The last mile of the transformation of biomedical achievements has become a "bottleneck" for biomedical technology and industry. Shanghai Tianci International Pharmaceuticals Co., Ltd. has used an innovative equation - "A + W" achievement transformation platform to solve the difficulties in the transformation of technological achievements in the biomedical industry.
Why is it difficult to address the last mile?
Usually scientists or entrepreneurs will face the same problem after completing the development of a new drug technology, that is, how to achieve production and marketing. In the past, in order to achieve new drug production in our country, they must become a production-oriented enterprise, with land and GMP factories, and sales depend on professional marketing team with GSP qualification. Scientists and entrepreneurs devote most of their energy and financial resources to the research of new drugs. Faced with the follow-up problems of transformation of achievements, they often feel lost. The objective problems of funds, resources, experience and roles become invisible obstacles and limit the development of the whole industry.
At the same time, there are strict technical requirements for GMP pharmaceutical factories. The construction cost of each factory generally totals hundreds of millions of RMB. Some R&D units have only one technological achievement. For this purpose, they also need to build factories. Single factories often have excess capacity. Repeated construction leads to a lot of waste of funds, land resources and excess capacity. Moreover, it is difficult to register drugs and obtain financing. Many technology-based enterprises can hardly obtain approval from the National Medical Products Administration. Before the scientific and technological achievements are transformed into drug certificates, it has become more difficult for technology-based enterprises to gain funds.
Seek the Innovative Solution: Create an “A+W” Flexible, Open and Sharing Platform
Shanghai Tianci Bio Valley Biological Engineering Co., Ltd. and Shanghai International Group Venture Capital Co., Ltd. have jointly invested in the establishment of Shanghai Tianci International Pharmaceuticals Co., Ltd. under the "mixed ownership" economic model, breaking through the "barriers" on the last mile, innovating and creating an "A+W" achievement transformation platform, and advancing the transformation of scientific and technological achievements “meter by meter”.
Land resources are scarce in Shanghai. The newly established Tianci Pharmaceuticals adopts the innovative mode of "unified construction, divided operation, integrated resources, benefit sharing" to maximize the industrialization ability of Shanghai's land resources, so that as many technological achievements holders as possible can keep the industrialization of new pharmaceutical products in Shanghai while their long-term interests are guaranteed. In the face of financing difficulties, Tianci International will set up a biomedical industry fund to transform the supporting achievements and introduce personalized financial services; in view of the difficulties in approving documents, it will set up a special drug registration service to help entrants obtain production approval documents; in the case of difficult sales of products, it will provide all-round sales services, so as to truly guarantee production and marketing, and ease entrants...
In the "A + W" achievement transformation model, "A" refers to the industrialization of 42 high-end generic drugs and 4 class I new drugs developed by Tianci International through more than ten years of independent innovation; "W" stands for "We Pharma", which means making medicine together in Chinese. Tianci International takes its own R&D technology as the core foundation, integrates biomedical R&D, production and sales to form a whole industry chain platform, which is a "flexible, open and giving" sharing platform for the whole industry chain. From the perspective of technological innovation of biomedicine itself or the model innovation of platform "A + W", it is in line with the strategic goal of building Shanghai as a technological innovation center with global influence.
It is known that the total investment of the "A+W" achievement transformation platform project is 2.4 billion yuan, and the biomedical achievement transformation base in Pudong Kangqiao Industrial Zone covers a total area of 211 mu, with a total building area of about 270,000 square meters, a total of 20 factories and 80 GMP production lines.
Tianci International is committed to building a platform of industrial chain aggregation with global influence, so that more scientists from all over the world come to Shanghai to "make medicine together", and people can afford highly-efficient secure drugs. Through building the transformation base of biomedical achievements, it establishes the "A+W" innovation and sharing mode, promotes the integration of talents, technology, R&D, production, capital and information data, realizes the integration and agglomeration function of upstream and downstream of biomedical industry chain, forms scale effect, and promotes scientific and technological achievements to enter a fast and benign transformation channel, striving to break through the bottleneck of industry, stimulate innovation and entrepreneurship, and lead the return of advanced manufacturing and high-end real economy.
Land resources are scarce in Shanghai. The newly established Tianci Pharmaceuticals adopts the innovative mode of "unified construction, divided operation, integrated resources, benefit sharing" to maximize the industrialization ability of Shanghai's land resources, so that as many technological achievements holders as possible can keep the industrialization of new pharmaceutical products in Shanghai while their long-term interests are guaranteed. In the face of financing difficulties, Tianci International will set up a biomedical industry fund to transform the supporting achievements and introduce personalized financial services; in view of the difficulties in approving documents, it will set up a special drug registration service to help entrants oIt is reported that the platform will provide public welfare service for the whole society. In the platform of "A + W" achievements transformation, the achievements of scientific and technological innovation can be shared for a long time. As long as the project can pass the demonstration of the expert committee, the entrants can get up to 80% profit sharing. If the annual profit tax of products reaches more than 100 million yuan, Tianci International will transform its achievements free of charge.
Rely on Intelligent Manufacturing to Improve the Quality of Domestic Drugs
What Tianci needs to do is not only to solve the problem of scientists' drug production, but also to redefine the quality of drugs, reshape the “Pure Gold Standard” made in Shanghai, promote the overall upgrading of domestic drug quality through advanced manufacturing technology, build the benchmark of China's high-end advanced manufacturing, and establish a high-end pharmaceutical brand with quality and excellence. Since 2015, China Food and Drug Administration has implemented the "Quality Consistency Assessment of Generic Drugs" to ensure that the quality and efficacy of newly approved generic drugs are consistent with those of the original drugs.
At present, the focus of domestic enterprises on "consistency evaluation" is mainly on process research and clinical bioequivalence (BE). However, it is easy to overlook the issue of how to ensure that products continue to maintain high-quality production after research. After consistency evaluation, the new technology will still be produced on the old production line. Will this greatly discount the previous research results? To this end, Tianci's "A+W" platform has laid out the intelligent manufacturing system in a far-sighted way, realizing the automation and continuous production of each production process; and adopts online real-time detection, alarm and feedback processing of the working state of the equipment; online cleaning and sterilization technology, aseptic monitoring and sterile linking technology, product automatic detection and screening technology, traceable identification technology, etc. to realize the unmanned pharmaceutical production at most. The company will also establish industrial Ethernet and large terminal servers to manage the production process and final quality of products, and accept the supervision of China Food and Drug Administration, international certification (FDA of U.S.A., EDQM of EU, etc.) and domestic and foreign users. It really strives to strictly control the surrounding environment in the pharmaceutical process, and truly achieves aseptic production, finally coming out of high quality "secure drugs".btain production approval documents; in the case of difficult sales of products, it will provide all-round sales services, so as to truly guarantee production and marketing, and ease entrants...
In the "A + W" achievement transformation model, "A" refers to the industrialization of 42 high-end generic drugs and 4 class I new drugs developed by Tianci International through more than ten years of independent innovation; "W" stands for "We Pharma", which means making medicine together in Chinese. Tianci International takes its own R&D technology as the core foundation, integrates biomedical R&D, production and sales to form a whole industry chain platform, which is a "flexible, open and giving" sharing platform for the whole industry chain. From the perspective of technological innovation of biomedicine itself or the model innovation of platform "A + W", it is in line with the strategic goal of building Shanghai as a technological innovation center with global influence.
It is known that the total investment of the "A+W" achievement transformation platform project is 2.4 billion yuan, and the biomedical achievement transformation base in Pudong Kangqiao Industrial Zone covers a total area of 211 mu, with a total building area of about 270,000 square meters, a total of 20 factories and 80 GMP production lines.
Tianci International is committed to building a platform of industrial chain aggregation with global influence, so that more scientists from all over the world come to Shanghai to "make medicine together", and people can afford highly-efficient secure drugs. Through building the transformation base of biomedical achievements, it establishes the "A+W" innovation and sharing mode, promotes the integration of talents, technology, R&D, production, capital and information data, realizes the integration and agglomeration function of upstream and downstream of biomedical industry chain, forms scale effect, and promotes scientific and technological achievements to enter a fast and benign transformation channel, striving to break through the bottleneck of industry, stimulate innovation and entrepreneurship, and lead the return of advanced manufacturing and high-end real economy.
