SUZHOU, China, March 24, 2021 -- Transcenta Holding Limited (Transcenta), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, today announced the expansion of its senior management team by appointing Dr. Xichen Zhang as Senior Vice President of Manufacturing and Dr. Steven Yu as Senior Vice President of DMPK & Translational Science.

Dr. Xichen Zhang has 27-year experience of GMP manufacturing, CMC development of clinical products, CTA/MA filing strategy, and life-cycle management of commercial products. Before joining Transcenta, he worked as Product Quality Director at Amgen, leading product quality teams of several new drug projects at various developmental stages, including Sensipar/Mimpara, Parsabiv, AMG223, AMG282, AMG420, AMG479, AMG592, and Sotorasib (AMG510). He played a key role in developing and advancing Parsabiv from early clinical stage to commercialization, and led the team rapidly completed product quality development of Sotorasib, which had been brought to MA filing stage with expected US approval soon. Dr. Zhang received his Ph.D. degree in Chemical Engineering from Queen's University in Canada.

Dr. Steven Yu has more than 20 years of experience in large molecule drug development and extensive expertise in PKPD evaluation, assay development/validation, biomarker development, immunogenicity assessment, and biotransformation assessment supporting both discovery and clinical projects. Before joining Transcenta, he was the VP of DMPK & Clinical Bioanalysis at ChemPartner. Dr. Yu spent most of his career with global pharmaceutical companies including Amgen, Boehringer Ingelheim, Shire, and Takeda. Dr. Yu had a Ph.D. degree in biochemistry from Loma Linda University, and an MBA in Global Business from Pepperdine University.

"We are honored to have Dr. Xichen Zhang and Dr. Steven Yu join the Transcenta team," said Dr. Xueming Qian, CEO of Transcenta. "As we continue to enrich and advance Transcenta's pipeline with more innovative antibody drug candidates entering clinical trial or moving into late-phase clinical trial, the demand for large-scale manufacturing and DMPK and translational research work is growing rapidly. As seasoned professionals, Dr. Zhang and Dr. Yu will further solidify the advantages of Transcenta as a fully-integrated biopharmaceutical company."

"Transcenta is a leader in flexible manufacturing facility design and continuous biomanufacturing technology." Dr. Xichen Zhang said, "I am very excited to join Transcenta and lead the effort to further enhance capability and ensure global standard product quality in clinical and commercial manufacturing."

"DMPK and translational research is an important part of the drug development throughout the R&D processes from drug discovery to IND filing." Dr. Steven Yu said, "I hope my experience will help Transcenta to select molecules with higher potency and better safety profiles, and further improve the success rate of clinical trials."