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 announced 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).
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.
About Xuanzhu Biopharm
Xuanzhu Biopharm is an innovative drug research institute of Sihuan Pharmaceutical, a large domestic pharmaceutical group. It is an innovative biopharmaceutical company rooted in China with a global perspective and focusing on tumors, metabolic diseases, infections and other fields. Xuanzhu was established in 2002, mainly engaged in the research and development of new molecular entity drugs. The company has innovative platforms such as small molecule, bispecific antibody and bispecific antibody- ADC. large molecule double antibody and double antibody ADC. Since its establishment, Xuanzhu Biotechnology has invested more than 2 billion. At present, it has formed a completed new drug research and development system, which covers the design and evaluation of new drug structures, the establishment of candidate compounds, clinical research, and the application of new drugs. The company’s pipeline was rich, more than 25 new drugs were under development, of which 2 new drugs are about to apply for NDA and more than 10 new drugs are in different clinical stages. Xuanzhu Biotechnology has successively passed the intellectual property management system and ISO9001 quality management system certification. It is at the leading level in the domestic drug research and development field and is committed to building a world-class innovative drug research platform.
About WuXi XDC
WuXi XDC is a joint venture company established by WuXi Biologics and Hequan Pharmaceuticals, focusing on providing end-to-end CDMO services for antibody-conjugated drugs (ADC) and other bio-conjugated drugs. The services cover R&D and production of antibodies and other conjugated biological drugs, linkers/chemical payloads, conjugated stock solutions and preparations. WuXi XDC has successfully empowered multiple ADC drugs to complete the new drugs from DNA to application for IND within 15 months. compared with the traditional development time almost reduced by half. Currently, nearly 50 ADC drugs at different stages are being developed on the WuXi XDC platform,of which 16 drugs that have been submitted to INDs and 6 drugs are in phase II/III clinical trials.