CAR-T Products: Global Market and Latest Sales Performance

As of now, there are 10 CAR-T products that have been approved and launched globally, with 6 of them approved by the FDA. The FDA-approved CAR-T products include Kymriah by Novartis, Yescarta and Tecartus by Gilead/Kite, Breyanzi by BMS, Abecma by Celgene, and Carvykti by Legend Biotech.

In addition to the FDA-approved products, there are 4 CAR-T products that have been approved in China. These include the recently approved Naxitamab injection, as well as Aklimaris injection by Fosun Kite, Rucaparib by Pharmaron, and Igiloi injection developed and commercialized by Xinda Biopharm and Reindeer Biotech. Aklimaris and Rucaparib are indicated for lymphoma, while Igiloi is used to treat relapsed or refractory multiple myeloma (R/RMM) in adult patients who have received at least 3 lines of treatment (including a proteasome inhibitor and an immunomodulatory agent). Igiloi was just approved and launched in June this year.

The CAR-T products that have been approved and launched in the market have generally commanded high prices. The domestically available Aklimaris injection is priced at 1.2 million yuan per dose, Rucaparib injection is priced at 1.29 million yuan per dose, and Igiloi injection is priced at 1.166 million yuan per dose.

The prices of CAR-T products in foreign markets are even higher, often two to three times the price of domestic products, ranging from 2.5 million to 3 million yuan. The highest-priced CAR-T product currently is Novartis' Kymriah, priced at 3.264 million yuan per dose, while the lowest-priced products are Yescarta and Tecartus by Kite Pharma, both priced at 2.563 million yuan per dose.

Despite the high prices, a large body of clinical data has demonstrated the feasibility of CAR-T cell therapy. Since their introduction to the market, CAR-T products have seen a consistent increase in overall sales. Recently, major pharmaceutical companies have released their Q3 2023 financial reports, which also included the performance of some CAR-T therapies in the first half of the year. As expected, most CAR-T products continue to be favored by patients.

Gilead has excelled in the CAR-T drug field, with two CD19-targeted CAR-T products (Yescarta and Tecartus) performing well in terms of sales. Yescarta achieved the highest sales performance, reaching $739 million in H1 2023 (+46%), and continued to show strong growth in Q3 2023 with sales of $391 million (+23%). Tecartus achieved global sales of $177 million in H1 2023 (+30%), and $96 million in Q3 2023 (+18%), meeting expectations.

Similarly, Bristol Myers Squibb (BMS), with its CD19-targeted Breyanzi and BCMA-targeted Abecma CAR-T products, has shown outstanding performance in this field. The combined revenue of these two CAR-T products in H1 2023 was $450 million. Breyanzi demonstrated rapid growth, with sales of $171 million in H1 2023 (+106%) and $92 million in Q3 2023 (+109%). Abecma achieved sales of $279 million in H1 2023 (+78.8%) and $93 million in Q3 2023 (-14%), experiencing a slight decline.

According to Johnson & Johnson's financial report, Carvykti, a BCMA CAR-T therapy developed in collaboration with Legend Biotech, has also achieved impressive sales performance. Carvykti was only approved for market entry in the US in February 2022, relatively late compared to other FDA-approved CAR-T products. However, its sales in H1 2023 reached $189 million, surpassing the full-year sales of $134 million in 2022. In Q3 2023 alone, Carvykti generated sales of $152 million. With rapid growth in quarterly sales, Carvykti is expected to exceed $500 million in sales this year and reach the billion-dollar mark next year, aligning with Johnson & Johnson's previous sales expectations for the drug in the first 1-2 years after market entry.

In contrast to Gilead, Johnson & Johnson, and BMS, Novartis appears to be facing some challenges in the CAR-T market. According to Novartis' H1 2023 financial report, Kymriah's sales in the first half of the year were $260 million, a 10% decline compared to the previous year. In 2022, Kymriah achieved sales of $536 million, also down by 9% compared to theprevious year. In Q3 2023, Kymriah's sales were $139 million, showing a slight improvement compared to the previous quarters. Novartis has been working to address the challenges faced by Kymriah, including optimizing manufacturing processes and expanding the product's label to target additional indications.

In summary, CAR-T products have made significant strides in the global market, with several products demonstrating strong sales performance. Gilead's Yescarta and Tecartus, BMS's Breyanzi and Abecma, and Johnson & Johnson's Carvykti have all shown positive growth and market acceptance. Novartis's Kymriah, while facing some challenges, continues to be an important player in the CAR-T field. As the market evolves and more clinical data becomes available, it is expected that CAR-T therapies will continue to play a critical role in the treatment of various cancers.