On January 2, 2025, San Francisco, USA and Suzhou, China - Xinda Biopharmaceutical Group (hereinafter referred to as "Xinda Biopharmaceutical"), a biopharmaceutical company dedicated to the research and development, production, and sales of innovative drugs in major disease fields such as oncology, autoimmune, cardiovascular and metabolic, and ophthalmology, announced today that it has reached a global exclusive cooperation and licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to promote the development of IBI3009, a new generation of antibody coupled drug (ADC) candidate products targeting Delta like ligand 3 (DLL3), aiming to provide a new treatment option for patients with advanced small cell lung cancer (SCLC). IBI3009 has currently obtained clinical application (IND) approval in Australia, China, and the United States, and the first patient in phase I clinical trials will be administered in December 2024.

IBI3009： Potential best in class DLL3 ADC candidate drugs
IBI3009 specifically targets DLL3, an antigen that is lowly expressed in normal tissues but significantly overexpressed in specific cancer types, particularly SCLC and other neuroendocrine tumors. As one of the potential best in class and leading development targeted DLL3 ADCs, IBI3009 is designed and developed based on Innovent Biologics's proprietary TOPO1i platform, a novel topoisomerase I inhibitor. IBI3009 has demonstrated encouraging anti-tumor activity in multiple tumor burden mouse models, especially in chemotherapy resistant tumor types, and has good safety characteristics.

Dr. Zhang Suhua, Chief Business Officer of Innovent Biologics, said, "We are pleased to once again establish a strategic partnership with Roche, a global leader in oncology pharmaceuticals, to advance the development of our potential best in class DLL3 ADC candidate drug. We look forward to combining Innovent Biologics's innovative technology with Roche's scientific insights and global research and development capabilities to jointly promote the accessibility of high-quality innovative drugs and benefit more patients worldwide as soon as possible

Boris L. Za ï tra, Global Head of Corporate Business Development at Roche Group, said, "We are pleased to establish a partnership with Sinovac Biotech to jointly promote this innovative and under development therapy for small cell lung cancer. This collaboration relies on Roche's continuous innovation and deep accumulation in the ADC field, aiming to provide transformative therapeutic drugs for solid tumor patients and meet their unmet needs

According to the agreement, Sinovac Biotech grants Roche IBI3009 exclusive rights for global development, production, and commercialization. Both parties will jointly be responsible for the early development of the ADC candidate drug, and subsequent clinical development will be handled by Roche. Innovent Biologics will receive a down payment of $80 million, potential milestone payments for development and commercialization up to $1 billion, and a gradient sales commission based on global annual net sales in the future.

Source: https://pharm.jgvogel.cn/c1479020.shtml