SBP GROUP(01177): Application for market approval of "CLDN18.2 ADC" new drug receives acceptance.

SBP GROUP (01177) has announced that its wholly-owned subsidiary, Lexin Medical Technology (Shanghai) Co., Ltd. (Lexin Medical), has submitted a new drug application for the innovative drug Vintecobi (CLDN18.2 ADC) (research code: LM-302) developed independently to the Center for Drug Evaluation (CDE) of China National Medical Products Administration and has been accepted for review. It is intended for patients with CLDN18.2 positive, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) who have received at least two prior lines of systemic treatment. On May 22, this indication has been included in the priority review and approval program by the CDE. LM-302 is an antibody-drug conjugate (ADC) targeting CLDN18.2, composed of a recombinant humanized monoclonal antibody linked to the small molecule toxin MMAE. LM-302 can accurately identify CLDN18.2 positive tumor cells and its carried MMAE also has bystander effect, further killing surrounding tumor cells with low or heterogeneous expression. Additionally, LM-302 can induce immunogenic cell death (ICD), and when used in combination with PD-1 inhibitors, it can exert a synergistic anti-tumor effect, providing an important mechanism for the "ADC + immune" combination therapy. The acceptance of the LM-302 new drug application is based on positive results from a Phase III pivotal clinical study. This study evaluated the efficacy and safety of LM-302 as monotherapy in third-line and above CLDN18.2 positive locally advanced or metastatic GC/GEJ. The study has completed interim analysis and achieved two study endpoints, with the relevant data expected to be formally announced at an international academic conference in early 2027. In addition to the third-line and above CLDN18.2 positive locally advanced or metastatic GC/GEJ indication applied for in this submission, LM-302 is also conducting a Phase III pivotal clinical study on the combination of PD-1 inhibitors for first-line treatment of CLDN18.2 positive locally advanced or metastatic GC/GEJ. Both indications have been granted breakthrough therapy designations by the CDE, and LM-302 has obtained Orphan Drug Designation (ODD) for three indications from the U.S. Food and Drug Administration (FDA), covering gastric cancer, pancreatic cancer, and cholangiocarcinoma, three tumor types with high unmet clinical needs.