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On April 18, 2025, Kygent Therapeutics (Shanghai) Co., Ltd (Kygent) 's self-developed KY-001 received FDA Orphan Drug Designation (ODD) for treating malignant pleural mesothelioma.
In 2024, KY-001 received an clinical trial applications from China's CDE. For this FDA submission, SDM Bioservices provided application services (including writing, reviewing, and submitting) and communicated with the FDA. Amid evolving global regulations, SDM's expertise in medical, Regulatory Affairs and scientific project management ensured successful execution of orphan drug designation through close collaboration with Kygent.
SDM team specializes in global pharmaceutical, vaccine and medical device market access, offering regulatory strategy, consulting, clinical development and compliance support. With a team of experts experienced in multi-region regulatory environment, SDM ensures smooth submissions through streamlined communication with regulators.
About KY-001
KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation, including NF2-deficient cancers (e.g., malignant pleural mesothelioma) and refractory tumors with YAP/TAZ fusions or upstream mutations (e.g., breast/ovarian cancer).
About Kygent
Kygent Therapeutics, founded in 2021 and based in Shanghai's Zhangjiang Hi-Tech Park, is an innovative biopharma company focused on oncology and immuno-oncology. With a pipeline of breakthrough therapies targeting novel drug discovery, it aims to deliver differentiated treatments to patients.
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KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation.
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