Entry ID | 2644 |
INN | None |
Status | Clinical |
Drug code(s) | KN057 |
Brand name | None |
mAb sequence source | mAb - source TBD |
General Molecular Category | TBD |
Format, general category | TBD |
Format details | None |
Isotype (Fc) | TBD |
Light chain isotype | TBD |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | Tissue factor pathway inhibitor |
Indications of clinical studies | Hemophilia |
Primary therapeutic area | Cardiovascular / hemostasis disorders |
Most advanced stage of development (global) | Phase 3 |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | December 21, 2019 |
Start of Phase 2 | July 15, 2022 |
Start of Phase 3 | January 09, 2024 |
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 | Suzhou Alphamab Biotechnology Co. Ltd |
Licensee/Partner | Sichuan Yuanda Shuyang Pharmaceutical Co. Ltd. |
Comments about company or candidate | NCT06569108 Phase 3 study started in April 2024. March 2024: US ophan drug designation for treatment of hemophilia A (https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=994023) NCT06312475 Phase 3 study started in January 2024 January 9, 2024, the "Evaluation of KN057 Injection in Hemophilia A and Hemophilia B Patients with Inhibitors" sponsored by Suzhou Alphamab Biotechnology Co., Ltd. (hereinafter referred to as "Suzhou Alphamab") "A Randomized, Open Study on the Efficacy and Safety of Injection Prophylaxis (KN057-A-301)" and "Evaluating the Effectiveness of KN057 Injection Prophylaxis in Patients with Hemophilia A and Hemophilia B Without Inhibitors Randomized, open-label study of safety and safety (KN057-A-302), two phase III clinical studies were officially launched at the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), the leader unit of this study. September 20, 2023: Suzhou Alphamab Biotechnology Co., Ltd. and Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuanda Life Sciences Group Co., Ltd. jointly announced that the two parties have signed a cooperation agreement for the Greater China rights license of the tissue factor pathway inhibitor ( TFPI ) monoclonal antibody KN057 independently developed by Suzhou Alphamab. NCT05421429 Phase 2 started in July 2022. CXSL1900141 host date is Dec 21, 2019. |
Full address of company | 175 Fangzhou Road, SIP, Suzhou, China ยท Zip code : 215127 Asia China https://www.alphamabonc.com/en/contact/contactus/index.html |
KN057 is a monoclonal antibody independently developed by Suzhou Alphamab with independent intellectual property rights. By specifically targeting TFPI , it neutralizes the inhibitory effect of TFPI on FXa and TF/FVIIa complexes, maintains thrombin levels, and prevents bleeding.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |