Complex preparations are opportunities for Chinese pharmaceutical innovation

With the continuous optimization of the innovative environment and the common pursuit of appropriate drug treatment has become the focus of discussion from all walks of lifeThe 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 calling Multi-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