SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb, entered an exclusive license and collaboration agreement to co-develop and commercialize SystImmune’s  BL-B01D1 in the U.S. BL-B01D1 is a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). 
 
SystImmune will be responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world.
 
BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global Phase 1 study in metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical studies of BL-B01D1 demonstrate promising anti-tumor activity in patients with a range of solid tumors that had progressed after standard of care treatments, including NSCLC and breast cancer.
 
SystImmune will receive $800 million upfront and as much as $500 million in contingent near-term payments. SystImmune is eligible to receive additional payments of up to $7.1 billion based on development, regulatory and sales performance milestones for a total potential consideration of up to $8.4 billion. The companies will share certain global development expenses and profits and losses in the U.S. SystImmune retains exclusive development and commercialization rights in Mainland China, where BMS will receive a royalty on sales. 
 
“Recent BL-B01D1 trials have shown broad potential across different solid tumors as well as a manageable safety profile,” said Dr. Yi Zhu, Chief Executive Officer at SystImmune. “We have long admired Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology, and this strategic collaboration is an exciting step forward in delivering potential antitumor medicines to patients worldwide.”
 
Samit Hirawat, MD, Executive Vice President, Chief Medical Officer, Drug Development at Bristol Myers Squibb, said, “SystImmune’s BL-B01D1 adds yet another ADC to our diverse pipeline and helps strengthen our approach of matching the most appropriate therapeutic modality to areas of unmet medical need across solid tumor oncology. We look forward to working with SystImmune to advance BL-B01D1 in hopes of offering a differentiated treatment option for patients in need.”