Unveiling the Pricing of China's Fifth Domestic CAR-T Therapy: Can Annual Sales Reach 1 Billion?

In a recent announcement, the fifth domestically developed CAR-T therapy in China, known as Zevokeolunsei injection (marketed as Saikai Ze), revealed its initial price of 1.15 million yuan per vial. Furthermore, the company anticipates that the peak annual sales of this cell therapy product, developed by CARsgen, could exceed 1 billion yuan. This approval by the National Medical Products Administration marks a significant milestone for CARsgen, a company that debuted on the Hong Kong Stock Exchange in 2021. However, despite positive market prospects, the company has faced scrutiny from investors. This article delves into the details of the pricing announcement and explores the potential for achieving substantial sales figures.

The Journey of CARsgen:

CARsgen, founded in 2014, became the 32nd unprofitable company to list on the Hong Kong Stock Exchange through the 18A channel. The company raised approximately $400 million with an initial public offering price of HK$32.80 per share. Despite the positive news of its important product's market approval, CARsgen' stock price has remained relatively stagnant at around HK$6 per share. This lackluster response from the capital market has drawn criticism from some investors.

Development and Clinical Trials:

Like many CAR-T companies, CARsgen' technology originated from clinical practices in hospitals. The founder, Li Zonghai, hails from Quanzhou, Fujian Province, and previously worked at Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, where he also served as a doctoral supervisor. The collaboration between CARsgen and the Interventional Oncology Department of Renji Hospital began in May 2015, focusing on conducting clinical trials for advanced hepatocellular carcinoma (HCC).

Regulatory Approval and Clinical Progress:

The CAR-T therapy product, Zevokeolunsei injection, received Phase I clinical trial approval on January 15, 2024. Initially, the trial was limited to treating GPC3-positive stage IIIa liver cancer patients at risk of recurrence after surgical resection. The product is a fully human anti-CT053BCMA CAR-T cell therapy. It is worth noting that the company selected several medical institutions, including Beijing Chaoyang Hospital affiliated with Capital Medical University, the First Affiliated Hospital of Soochow University, Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Tianjin Medical University General Hospital, the First Affiliated Hospital of Zhejiang University, the First Affiliated Hospital of Wenzhou Medical University, and Peking University Third Hospital, to conduct its domestic registration clinical trials. Unfortunately, the foreign registration clinical trial was recently suspended by the FDA.

CAR-T Pricing Landscape:

Zevokeolunsei injection is the fifth CAR-T cell therapy product to be approved for marketing in China. The previously approved CAR-T products by the National Medical Products Administration include Akilunsei injection, Ruijiolunsei injection, Yijiolunsei injection, and Najiolunsei injection, all of which target hematologic malignancies. Among these therapies, Zevokeolunsei injection and Yijiolunsei injection share the same indications. The prices of these five CAR-T therapies range from over 1 million yuan, with Najiolunsei injection from He Yuan Bio-Pharmaceutical being priced at 999,000 yuan per vial. Other companies such as Fosun Kite, WuXi AppTec, and Xunliu Bio/Trust Bio have priced their respective CAR-T products at 1.2 million yuan per vial, 1.29 million yuan per vial, and 1.166 million yuan per vial. Currently, over 10 CAR-T therapies have been approved globally.

Sales Performance and Future Outlook:

Taking into account the sales performance of CAR-T therapies in 2023, Yescarta by Gilead Sciences generated sales of $1.5 billion, a 24% increase compared to the previous year. Yescarta became the only CAR-T therapy to surpass the billion-dollar sales mark, driven by strong demand for the treatment of relapsed or refractory large B-cell lymphoma in the second and third lines of therapy. Kymriah, the first globally approved CAR-T therapy by Novartis, with its hefty price tag of $475,000 per vial, reported sales of $508 million in 2023, experiencing a decline for the second consecutive year. Legend Biotech's CAR-T therapy achieved sales of $500 million in 2023, reflecting a remarkable 273% year-on-year growth. However, it is important to note that Legend Biotech's CAR-T therapy has not yet received market approval in China. The performance of CARsgen in replicating its sales achievements domestically remains to be seen.

The unveiling of the pricing for China's fifth domestically developed CART therapy, Zevokeolunsei injection, has sparked anticipation in the market. Priced at 1.15 million yuan per vial, CARsgen aims to achieve annual sales exceeding 1 billion yuan. Despite facing scrutiny from investors, the company's journey from clinical origins to stock market listing has been significant. The approval of Zevokeolunsei injection marks a milestone for CARsgen. However, the company's stock price has remained relatively stagnant. The product's Phase I clinical trial approval and selection of medical institutions for registration trials demonstrate progress in its development. Comparatively, other CAR-T therapies in China have achieved varying sales figures, with Yescarta leading the pack. The future sales performance of Zevokeolunsei injection and its potential in the domestic market remain to be seen.