Baili Tianheng disclosed on the morning of December 12th that its wholly-owned subsidiary SystImmune, Inc (hereinafter referred to as "SystImmune") and Bristol Myers Squibb (hereinafter referred to as "BMS", New York Stock Exchange code: BMY) reached a global strategic cooperation agreement on December 11 regarding the development and commercialization rights of BL-B01D1, with a potential total transaction amount of up to $8.4 billion.
The announcement shows that SystImmune and BMS are in contact with BL-B01D1 (EGFR) × The HER3 dual antibody ADC project has reached an exclusive licensing and cooperation agreement. BL-B01D1 is a potential first of its kind EGFR/HER3 bispecific antibody drug conjugate (ADC). According to the cooperation agreement, both parties will cooperate to promote the development and commercialization of BL-B01D1 in the United States. SystImmune will be solely responsible for the development, commercialization and production of BL-B01D1 in Chinese Mainland through its affiliated companies, as well as the production of some drugs for use outside Chinese Mainland. BMS will be exclusively responsible for the development and commercialization of BL-B01D1 in other regions around the world.
After the cooperation agreement takes effect, BMS will make a down payment of $800 million to SystImmune, as well as up to $500 million in recent contingent payments; After achieving development, registration, and sales milestones, SystImmune will receive an additional payment of up to $7.1 billion; The potential total transaction volume can reach up to $8.4 billion. The milestone payment stipulated in the cooperation agreement needs to meet certain conditions, and there is still uncertainty in the final milestone payment.
BL-B01D1 is an ADC based on bispecific topoisomerase inhibitors that can target both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFR) simultaneously × HER3). We are currently conducting a global multicenter Phase I clinical study (BL-B01D1-LUNG101) to evaluate its safety and efficacy in patients with metastatic or unresectable non-small cell lung cancer (NSCLC). The early clinical research data of BL-B01D1 have been announced at the 2023 American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO) and San Antonio breast cancer Seminar (SABCS). These data show that BL-B01D1 shows promising anti-tumor activity in patients with non-small cell lung cancer and breast cancer who have progressed after standard treatment.
According to the information on Baili Tianheng's WeChat official account on the 12th, Zhu Yi, chairman and general manager of the company and chief executive of SystImmune, said, "This strategic cooperation is an important step to provide potential anti-tumor drugs to patients around the world, and we look forward to active and fruitful cooperation." Samit Hirawat, Chief Medical Officer and Head of Drug Development, said, "SystImmune's BL-B01D1 adds an ADC to our diversified research and development pipeline, which aligns well with our strategy of providing the most suitable treatment model for unmet solid tumor treatment needs. We look forward to working with SystImmune to make BL-B01D1 a differentiated treatment choice for patients in need."