On March 1st, CARSGEN-B (2171.HK) announced that Zevokeolunsei injection has been approved by the regulatory authority for listing.
As a CAR-T cell product targeting BCMA (B-cell maturation antigen), Zevokeolunsei injection is approved for the treatment of relapsed or refractory multiple myeloma (R/R MM) in adult patients who have progressed after at least third-line treatment (having used at least one proteasome inhibitor and immunomodulatory agent).
It is worth mentioning that this is the fifth CAR-T cell product to be listed domestically.
Prior to this, Fosun Kite's Axicabtagene Ciloleucel injection, JW THERAP-B's Rucaparib injection, Innovent BIO's Idecabtagene injection, and Hengyuan BIO's Nacabtagene injection have been successfully approved and listed in China.
In terms of target, this is the second CAR-T cell product targeting BCMA domestically, following Idecabtagene injection.
Meanwhile, both Zevokeolunsei injection and Idecabtagene injection target the indication of R/R MM.
Multiple myeloma is a refractory malignant plasma cell disease, accounting for about 10% of hematologic malignancies.
Frost and Sullivan predicts that by 2023, the number of multiple myeloma patients in China will be approximately 153,000, increasing to 266,300 by 2030.
Currently, CARSGEN-B has granted the exclusive commercialization rights of Zevokeolunsei injection in mainland China to Huadong Medicine (000963.SZ). In addition to paying an initial payment of 200 million yuan, Huadong Medicine will also pay up to a maximum of 1.025 billion yuan in registration and sales milestone payments.
However, the commercial success of Zevokeolunsei injection remains uncertain.
On one hand, the potential risks of CAR-T therapy are drawing attention from regulatory authorities.
In January 2024, the FDA requested that approved CAR-T cell therapy products add &#34;potential secondary T-cell lymphoma after treatment&#34; to the black box warning. Domestic regulatory authorities have also followed the FDA in issuing risk warnings for CAR-T products.
However, some studies suggest that the risk of developing a second cancer after CAR-T cell therapy is low. (Note: The black box warning is a warning sign required by the FDA for drug companies to state adverse reactions in the drug package insert)
Recently, researchers at the Perelman School of Medicine at the University of Pennsylvania reported in the journal Nature Medicine that after analyzing over 400 patients treated at the University of Pennsylvania Medical School, they found that any type of second cancer after CAR-T cell therapy is rare.
The Wall Street News · Visionary Team believes that although CAR-T therapy carries certain risks, ongoing research indicates that these risks have limited impact on patients. The approval of CARSGEN-B's ZEVOLOXIMAB injection marks the first CAR-T product approved since the black box warning, demonstrating that regulatory authorities still consider the benefits of CAR-T therapy for patients far outweigh the risks.
On the other hand, the high cost of CAR-T therapy remains a challenge. The selling prices of domestically available CAR-T cell products are mostly in the million-dollar range, limiting their accessibility and posing obstacles to commercialization.
CARSGEN-B is currently seeking to expand internationally with the ZEVOLOXIMAB injection, advancing Phase 1b/2 clinical trials in North America to evaluate its safety and efficacy in treating R/R MM.
Regardless, the milestone of ZEVOLOXIMAB injection's market approval holds significant importance for CARSGEN-B—it marks the first step towards commercializing their pipeline, shedding the &#34;zero revenue&#34; label.
With the promotional capabilities of Huadong Pharmaceuticals, the commercial success of ZEVOLOXIMAB injection remains highly anticipated, and the market is eagerly awaiting the outcome.
However, the market's expectations for CARSGEN-B are more focused on breakthroughs in solid tumors. Currently, CARSGEN-B's humanized Claudin18.2 CAR-T product &#34;CT041&#34; in the pipeline is primarily used to treat gastric and pancreatic cancers, and is currently in Phase II/III clinical trials. Image

The fifth domestic CAR-T therapy has arrived in China: CARSGEN-B approved for the treatment of multiple myeloma.