Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 13 |
| INN | Penpulimab |
| Status | Approved |
| Drug code(s) | AK105 |
| Brand name | ANNIKO, 安尼可® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| 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 | Hodgkin's disease, Hepatocellular carcinoma, MSI-H or dMMR Advanced Solid Tumors, Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors (single Phase 2 study); Hepatocellular Carcinoma, Non-small cell lung cancer, Nasopharyngeal Carcinoma, 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) | December 22, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | November 27, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2021 |
| Date of first US approval | |
| INN, US product name | Penpulimab |
| US or EU approved indications | None |
| Company | Akesobio Australia Pty Ltd |
| Licensee/Partner | Specialised Therapeutics Asia Pte Ltd, Sino Biopharm |
| Comments about company or candidate | Nov 2024: Akeso, Inc., announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC). This marks penpulimab's fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer. Apr 2023: Specialised Therapeutics Asia Pte Ltd will partner with CTTQ-Akeso (Shanghai) Biomed. Tech. Co., Ltd. (CTTQ-Akeso)(jointly established by Akeso, Inc. (9926.HK, Akeso) and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. to commercialise a new immuno-oncology therapy in Australia, Singapore and across Southeast Asia. The therapy ANNIKO® (penpulimab) is an anti-PD1 monoclonal antibody currently under regulatory review by the US FDA for nasopharyngeal carcinoma – a difficult to treat form of head and neck cancer. January 16, 2023: Anniko® (penpulimab), co-developed by the Company with Sino Biopharmaceutical Limited, combined with chemotherapy as the first line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) has been granted marketing approval by the National Medical Products Administration (NMPA) of the People’s Republic of China August 5, 2021 I Akeso, Inc. announced that the anti PD-1 monoclonal antibody drug Penpulimab monoclonal antibody injection co-developed by the Company with Sino Biopharmaceutical Limited, has obtained marketing approval by the National Medical Products Administration of China, for treatment of patients with relapsed or refractory ("r/r") classic Hodgkin's lymphoma ("cHL") after at least second-line systemic chemotherapy treatment. Penpulimab has been granted Breakthrough Therapy, Orphan Drug (Feb 2021) and Fast Track designations by the FDA for the treatment of metastatic nasopharyngeal carcinoma. May 24, 2021: Akeso, Inc. announced that Penpulimab (AK105), an PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited, has submitted a Biologics License Application to the FDA for third-line treatment of metastatic nasopharyngeal carcinoma. Penpulimab has already obtained breakthrough therapy designation and fast track designation from the FDA for third-line treatment of metastatic nasopharyngeal carcinoma. Penpulimab's BLA submitted to the FDA will be reviewed under the new policy of RTOR, which aims to accelerate the process of drug approval. RTOR is a major and innovative new oncology drug approval policy issued by the Oncology Center of Excellence ("OCE") of the FDA. Company update of Aug 2020 indicates NDA was submitted. Silde 22, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf ◼ Single-arm registrational trials for Penpulimab for the treatment of cHL and NPC ◼ NDA filed for 3L R/R cHL in May 2020 ◼ Expected to file NDA for ≥3L NPC in 1H 2021 NCT04344158 Phase 3 in hepatocellular carcinoma not yet recruiting when posted on April 14, 2020. In September 2019, the company completed the patient enrolment of a Phase II registrational trial to evaluate penpulimab (AK105) (PD-1) for the treatment of 3L relapsed or refractory classical Hodgkin’s lymphoma (cHL), following the enrolment of the first patient in January 2019 and obtaining the pivotal trial status granted by the CDE. They expect to submit an NDA to the NMPA around mid-2020. NCT03866980 and NCT03866993 Phase 3 studies in lung cancer recruiting as of Nov and Dec 2018, respectively. NCT04172571 Phase 2 in liver cancer. NCT03352531 Phase 1 study |
| Full address of company | Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia Australia Australia https://www.akesobio.com/en/about-us/contact-us/ |
Immune checkpoint modulator. AK105 is a humanized IgG1 mAb that blocks PD-1 binding to PD-L1 allowing T-cells to recognize and kill tumor cells. Key attributes of AK105 include antibody engineering to eliminate Fc mediated effector function, and a slower off-rate on antigen binding resulting in improved receptor occupancy (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.e14006?af=R)
| Anticipated events | Regulatory review in US |
| Factor(s) contributing to discontinuation | None |