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    Home > Medical News > Medical World News > Complex preparations are an opportunity for innovation in Chinese medicine.

    Complex preparations are an opportunity for innovation in Chinese medicine.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    With the continuous optimization of the innovative environment, the common pursuit of appropriate drug treatment has become the focus of heated discussion from all walks of life.
    July 18-19, by the Beijing Pharmaceutical Society, "Clinical Drug Treatment Journal" sponsored by the third clinical drug treatment conference as the theme, the National Committee of the Chinese People's Political Consultative Conference, the deputy director of the National Committee of the Chinese Academy of Medicine, The Chinese Pharmaceutical Society President Sun Xianze, the Academy of Military Science and Technology, Chinese Academy of Engineering Chen Wei, the National Health and Care Commission, the Director of the Institutional Reform Liang Wannian, Deputy Director of the Beijing Municipal Drug Administration, Liang Hong, president of the Beijing Pharmaceutical Society, Zhang Wei, former secretary-general of the National Pharmacopoeia, pharmaceutical expert, Professor Li Dakui of Beijing Concord Hospital, Researcher Jin Shaohong of the Chinese Academy of Inspections and the President of major hospitals in Beijing attended the conference and conducted high-end academic exchanges with representatives of the national clinical pharmacy researchers, research institutes and pharmaceutical industry through online and offline.
    was held at the same time as the Sub-Forum on "New Advances in Drugs - Promoting Clinical Accessibility of Complex Preparations" sponsored by the Alliance for Excellence in Development Technology in the Industry of g?
    time, CDE is publicly soliciting opinions on the development of the Technical Guidelines for Clinical Trials of Chemical-Improved New Drugs, and the development and clinical application of complex formulations have naturally become the focus of discussion at this conference.
    it is understood that the forum also launched a complex formulation of clinical accessibility research topics.
    clinical advantages are obvious, the development is difficult 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 at the same time, whether it is improved new drugs or generic drugs, there are technical difficulties.
    " the development of complex formulations is not only a technical issue, but also a matter of whether the availability of these drugs can be reliable.
    " Li Dakui is an analysis of the importance of complex preparation research and development and approval of listing.
    noted 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 lying unmet.
    China's complex preparations are heavily dependent on imports, which is the root cause of the state's encouragement of the development of complex preparations, including improved new drugs and generic drugs.
    it is understood that by the high technical barriers, patent protection, key accessories and equipment constraints and other factors, even europe and the United States and Japan and other countries approved complex preparations generic drugs are very limited.
    although China has very few complex preparations on the market, such as bright pro-polyrin microsphere, poly-phonosis liposomes, but faced with the problem of consistent evaluation of generic drugs.
    " solutions to the clinical accessibility of complex preparations are fundamental in encouraging and accelerating the research and development and marketing of domestic preparations.
    two paths can be considered in the future: one is a new, improved drug, and the other is a generic drug.
    because the imitation of complex preparations is very difficult, it is recommended to give priority to encourage the development of improved new drugs, to allow complex formulations of improved new drugs to achieve biological equivalent or non-poor efficacy with the original drug can be approved for market, increase drug selection, meet clinical drug accessibility.
    " Zhang Wei called.
    more than a breakthrough, innovative research and development force to encourage enterprises capable of doing 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 and
    li said in a special report.
    special injections such as liposomes and microspheres are the evergreen trees of the global pharmaceutical industry, and the market effect is not less than NCE new drugs due to their unique clinical advantages.
    the development of such products should be improved new drugs as a breakthrough, find the right differentiated market positioning, carry out international registration and clinical, Green Leaf Pharmaceuticals 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 are based on the principle of case-by-case, and do not impose clinical advantages, at the same time, because different product stakes vary, enterprises should take the initiative to communicate with the drug regulatory departments to clarify the relevant technical requirements.
    Zhou Jianping pointed out that" transdermal paste is another creative therapy, it has many advantages, such as long-term release of drugs to avoid oral drug concentration caused by the peak and valley phenomenon, to avoid the liver's first over effect, adverse reactions can be interrupted at any time to administer the drug."
    but the current lack of transdermal paste related technical guidelines, the relevant requirements are gradually standardized.
    " meeting, inhalation agents also become a direction to explore.
    " this is a high-end formulation of the combination of drugs, inhalation preparations local drug administration has become the preferred treatment for chronic respiratory diseases.
    such as the first inhalation of the antibiotic-type drug tubmycin inhalation solution, it solves the needs of bronchodilatal patients.
    " Jin Fang believes that the development of complex preparations test research and development capabilities.
    high-end interview: Optimizing innovative ecology to promote better service clinical lying of new drugs On the afternoon of July 18, in the sub-forum on "New Progress in Medicines - Promoting Clinical Access of Complex Preparations", the experts generally reflected that the development of new drugs with improved complex formulations should be promoted in the form of clinical accessibility systems from the establishment of review standards, improve approval efficiency, improve market access and evaluation of clinical value.
    in this regard, "Pharmaceutical Economics" interviewed some authoritative experts for this advice.
    guests: Zhou Jianping (Professor of Chinese Pharmaceutical Sciences University) Yang Yue (Professor of Shenyang Pharmaceutical University) Chen Wei (Professor of Neurology, Xuanwu Hospital, Beijing) Qu Hengyan (Director of clinical research room of the Fifth Medical Center of the PLA General Hospital) Li Hexin (President of Global Research and Development of Green Leaf Pharmaceutical Group) Is a strategic fulcrum reporter: What is the significance of encouraging the development of high-end formulations to promote the leap of China's pharmaceutical industry? Yang Yue Yangyue, a professor at Shenyang Pharmaceutical University, said: China's leap into a pharmaceutical power will have to be supported by the cultivation of more and more new drugs with independent intellectual property rights.
    and cultivate these new drugs not only refers to the original new drugs, improved new drugs are equally important, but also more in line with China's current pharmaceutical industry development.
    -improved innovation is a successful experience of the Japanese pharmaceutical industry.
    Japanese regulators encourage companies to develop new and improved drugs and give longer market-specific incentives, corporate enthusiasm is fully mobilized, but this encouragement is not blind, but only more clinical value can be encouraged, which is a good path.
    domestic really can do a kind of original innovation of the enterprise very few, the product improvement has been listed to make its clinical value higher will be the main battleground of future drug innovation.
    Reporter: What are the innovative advantages of high-end preparations? Chen Qi, 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 the efficacy of drugs, reduce toxic side effects or improve patient compliance.
    somewhat, new, improved drugs have an advantage over those already on the market, and may even offer some leading opportunities.
    such as new dosage forms can bring drugs into the blood-brain barrier and cells and other special functions, microspheres, nanoparticles, etc. are new directions.
    simplify the approval process focus on institutional innovation reporter: At present, CDE is developing guidelines for improved new drugs, how can the review and approval process improve efficiency? Qu Hengyan, Director of Phase 1 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 follow the european and American guidelines, so in the design of the design, special points and key points to communicate with CDE 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 is no relevant signs or no need to do the test need not do it all.
    recommended a detailed analysis of the data obtained in the medium term, which would be instructive for follow-up studies, and that the process would not slow down but accelerate.
    Chen Wei: The complexity of preparation improvement is not to change the drug's treatment mechanism and effect, but mainly to change the pharmacokinetics of the drug, so to do more stringent phase I and II clinical trials, which can not only observe the possible side effects of dosage changes, but also to understand the pharmacokineticchange changes in clinical treatment, but do large samples of multi-center clinical efficacy may not be significant, as to the side effects after the market requires four phases to pay attention to long-term toxicity.
    Green Leaf Pharmaceutical Group's global research and development president Li Xin Li Xin: the technical requirements of new drugs with complex preparations to improve the model to comply with international standards, that is, safety, effectiveness and quality control, at the same time, according to the actual situation of China's drug use, to consider the clinical drug access, to encourage domestic enterprises to carry out research and development.
    now the domestic complex preparationmanufacturers are not many, micro-ball products only listed in the country three or four, more than a decade has not been listed new products, this situation needs to be improved.
    the United States does not describe clinical advantages as long as its efficacy, safety and quality are fully demonstrated in its filing.
    We hope that the review policy will be clearer in the future so that business innovation can be conducted with purposeful research and reporting.
    Reporter: From this point of view, how should the new modified drug optimize clinical trial program? Yang Yue: The order of international drug market is roughly: "original -improvement-imitation" trilogy, and the domestic because of the long-term development of generic drugs, the past definition of improvement and imitation is not clear, so did not establish the listing order in the review, nor evaluated 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.
    European and American countries first establish different paths in the listing review, which is closely related to the requirements of listing information, and at the same time explore the establishment of regulatory science of complex preparations to promote the improvement and imitation of complex preparations.
    for complex generics, the use of progressive, step-by-step evaluation ideas, that is, according to pharmacological consistency, biological equivalence and clinical treatment equivalent gradual evaluation ideas, the end of the previous stage of research, according to the differences with the reference formulation brought about by the risk and uncertainty, to determine the next step of what research, this evaluation will save a lot of costs, some clinical studies may be exempted. At the same time, the
    , the development of many models, simulation and other regulatory science tools, methods to replace the requirements of complex preparations of clinical research, thereby reducing research costs, promote the lack of competition for the imitation of complex preparations.
    therefore, high-end complex formulations are encouraged to improve existing review paths and review criteria, develop many models or innovative evaluation methods based on different formulations, and establish a scientific and complete evaluation system for formulation innovation.
    innovation should be in full bloom, access to recognition is very important reporters: from the market access aspects of how to encourage innovation of preparations, improve the public clinical drug use is available? Yang Yue: There was a time when generics and improvements of innovative drugs were blind, the core purpose of the modified dosage form was not clinical value, but in order to obtain separate pricing in the bidding and procurement of drugs, since the 2015 drug review and approval reform, clinical value orientation is very obvious.
    the new Drug Registration Management Measures place special emphasis on clinical value-oriented innovation.
    my understanding is that for new modified drugs, clinical value is reflected in two aspects, the unmet clinical treatment needs or the advantages of previous treatments, and this clinical value is closely related to the accelerated review path such as priority review.
    the question now is, is the evaluation of clinical value in the review consistent with the evaluation of the value of the product's 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 generics is not only reflected in the comparison of efficacy, but also in the aspect of safety and compliance.
    for example, a retardant needs to eat three times a day, now become once a week, a single high price but good efficacy, patient compliance is better, this is not the embodiment of clinical value? Only when the review and evaluation system and the access evaluation criteria are consistent can we continue to encourage innovation and generic copyof of new drugs with improved complex formulations, improve clinical accessibility, and how to integrate these two points in the future is crucial.
    Li Hexin: From the perspective of access, the most important point of encouraging Chinese enterprises to independently develop new drugs with improved complex formulations is that the pricing policy should be tilted.
    complex formulations reflect good clinical advantages, such as the use of liposomes and targeted drug-giving technology, the clinical defects of the original drug to be successfully improved, in the premise of maintaining the specific efficacy of yew alcohol, improve its clinical safety, reduce adverse reactions, through improvement to better meet clinical needs, but also extend the life cycle of the product.
    these improved new drugs in the clinical advantages even better than new drugs, in the pricing should also give them the corresponding advantages, but at present, the pricing of improved new drugs has not been enough attention.
    second, pharmaceutical innovation is often government-led innovation, so the awareness of relevant departments is very important.
    innovation should be down to earth, not blindly pursue "new".
    innovation is not an end, but a means.
    if innovation in treatment can bring benefits to patients, it is important to promote and encourage.
    recognition of innovation has two aspects: first, the review stage of the recognition of innovation, and second, the health insurance sector recognized innovation, only the recognition of both can promote the healthy development of improved new drugs. Zhou Jianping, a professor at China Pharmaceutical University,
    : This requires complementary policies.
    I feel the need to give more policy support to complex preparations and to manage complex preparations in a hierarchical manner. objectively,
    , the current policy does not take into account the social and clinical value of high-end formulations and the value of the pharmaceutical industry.
    high-end preparations from patents to review and approval, to pricing, health insurance, collection and other market access policies need top-level design, policies should be coordinated.
    (reproduced from The Medical Economics)
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