BioKail Therapeutics Announces FDA Approval of IND Application for Innovative ADC BIO-106 Targeting TROP-2
Recently, the Investigational New Drug (IND) application for BIO-106, an innovative antibody-drug conjugate (ADC) developed by Baikai Biopharma, was approved by the U.S. Food and Drug Administration (FDA). Clinical studies of BIO-106 in the United States have also officially commenced.
BIO-106 is a novel ADC product targeting TROP-2.Baikai Biopharma has conducted specific design based on the pathophysiological expression characteristics of TROP-2, and adopted its independently developedPayload Technology, thereby giving BIO-106 a wider therapeutic window and improved safety profile. Baikai Biopharma holds full international independent intellectual property rights for BIO-106, including the TROP-2 antibody and the payload.
Dr. Haifeng Bao, CEO and Co-founder of Baikai Biopharma“He stated: ‘As a biopharmaceutical company exclusively focused on the development of novel antibody-drug conjugate (ADC) therapeutics, Baikai Biomedicine has been committed to ADC technological innovation since its inception, with a particular emphasis on payload technology development. The approval of our first Investigational New Drug (IND) application in the United States represents a milestone for Baikai Biomedicine, as it signifies the company’s transition from technological platform innovation to a new phase of clinical development.’”
The clinical trial of BIO-106 was officially launched in the United States on the day of its approval, demonstrating Baikai Biopharma’s extensive experience in new drug development and strong execution capabilities. BIO-106 is also the second TROP-2-targeting antibody-drug conjugate (ADC) product from China’s biopharmaceutical sector to undergo clinical trials in the United States. Over the next three years, Baikai Biopharma will advance one ADC product into global clinical trials each year, making its future highly promising.
Hangzhou Baikai Biomedical Co., Ltd. is a biopharmaceutical technology company dedicated to the research and development of novel antibody-drug conjugate (ADC) anti-tumor drugs. Founded by overseas experts, Baikai Biomedical’s core R&D team comprises scientists from renowned multinational biopharmaceutical companies or those who have held authoritative R&D positions in research institutions. Team members possess years of successful experience across various domains of ADC new drug development. Baikai Biomedical’s mission is to provide tumor patients with best-in-class, first-in-class ADC anti-tumor drugs, enabling more effective cancer treatment.