Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 70 |
| INN | Pucotenlimab |
| Status | Approved |
| Drug code(s) | HX008, AK-103 |
| Brand name | Puyouheng |
| mAb sequence source | mAb 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 | Non-small Cell Lung Cancer, melanoma, Hepatocellular Carcinoma, Bladder Cancer, Melanoma, Anaplastic Thyroid Cancer, gastric cancer, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2018 |
| Start of Phase 2 | September 30, 2018 |
| Start of Phase 3 | April 01, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2022 |
| Date of first US approval | |
| INN, US product name | Pucotenlimab |
| US or EU approved indications | None |
| Company | LEPU BIOPHARMA, HanX Biopharmaceuticals, Taizhou Hanzhong biomedical Co. LTD |
| Licensee/Partner | Hutchison MediPharma |
| Comments about company or candidate | July 22, 2022: LEPU BIOPHARMA is an innovation-driven biopharmaceutical company focusing on oncology therapeutics with a strong China root and global vision. On July 22, 2022 (Beijing time), the company announced that its first innovative biological drug, anti-PD-1 monoclonal antibody – Puyouheng (pucotenlimab injection), has been conditionally approved for marketing by the National Medical Products Administration (NMPA). The drug is applicable for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, which are as follows • Patients with advanced colorectal cancers have progressed following previous treatment with a fluoropyrimidine, oxaliplatin and irinotecan; • Patients with other advanced solid tumors that have progressed following at least previous first-line therapy with no satisfactory alternative treatment options. The approval is based on a multi-center, open-label, phase II clinical study with a primary study endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST1. NCT04616443 Phase 1/2 in melanoma sponsored by Wuhan Binhui Biotechnology Co., Ltd., started in Oct 2020. NCT04486651 Phase 3 in gastric cancer started Sep 16, 2020. NCT04574817 Phase 2 in thyroid cancer not yet recruiting as of Oct 6, 2020 Phase 2/3 in China according to a partner's SEC filing dated May 2019 (https://sec.report/Document/0001104659-19-029989/). NCT03704246 Phase 2 study started in Sep 2018. Nov 2018: Taizhou Hanzhong Pharmaceuticals enters into a global collaboration agreement with Hutchison MediPharma for clinical development in Solid tumours (Combination therapy). Originator is HanX Biopharmaceuticals. Phase 1b CTR20191676, Phase 1 CTR20180125 in Chinese clinical trials registry. Akeso Biopharma is involved; relationship with other companies is not clear. |
| Full address of company | No.651, Lianheng Road, Minhang District, Shanghai, CHINA Asia China https://en.lepubiopharma.com/contact |
Immune checkpoint target. Recombinant humanized IgG4S228P anti-PD-1 monoclonal antibody with an engineered Fc domain. S228P S254T V308P N434A mutations for hinge stabilization and half-life extension. https://pubmed.ncbi.nlm.nih.gov/32106752/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |