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Medicinal glass bottles will enhance the industry to upgrade the standard

Font Size: [Big][Mid][Small] 2017/4/12    Views: 966    
"In the past for a long time, multinational pharmaceutical companies have been in the introduction of research and development projects (in-licensing), until recently began to some projects for external licensing (out-licensing)." January 17, Merck is responsible for the global JasonLu, Director of Business Development at Project Licensing and Asset Management, said at the 2nd Asia Conference on Clinical Trials Outsourcing in Shanghai that 52 of the R & D projects implemented in Merck in 2011 were 52 projects that were licensed for development and co-development Externally approved items.
External permission gets hot
According to JasonLu, Merck's external licensing team is based on the company's $ 41.1 billion acquisition of Schering-Plow in 2009, which resulted in a coincidence of the company's many assets and the need to redefine the development of their priorities The
And the current external licensing team is a department dedicated to evaluating all prioritized projects in Merck, assessing which projects will enter the external licensing pool and look for possible external collaborations for these relatively inactive projects in the global R & D community partner.
In fact, Roche, Pfizer, GlaxoSmithKline, Sanofi, Bristol-Myers Squibb and other pharmaceutical giants are in a similar cooperative R & D model.
"In general, a large pharmaceutical company to carry out new drug research and development projects may have hundreds, due to R & D funding is limited, the local registration and lack of market experience, the enterprise is difficult to make all the items go hand in hand." China Foreign Investment Enterprise Association drug development And the Development Industry Committee (RDPAC) media director Zuo Yugeng told this reporter, "So, the original research and pharmaceutical enterprises will be part of the project to implement the external licensing cooperative R & D model, and partners to jointly bear the risk of R & D to improve research and development efficiency.
The original research drug Nuggets
"The introduction of international cooperation has become one of the main strategies for the new R & D projects in Syngenta Pharmaceuticals," said Wang Peng, chief scientist of the Emerging Pharmaceutical Company. "The introduction of" Let us increase the quality of R & D projects, through international cooperation to enhance their research and development capabilities.
China has a wealth of clinical research resources, coupled with R & D personnel and clinical trial cost is relatively low, the original research and pharmaceutical enterprises and domestic pharmaceutical R & D enterprises to accelerate product development process, and to promote China's domestic clinical trials.
It is understood that Hengrui, precursor and other local pharmaceutical enterprises of new drug research and development projects have a number of foreign pharmaceutical companies from the external licensing projects, including intellectual property rights and development rights permit. As the original drug companies hope that partners in the field of drug repositioning and re-use of new ideas and ways to achieve their choice of partners will focus on their innovative research and development capabilities.
Among these licensing projects, the majority of Chinese companies are regional rights and interests, that is, in China's exclusive development and sales rights, such as the precursor and BMS joint research and development of cancer and cardiovascular disease in the field of drugs.
"There is no purchase of ingredients, the first through the early research and development to the clinical research work to obtain the interests of the Chinese market, from chemical production control (CMC) to clinical drug production and so on in accordance with American standards to do." Wang Peng said, In fact, after we have established our cooperation, about half of the world 's multinational companies have worked with us to explore similar cooperation, so I think this is the main model for future research and development of new drugs.
Of course, there are a small number of projects to obtain global rights, such as Shanghai Hua medicine to buy Roche's new drug development and distribution rights, Sansheng Pharmaceutical 6.25 million US dollars to buy Pegsiticase global management rights.
Under the license agreement, the original research company will usually receive pre-payment of technology transfer and clinical development, drug declaration and industrialization of the stage of the results of the money, that is often said that the "milestone" type of payment, and the introduction of the company jointly assume the risk of R & D. If the product is successfully listed, the original research company will also get the agreed sales share. "R & D of new drugs is not a one-man show, but a relay race, the need for all aspects of co-operation, the establishment of mutually beneficial cooperation symbiotic system is the development trend." Jiangsu Hengrui Co., Ltd. Chairman Sun floating in view.
In fact, the external licensing project is far from limited to drugs, JasonLu said that Merck has any patented protection of any inbound projects may enter the external licensing project library, which includes technology platform, research tools and materials, small molecules, biological macromolecules , Medical equipment and so on.
Local business opportunities
In the foreign original drug companies to the domestic pharmaceutical enterprises for external licensing at the same time, there are a few domestic innovative pharmaceutical companies will use the right to use the patent abroad.
Shenzhen micro-core Biotechnology Co., Ltd. President and chief scientific officer Lu Xianping in this conference revealed that the company's own research and development of new targeted anti-cancer drug Xindaben this month will be submitted to the State Food and Drug Administration to declare Application for new drug certificate.
According to the reporter to understand, 5 years ago, the micro-core biology has the international patent Xidaben patent granted to the United States HUYA biotechnology company. In the following years, microblogs co-developed with HUYA, microbiological organisms in China to start clinical trials, and HUYA in the United States and Europe.
Micro-core biological through the first of its innovative results of global intellectual property protection, and then in addition to the rights of China to foreign countries to the strength of foreign enterprises, foreign enterprises to do clinical development and marketing, domestic by their own follow-up development and industrialization The In this way, enterprise products will be able to enter the international market in the shortest possible time, and the industrialization process of global synchronization. In addition, through cooperation with local enterprises, can crack some policy barriers.
In addition to the early joint development of the project, the licensing project also has some more mature medical projects, such as Shanghai NovoMed Pharmaceutical (NovaMed) is specifically from Sanofi, Pfizer, Baxter and other companies to introduce mature products in China exclusive sales rights. Due to the business model has the potential, from 2006 to 2011 by the United States of America 赛 Health Pharmaceutical to 100 million US dollars acquisition, only a short period of 5 years.
But this adjustment will make the glass in the melting of the temperature greatly improved (than the original melting temperature to increase 60 ~ 100 ℃), in the traditional horseshoe flame furnace melting is extremely difficult, so Zhengchuan full electric melting furnace to solve Glass melting problem. In addition to the introduction of other metal oxides, glass to improve the characteristics of the viscosity of the temperature point for the bottle after the processing to achieve low temperature to create conditions. By adjusting the composition, the boron content in the glass is close to 8%, the expansion coefficient is between 62 ~ 65 (× 10 ~ 7 / ℃), and the glass method is less than 0.07.
Second, to enhance the processing capacity after the bottle. The specific approach is to control the following links: 1. Bottle speed reduced, the machine speed is too high required processing temperature is high, easy to cause a large number of glass B2O3, Na2O volatile, the volatiles in the bottle wall temperature lower condensation , After the bottle perfusion solution, the volatiles dissolved, and finally will lead to the inner surface of the glass bottle water failure; 2. After processing gas and oxygen pressure requirements are relatively stable, does not cause the bottle processing temperature fluctuations; The temperature can not be too high. "Glass bottle water level is generally in the HCB level, 2ml individual can reach HC1, but the test values are close to the standard value of the edge; adjusted glass inner surface water level all reach HC1, and the test value is relatively small, Tube and domestic neutral glass tube production of glass bottle test value is also small. "Fan Yong said.
Experiments show that the realization of medicinal glass double water 1, first of all to optimize the material of the glass, in the current national conditions, the use of ingredients to optimize the adjustment, the existing 7.0 low borosilicate medicinal glass performance appropriate to optimize Upgrading and processing of the bottle after the process of processing, is fully able to meet the requirements of medicinal glass double water level 1, and the cost will not increase too much, compared to 5.0 neutral glass in terms of packaging costs brought about by the packaging costs Not big. But we do not recommend the use of pickling or creaming, etc. to deal with HC1 level to reach the glass bottle. Because this treatment after the destruction of the glass surface of the physical structure, can easily lead to the use of glass bottles in the process of film. Source of Chinese medicine










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