TAbS







KN057 Clinical TBD

Antibody Information

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

Therapeutic information

Target(s) Tissue factor pathway inhibitor
Indications of clinical studies Hemophilia
Primary therapeutic area Cardiovascular / hemostasis disorders

Development stage information


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 information

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

Description/comment

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.

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None