Pudong New Area
Typical Cases of Reform and Innovation [14]
Recently, HUTCHMED (China) Co., Ltd. (HUTCHMED) in Pudong has once again reported good news: its partner Takeda has received approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan to produce and sell FRUZAQLA. (fruquintinib) is indicated for the treatment of patients with previously treated metastatic colorectal cancer. This means that fruquintinib has been successfully approved in Japan, making it the first Chinese original innovative drug approved in Shanghai's three major global mainstream markets, Europe, the United States and Japan.
Fruquintinib is also the first innovative drug in Shanghai to benefit from the marketing authorization holder system.
Break the high threshold and accelerate the industrialization of innovative drugs
Before the implementation of the Marketing Authorization Holder (MAH) system, domestic innovative pharmaceutical companies had a high threshold that was difficult to cross, and there was a "bundling system" between marketing authorization and production license: due to problems such as production and factory construction costs, as the main body of research and development of pharmaceutical scientific and technological achievements, R&D institutions and scientific researchers lost the final market rights and interests of technological achievements due to the inability to obtain the approval number, and often could only choose to transfer the technology to the manufacturer.
At the same time, the R&D transferor and the transferee cannot achieve a "win-win" situation: the transfer cost of clinical approval documents or new drug certificates is far from making up for the loss of market rights and interests due to technology transfer, and the enthusiasm for continuous research and development of new drugs is not high; The transferee company only obtains the final product, but cannot fully grasp the professional and technical information in the process of drug development, and it is difficult to re-innovate the transferred technology.
In 2016, the Shanghai Pilot Free Trade Zone piloted the Drug Marketing Authorization Holder System (MAH System) commonly used in developed pharmaceutical countries and regions such as Europe and the United States, which adopts the management model of separating drug marketing authorization and production authorization, allowing drug marketing authorization holders to produce drugs on their own or entrust other manufacturers to produce drugs. The main difference between it and the previous management system is that R&D institutions and researchers are allowed to hold a drug approval number, become a drug marketing authorization holder, and take full responsibility for the safety, effectiveness and quality controllability of the drug.
On September 30, 2022, Hua Medicine, an innovative pharmaceutical company in Pudong, received marketing approval from the National Medical Products Administration of China (NMPA), making it the first GKA drug approved for marketing in the world, and has achieved nationwide prescription drug sales. It took more than 10 years for Huatangning to go from original research to the public, and in the process, the implementation of the pilot of the Drug Marketing Authorization Holder System (MAH) directly accelerated the launch of this new drug. Also enjoying this policy are China's first self-developed tumor immunotherapy drug PD-1 monoclonal antibody - toripalimab injection of Shanghai Junshi Biomedical Technology Co., Ltd.
Breaking the high threshold, the industrialization and commercialization schedule of a number of Pudong "innovative drugs" are all in advance in "years".
The vitality of market competition and ecological optimization has further burst out
MAH is a system in line with the world, which inhibits the low-level redundant construction of pharmaceutical enterprises from the source, improves the enthusiasm of new drug research and development, and also brings a broad space for the development of commissioned production, fully demonstrating the reform effect of the Shanghai Pilot Free Trade Zone.
At the Boehringer Ingelheim Biopharmaceutical Base in Zhangjiang, Pudong, the first innovative biologics in China to be marketed under a contract manufacturing model, tislelizumab from BeiGene (Shanghai) Biotechnology Co., Ltd. was born. Boehringer Ingelheim Biopharma (China) Co., Ltd. is the contractor and the first provider of biopharmaceutical contract manufacturing solutions in China. With the help of Boehringer Ingelheim's biopharmaceutical base, biopharmaceutical innovators will be able to better commercialize their products and maximize their value, and the participation of multinational Boehringer Ingelheim will also fill in a key piece of the puzzle for the closed loop of China's biopharmaceutical industry chain.
After the implementation of the holder system, drug R&D institutions and scientific researchers can establish their own enterprises to produce drugs, or they can entrust enterprises to produce drugs, which can avoid the low-level duplication of "large and complete" and "small and complete" enterprises. At the same time, it also greatly mobilizes the enthusiasm of R&D institutions and scientific researchers to devote themselves to drug R&D and innovation, which is conducive to enhancing the international innovation and competitiveness of the mainland pharmaceutical industry. After the full implementation of the holder system, the pace of concentration and innovation agglomeration of the pharmaceutical industry will be further accelerated, and the vitality of market competition and ecological optimization will also be further burst out.
The bottom line of innovation is "safety". After the pilot, the holder is responsible for the whole life cycle of drug quality, and this clear and strict responsibility system also effectively strengthens the full implementation of the holder's management responsibility "from the laboratory to the hospital", and the holder will not only pay attention to the research and development of the drug, but also pay attention to the production, warehousing, transportation, sales and many other links of the drug, so as to effectively protect the health rights and interests of consumers.
There is no optimal soil for innovation, only better. The system innovation of the free trade zone takes the initiative to break through the barriers of the previous science and technology industry links, and stimulates the surging power of scientific and technological innovation.
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