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Tyligand Bioscience Receives Clinical Trial Clearance from U.S. FDA and China NMPA for Dual Function Immune Agonist TSN222

Shanghai, Feb. 16, 2023 – Tyligand Bioscience, a clinical stage biotech company focused on the development of innovative drugs to treat drug-resistant tumors, today announced that it has received Investigational New Drug clinical trial approval recently from both U.S. Federal Food and Drug Administration (FDA) and Chinese National Medical Product Administration (NMPA) for TSN222, the world's first dual action small molecule immune agonist. TSN222 is a novel bifunctional small molecule designed with sequential and synergistic release of both immune agonism and cytotoxic functions modulated in vivo by pharmacokinetics. It not only activates interferon production in the tumor microenvironment, but also selectively kills tumors cells to prime the adaptive immune system. TSN222’s preclinical data showed good tolerability, excellent tumor suppression efficacy and sustainable immune memory.

"TSN222 is the first product off the DATIA® (Dual Action Tumor Immune Agonist) platform to enter clinical development," said Tony Zhang, PhD., co-founder and CEO of Tyligand, " The achievement of this important milestone demonstrates the team's ability to produce quality clinical candidates by actualizing the "Tie + Ligand" platform concept with innovative molecular design capabilities. We will build a differentiated product pipeline based on the DATIA® platform and actively expand external collaborations to accelerate the discovery and development of more effective and accessible therapeutic options for the patients."

Tyligand Bioscience is a clinical-stage biotech company founded in 2017, focusing on the discovery and development of innovative cancer therapeutics. The company commenced business operations in 2018. Leveraging decades of profound experience in leading drug discovery and development at multinational pharmaceutical companies, the management team has successfully established technology platforms with fully integrated capabilities across small molecules and antibody-drug conjugates (ADCs). Serving as an innovation engine, these platforms have enabled the company to build a diversified pipeline encompassing multiple drug candidates.

Consistently driven by the mission to address significant unmet clinical needs, Tyligand Bioscience is dedicated to becoming a leading global biopharmaceutical enterprise. By continuously delivering high-quality, differentiated innovative therapies, the company aims to improve the quality of life for patients worldwide and create long-term commercial value.

For more info about Tyligand Bioscience, please visit www.tyligand.com

- Tyligand Bioscience