On September 29, 2021 Sihuan Pharmaceutical Holding Group Co., Ltd.,and WuXi XDC, a global CDMO company dedicated to end-to-end bioconjugates services under WuXi Biologics (Cayman) Inc. (Hong Kong Stock Exchange stock code: (2269), jointly reported that, Xuanzhu Kangming, the biological platform company of Xuanzhu Biopharmaceutical Co., Ltd, of Sihuan Pharmaceutical, and WuXi XDC to reach the R&D and manufacturing service collaboration for an innovative biological product KM501, a bispecific antibody drug conjugate (ADC) (Press release, XuanZhu Pharma, SEP 29, 2021, View Source [SID1234632638]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
KM501 is a bispecific antibody drug conjugate for the treatment of low & medium expression of HER2 which independently developed by Xuanzhu Kangming. It is currently in the pre development stage of investigational new drug (IND).
Pursuant to the collaboration agreement, Xuanzhu Kangming will promote the R&D process of KM501 bispecific ADC through the integrated CMC service of WuXi XDC. WuXi XDC will provide end-to-end services such as antibody, linker, payload, analytical method and process development, conjugate DS and DP to support the IND application of KM501 ADC.
The establishment of this strategic collaboration with WuXi XDC will accelerate and empower the development of innovative KM501 bispecific ADC. As one of the important projects from Xuanzhu’s innovative development pipeline, we believe that WuXi XDC ‘s end-to-end service and the rich experiences in the field of antibody drug conjugate CDMO service will provide sufficient support for KM501 bispecific ADC development in order to successfully submit IND application in the near future, help to accelerate its entry into clinical trials, verify its clinical treatment potential as soon as possible, and solve the unmet clinical needs.
About KM501
KM501 is a bispecific antibody drug conjugate for HER2-HER2 independently developed by Xuanzhu Kangming, the biological platform of Xuanzhu Biopharmaceutical Co., Ltd. The antibody part of the product can simultaneously bind two non-overlapping epitopes of HER2, ECD4 (Trastuzumab targeting domain) and ECD2 (Pertuzumab targeting domain). This unique design can produce a variety of mechanism of actions, including dual HER2 signal blocking and enhancing the binding between antibody and HER2, so as to enhance the clearance of HER2 protein from cell surface and improve antibody mediated antitumor activity.
About HER2 Market Potential
HER2 positive, HR negative breast cancer is the largest application of therapeutic area of HER2, has several products. With its rich indications, the total sales in 2020 exceed US $10 Billion. HER2 bispecific ADC, as a new generation of HER2 ADC products, is expected to share the breast cancer market in the future and bring more gospel to breast cancer patients. At the same time, HER2 is also highly expressed in a variety of tumors, such as gastric cancer, bile duct cancer and colorectal cancer, which potentially show huge market space.