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    Home > Medical News > Latest Medical News > Billions of market changes! CRO or fully contracted "Pharmaceutical Preparation Innovation" business

    Billions of market changes! CRO or fully contracted "Pharmaceutical Preparation Innovation" business

    • Last Update: 2020-06-26
    • Source: Internet
    • Author: User
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    Guide: Small and medium-sized enterprises are unable to develop innovative drugs, CRO foundry "preparation innovation" a good way outthe progress of the times, medical development, people's demand for pharmaceutical preparations is also getting higher and higher, as the domestic pharmaceutical industry' first pillar industry, the research level of new formulations is also constantly improving, the market share of innovative preparations has also recently increased greatlycompared with traditional dosage forms, the pursuit of greater clinical advantages is the primary purpose, so improving drug compliance, improve drug efficacy, reduce drug side effects, fill the drug gap and prevent drug abuse is the main demand of preparation innovation, but also to judge the enterprise preparation innovation ability of the important standardspecific content, from the previous examples can be seen:preparation technology innovation (e.gtargeted development, antibody coating stent, sodium bicarbonate instead of intestinal-soluble coating), etc.);innovation in reducing the number of oral administrations (sodium ibsumite treatment of osteoporosis oral tablets in menopausal women 1 time a month);the programme of administration (contraceptive options for oral contraceptives)packaging innovations (e.gmomisone powder with DuPont Innovative Packaging Award-winning containers and white protein infusions with plastic bag filling)data from: Huang ShengyanApplication of pharmaceutical accessories in the development of innovative pharmaceutical preparationsShanghai Pharmaceutical Industry Research Institute1997, (04)Over the past decade, the average annual compound growth rate of new global formulations has reached more than 10%, ahead of the average growth level of the pharmaceutical industryAt present, the utilization rate of new formulations in China is less than 5%, far below the global average, and the prospects for the development of the industry are broad With the upgrading of pharmaceutical consumption, the use of new formulations is an inevitable trend, China's new formulation market will show explosive development according to incomplete statistics, the market size of China's pharmaceutical preparations industry in 2019 will be about 1.21 trillion yuan, an increase of 8.04 percent over 2018 and a faster growth rate in the industry With the obvious trend of aging population, the improvement of living standards, the strengthening of health awareness, the continuous improvement of the social security system and the continuous development of pharmaceutical science and technology, the human demand for pharmaceutical preparations will continue to increase, the market size of pharmaceutical preparations industry will continue to grow and the two important factors that determine the development of the formulation industry as a whole are mainly driven by technology and capital Large multinational pharmaceutical companies, with their strong capital and strong research and development, can continue to "define" the innovation of preparations, so as to achieve the goal of expanding the market, to obtain near monopoly profits Domestic enterprises suffer from it, but there is no way to return, after all, the gap between capital and research and development strength is still huge, how to compete and the current domestic "imitation drug" era has gradually withdrawn, in order to improve market competitiveness, many enterprises have gradually increased investment in new drug research and development, and gradually to the new drug innovation model conversion to the market with independent intellectual property rights of new drugs Preparation innovation has undoubtedly become an important direction for many small and medium-sized enterprises to compete for market share and enhance the competitiveness of the industry under the difficult circumstances of this era, in recent years a large number of CRO enterprises began to help pharmaceutical companies to carry out innovative research and development of preparations, and in today's drug preparation development process, low-solubility of drugs more and more widespread, nearly 70% of new drug candidate compounds are insoluble drugs In terms of development difficulties, the increasing, and the major CRO enterprises have to be innovative in the formulation of the show drug Mingkang drug MingKang, as a leading enterprise in the CRO industry, is bound to expect to meet the needs of customers in many aspects, and strive for all aspects Drug research and development services are also a one-stop service from pre-prescription research, preparation development, supporting analytical support and production of clinical trial preparations, and drug registration services (commonly known as "one-stop service"), which helps customers quickly and easily move NCE from the preclinical research phase to the NDA declaration stage, which fully includes the preparation development process since the completion of the integration of the preparation development services business in 2019, the company has achieved remarkable results in the integrated service strategy of the whole industry chain of CMC, and the revenue of the preparation development business has also grown rapidly During the signing of 52 service projects, and through the eCTD way, for many domestic and foreign partners successfully fdaIND declaration, FDA license, access to clinical research December 2019, pharmaceutical Mingkang started construction of Wuxi Heye Pharmaceutical Synderg Pharmaceutical synth development services and preparation production phase 1 project In addition to commercial production services, the future Wuxi site will also provide prescription drug development for solid and sterile preparations, as well as clinical drug production services , as the main small molecule CMO business carrier of pharmaceutical Mingkang, the performance growth is stable In recent years, the growth rate of performance has basically remained above 20%, with a cadra -growth rate of 26.26% over five years For the whole of 2017, total pharmaceutical revenue was RMB2,189 million, up 24.12% YoY At present MAH is a large number of pilot, covering the preparation business CMO company will first get MAH policy dividends, the first phase of the project to introduce international advanced solid preparation production, packaging line, has been put into production and for the global customers to provide new drug preparation services also according to the financing plan announced by Pharmaceutical Mingkang in the previous period, it is proposed to issue no more than 75 million shares of shares to no more than 35 specific investors in The A-shares, raising a total amount of not more than 6.528 billion yuan, the fund-raising purposes include the use of new drug preparations for Wuxi Andi Pharmaceuticals development services and preparation production of the first phase of the project and the global research and development center and supporting projects of the whole pharmaceutical industry It can be imagined that the drug Mingkant on the "preparation development" of the degree of attention must have increased, the author guessed that "nothing but the benefits." source: Wuxi hesy pharmaceutical industry official website source: Wuxi hesy pharmaceutical official website Medixi Medixi is rare in China, can provide from the pilot compound screening, optimization, api preparation, preparation process development, pharmacological research to pre-clinical pharmacokinetics and drug safety evaluation and a series of services integrated CRO has more than a dozen different types of preparation process research and quality research commonly used equipment and instruments, but also has the development of slow-controlled release agents, nano-preparations, fat emulsions and other new technologies research and development capabilities Research and development team personnel have a strong professional level and rich experience in preparation process research, analysis, to ensure that the standard, high quality, efficient completion of preparation prescription process research, quality research, and establish the corresponding process control indicators, and ultimately achieve the industrial production of products in the preparation of new technology services, the characteristics are distinct single-layer or double-layer slow-controlled release tablet preparation development - using skeleton and coating technology
    slow release or delayed release micro-pills filled capsules - the use of slow-controlled release of small pills, particles, small pieces into hollow capsules to achieve slow release microsphere preparation technology - the drug dissolved or dispersed in polymer materials, and then the solvent evaporation method to form a diameter of 1-25 m skeleton-type micro-spherical entity, with slow release microsacint preparation technology - the use of natural or synthetic polymer materials to wrap the drug into a drug bank-type structure, the use of a carrier with slow release performance to make the cystic material to achieve the slow release of the drug liposome technology--using thin-film dispersion method, inverting evaporation method and other methods, the drug is enveloped in the follicle seofiized by the lipid double molecular layer to form a preparation more importantly, Medixi claims to have airflow crushing and grinding technology to make micro-powder, nano-suspension or micron mixing after granulation, spray drying solid dispersion, hot melt extrusion technology, liquid capsule filling technology five technologies to fully support the development of preparations is also unique in preparation development services: preparations department has a professional solution innovative drug technology platform and professional high-end formulation technology platform, focusing on insoluble drugs and high-end preparation research and development services solvethe the solubility and permeability of drugs through special technologies, improve the success rate of drug development, shorten the research and development time, and promote compounds to become truly valuable new drugs Has established and perfected solid dispersion (e.g hot melt extrusion, etc.), micro-powdering, dissolving, enzymatic, in vitro dissolving /in vivo PK comprehensive evaluation and other technical platforms not only has an excellent performance in the development and research of traditional dosage forms, but also establishes a technical platform for high-end preparations such as inhalation administration, eye administration, transdermal administration, slow-controlled release of drugs, and new particle system sedatives established a sound oral solid GMP workshop, GMP analysis laboratory, a sound QA system has experienced research and development team, and a wealth of innovative drugs, consistency evaluation, improved new drugs successful research and development experience, China and the United States double reporting experience, project management experience one-stop preparation research and development services, including full formulation research (research and development and clinical sample production), safety evaluation, packaging compatibility, membrane verification, packaging sealing, pre-BE and BE research of course, a single A-share CRO listed enterprises, there are currently 14 as many, statistics of the national CRO enterprises are no less than 1000, the enterprise's numerous CRO industry is not only the above two involved in "preparation innovation", most CRO enterprises are involved, the above example is only to point the CRO industry on the "preparation innovation" of the powerful driving force, only this summary in general, at present, a large number of domestic preparation innovation from the traditional preparation enterprises to professional CRO enterprise situated, and the main return benefits are not very prominent oral slow-control release preparation era will also fade coincides with May 14, 2020, the State Drug Administration (later known as NMPA) website published "on the implementation of chemical injection generic drug quality and efficacy consistency evaluation of the announcement", marking the injection consistency evaluation work officially landed the future preparation innovation market will be the injection improvement and drug-giving approach to improve the main, after all, the four preparation innovation direction in the preparation of technological innovation mainly consider cost reduction, packaging innovation mainly consider marketing, the remaining two as the core competitiveness of enterprises may have more advantages
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