Zydus Lifesciences Ltd., a leading global healthcare company, has signed an exclusive development, licensing, supply, and commercialization agreement with Synthon BV, Netherlands. This collaboration focuses on a novel 505(B)(2) oncology product for an undisclosed target, marking a significant advancement in cancer treatment.
Under the agreement, Synthon will handle the development, manufacturing, and supply of the finished product. Zydus will be responsible for NDA submission and commercialization in the U.S. The product is expected to be filed in 2026 and will offer additional strengths designed to reduce pill burden, allow dose flexibility, and enhance patient compliance.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Ltd., expressed enthusiasm for the partnership, stating, “This collaboration will provide access to a high unmet need therapy. By combining our expertise, we aim to address critical healthcare challenges.”
Anish Mehta, CEO of Synthon BV, highlighted the innovation behind the project, stating, “This 505(B)(2) product underscores Synthon’s expertise in complex product development. Our partnership with Zydus will ensure patients receive critical treatment alternatives for this challenging condition.”
This strategic collaboration reinforces Zydus Lifesciences’ commitment to innovation in oncology and Synthon’s expertise in developing clinically differentiated pharmaceutical products. As the anticipated 2026 filing approaches, this partnership is set to deliver enhanced treatment options for cancer patients, improving accessibility and effectiveness in oncology care.
