On June 23, the CDE (Center for Drug Evaluation) website showed that Chia Tai Tianqing Pharmaceutical Group's application for marketing authorization of vetectobactimab for injection was accepted. This monotherapy is indicated for patients with CLDN18.2-positive, locally advanced, or metastatic gastric/gastroesophageal junction adenocarcinoma who have received at least two lines of prior systemic therapy . Previously, this drug had been formally included in the CDE's priority review and approval process .

Screenshot source: CDE official website
Vitacotobactam (development code: LM-302 ) is an antibody-drug conjugate (ADC) targeting Claudin18.2 (CLDN18.2) developed by Lixin Pharmaceuticals. It specifically binds to CLDN18.2-positive tumor cells, enters the cells via endocytosis, and releases small molecule toxins to achieve precise killing of tumor cells.

In July 2025, China Biopharmaceutical announced that it would acquire 100% of Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. for a net consideration of approximately US$500 million , bringing the latter’s highly regarded bispecific antibody and ADC technology platforms into China Biopharmaceutical.

As a potential first-in-class (FIC) candidate, vetectobactam has shown clinical potential in the treatment of gastric cancer, pancreatic cancer, and biliary tract cancer , and is expected to expand new treatment options for patients with low CLDN18.2 expression and low PD-L1 expression.

At the 2024 ASCO Congress, Lixin Pharmaceuticals announced the results of an open-label, multicenter, dose-escalation, and extended Phase I/II study of vetecocumab . This study aimed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of vetecocumab in patients with CLDN18.2-positive advanced solid tumors.

As of September 23, 2023, a total of 135 patients had received vetcotulabizumab treatment, with a median of two lines of prior systemic therapy (range 1-4).

In Phase I and II studies, the most common treatment-related adverse events (TRAEs) were leukopenia, neutropenia, anemia, vomiting, and nausea. The most common grade ≥3 TRAEs were neutropenia and leukopenia.

In the Phase II dose-expansion study, 52 patients with CLDN18.2-positive (TC≥50%, IHC≥2+) adenocarcinoma of the stomach/gastroesophageal junction were enrolled (4 patients received 2.4 mg/kg every 3 weeks; 48 patients received 1.8 mg/kg every 2 weeks). Based on pharmacokinetic, safety, and efficacy data analysis, the 1.8 mg/kg Q2W regimen was selected for further evaluation.

In 36 evaluable patients with gastric/gastroesophageal junction adenocarcinoma (all of whom had received at least two prior therapies), 11 patients achieved partial response (PR) and 16 achieved stable disease (SD). The objective response rate (ORR) was 30.6% (11/36), and the disease control rate (DCR) was 75.0% (27/36). The median progression-free survival (PFS) was 7.16 months (95% CI 2.72-NA). The median overall survival (OS) has not been reached, and the 6-month OS rate was 95.0% (as of November 15, 2023).

At the 2025 ASCO Congress, Lixin Pharmaceuticals presented updated research data on vetexulizumab in combination with toripalimab for the treatment of gastric cancer: In 41 evaluable patients, the objective response rate (ORR) was 65.9% , and the disease control rate (DCR) was 85.4% . Among the 32 patients with CLDN18.2 expression ≥25%, the ORR was 71.9%, and the DCR was 96.9%. Stratified analysis by PD-L1 expression showed that the ORR was 63.3% for patients with PD-L1 CPS <1 and 77.8% for patients with CPS ≥1.

Currently, two Phase III studies have been conducted on this drug: one for monotherapy in third-line or higher CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (registration number: NCT06351020/CTR20240955 ); and the other for combination therapy with PD-1 in the treatment of first-line CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma patients ( registration number: NCT07385703/CTR20260165 ) .

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