Beijing News (reporter Wang Kara) On January 26, the National Development and Reform Commission and the Ministry of Commerce issued the "Opinions on Several Special Measures for Shenzhen to Build a Pioneering Demonstration Zone of Socialism with Chinese Characteristics to Relax Market Access" (hereinafter referred to as the "Opinions"), which mentioned that it supports the research and development of new medical products and technologies such as stem cell therapy, immunotherapy and gene therapy. At present, in the industry's hottest immune cell therapy, two CAR-T cell therapies have been approved in China, keeping pace with the world. The industry believes that as a pilot demonstration area, Shenzhen pilot supports the research and development of the above products, and the research and development process of domestic innovative therapy products is expected to accelerate in the future, break the monopoly through full competition in the market, and better meet the treatment needs of domestic patients.
Domestic cell therapy is developing rapidly
In fact, as early as 2020, Shenzhen has taken the lead in legislating for the development of the cell and gene industry. The Regulations on the Qianhai Shekou Pilot Free Trade Zone of the Shenzhen Special Economic Zone, which came into effect on October 1, 2020, stipulate that medical institutions and scientific research institutions in the free trade zone can carry out research and transformation application of stem cells, immune cells, gene therapy, monoclonal antibody drugs, tissue engineering and other new technologies in accordance with their own technical capabilities. The Planning and Budget Working Committee of the Standing Committee of the Shenzhen Municipal People's Congress also began to organize the drafting of the "Regulations on the Promotion of the Cell and Gene Industry in the Shenzhen Special Economic Zone (Draft)" in December 2020, and solicited public opinions in November 2021.
Among the innovative therapies with high attention in the pharmaceutical industry, CAR-T cell therapy in the field of immunotherapy has the highest attention. According to the data of Flint Creation Research Report, in the clinical trials of immune cell therapy, CAR-T cells are the mainstay, accounting for 89%, highlighting the rapid development of CAR-T cell immunotherapy in China in recent years, and clinical trials have shown a "blowout" state. The industry believes that there is a possibility of overtaking in curves in China.
As the hottest immune cell therapy at present, CAR-T cell therapy has five products approved for marketing worldwide. The earliest to be approved for listing was Novartis Kymriah, which was approved in August 2017. Two months later, Gilead's Kite company, Yescarta, was approved for marketing in the United States in October 2017, becoming the world's second approved CAR-T cell therapy.
China is keeping up with the world. Up to now, a total of two CAR-T cell therapies have been approved for listing in 2021, namely Agilensa (trade name "Yi Kaida") introduced by Fosun Kate, and Ricciola (trade name "Benoda") developed by WuXi Junuo on the basis of JCAR017 of Juno Company in the United States, which is also known in the industry as the "first year of commercialization of Chinese cell therapy". Frost & Sullivan Research Report predicts that the market size of China's cellular immunotherapy products will rise from 1.3 billion yuan in 2021 to 10.2 billion yuan in 2023, with a compound annual growth rate of 181.5%, and the market size is expected to reach 58.4 billion yuan in 2030.
The supervision of production, circulation and other links still needs to be improved
According to the statistics of the Beijing News reporter according to the Lilac Garden Insight database, there are 24 domestic companies layout CAR-T therapy, in addition to Fosun Kate and WuXi Junuo, there are legendary biological, Keji biological, reindeer medical, Sibiman biological, Xinda biological and so on. Legendary Biology, a subsidiary of Kingsway, is the first company in China to obtain CAR-T clinical trials, and its self-developed Sidaki ollensy has submitted a listing application in the United States in December 2020 for the treatment of patients with relapsed or refractory multiple myeloma. According to the Lilac Garden Insight database, on November 5, 2020, Cedar Chiolansa was included in the breakthrough therapeutic variety in China, and is currently progressing to Phase II clinical trials.
Flint creation data show that in cellular immunotherapy, in addition to CAR-T cell immunotherapy, there are dendritic cells, lymphocytes, multi-antigen autoimmune cells, RAK cells, the first three account for 3% respectively, RAK cells account for 2%. From the perspective of clinical progress, at present, 97% of immune cell therapy products are in the phase I and phase II clinical stages, of which 23 are in the phase I stage, accounting for 64%, and a total of 12 are in the phase II stage and the phase I + II stage joint development, accounting for 33%. In addition, only 1 product is in phase III.
In recent years, the National Health Commission, the State Food and Drug Administration and other departments have frequently issued guidance documents related to cellular immunotherapy, but the Flint Creation Research Report pointed out that the relevant documents currently issued do not cover the product life cycle in place, and the stability of policy documents is not high. For example, in terms of supervision, it is more focused on non-clinical research and clinical trial research, and has less involvement in commercial production, product circulation and post-marketing supervision. With the continuous advancement of technology, industry and industry, more products will enter the industrialization and commercialization links, and the relevant policies of cell therapy in the mainland will inevitably become more and more comprehensive and perfect in the future.
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