CAR-T cell therapy has finally crossed the threshold into treating solid tumors.

CARSGEN-B recently announced that its self-developed Claudin18.2-targeted autologous humanized CAR-T cell therapy product, Kailimei® (Surogeniolunse Injection, hereinafter referred to as "Kailimei"), has received New Drug Application approval from the National Medical Products Administration.

This product is indicated for the treatment of Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy.

This marks the world's first CAR-T cell therapy product approved for the treatment of a solid tumor, potentially unlocking significant commercial prospects for CARSGEN-B.

In recent years, CAR-T therapy has undergone initial commercial validation in the field of hematologic malignancies, but the patient base for blood cancers is limited, creating a relatively clear market ceiling.

The situation is different for solid tumors. Taking gastric cancer as an example, there are approximately 970,000 new cases and about 660,000 deaths globally each year. China accounts for roughly 47% of the global gastric cancer patient population, providing a substantial potential patient base for the future uptake of Kailimei.

The listed price for Kailimei has been set at 990,000 RMB per treatment course.

CARSGEN-B stated that this pricing takes into comprehensive consideration factors including the pricing of already-marketed CAR-T products, epidemiology, and payment capabilities. Concurrently, the company plans to leverage innovative payment methods such as commercial health insurance to improve patient access.

It is understood that CARSGEN-B anticipates Kailimei will reach its peak sales in approximately 4 to 5 years, with an estimated peak of around 2 billion RMB. For the remainder of this year, the company expects to receive roughly 200 orders.

Based on this projection, Kailimei's sales for 2025 are expected to reach approximately 198 million RMB.

Regarding channel development, CARSGEN-B is adopting a strategy of "starting from the high-end and achieving precise coverage." In the initial commercialization phase, the focus will be on prioritizing 100 leading oncology hospitals or the oncology departments and cell therapy centers of top-tier general hospitals.

Prior to Kailimei's launch, CARSGEN-B had already certified 55 treatment centers. The aim is first to establish clinical benchmarks through core hospitals and expert resources, then gradually expand coverage.

This approach aligns with the inherent commercial characteristics of CAR-T products. Unlike conventional anticancer drugs, CAR-T therapy is not a simple "prescription and administration" model. It involves a systematic process encompassing patient screening, cell collection, manufacturing, reinfusion, and long-term follow-up.

Beyond the domestic market, overseas markets are also viewed as a source of growth.

CARSGEN-B plans to advance overseas registration in a tiered manner based on the acceptance level of its core clinical data from mainland China by different regional regulators: in regions with higher acceptance like Singapore and Saudi Arabia, rapid application will be pursued relying on Chinese clinical data; in regions like Australia, South Korea, and Japan, applications will be based on Chinese data supplemented by local small-sample confirmatory clinical studies; in markets with stricter regulatory requirements such as the US, Europe, and Canada, the company will leverage existing qualifications to communicate with regulators and advance registration pathways that meet local standards.

However, the commercialization path for solid tumor CAR-T therapy is not without challenges.

The 990,000 RMB price tag indicates that payment capability remains a core variable. Commercial insurance, inclusive healthcare insurance, and potential future diversified payment systems will directly impact patient accessibility.

Whether Kailimei can successfully navigate pricing, payment, hospital coverage, and overseas expansion to ultimately translate this technological breakthrough into revenue growth is now under close observation.