Sino Biopharmaceutical’s subsidiary’s innovative drug LM-302 has been included in the Breakthrough Therapy Program
August 21, 2025
Source: drugdu
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On August 19, Sino Biopharmaceutical (01177) issued an announcement, announcing that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., independently developed an innovative drug.LM-302 (CLDN18.2ADC) has been included in the Breakthrough Therapy Designation program by the Center for Drug Evaluation of the China National Medical Products Administration for the first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with a PD-1 monoclonal antibody.
LM-302 is a potential first-in-class antibody-drug conjugate targeting CLDN18.2. Clinical studies have demonstrated an objective response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients. For 32 patients with CLDN18.2 ≥ 25%, the ORR was 71.9% and the DCR was 96.9%. This drug is currently undergoing a Phase III clinical trial in China. Its inclusion in the Breakthrough Therapy program is expected to accelerate its market launch, providing an innovative treatment option for more patients with CLDN18.2-positive gastric cancer.
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