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Recently, Xuanzhu Biopharmaceutical (Xuanzhu) and its wholly-owned subsidiary Beijing Xuanzhu Bio, obtained clinical trial approval for the double-antibody ADC drug KM501 (No.: 2023LP00278). This product is suitable for the treatment of advanced/metastatic solid tumors with positive/expression, amplification or mutation of HER2, including related advanced tumors with low expression of HER2. The drug is the world's first double-antibody ADC drug that completely knocks out fucose, and is expected to become the "Best in Class" drug.
Shanghai Medicilon Inc. (Medicilon), as a partner of Xuanzhu, provided KM501 with GLP-compliant preclinical research services based on the Medicilon Antibody Development Service Platform, including pharmacokinetic studies and safety evaluation. This has won time for Xuanzhu to advance the KM501 into clinical research as fast as possible.
As a one-stop pharmaceutical preclinical R&D service platform CRO, Medicilon has continuously iterated new drug R&D technologies for 19 years. In the field of ADC drug research and development, Medicilon provides clients with one-stop preclinical research services such as ADC Payloads synthesis, ADC drug conjugation, ADC pharmacodynamics evaluation, ADC pharmacokinetics evaluation and ADC safety evaluation.
Since the establishment of Medicilon Antibody Drug Conjugate (ADC) R&D Service Platform, Medicilon has accumulated many well-known world wide pharmaceutical companies and scientific research institutions, successfully assisted in the clinical approval of ADC projects of innovative pharmaceutical companies such as Bio-Thera and DAC Biotech, and won the continuous trust and praise of clients and long-term collaboration. Medicilon successfully assisted Xuanzhu’s KM501 in clinical approval, which provided valuable experience for the Medicilon Antibody Drug Conjugate (ADC) R&D Service Platform to assist in the preclinical research and development of more new generation ADC drugs.
Medicilon congratulates Xuanzhu’s KM501 on the clinical approval, and looks forward to the smooth clinical progress of the drug, providing a competitive new choice for patients with solid tumors. The era of new drugs is moving forward. Medicilon's latest technology platform will continue to help global clients develop new drugs through high-tech, high-efficiency, high-quality, and cost-effective R&D services.