YuHe Biotech Appoints Dr. Changting Haudenschild as Chief Medical Officer and Dr. Yongzeng Wang as Chief Technology Officer

Juventas Appoints Dr. Changting Chen as Chief Medical Officer and Dr. Yongzeng Wang as Chief Technology Officer

On July 2, 2021, Juventas (Tianjin) Co., Ltd. (hereinafter referred to as “Juventas”) announced that Dr. Changting C. Haudenschild, M.D., former Medical Reviewer/Team Leader at the U.S. FDA Center for Biologics Evaluation and Research (CBER), and Dr. Yongzeng Wang, Ph.D., global quality audit expert in “cell and gene therapy,” have officially joined Juventas. Dr. Haudenschild will serve as the company’s Chief Medical Officer (CMO), taking full responsibility for the company’s global clinical development strategy and execution, as well as the formulation and management of medical and regulatory strategies; Dr. Wang will serve as the company’s Chief Technology Officer (CTO), taking full responsibility for technical decision-making and management, including the establishment and operation of Juventas’ Quality Management System (QMS) and the development of cell manufacturing processes.

JuventasDr. Lu Lulu, CEO, welcomed Dr. Chen Changting and Dr. Wang Yongzeng to Juventas, stating: “Internationally experienced innovative talent is a critical strategic resource and essential developmental requirement for innovative biopharmaceutical companies to achieve leapfrog growth and compete globally. We are confident that with the addition of these two international experts, their extensive experience and outstanding capabilities in cell therapy clinical development, regulatory strategy formulation, process development, quality system establishment, and leadership will inject strong momentum into Juventas’ new drug R&D, technological innovation, and global expansion.”

JuventasCMO Dr. Changting Chen

Dr. Changting Chen sinceServed at the U.S. FDA from 2005 to 2018 as a Medical Officer/Team Leader in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER). He was responsible for the review and approval of Investigational New Drug (IND), Biologics License Application (BLA), and Investigational Device Exemption (IDE) submissions for biologics, including cell therapies, gene therapies, and tissue regenerative medicine products, as well as the design and review of special regulatory pathways such as Fast Track and Breakthrough Therapy. As Clinical Lead, he directed the clinical team in completing marketing approvals for multiple cell and gene therapy products, particularly pioneering products in fields such as the world’s first adeno-associated virus (AAV) vector-mediated gene therapy (LUXTURNA) and umbilical cord blood hematopoietic progenitor cell therapy (HPC, Cord Blood). Dr. Changting Chen has made pioneering contributions to regulatory science research in cell and gene therapy and served as a lead author for multiple FDA regulatory guidance documents.

JuventasCTODr. Wang Yongzeng

Dr. Wang Yongzeng is an International Cell Therapy Quality Audit Expert and a Global Quality Auditor for Cell and Gene Therapy ((GTP/GMP cell and gene therapy audits), he has repeatedly established and launched technical platforms from scratch, successfully achieving GMP-compliant clinical supply. He has led technical teams in strict compliance with regulatory requirements (FDA/EMA/cFDA) to deliver GMP-compliant clinical manufacturing, prepare IND/BLA filings, and plan commercial manufacturing facilities. Dr. Wang Yongzeng has achieved outstanding accomplishments in manufacturing operations, development centers, quality systems, and GTP/GMP quality audits for collaborative suppliers, including hospitals. The projects under his leadership have successfully advanced into high-end global platforms for cell and gene therapy clinical trials and commercial manufacturing. He played a pivotal role in the global commercialization of the world’s first CAR-T product and in the quality assurance of global clinical trials. With a long-standing dedication to the cell therapy sector, Dr. Wang possesses a broad international perspective, extensive credentials, and profound experience. He has also delivered significant results in establishing quality management teams and ensuring the efficient operation of international projects, encompassing manufacturing, quality (QA/QC/validation), MS&T, CMC management, engineering, and supply chain establishment.

Juventas was founded inFounded in June 2018, Juventas is a next-generation biopharmaceutical enterprise driven by innovative cell and gene technologies. Through in-depth collaboration with premier national research institutes and clinical research centers, it focuses on the research, development, and commercialization of innovative therapeutics such as immune cell therapies, and is dedicated to building an industry-leading platform for the R&D, clinical translation, and commercialization of cell therapy drugs. Its first core product, CNCT19 Cell Injection, has been granted "Breakthrough Therapy" designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is expected to become the first commercially launched CD19-targeting CAR-T product with proprietary intellectual property.

JuventasCEO Dr. Lulu Lv

Dr. Lu Lulu stated that, as the relevant core products advance to registration clinical trials,With the advancement to Phase II and the establishment of a pipeline R&D system centered on core platforms such as CAR technology, iPSCs technology, and gene editing technology, Juventas has entered the fast lane of development and embarked on a period of rapid growth.

The addition of Dr. Chen Changting and Dr. Wang Yongzeng further strengthens Juventas' capabilities in international development and will open up new prospects for its global strategic expansion.