests if there are no relevant signs or no need to do the test simply do not have to do all It is recommended that a detailed analysis of the data obtained in the early stages in the medium term will provide a guiding value for follow-up studies and that the process will not slow down but will accelerate Chen Wei: The complexity of preparation improvement is not to change the treatment mechanism and effect of the drug but mainly to change the pharmacokinetics of the drug, so to do more stringent phase I and II clinical trials this can observe the side effects of pharmacokinetic changes in clinical treatment and to understand the proscosine changes in clinical treatment, but then do large sample multi-center phase III clinical efficacy to prove that the significance may not be as good as the side effects can be required after the market to pay attention to long-term toxicity so the recommendation of complex approval of three clinical recommendations Green Leaf Pharmaceutical Group Global Research and Development President Li Xin Li Xin: the technical requirements of new drugs with complex preparations to comply with international standards that are safe, effective and controllable quality at the same time to consider clinical drug use in accordance with the actual situation of China's drug use to encourage domestic enterprises to carry out research and development Now the domestic complex preparation manufacturers not many microsphere products domestic only listed for more than three or four decades without the listing of new products this situation needs to be improved The United States does not specifically describe its clinical advantages as long as it fully demonstrates its efficacy, safety and quality We hope that the review policy will be clearer in the future so that enterprise innovation can be purposeful in research and reporting Reporter: From this point of view, how can improved new drugs optimize clinical trials? Yang Yue: The order of international drug market listing is roughly: "original improved imitation" trilogy and the domestic because of the long-term development of generic drugs in the past on the definition of improvement and imitation is not clear, so the review did not establish the listing order also did not evaluate the three types of products clinical value of the order This kind of evaluation system of review approval and clinical value integration is a relatively lacking link in China Europe and the United States first in the listing review to establish different paths and listing information requirements are closely related to the establishment of a regulatory science of complex preparations to promote the improvement and imitation of complex preparations For the progressive, step-by-step evaluation of complex generics, i.e based on pharmacological consistency, bioequivalence and clinical treatment equivalent gradual evaluation of ideas prior to the end of the study based on the difference sourcing with the reference formulation to determine the next step of the study this evaluation will save a lot of costs some clinical studies may be exempted At the same time, the development of many models, simulation and other regulatory science tools, methods instead of complex preparations of clinical research requirements to reduce the cost of research to promote the lack of competition of complex preparations imitation High-end complex formulations are therefore encouraged to improve existing review paths and review criteria to develop many models or innovative evaluation methods based on different formulations to establish a scientific and complete evaluation system for formulation innovation Innovation should be full of flowers to enter the party recognition is very important Reporter: from the market access aspect show should encourage the innovation of preparations to improve the public clinical drug access? Yang Yue: There was a time when the core purpose of the generic and improved generics of innovative drugs and the improvement of the blindly modified dosage form was not clinical value but the clinical value orientation since the annual drug review and approval reform can be obtained in the bidding and procurement of drugs The new Drug Registration Management Measures place special emphasis on clinical value-oriented innovation My understanding is that the clinical value of improved new drugs is reflected in two unmet clinical treatment needs or an advantage over previous therapies, which are closely related to accelerated review paths such as priority review Now the question is whether the evaluation of clinical value in the review is consistent with the evaluation of the value of the product follow-up into the health insurance catalog? This involves predictability, stability and continuity of research and development incentives The clinical value of improved new drugs and complex genericdrugs is not only reflected in the comparison of efficacy, but also in the aspect of safety and compliance advantage For example, a retardant need to eat three times a day now become a single-time-a-week high price but good efficacy of patients compliance better this is not the embodiment of clinical value? Only consistency in the review evaluation system and access evaluation criteria can continue to encourage innovation in innovative and generic generics of new drugs for complex formulations to improve clinical accessibility and how to integrate these two points in the future is critical Li: From the perspective of access to encourage Chinese enterprises to independently develop complex preparations for the improvement of new drugs the most important point is that the pricing policy should be tilted Complex preparations reflect good clinical advantages such as yew alcohol lipids using lipids and targeted drug-giving techniques to successfully improve the clinical defects of the original drug to improve its clinical safety and reduce adverse reactions through improved better clinical needs to meet the life cycle of the product The clinical advantages of these modified new drugs are even better than the pricing of new drugs should give them corresponding advantages but the pricing of improved new drugs has not been paid enough attention Second, pharmaceutical innovation is often government-led innovation, so the relevant departments of the understanding is very important Innovation should be down-to-earth rather than blindly pursuing "new" Innovation is not an end but a means If innovation in treatment can bring benefits to patients, it is necessary to advocate and encourage There are two aspects to the recognition of innovation: first, the innovation recognized in the review stage and the second is that the innovation recognized by the health insurance link can only promote the healthy development of the new improved drug if the recognition of both is in place at the same time Zhou Jianping, a professor at China Pharmaceutical University, said: This requires complementary policies I think there is a need to give more policy support to complex preparations for the hierarchical management of complex preparations Objectively speaking, the current policy does not take into account the social and clinical value of high-end formulations and the value of the development of the pharmaceutical industry High-end preparations from patents to review and approval to pricing, health insurance, collection and other market access policies need to be coordinated at the top of design policies (Rereproduced from Medical Economics)
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