Bioray Biopharma Enters the "Dual-An" Era in IBD with the Official Launch of Anbait® (Infliximab for Injection)
March 12, 2022, “Together for a Future: Anbait” hosted by Zhejiang Biory Pharmaceutical Co., Ltd. (hereinafter referred to as “Biory”)®The “National Launch Conference” was grandly held. Renowned experts and scholars in the field, including Professor Chen Minhu from the First Affiliated Hospital of Sun Yat-sen University, Professor Wu Kaichun from Xijing Hospital of Digestive Diseases, Air Force Medical University, and Professor Qian Jiaming from Peking Union Medical College Hospital, together with Dr. Wang Haibin, CEO of Bio-Thera Solutions, jointly participated in this prestigious event to support Anbait.®Upon its market debut, in-depth discussions and exchanges were conducted on topics such as “Building an IBD Multidisciplinary Team (MDT) Collaborative Model” and “The Career Development Path for Young IBD Physicians,” jointly exploring the new future of the inflammatory bowel disease (hereinafter referred to as “IBD”) field in China.
The meeting opened with remarks delivered by Professor Chen Minhu and Dr. Wang Haibin, respectively.
“Looking back, the field of inflammatory bowel disease (IBD) in China has traversed a glorious 40-year journey since 1980, and we are now at the dawn of the IBD 3.0 era.” In his address titled “Forty Years of IBD in China and Prospects for the IBD 3.0 Era,” Professor Chen Minhu reviewed the developmental trajectory of China’s IBD field and outlined its future prospects. He stated, “Regarding the future development of IBD in China: transitioning from data to evidence requires sincere collaboration; interdisciplinary integration demands vision and strategic perspective; basic research necessitates time and patience; and the professional growth of young IBD physicians calls for dedication and hard work.”
Dr. Wang Haibin, CEO of Bio-Thera Solutions, stated, “Bio-Thera Solutions is deeply committed to the research, development, and commercialization of therapeutic products in the field of inflammatory bowel disease (IBD). We continue to enhance the competitiveness of our core products, stay true to our original mission, and strive to provide patients with a diverse and reliable portfolio of solutions. Furthermore, we will actively collaborate with Chinese experts and scholars to boldly explore innovations in the IBD field, addressing the long-standing unmet clinical needs of patients in China. The successful market launch of Anbaituo, which has received special support from the National Major New Drug Creation Project, marks that, following Anjianning®(Adalimumab) marks another significant milestone for Bio-Thera Solutions in the field of inflammatory bowel disease (IBD), establishing a comprehensive “dual-Adalimumab” product portfolio in this therapeutic area and providing IBD patients with higher-quality treatment options and greater clinical benefits.
It is reported that Anbaiter®, which has recently received marketing approval, is Infliximab for Injection, a chimeric human-mouse monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α) independently developed by Bio-Thera Solutions. The development of this drug was supported by the National “Major New Drug Creation” Special Project. It is primarily indicated for the treatment of rheumatoid arthritis, Crohn’s disease in adults and children aged 6 years and older, fistulizing Crohn’s disease, ankylosing spondylitis, psoriasis, and ulcerative colitis in adults.
Data indicate that inflammatory bowel disease (IBD) is a chronic inflammatory intestinal disorder primarily affecting the digestive system, encompassing Crohn’s disease (CD) and ulcerative colitis (UC). Over the past two decades, the incidence of IBD in China has risen rapidly. According to data from Huajing Industry Research Institute, the market size of China’s pharmaceutical treatment industry for IBD is expected to expand further as the patient population continues to grow.
Tumor necrosis factor-alpha (TNF-α), as one of the important cytokines in the body, is indispensable for maintaining homeostasis and defending against various pathogenic factors. Anbaiter® can bind with high affinity to both the soluble form (sTNF-α) and the transmembrane form (tmTNF-α) of TNF-α, inhibiting its binding to receptors and reverse signal transduction, thereby improving inflammatory responses and autoimmune diseases to meet patients' treatment needs. The launch of Anbaiter® has provided Chinese patients with inflammatory bowel disease (IBD) with a high-quality therapeutic option.
At this launch event, Biocytogen specially set up the “Baijia Forum” session, where attending experts discussed “From Anbait®In-depth discussions were held on three major topics: “The Path to High-Quality R&D: Envisioning the New Future of Biopharmaceutical Development in China,” “Building a Multidisciplinary Team (MDT) Collaborative Model,” and “Career Development Pathways for Young Physicians in IBD,” providing new insights and perspectives for the advancement of IBD care in China.
“Infliximab is a blockbuster product in the field of autoimmune diseases and is one of the biologics with the most extensive clinical experience, the most robust evidence-based medicine support, and the broadest patient population.” Dr. Wang Haibin, CEO of Bio-Thera Solutions, delivered a speech titled “From Anbaiter®In her speech, “Charting the Path of High-Quality R&D: Envisioning the New Future of Biopharmaceutical Development in China,” she provided an in-depth explanation of the R&D journey of Anbaita® (infliximab biosimilar). She stated, “From project initiation in 2013 to market launch in 2021, Anbaita®, as an infliximab biosimilar, underwent continuous ‘head-to-head’ similarity assessments throughout the entire R&D process. Its efficacy, pharmacokinetics, immunogenicity, and safety were comprehensively evaluated in clinical studies spanning pharmaceutical development, preclinical research, and clinical trials. Looking ahead, we will continue to focus on the field of inflammatory bowel disease (IBD), driving continuous innovation in biopharmaceutical R&D based on clinical needs, to provide patients with better treatment options for IBD.”
Professor Qian Jiaming of Peking Union Medical College Hospital stated, “By gaining insight into the research and development journey of Anbaituo®, particularly the quality control measures implemented during its development, we have grown more confident in domestically produced biologics. We also believe that Biopharm will continue to deliver safe and effective therapies to more patients in the future.”
At the conference, Professor Wu Kaichun from Xijing Hospital of Digestive Diseases, Air Force Medical University, provided a comprehensive and in-depth interpretation of the IBD-MDT (Multidisciplinary Team) collaborative model. Professor Wu Kaichun stated, “The IBD-MDT model leverages multidisciplinary team-based diagnosis and treatment to provide accurate diagnostic evidence for patients with inflammatory bowel disease (IBD), formulate standardized, comprehensive, multidisciplinary, and individualized treatment plans along with dynamic follow-up schedules, thereby improving patient prognosis and enhancing quality of life.”
Professor Gao Xiang from the Sixth Affiliated Hospital of Sun Yat-sen University, Professor Cao Qian from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Professor Zhong Jie from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Professor Zhu Weiming from the General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army engaged in an insightful dialogue on the development of multidisciplinary team (MDT) collaboration models. The participating experts unanimously agreed that an IBD-MDT team should be led by seasoned chief specialists and comprise outstanding physicians who demonstrate professionalism, resilience, and passion in their respective fields. Mutual growth among team members is fostered through extended periods of practical collaboration and refinement. Furthermore, establishing robust communication mechanisms is essential to facilitate the effective operation of IBD-MDT teams, thereby enhancing patient care.
Furthermore, Professor Wang Yufang from the Department of Gastroenterology at West China Hospital of Sichuan University, Professor Yang Hong from Peking Union Medical College Hospital, Professor Liang Jie from Xijing Hospital of Digestive Diseases of Air Force Medical University, and Professor Shen Jun from Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine jointly discussed the career development path for young physicians specializing in inflammatory bowel disease (IBD). The experts emphasized that young IBD physicians are the backbone of the future development of the IBD field in China. They urged these physicians to devote themselves to specialized study, remain grounded in clinical practice, and prioritize patient-centered care. While managing diverse patient cases, young physicians should engage in continuous learning, summarize clinical experiences, conduct rigorous scientific research, and keep abreast of international advancements to enhance their professional competitiveness.
Professor Chen Minhu concluded, “At today’s national launch event for Anbaituo®, the active participation of experts has sparked a vibrant exchange of ideas. This has provided valuable insights into the use and development of domestically produced biologics and offered strategic recommendations for better advancement in the IBD 3.0 era. Standing at the dawn of the IBD 3.0 era, we are confident that, through the joint efforts of experts and colleagues, China’s IBD 3.0 era will achieve international recognition and flourish.”
At Anbait®Concurrently with the market launch, Bio-Thera Solutions initiated the “Chang Qing Teng – IBD Young Researcher Fund” to promote basic and clinical research on inflammatory bowel disease (IBD) in China and support the scientific development of young domestic IBD physicians. Professor Chen Minhu also officially announced the detailed guidelines for the “Chang Qing Teng – IBD Young Researcher Fund,” which primarily cover the scope of applications, eligibility criteria, funding amounts, and project activities.
Anbote®Its successful market launch will, on the one hand, meet the substantial and long-unmet domestic demand. On the other hand, it marks that Bio-Thera Solutions has established a comprehensive “dual-anti” product portfolio in the field of inflammatory bowel disease (IBD), further expanding its leading advantage. In the future, Bio-Thera Solutions will leverage this opportunity to deepen its pipeline layout in the immunology sector, providing patients with a comprehensive and diverse range of products and solutions.