Cell Therapy Gains Momentum as Major Pharma Companies Accelerate Strategic Layouts

　　【Pharmaceutical Network: Market Analysis】Recently, GenScript Biotech announced that its non-wholly owned subsidiary, Legend Biotech Corporation ("Legend Biotech"), will jointly invest with Janssen Pharmaceutical NV (Janssen) to establish a manufacturing facility in Belgium ("Belgium Manufacturing Facility") to expand global production capacity for innovative cell therapies. It is understood that Legend Biotech and Janssen Biotech, Inc. had previously entered into a collaboration and license agreement to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel). Cilta-cel is an investigational CAR-T cell therapy for the treatment of patients with relapsed and refractory multiple myeloma.
 

Coincidentally, on June 17, Kite, a Gilead Sciences company, and Shoreline Biosciences also announced a strategic partnership to develop novel cell therapies spanning multiple hematologic malignancy targets. Specifically, according to the terms of the agreement, this collaboration will combine Shoreline’s deep expertise in induced pluripotent stem cell (iPSC) differentiation and genetic reprogramming with Kite’s extensive capabilities in cell therapy development, commercialization, and manufacturing to jointly develop a series of innovative allogeneic candidate therapies for the treatment of hematologic malignancies.
 

It is understood that cell and gene therapy refers to the process of transferring specific genetic material into a patient's target cells, modulating individual gene expression or repairing abnormal genes through methods such as gene addition, gene correction, and gene silencing, with the ultimate aim of curing diseases. In cancer treatment, cell and gene therapy is widely recognized by the industry as holding significant potential. In fact, in addition to the aforementioned companies, many enterprises have also been increasing their investments and strategic deployments in the cell therapy sector in recent years.
 

According to incomplete statistics, as of April 16, 2021, there were 2,073 investigational cell therapy drugs in the global pipeline, an increase of 572 compared to the 2020 update. This represents a 38% growth over the past year, whereas the growth from 2019 to 2020 was 48%. Among different types of cell therapies, CAR-T cell therapies continue to maintain a leading position, with 299 new drugs added to the pipeline, representing a 35% increase compared to 2020.
 

In light of the above, seizing the commanding heights of biotechnology and the bioindustry has become a major strategy for countries to enhance their competitiveness and secure the initiative in development. As a pivotal sector in the new wave of biotechnological transformation, the cell industry has also been designated as a priority direction for focused support. In China, a series of policies have been successively introduced in recent years to advance research in the field of cell therapy and foster the healthy and orderly development of related clinical industries. For instance, the *13th Five-Year Plan for the Development of National Strategic Emerging Industries*, the *13th Five-Year Plan for the Development of the Bioindustry*, the *13th Five-Year Special Plan for Scientific and Technological Innovation in Health and Healthcare*, and the *Action Outline for Promoting High-Quality Development of the Health Industry (2019–2022)* all explicitly emphasize the need to strengthen research on key technologies such as stem cell and immune cell therapies.
 

Currently, under policy guidance, China's cell therapy industry is developing steadily. Notably, the domestic marketing application for Fosun Kite's CD19-targeting CAR-T product, axicabtagene ciloleucel injection, is currently under regulatory review and is expected to receive approval from the NMPA in the near future. Upon launch, it is poised to become the first CAR-T cell therapy marketed in China. It is understood that axicabtagene ciloleucel injection corresponds to Yescarta, a CD19-targeting autologous CAR-T cell therapy product licensed to Fosun Kite from Kite Pharma, a subsidiary of Gilead. In February 2020, Fosun Kite submitted a marketing authorization application in China for axicabtagene ciloleucel injection for the treatment of adult relapsed or refractory large B-cell lymphoma, and it was granted priority review by the CDE in March 2020.
 

Overall, the cell therapy industry in China has entered a steady "acceleration track," with promising prospects. In this regard, industry insiders believe that whoever establishes a first-mover advantage will likely secure a commanding position in market competition. However, it is worth noting that this also signals increasingly fierce competition among enterprises in the future cell therapy market.