On January 11, 2024 local time in Berlin, Germany, the "International Phase III Clinical Trial Enrollment and Phase I Trial Results Conference" of Denosumab Injection (BA6101 and BA11021) independently developed by Boan Biotech was successfully held. Dr. Rainard Fuhr of Parexel International GmbH, Dr. Changlin Dou, President and Chief Operating Officer of Boan Biotech, and Dr. Ming Zhou, Chief Medical Officer of Boan Biotech, and the core members of the Phase I clinical trial gathered together to discuss the results of the Phase I clinical trial and the application prospects of this product in the international market, so as to accelerate the international development process of BA6101 and BA1102.
Dr. Dou Changlin (front row, 5th from left), Dr. Zhou Ming (front row, 4th from left) and the investigator team
BA6101 and BA1102 are biosimilars to Prolia® and Xgeva®, respectively. Prolia® is widely used worldwide for osteoporosis, while Xgeva® is used worldwide for the treatment of solid tumor bone metastases and multiple myeloma, giant cell tumor of bone, and hypercalcemia.
In November 2022, the first domestically produced denosumab injection, BA6101 (Boyoubei ®), was first launched in China, and received positive feedback from doctors and patients in clinical application. In March 2023, the marketing authorization application for BA1102 was accepted by the National Medical Products Administration (NMPA) and will soon be approved for marketing.
In 2020, the phase I clinical trial was approved in the United States and Europe, and the phase I clinical trial (pharmacokinetic comparison trial) in Europe has been completed and announced for the first time at this meeting, and the phase III clinical trial (efficacy comparison study) in 2022 has been approved in Europe, the United States and Japan, and all subjects have been enrolled.
At the Berlin meeting, Dr. Rainard Fuhr, the principal investigator of the Phase I trial, and the Boan Biotech team exchanged clinical data and results in detail. The clinical trial is a randomized, double-blind, three-arm, single-dose comparison study of Prolia® from Europe and the United States. The results showed that BA6101, Prolia® in the European Union and Prolia® in the United States reached bioequivalence in pharmacokinetics and pharmacodynamics, respectively, and the safety and immunogenicity were similar.
Plasma concentration-time curve of Boan Biodenosumab International Phase I clinical trial
At present, the international multicenter efficacy-safety comparative clinical trial (phase III) of denosumab is being carried out simultaneously in Europe, the United States, and Japan. The trial is a randomized, double-blind, parallel, and original reference drug control international multi-center clinical study comparing the efficacy, safety, pharmacokinetics and immunogenicity of Boan Biotech's denosumab injection with Prolia®, the original reference drug. According to the industry guidance "Scientific Considerations for Demonstrating Biosimilarity to Comparators" issued by the U.S. Food and Drug Administration (FDA)2, the "Biosimilar Guidelines" issued by the European Medicines Administration (EMA)3, the "Guidelines for Quality, Safety and Efficacy Assurance of Biosimilars" issued by the Japan Pharmaceutical and Medical Device Agency (PMDA)4, and Boan Biotech and the FDA, After the completion of the international multi-center comparative clinical trial, BA6101 and BA1102 can submit marketing applications to the FDA, EMA and PMDA respectively, applying for all indications of the original reference drug.
About Boan Biotech
Boan Biotech (6955.HK) HK) is a fully integrated biopharmaceutical company specializing in the development, manufacturing and commercialization of biologics with a focus on oncology, autoimmune, ophthalmology and metabolic diseases. The company's new drug discovery activities revolve around multiple platforms, including fully human antibody transgenic mouse and phage display technology platform, bispecific T-cell Engager technology platform, antibody drug conjugation (ADC) technology platform and cell therapy platform.
Anbio has a complete fully integrated industrial chain covering antibody discovery, cell line development, upstream and downstream process development, analytical and bioanalytical method development, technology transfer, non-clinical research, clinical research, regulatory and regulatory registration, and commercial-scale production. In the field of cell therapy, Boan focuses on a new generation of enhanced and modulated T cell therapy technologies to develop safer, effective and affordable cell therapy products.
At present, Boan Biotech has two commercial products, as well as a number of innovative biologics and biosimilars with international intellectual property protection. In addition to China, Boan Biotech is also engaged in the development of biopharmaceutical products in overseas markets, including Europe and the United States. Based on the differentiated product portfolio and the continuous maturity of commercialization capabilities, Boan Biotech has built a whole industry value chain operation system covering "R&D-production-commercialization", laying a solid foundation for its long-term high-quality development.
1. Note: The former product codes of Boan Biodenosumab BA6101 and BA1102 are LY06006 and LY01011, respectively
2.FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015
3.EMA. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 2015
4.PMDA. Guideline for the quality, safety, and efficacy assurance of follow-on biologics. 2009