At present, Shanghai Tianci International Pharmaceuticals Co., Ltd. signed cooperation agreements with Fosun Kite Biotechnology Co., Ltd. and Shanghai Green Valley Pharmaceutical Co., Ltd. respectively, which marked the official completion of industrialization of two major domestic innovative drugs in Zhangjiang Hi-Tech Park. According to this cooperation agreement, two original innovative drugs, Yescarta, a new drug of Fosun Kate, and sodium oligo-mannurarate capsules (GV971), developed by Green Valley Pharmaceutical, will be officially launched on the sharing pharmaceutical platform of Tianci International for production and come in the market fully. This cooperation also means that Tianci International, the first domestic sharing pharmaceutical platform, has officially put into operation.
In order to overcome these difficulties through the market-oriented innovation model, Tianci International has made innovations, broken the traditional barriers of interests, and created a sharing pharmaceutical platform that meets the needs of the new era. Under the guidance of the national drug Marketing Authorization Holder (MAH) policy, Tianci International has built a “Science & Innovation Dream Works” through many years of hardships, which will be put into production.
Located in the south of Zhangjiang Hi-Tech Park and covering 211 mu and a construction area of 280,000 square meters, Tianci “Science & Innovation Dream Works” has 20 standard workshops and can undertake 80 GMP production lines at most. As Zhangjiang is known as "China Pharmaceutical Valley", this base will strongly support Zhangjiang's biomedical innovation chain as a functional platform for the transformation of Zhangjiang's biomedical achievements. Tianci International integrates R&D, production and sales resources to form a "flexible, open and giving" sharing platform and address the last mile, namely the industrialization of innovative medicine. Yescarta and GV971 are the first contracted cooperation projects of Tianci International. In the future, more original innovative drugs will be manufactured in Science & Innovation Dream Works.
Li Hanpu, Chairman of Tianci International, said, "Science & Innovation Dream Works differs greatly from the traditional pharmaceutical factory in concept and mode. As we all know, new drugs are all found under the stages of drug discovery, preclinical research, clinical research, production, commercialization and so on; every new drug cannot be marketed without the support of pharmaceutical factories.
Traditional pharmaceutical factories are more insular, often only producing their own drugs without any social service and creativity, thus failing to innovate mostly. In view of these disadvantages, Tianci innovatively creates a world-class sharing pharmaceutical platform, which not only greatly improves the pharmaceutical productivity efficiency and remarkably reduces the overall cost of the industry, but also improves the transformation rate of innovative R&D results.”
In November 2015, China began to try out the Marketing Authorization Holder (MAH) system. After the pilot implementation, the separation of marketing license and production license makes new drug industrialization much easier and cheaper, and it has become a successful path for new drug R&D enterprises to achieve rapid approval of high-quality innovative drugs. As of November last year, the reporters find that Pudong New Area has accepted MAH pilot applications of 58 kinds submitted by 36 applicants. Among them, 31 class I innovative drugs have not been marketed at home and abroad, accounting for 97% of the city, most of which come from Zhangjiang.
In addition, in the field of "immunotherapy" in which global technology enterprises are competing, three of the top four companies in the field of CAR-T (chimeric antigen receptor T cell immunotherapy) are located in Zhangjiang, with 5 out of 7 domestic clinical trial batches.Yescarta, a new drug of Fosun Kate, is the CAR-T therapy and the leading treatment technology of malignant tumor in the world, which is expected to fill the domestic gap. But with so many new drugs coming out, how can Zhangjiang guarantee the production of original and innovative drugs when the production resources are very scarce? How can it transform "Zhangjiang R&D" into "Zhangjiang Intelligent Manufacturing"? How can it gradually develop the cost center of pharmaceutical R&D into the profit center of Chinese innovative enterprises?
Lou Qi, the general manager of Zhangjiang Biomedical Base Development Co., Ltd., said that sharing pharmaceutical platform is becoming a new trend and is expected to solve this bottleneck. The next step is to strategically introduce high-end capacity of contract development manufacture organization (CDMO) in the Hi-Tech Park. "Through high technology level, great supply scale and well-developed business model of CDMO, the platform will become the mainstream way for biotechnology companies to realize industrialization."
In addition, government departments are expected to focus on and support the sharing pharmaceutical platform, and comprehensively improve the service level and promote the professional capacity building of the entire industry. They aim to not only greatly reduce the financial pressure of R&D teams through Tianci sharing platform, but also utilize the professional ability of this platform to improve the quality management and cost control level, so as to make the “Zhangjiang medicine” brand and new drugs manufactured in Shanghai truly go global.