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@#In order to comprehensivehy evaluate the stage of China in the global drug innovation, to further optimize the environment for drug innovation in China, and to unleash the vitality of drug innovation, this article mainly analyzes through comparison China''s situation of drug innovation in global competition from such perspectives as the current situation of the global drug R&D innovation market, R&D investment, product pipeline, policy support, and development trends, combined with the characteristics of China''s drug innovation development.It can be seen that China''s pharmaceutical innovation is faced with such practical problems as lagging behind some developed countries in terms of innovation development, companies bunching into research and development innovation, sudden research and development rush, and excessive dependence on capital markets for pharmaceutical innovation.Accordingly, this paper puts forward suggestions on continuously improving China''s new drug innovation environment, rationally selecting differentiated competition and new tracks, reasonably formulating drug innovation development strategies, guiding capital to return to innovative research and development, and constructing a "double cycle" strategy for drug innovation.
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Pharmacological activity and drug likeness depend in principle upon the microscopic structure and macroscopic properties of drugs, which reside in their molecular structures. By means of medicinal chemistry the evolution of an active compound to a novel drug (NME) essentially makes the two pillars coexistence in one chemical structure, which either could merge as an intrinsic structure or connect from external fragments to each other with covalent bonds. Since the new millennium the advance in biology provides several knowledge and technologies, for example humanized monoclonal antibody, proteasome-ubiquitin system, allosteric modulation, natural macromolecules, structural biology, etc., for innovation of novel medicines. Taking several examples on marketed drugs or drug candidates in clinical trials, this article tries to concisely illustrate R & D conception of biology-driven drug design.
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On August 9, 2015, the State Council promulgated the "Opinions of the State Council on the reform of drug and medical device review and approval system" (Guofa 2015 No. 44), and established the "clinical value-oriented drug innovation" model to encourage the research and development of new drugs. Following that, China Food and Drug Administration (CFDA) promulgated the "Notice on several policies for drug registration review and approval" (2015 No. 230 ) on November 11, 2015, clearly specifying that CFDA would "implement one-time approval for clinical trials application of the new drugs, and no longer take a phased declaration, review and approval system; for the new drugs that apply for clinical trials, mainly review the scientific natureof the clinical protocols and the risk control of the new drugs to guarantee the safety of subjects". Accordingly, the evaluation ideas and forms of new drug registration have also been adjusted greatly. For example, issues like the rationality of the drug manufacturing process, whether the scale can reflect the stability of the process, whether the preparation process is sufficient, and whether the choice of dosage form is reasonable are no longer the focus of evaluation before clinical trials. Issues regarding whether the preparation process design is reasonable, whether the effective components can be transferred to the preparation to a maximum extent, whether the process parameters determined in small and middle pilot trials can adapt to the requirements of mass production, no longer act as the reasons for refusing the clinical trials. The corresponding risks shall be borne by the applicant as the subject of liability. The focus in registration evaluation is mainly transferred to how to ensure the consistence of quality between clinical trial samples and the samples already available on market by guaranteeing stable sources of drug raw materials and stable quality of medicines as well as control of the whole preparation process. These issues run through the whole process of new drug development, but also have different focuses in different stages. According to the "Measures on communicating about drug research and development and technical review" (2016 No. 94) (On Trial) issued by CFDA on June 2, 2016, the applicants may communicate with the drug evaluation center in different phases in the process of new drugs registration in respects of medicine material problems, technological problems, and quality control of the preparations. In this paper, the transformation of Chinese medicine research model was described mainly in the following aspects: how to control the quality of medicines from origins, technology design of the preparation and technology process research, and how to establish whole-process quality system. The paper also reflects the concept that the quality of new Chinese drugs research and development comes from design.
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Caenorhabditis elegans (C.elegans), has developed into an useful model for biomedical research, particularly in the targets of novel drugs and the related mechanism.C.elegans, combining with cost-effective cultivation, simple biological structure, make for high-throughput screenings in vivo model.In this review, we explore the feasibility of C.elegans in drug activity evaluation of complex systems.Because of the body independence of C.elegans, it provided good platform for the efficacy and mechanism of research on new drugs as well as Chinese herbal extract in vivo, showing a good prospect.
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Druggability is crucial in pharmaceutical drug development as the source of drug research. Druggability research will face greater challenges because Chinese materia medica (CMM) is the multicomponent drug. In this paper, ideas and methods of study on CMM druggability were mainly proposed in combination with the chemical material basis of muticomponents of CMM.