Sino：LM-302 has been formally accepted for review.
On June 23, the CDE official website showed that the new drug application (NDA) for Chia Tai Tianqing’s Vitekotuo Biantibody for Injection has been accepted. It is indicated as monotherapy for patients with CLDN18.2-positive, locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma who have received at least two prior lines of systemic therapy.
The drug had previously been granted priority review by the CDE. Vitekotuo Biantibody (development code: LM-302) is a Claudin18.2 (CLDN18.2)-targeting antibody-drug conjugate (ADC) developed by Lixin Pharma. It achieves precise killing of tumor cells by specifically binding to CLDN18.2-positive tumor cells, followed by internalization and release of a small-molecule toxin.
In July 2025, Sino Biopharmaceutical announced the acquisition of Lixin Pharma for a net consideration of approximately $500 million, bringing its bispecific antibody and ADC technology platforms under the Sino Biopharmaceutical umbrella. As a potential first-in-class (FIC) candidate, Vitekotuo Biantibody has demonstrated clinical potential in gastric cancer, pancreatic cancer, and biliary tract cancer, and is expected to expand treatment options for patients with low CLDN18.2 expression and low PD-L1 expression.
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