Another Domestic CAR-T Therapy Approved as Cell Therapy Sector Remains Hot

　　【Pharmaceutical Network Industry DynamicsIn recent years, the cell therapy track remains heated, and local innovative pharmaceutical companies continue to welcome the approval of CAR-T products. For instance, on November 8, 2023, according to information from the National Medical Products Administration (NMPA) website, the New Drug Application (NDA) for the CAR-T product Naciorlen Injection submitted by Juventas has been officially approved, becoming the first CAR-T product in China approved for marketing to treat acute lymphoblastic leukemia.
 

With the launch of Naciorl Injection, there are now four CAR-T products approved in China. In June 2021 and September 2021, Fosun Pharmaceutical's joint venture company Fosun Kite’s CAR-T product Axicabtagene Ciloleucel Injection and JW Therapeutics' CAR-T product Relmacabtagene Autoleucel Injection were successively launched, both indicated for lymphoma. In July 2023, Innovent Bio and IASO Bio jointly developed and commercialized CAR-T product Ebcartagene Autoleucel Injection, which was approved for marketing to treat adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
 

In addition to being approved for marketing, China-produced CAR-T therapies are also gradually expanding overseas. For instance, Legend Biotech's CAR-T product received news of going global on November 13, 2023. The company announced that it would enter into an exclusive global licensing agreement with Novartis for Legend Biotech’s specific DLL3-targeted chimeric antigen receptor T-cell (CAR-T) therapy, including its autologous CAR-T cell therapy candidate LB2102 (NCT05680922). Under the agreement, Legend Biotech will receive an upfront payment of $100 million and is eligible to obtain up to $1.01 billion in clinical, regulatory, and commercial milestone payments, as well as tiered royalties. This deal marks another major overseas transaction for Legend’s CAR-T therapy after its collaboration with Johnson & Johnson.
 

CAR-T cell therapy has demonstrated enormous clinical treatment potential. The pharmaceutical industry has long dreamed of conquering cancer, and cellular immunotherapy is widely recognized as a major breakthrough. Consequently, the CAR-T cell field has become one of the hottest areas in the biopharmaceutical industry, with China leading in the number of clinical studies. Data shows that there are currently over 25 CAR-T products under research in China, involving companies such as Legend Biotech, CARsgen Therapeutics, and Senlang Bio. In hematological tumors, target points are relatively concentrated, mainly focusing on CD19 and BCMA.
 

Some institutions have pointed out that CAR-T products, as high-end customized anticancer therapies with high costs and significant clinical benefits, still possess substantial market potential despite the short-term inability to pass healthcare economics evaluations. This is driven by cost optimization, commercial insurance, and local supplementary medical plans. For instance, after JW Therapeutics' Relmacabtagene Autoleucel Injection was launched in September 2021, its production costs were continuously reduced, while inclusion in commercial insurance and local supplementary medical plans gradually increased. This resulted in dual growth in orders and infusions in H1 2023, with revenue increasing by 32.93%.
 

Data predicts that from 2021 to 2025, the compound annual growth rate of China's CAR-T therapy market size (calculated at cost price) will be 151.0%, increasing from 2 billion yuan in 2021 to 8 billion yuan. With more CAR-T products being approved, the market size is expected to reach 28.9 billion yuan by 2030.
 

However, analysts also pointed out that despite the successive approvals of CAR-T products in China and their significant advantages, their commercialization still faces enormous challenges, mainly reflected in the "astronomical" treatment costs and limited production capacity. How to break through this situation has become a major challenge for many companies. Some individuals stated that in the future, if CAR-T companies can expand in terms of targets and indications, or possess breakthrough core technologies that improve efficacy, increase production capacity, and reduce costs, they will stand out in the competition within the CAR-T cell therapy market.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.