2023 Global CAR-T Therapy Sales Performance and Product Overview

Mar 07, 2024 08:08 CST Updated 08:08

Legend Biotech

Tumor Cell Immunotherapy Developer

Novartis

Drug Development and Manufacturing

Gilead Sciences

Antiviral Drug Developer

Bristol-Myers Squibb

Biopharmaceutical and Nutritional Product R&D and Sales

JW Therapeutics

Developer of Cellular Immunotherapy Products

IASO Biotechnology

Cancer Treatment New Drug Developer

Currently, nine CAR-T therapies have been approved for marketing worldwide. As major pharmaceutical companies have recently released their 2023 performance reports, the 2023 report cards for most CAR-T therapies have also been unveiled.

Novartis' Kymriah Continues Downward Trend

Kymriah, once basking in the glory of being the "world's first approved CAR-T therapy," is gradually losing its first-mover advantage. According to Novartis' 2023 performance report, Kymriah's sales for the year amounted to $508 million, a year-on-year decrease of 5%. This downward trend reappeared, as its 2022 sales performance was $536 million, a year-on-year decline of 9%. As the earliest marketed and most expensive ($475,000) CAR-T therapy currently available, Kymriah has become the only CAR-T product with declining revenue.

Regarding the first decline in performance in 2022, Novartis stated that new competitors are entering the diffuse large B-cell lymphoma (DLBCL) market. These competitors are able to launch products in earlier production line markets and also capture shares in later production lines. This new environment has directly impacted the sales of Kymriah.

Gilead's Yescarta Continues to Rise

Gilead's CAR-T Therapy Yescarta (Axicabtagene Ciloleucel) Shines in 2023 with Continued Growth: According to Gilead's earnings report, its sales performance for the year reached $1.5 billion, a 24% increase compared to $1.16 billion in 2022. This growth was primarily driven by strong demand for second- and third-line treatments of relapsed or refractory large B-cell lymphoma (R/R LBCL). Yescarta is also currently the only CAR-T therapy with sales exceeding $1 billion. Another CAR-T therapy from Gilead, Tecartus, also performed well in 2023, with total sales reaching $370 million.

In November 2023, the U.S. FDA announced an investigation into the serious risk of T-cell malignancies in patients following autologous CAR-T cell immunotherapy targeting BCMA or CD19, involving six marketed CAR-T products. At that time, regarding this investigation by the FDA, Gilead Sciences stated in a declaration that the company remains confident in the overall safety of Tecartus and Yescarta. These two therapies have treated 17,700 cancer patients to date, and so far, there is no evidence indicating a causal relationship between them and the development of new malignancies.

Legend Biotech's Carvykti Shines Brightly

Carvykti's performance in 2023 can be considered exemplary. Its sales from the first quarter to the fourth quarter of 2023 were $72 million, $117 million, $152 million, and $159 million, respectively, with a total sales revenue of $500 million. Compared to $134 million in 2022, this represents a year-over-year increase of approximately 273%.

Recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended expanding the indication of Carvykti to include adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy (including an immunomodulatory agent and a proteasome inhibitor), have experienced disease progression on their last line of therapy, and are lenalidomide-refractory. With this, Carvykti becomes the first CAR-T therapy to receive a positive opinion from the EMA’s CHMP for second-line treatment in patients with relapsed or refractory multiple myeloma. The CHMP's positive opinion will now be reviewed by the European Commission, which will make the final approval decision.

In China, the marketing application of Carvykti has been officially accepted by the National Medical Products Administration (NMPA) and included in the priority review and approval process.

BMS's Two CAR-T Therapies Show Strong Growth Momentum

Bristol-Myers Squibb's two CAR-T therapies, Abecma and Breyanzi, achieved total sales of approximately $836 million in 2023. Among them, Abecma generated $472 million, representing a year-over-year increase of 22%. Breyanzi delivered an even more impressive performance with total sales reaching $364 million, marking a 100% year-over-year growth. Previously, some industry insiders had expressed concerns that Breyanzi’s late market entry and intense competition from therapies targeting the same indications would make it difficult to boost its subsequent sales. However, Breyanzi ultimately overturned this pessimistic view with an outstanding sales performance.

The combined sales performance of the six CAR-T therapies in the first half of the year was $3.714 billion.

Performance of China-produced CAR-T therapies not disclosed

JW Therapeutics' CAR-T product, Relmacabtagene Autoleucel, has not yet disclosed its 2023 performance. According to its interim report, the sales revenue of Relmacabtagene Autoleucel reached 87.7 million yuan in the first half of 2023. As JW Therapeutics' first product, Bynoda has already been approved for two indications in China: for the treatment of adult patients with r/r large B-cell lymphoma (LBCL) after second-line or later systemic therapy, and for the treatment of patients with relapsed or refractory follicular lymphoma (r/r FL). In January this year, JW Therapeutics announced that the new indication marketing authorization application for Relmacabtagene Autoleucel for the treatment of patients with relapsed or refractory mantle cell lymphoma had been accepted by the National Medical Products Administration. In April last year, the clinical trial application for Relmacabtagene Autoleucel for the treatment of moderate to severe refractory systemic lupus erythematosus was also approved.

IASO Bio's BCMA-targeted CAR-T therapy, Equecabtagene Autoleucel, was approved by the National Medical Products Administration in June 2023, becoming the first approved BCMA-targeted CAR-T product in China. It is priced at 1.166 million yuan, with no sales performance disclosed yet.

Hoyuncell's Najiolumab was approved for marketing in November 2023 for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). It is the first CAR-T product approved in China for the treatment of acute lymphoblastic leukemia, priced at 999,000 yuan, making it the lowest-priced CAR-T product currently approved in China, breaking the million-yuan price barrier for CAR-T therapies.

Source: MedValley

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Text: Internet

Typesetting: Yao Mo