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Research Report
QLM-2011: An Investigational Agent in Early-Phase Clinical Development for Advanced Solid Tumors
I. Executive Summary
This report provides a comprehensive analysis of QLM-2011, an investigational chemical drug originated by Qilu Pharmaceutica Hainanco Ltd. and under active development by Qilu Pharmaceutical Co., Ltd. and Qilu Pharmaceutica Hainanco Ltd..[1] Currently, QLM-2011 is in Phase 1 clinical development, targeting patients with advanced malignant solid neoplasms.[1] A key characteristic of QLM-2011 at this stage is its undefined mechanism of action, a common feature for novel molecular entities in early exploratory phases.[3]
Two Phase 1 clinical trials, NCT06925659 and CTR20251241, are registered, both currently in the "not yet recruiting" phase. These studies aim to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLM-2011 administered intravenously in patients with advanced solid tumors.[1] While preclinical studies in solid tumors have been conducted in China to support the initiation of these human trials [3], specific details of these studies, comprehensive patent information, and a definitive chemical classification beyond "chemical drug" and "antineoplastic" are not publicly available in the provided information. The development of QLM-2011 aligns with Qilu Pharmaceutical's broader strategic focus on expanding its portfolio of innovative oncology therapeutics. The outcomes of the initial Phase 1 trials will be critical in determining the future trajectory of QLM-2011, including elucidation of its potential mechanism and identification of responsive patient populations.
II. QLM-2011: Drug Profile and Characteristics
A. Identification and Originator
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/13 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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