CARSGEN-B (HKG: 02171) shares experienced a significant surge on heavy volume, climbing more than 8% at one point during the trading session. At the time of writing, the stock was up 6.79% to HK$16.82, with a substantial turnover of HK$150 million.

The notable price movement follows a major regulatory announcement. On June 22nd, the National Medical Products Administration approved the market launch of CARSGEN's "Surajit Orelun Injection." This therapy is indicated for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2 positive, HER2 negative, and has failed at least two prior lines of therapy.

This approval represents a historic breakthrough in the field of cellular therapy. All previously approved CAR-T cell therapies have targeted hematological cancers, making Surajit Orelun the world's first commercially approved CAR-T therapy for solid tumors.

Public information indicates that Surajit Orelun is the second commercialized product from CARSGEN, following "Saikaze." In 2025, CARSGEN reported revenues of approximately RMB 126 million, primarily driven by the sales ramp-up of Saikaze.

In a further development this year, the company announced in February a significant investment of up to RMB 370 million to construct an advanced commercial-scale manufacturing facility for CAR-T cell therapy products in Shanghai's Jinshan District.