Shanghai, May 26, 2026 — OTR Therapeutics, a clinical-stage biotechnology company dedicated to transforming early-stage innovations into globally impactful therapies, today announced that the China National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for OTR-8100, an innovative oral anti-tumor small molecule candidate.

The clearance enables OTR Therapeutics to initiate an open-label, multicenter Phase Ib/II clinical study of OTR-8100 in China in patients with advanced malignant tumors. This milestone marks OTR’ official transition into a clinical-stage R&D company, 15 months after its inception.

OTR-8100 is a novel, anti-tumor oral small-molecule inhibitor that has demonstrated superior in vitro and in vivo efficacy and compelling combination therapy potential in preclinical studies. Its favorable clinical pharmacokinetic profile and preliminary anti-tumor activity observed in early-stage clinical trials strongly support its further clinical development as a potential best-in-class therapy for multiple solid tumors. 

OTR-8100 is a high-potential asset that OTR strategically acquired through an external partnership. Including OTR-8100, OTR has successfully acquired multiple innovative assets and built a diversified pipeline spanning oncology, immunology & inflammation, and cardiometabolic diseases.

About OTR Therapeutics

OTR Therapeutics is a clinical-stage biotechnology company dedicated to transforming early-stage innovations into globally impactful therapies for critical diseases with high unmet medical needs. With a strategic focus on oncology, immunology and inflammation, and cardiometabolic diseases, we discover and acquire distinctive assets in preclinical and early clinical stages, and accelerate their development into differentiated, clinically impactful treatments through our R&D hub built for speed, quality and efficiency. By combining scientific rigor with agile partnerships, we deliver exceptional value to our partners and patients worldwide. From our advanced R&D center in Shanghai’s Zhangjiang Hi-Tech Park, we actively collaborate with a global network of partners across the US, Europe, and Asia. www.otr-tx.com