Linglong Zou

Linglong Zou, PhD, stands among the emerging global leaders shaping the future of biologics development,  bioanalytical sciences and technologies through a career defined by scientific depth, technology innovation, regulatory impact, and innovation-led leadership. With more than two decades of industry experience, Dr. Zou has played a significant role in advancing biologic and biosimilar development on a global scale, helping expand patient access to life-changing therapies globally.

He earned his doctorate in Pharmacology from Chinese Academy of Sciences and completed postdoctoral training at Baylor College of Medicine, USA before entering the industry in 2001 as an analytical and bioanalytical scientist at Tanox, Inc., a Genentech company. This early foundation in rigorous scientific research set the stage for a career focused on both technical excellence and real-world therapeutic impact.

Dr. Zou went on to hold senior leadership roles at Teva Pharmaceuticals USA and Henlius Biotech Co., where his responsibilities steadily expanded across bioanalytical strategy, assay development, and regulatory support. As Senior Director of Biologic Assays and Technology at Teva and later General Manager of Bioanalytical Sciences at Henlius, he was instrumental in supporting the bioanalysis and regulatory approval of 16 biologic products worldwide, including nine biosimilars referencing major therapies such as Herceptin, Avastin, Rituxan, and Humira. These programs have significantly reduced treatment costs while improving access to critical therapies for patients with cancer and autoimmune diseases.

In 2022, motivated by the opportunity to apply his expertise more broadly, Dr. Zou founded Kanwhish Biotech Co., a bioanalytical-focused contract research organization headquartered in Suzhou, China. Since its inception, Kanwhish has supported more than 100 global clients, delivering high-quality bioanalytical services across a wide range of development programs. In alignment with evolving FDA initiatives aimed at accelerating biosimilar development and lowering drug costs, the company has expanded its analytical capabilities and established strategic partnerships with biologics CDMOs and clinical CROs, enabling integrated, end-to-end development solutions.

Known for his innovation-driven mindset, Dr. Zou has developed multiple novel technologies, methodologies, and tools that address long-standing challenges in bioanalysis. His work includes the creation of a generic bioanalytical assay platform for preclinical pharmacokinetic and anti-drug antibody assessments of complex biologics, significantly reducing assay development timelines. He has also introduced practical solutions to overcome drug interference in clinical immunogenicity testing through the design of compact, magnetic-bead–based sample pretreatment devices and cost-effective automation platforms.

Guided by a strong quality-by-design philosophy, Dr. Zou continues to transform bioanalysis into a more efficient, reliable, and scalable discipline. His leadership bridges scientific rationale and technology innovation with operational execution, positioning him as a global contributor to the future of biologics, biosimilars, and accessible healthcare product development.