The Phase 3 trial results of Boan Biotech’s anti-tumor denosumab injection (Chinese trade name: Boluojia, code-named BA1102, and formerly code-named LY01011) were recently published in Journal of Bone Oncology.
Link to the paper: https://doi.org/10.1016/j.jbo.2025.100661
As a biosimilar of XGEVA®, BA1102 contains the same active ingredient denosumab, a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL. Denosumab is recommended by many prestigious guidelines in China and abroad as a first-line therapy for delaying or reducing skeletal-related events in patients with bone metastases from solid tumors and multiple myeloma. It is also a preferred treatment for giant cell tumors of bone when they are unresectable or when surgical resection is likely to result in severe morbidity. Denosumab has been in clinical use for over a decade, and is recommended as a preferred treatment by multiple authoritative guidelines, including those from American Society of Clinical Oncology (ASCO)1, European Society of Medical Oncology (ESMO)2, National Comprehensive Cancer Network (NCCN)3, and Chinese Society of Clinical Oncology (CSCO)4.
The Phase 3 clinical trial of BA1102 led by Professor Hu Xichun from Fudan University Shanghai Cancer Center was a multicenter, randomized, double-blind, active-comparator, parallel-controlled trial comparing BA1102 with the reference drug XGEVA for efficacy and safety in 850 Chinese patients with bone metastases from solid tumors. Subjects were randomised in a 1:1 ratio to receive 120 mg of BA1102 (n=424) or 120 mg of the reference drug (n=426) subcutaneously once every four weeks.
The primary endpoint for assessing bioequivalence was the natural logarithm of change of the uNTX/uCr ratio at week 13 from baseline, whereas the secondary endpoints include the first on-study skeletal-related event, the percentage change of the s-BALP level, etc., as well as safety and immunogenicity indicators. The study met all primary and secondary endpoints, demonstrating that BA1102 and the reference drug were comparable in terms of efficacy. Additionally, they were highly similar in terms of safety, immunogenicity, and pharmacokinetics, with no statistically significant differences observed.
Time courses of the mean (SD) of the natural logarithm changes of uNTX/uCr from baseline (entire study)
BA1102 was developed following Boan Biotech’s global R&D strategy. It was approved for marketing in China in May 2024 for the treatment of giant cell tumors of bone. The drug is undergoing an international multicenter Phase 3 clinical trial in Europe, the U.S., and Japan. Upon the completion of the trial, the company will file marketing authorization applications to the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for all the approved indications of the reference drug. The reference drug has been approved across the world for treating bone metastases from solid tumors and multiple myeloma, giant cell tumors of bone, and hypercalcemia.
Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said:
"This rigorous Phase 3 study demonstrated the overall biosimilarity of BA1102 to the reference drug. The results of the trial were presented as a poster at the 2023 ASCO Annual Meeting, showing the international recognition for its quality and for China's ability to develop high-quality biosimilars. With the international multicenter clinical trial underway, I look forward to the approval of BA1102 in more countries and regions, providing a new high-quality treatment option for patients around the world."
About Boan Biotech
Boan Biotech (6955.HK) is a fully-integrated biopharmaceutical company developing, manufacturing, and marketing biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic diseases. The company's drug discovery activities revolve around multiple platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, ADC Technology Platform and Cell Therapy Platform.
Boan Biotech operates across the entire value chain of the industry covering antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, technology transfer, non-clinical research, clinical research, regulatory affairs and registration, and commercial production. In the cell therapy field, Boan Biotech focuses on a new generation of enhanced and regulated CAR-T technology, developing safer, more effective, and affordable treatments for patients.
Boan Biotech’s portfolio includes three products approved for marketing. Its pipeline includes two investigational drugs under review for their marketing applications, multiple novel biologics as drug candidates protected for their international intellectual property rights, and a number of biosimilar candidates. In addition to China, the company is also developing biopharmaceutical products in overseas markets, including the U.S., the EU, and Japan. With a differentiated portfolio and well-established commercial capabilities, Boan Biotech operates across the industry’s value chain from research and development to manufacturing and commercialization, laying a solid foundation for long-term, high-quality growth in the future.
References
1.
Anderson K, Ismaila N, Flynn PJ, et al. Role of Bone-Modifying Agents in Multiple Myeloma: American Society of Clinical Oncology Clinical Practice Guideline Update. Journal of Clinical Oncology. 2018, 36:8, 812-818
2.
Coleman R, Hadji P, Body JJ, et al. Bone health in cancer: ESMO Clinical Practice Guidelines [J]. Ann Oncol, 2020, 31(12):1650-1663.
3.
NCCN Guidelines for Patients, Bone Cancer. Version 1. 2025
4.
Chinese Society of Clinical Oncology (CSCO). Guidelines for the Diagnosis and Treatment of GCTB (2024).