Xiao X.

Richard Xue: A Senior Leader in Global Clinical Development Richard Xue is a highly accomplished clinical development executive with over 18 years of extensive experience spanning global pharmaceutical corporations and local biotech companies. He has a distinguished reputation for his strategic leadership, profound therapeutic expertise, and a proven track record of successfully guiding novel therapeutics and medical devices from early-stage development through to regulatory approval. Mr. Xue's career is characterized by his ability to build, lead, and manage high-performing, multidisciplinary clinical development organizations. He has held senior leadership positions with overarching responsibility for clinical operations, biometrics, medical affairs, and regulatory functions. His leadership has been instrumental in establishing and leading Regional Clinical Development organizations in the Asia-Pacific region, driving strategy and execution across diverse markets. He possesses deep, hands-on experience across a broad spectrum of therapeutic areas, including Oncology (e.g., NSCLC, cHL, Melanoma, various solid tumors), Ophthalmology, Infectious Diseases, Neuro-degenerative Diseases (e.g., ALS, Alzheimer's), Autoimmune/Immune Diseases, and Diabetes. This expertise encompasses the clinical development of biologics, small molecules, biosimilars, and medical devices. Mr. Xue's late-stage development and New Drug Application (NDA) approval experience is substantial. He has played a key role in the approval of numerous products, including the biologics Zimberelimab, the small molecules Tunlametinib and Lefamulin, various ophthalmic solutions (Dutrav, Vigamox, etc.), the biosimilar Basaglar, and medical devices like the Centurion Silver vision system and Panoptix intra-ocular lens. His early-stage development prowess is equally impressive, having successfully initiated and completed multiple First-in-Human (FIH) studies for innovative small-molecule compounds and possessing extensive Phase II and Investigator-Initiated Trial (IIT) experience. He is adept at crafting clinical strategies and developing protocols for a wide array of complex indications. Throughout his career, Mr. Xue has consistently demonstrated his ability to deliver results in demanding roles: As VP and China Head of Clinical Operation, Biometrics and Regulatory at Sironax, he successfully initiated and completed 5 FIH studies, conducted global Phase IIa studies, obtained 4 IND approvals, and built a comprehensive clinical quality system and a dynamic team from the ground up. At Kechow Pharma as Global Head of Biostatistics, Data Management & Medical Writing, he established a lean biometrics team and made significant contributions to the pivotal study and NDA approval of Tunlametinib. During his tenure as Head of Clinical Project Strategy, Biostatistics, & Data Management at Gloriabio, he strongly supported the NDA application and approval of Zimberelimab and led multiple clinical development strategies. As VP & Head of Clinical Operations/Biometrics/Portfolio Management at Sinovant Sciences, he founded multiple departments, secured 3 IND approvals within a year, and laid the foundation for the NDA of Lefamulin. In his nearly seven years at Alcon, progressing to Head of Clinical Development, Asia, he led or significantly contributed to the approval of over 10 drug or device products and successfully turned around NDA approvals in India. His foundational roles at Eli Lilly and PAREXEL provided him with deep, hands-on expertise in biostatistics, data management, and regulatory interactions, forming the bedrock of his later leadership success. Richard Xue holds a Doctorate in Health Care Management from Universidad Católica San Antonio, Spain, and dual Master of Science degrees in Biostatistics and Applied Statistics from the University of Hasselt, Belgium. He also completed post-graduate work in Applied Computer Science at Vrije Universiteit Brussels, Belgium. This robust educational background underpins his data-driven and strategic approach to clinical development, making him a respected leader capable of navigating the complexities of the global pharmaceutical and biotech landscape.