Source: eMedClub

The global cell therapy industry has entered a period of rapid development, and domestic favorable factors continue to appear.

The "Shanghai Action Plan to Promote Cell therapy Technological Innovation and Industrial Development (2022-2024)" (hereinafter referred to as the "Action Plan") was issued. It is clearly proposed that by 2024, Shanghai's cell therapy technology innovation source capacity will be significantly enhanced, clinical research and transformation application will be significantly accelerated, innovative resource elements will be efficiently allocated, industrial energy level will be greatly improved, and the industrial scale will reach 10 billion yuan. The gathering of innovative talents, the emergence of various scientific research institutions, clinical research and service platforms, and the gathering of leading scientific and technological enterprises have built a cell therapy innovation source and a new industrial plateau with prominent scientific and technological support and deep integration of innovation chains and industrial chains.

The introduction of this policy not only points out the direction for the development of the cell therapy industry in Shanghai, but also undoubtedly has great promotion and demonstration significance for the development of the domestic cell industry.

In fact, from the first cell therapy products approved for listing in China to the establishment and expansion of the Zhangjiang cell therapy industry, the Shanghai cell therapy industry has been developing for many years. The release of this policy has once again become a catalyst for the accelerated development of cell therapy industrialization in Shanghai.

Cell therapy has been intensively introduced

Cell therapy is a new medical method, which is to retransplant the living cells with specific functions into the patient through bioengineering, so as to achieve tissue or organ repair.

Cell therapy has many advantages over other medical treatments. Take CAR-T therapy, a typical example of cell therapy, which tends to have a prominent therapeutic effect on cancer. Car-t therapy uses gene therapy on human T cells to make them join chimeric antigen receptors (CAR), and the immune cells are "armed" to resist the invasion of tumor cells. Unlike traditional cancer treatment methods, cancer patients only need to receive one-time CAR-T treatment to achieve long-term cure, or even permanent cure.

In 2017, the cell therapy was first commercially validated. That year, the U.S. Food and Drug Administration (FDA) approved Kymriah developed by Novartis and Yescarta developed by Kite, so that the global cell therapy entered a period of rapid development.

In the field of cell therapy, the gap between China and the world is not large, and it is accelerating to catch up: in 2017, the first two CAR T treatment products in China came from Zhang Jiang's Fosun Kate and Ming Junuo, and were approved for listing; In 2019, Zhangjiang Cell Industrial Park landed and continued to expand, with a total planning area of 1,000 mu, attracting more than dozens of head companies in CAR-T and stem cell therapy.

The action plan for promoting cell therapy technological innovation and industrial development issued by Shanghai this time has put forward the industrial plan for building a "one core and multiple points" cell therapy industry characteristic cluster area and building a world-class cell therapy industry cluster.

Specifically, relying on Pudong Zhangjiang Cell and Gene Therapy Industrial Park, the core area of cell therapy technological innovation and industrial development will be built; Relying on Pudong Waigaoqiao Free Trade No. 1 Life Science and Technology Industrial Park, to build a cell therapy life and health industry demonstration; Relying on Life Blue Bay, a new area in Lingang, to build an internationally competitive cell therapy research and development manufacturing site; Relying on Jinshan Bay Bay Biomedical Port, to create a first-class commercial production site for cell therapy products in China; Promote the coordinated development of Jiading Nanxiang, Baoshan North Shanghai, Xuhuiguan Port, Minhang Pujiang, Fengxian Meigu and other cell therapy industry bases to build a world-class cell therapy industry cluster.

At the same time, the policy will increase support, and the cell therapy products registered in the city, obtained the listing license and transformed in the city will be given a maximum of 30 million yuan of financial support. Support cell therapy-related enterprises to purchase biomedical product liability insurance, and give 50% financial subsidies to eligible main premiums.

In this regard, Xiao Xinyi, senior investment manager of the investment department of Hiwang Capital, believes that this policy release is a major positive for the cell therapy circuit. "The announcement of this policy will have an important positive impact on cell therapy product innovation, regulatory review, and industrial chain development," she said.

First of all, cell therapy companies will pay more attention to product innovation, and more innovative cell therapy products will be accelerated to market. The promulgation of this policy shows that the country attaches great importance to cell therapy, and more funds and resources will be invested in this field in the future, and the innovation capacity of China's cell therapy products will be further enhanced.

Secondly, the regulatory review system for cell therapy will be further improved to accelerate the commercialization of cell therapy. "Compared with foreign countries, there is a lot of room for efforts in clinical supervision, product declaration and medical ethics of cell therapy in China," Xiao said. "This policy also shows that regulators are making continuous efforts to create a good institutional environment for cell therapy companies."

Finally, the upstream industry of cell therapy will receive more attention, and more upstream star companies with core technologies will be born in the future. "The upstream of the cell therapy industry chain is just as serious as the midstream medical research and development," Xiao said. "This policy shows that the government will strongly support the development of the upstream of the cell therapy industry chain, and will pay more attention to the research and development of core technologies and related talent introduction in the future."

17 cell therapy companies in Shanghai received more than 2 billion yuan in financing

According to public information, in 2022, a total of 17 Shanghai cell therapy companies have received more than 2 billion yuan of financing. This financing situation is still in the "capital winter" of the present, no doubt more valuable, which also confirms the capital market's concern and optimism for the Shanghai cell therapy industry from the side.

From the above financing data, in addition to strategic financing, these 11 financing are in the early angel round and round A stage, and there are only 4 series B and C rounds. It can be seen that the cell therapy industry in Shanghai is an emerging field, still in the early stage, and has great potential for development in the future.

From the perspective of financing area, 11 of the 17 enterprises are located in Pudong New Area, of which 9 are located in Zhangjiang High-tech Park. It can be seen from this that Zhangjiang has the advantages of agglomeration of cell and therapy industry, and it will become the leading location of cell therapy industry in Shanghai and even the whole country.

From the subdivision track, the majority of companies focus on immune cell therapy, including Juncel Biology focusing on TIL treatment research and development of solid tumors, Enkesai drug focusing on NK treatment, and Yuankai Biology with a number of CAR T drugs under research. In addition, some companies are focusing on stem cell treatments such as Probiotics and Cylivita.

From the financing amount, 8 of the 18 financing events exceeded 100 million yuan. For example, Yuanqi Biology received $120 million in Series B financing, led by Quan Chuang Capital, Qiming Venture Capital and Jianone Capital. Yuanqi Biology is the first company to develop CAR-T products for solid tumors such as liver cancer and ovarian cancer, and related products are in the middle and late clinical stage. In addition, it has taken the lead in laying out the TIL field, solving a number of bottlenecks, and has several TIL pipelines under development.

Another highly favored capital enterprise is Binoji Biology, founded at the end of last year, this year it received two rounds of angel round financing, each round of financing is more than 100 million yuan, investors are equally bright, including Wuxi Apptec, Hillhouse Capital and so on. Binoji Biology was founded by Academician Dong Chen, focusing on the field of T cells, is committed to developing a series of T cell therapy programs such as CAR-T, TIL and Treg. At present, the first product BEN101 has entered the stage of research and development and pharmacology and toxicology trials, and has started clinical preparation work.

In addition to the above two enterprises, Bangyao Biology, which has products in the research and development or clinical stage in stem cells and immune cells, has obtained more than 200 million yuan of B round financing from Shanghai Free Trade Zone Fund and Tasly Capital. Xingyi Ang Biotechnology, which focuses on the development of general-purpose mass-produced immune cell products based on IPSC-derived CAR-NK technology, has received $50 million in Series A financing from investors including Chende Capital, Yahui Investment, IDG Capital and others.

Sum up

In general, cell therapy belongs to the "high-precision" high-tech track, the maturity and development of the industry needs the support of high-level talents, investment institutions and government support, only multi-directional joint efforts can usher in the rapid development and efficient upgrading of the industry. In addition, in recent years, in addition to the field of medicine, some Internet giants have begun to show interest in the field of life sciences, whether Bytedance founder Zhang Yiming, or Meituan founder Wang Xing, have begun to study life sciences related knowledge, famous investor Shen Nanpeng has also begun to focus on this field, especially in the intersection of AI and life sciences. Investors see where the future of technology is headed.