IND Approval | StoneWise's Self-Developed Oral Small-Molecule SWA1211 Secures Clinical Trial Approvals in China and the US
On June 13, 2025, Beijing StoneWise Technology Co., Ltd. (hereinafter referred to as "StoneWise") announced the first patient dosing of SWA1211 tablets—an independently developed Hematopoietic Progenitor Kinase 1 (HPK1) inhibitor—at Shanghai East Hospital. This marks the official initiation of the Phase I clinical study evaluating the drug for advanced solid tumors.
In March 2025, SWA1211 tablets simultaneously obtained clinical trial approvals from China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). Co-led by Professor Guo Ye from Shanghai East Hospital and Professor Wang Hongxia from Fudan University Shanghai Cancer Center, the study aims to assess the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of SWA1211 tablets in patients with advanced solid tumors.
Ample evidence demonstrates that inhibiting HPK1 activity can activate the human immune system to treat tumors. Developed by StoneWise's R&D team based on the structural characteristics of this target, SWA1211 is a highly potent and selective oral small-molecule HPK1 inhibitor, efficiently designed using the company's proprietary AI models. Preclinical studies indicate SWA1211 has Best-in-Class potential: it exhibited significant antitumor efficacy as a monotherapy in multiple tumor animal models and showed enhanced synergistic antitumor effects when combined with PD-1 antibodies. Compared with disclosed clinical-stage HPK1 inhibitors targeting the same target, SWA1211 demonstrates distinct advantages in efficacy. Additionally, SWA1211 has a favorable safety profile with no significant toxicity observed in preclinical toxicology studies, supporting a promising therapeutic window.
About StoneWise
StoneWise, founded in 2018, is a technology company dedicated to AI-driven novel drug discovery.
Leveraging industry expertise, breakthroughs in AI technology, in-depth data governance capabilities, and robust software and hardware capabilities, the company has developed a multimodal AI 3D generation model focused on small molecules. Based on the GPT/Transformer architecture and integrated with geometric deep learning technology, this model can accurately generate molecules that match the targets and extend to multiple modalities. In addition, the company can provide customized solutions for the industry.
Based on this platform, our company have achieved remarkable results in the in-house R&D pipelines, with some having advanced to the clinical trial phase.
Currently, over 100 pharmaceutical enterprises and research institutions worldwide utilize this AI platform for early-stage R&D activities. Meanwhile, the physical library business derived from this foundational model is actively expanding both domestically and internationally.
Contact us: bd@stonewise.cn
