Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1733 |
| INN | Iparomlimab |
| Status | Regulatory review |
| Drug code(s) | QL1604, 艾帕洛利单抗注射液 |
| Brand name | (Pending) |
| mAb sequence source | mAb chimeric/humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Cervical Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2019 |
| Start of Phase 2 | |
| Start of Phase 3 | September 23, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Qilu Pharmaceutical Co., Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | China marketing application acceptance date is Sep 17, 2023 according to NMPA's CDE database. May 31, 2023: “A Phase Ib/II Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of QL1706 or QL1604 in Patients with Advanced HCC” results suggest that QL1706, in combination with bevacizumab, resulted in a higher ORR and longer PFS compared to QL1604 when used as first-line treatment for advanced HCC. These findings support further investigation of QL1706 plus bevacizumab for first-line treatment of advanced HCC in a phase III clinical trial.” December 4, 2022: “Qilu Pharmaceutical Releases Latest Results of QL1604 plus Chemotherapy as First-Line Treatment for Patients with Advanced Cervical Cancer in the Phase II Study at ESMO Asia Congress 2022”"We are pleased to release the latest study results of QL1604 plus chemotherapy as first-line treatment for patients with advanced cervical cancer. QL1604 plus chemotherapy showed promising antitumor activity and manageable safety profile as first-line treatment for women with R/M cervical cancer. Further investigations in this setting are ongoing." https://pipelinereview.com/index.php/2022120482172/Antibodies/Qilu-Pharmaceutical-Releases-Latest-Results-of-QL1604-plus-Chemotherapy-as-First-Line-Treatment-for-Patients-with-Advanced-Cervical-Cancer-in-the-Phase-II-Study-at-ESMO-Asia-C.html CTR20211777 Phase 2/3 in cervical cancer started in Sep 2020 recruiting as of first public information in May 2022. NCT04864782 Phase 2/3 in cervical cancer started in Sep 2020 terminated in Nov 2023 due to sponsor decision. NCT04435652 Phase 2/3 in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma was not updated after first posting in June 2020. NCT05649761 Phase 1 started in May 2019; NCT05801094 Phase 1 started in July 2020. |
| Full address of company | 8888 Lvyou Road , High-tech Zone , Jinan , 250104 , China Asia China https://en.qilu-pharma.com/contactdetails.html |
Immune checkpoint modulator. QL1604 is the anti-PD1 component of QL1706 [iparomlimab (anti-PD1) + tuvonralimab (anti-CTLA-4)].
| Anticipated events | Regulatory review China - anticipate approval |
| Factor(s) contributing to discontinuation | None |