Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 756 |
| INN | Picankibart |
| Status | Regulatory review |
| Drug code(s) | IBI112 |
| Brand name | None |
| 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) | IL-23p19 |
| Indications of clinical studies | Ulcerative Colitis, Psoriasis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2019 |
| Start of Phase 2 | August 01, 2021 |
| Start of Phase 3 | December 30, 2022 |
| 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 | Innovent Biologics (Suzhou) Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | September 26, 2024 I Innovent Biologics, Inc. announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. NCT06049810 Phase 3 in psoriasis due to start in Nov 2023. NCT05645627 Phase 3 in Psoriasis started, as per Feb 2023 press release; registrational study. Aug 2022: Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Moderate-to-severe Plaque Psoriasis Met Primary Endpoint. "...picankibart also shows potential advantages in long dosing intervals and long-term efficacy. I am confident and looking forward to the success of its upcoming phase 3 study" NCT05003531 Phase 2 is in Psoriasis NCT04511624 is a Phase 1 in healthy people. On Sep 1, 2020, Innovent Biologics, Inc. announced that the Phase I clinical study (CIBI112A101) of recombinant anti-interleukin 23p19 subunit antibody injection (IBI112) has completed the first healthy subject dosing in China. The study CIBI112A101 is a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety and tolerability in addition with PK/PD of IBI112 when administered as a single subcutaneous or intravenous dose in healthy Chinese subjects. Described as a novel antibody. |
| Full address of company | Jiangsu, P. R. China 215123 Asia China https://www.innoventbio.com/AboutUs/ContactUs |
Mutations in Fc fragment of IBI112 extended half-life compared to the wild-type IgG1 version in both human-FcRn-knock-in mice and cynomolgus monkeys. https://investor.innoventbio.com/media/1147/innovent-2020-rd-day-ppt_20201110.pdf
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |