Home Qilu Pharmaceutical Launches First-in-Class Bispecific Antibody-Drug Conjugate QLS5316 into Phase I Clinical Trial for Advanced Solid Tumors

Qilu Pharmaceutical Launches First-in-Class Bispecific Antibody-Drug Conjugate QLS5316 into Phase I Clinical Trial for Advanced Solid Tumors

Jan 20, 2026 16:23 CST Updated 16:23
Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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Recently,The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd. has registered aQLS5316 ForAdvanced Solid TumorsPhase I clinical trial. According to public data, this is the first time the drug has been initiated in clinical trials.

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Screenshot source:Drug Clinical Trial Registration and Information Disclosure Platform Official Website

This is aA Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5316 Monotherapy in Patients with Advanced Solid Tumors, Planning to Enroll 300 Participants Across 25 Institutions in China. The Medication Regimen isIntravenous infusion 1.6~9.6mg/kg, adjust according to the trial conditions.Q3W(21 days as 1 treatment cycle)

Combined with external clinical trial recruitment information andClinical Trial Inclusion and Exclusion Criteria (ExclusionPreviously received antibody-drug conjugate treatment containing a topoisomerase I inhibitor; or previously received EGFR and/or c-MET targeted ADC.),Insight database speculates that QLC5513 might beA Highly Selective TargetingEGFR/c-MET Dual-antibody ADC

According to statistics from the Insight database, Qilu Pharmaceutical has a total of 5 ADC products that have entered the clinical stage, includingInRMB 1.345 billionThe price of MHB088C introduced by Minghui PharmaceuticalsB7-H3 ADC)etc., among which onlyQLS5316 A product forDual-Target ADC

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Screenshot source: Insight Database

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Editor:ccai
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