On November 28, 2025, Hebio Cellgenex Therapeutics Co., Ltd. made a significant announcement: its independently - developed Naxiocel Injection has received marketing approval from the National Medical Products Administration. This approval is specifically for treating relapsed or refractory large B - cell lymphoma (r/r LBCL) in patients who have undergone second - line or higher systemic therapies.

This achievement represents the second new drug approval for the product in China. Previously, in November 2023, it was approved for the treatment of adult relapsed or refractory B - cell acute lymphoblastic leukemia (r/r B - ALL).

In the context of China's medical landscape, Naxiocel Injection holds a pioneering position. It has emerged as China's first CD19 CAR - T product with completely independent intellectual property rights. Moreover, it stands out as the sole CAR - T cell therapy product in the country that covers both leukemia and lymphoma indications.

The approval of Naxiocel Injection is a testament to China's prowess in original innovation and its commitment to high - quality industrial development within the cell therapy field. It showcases the nation's ability to develop cutting - edge medical solutions and contribute to the global advancement of cell - based therapies.