Boan Biotech today announced that Boluojia®, a denosumab injection (120mg) developed by the company, has been approved for marketing by China’s National Medical Products Administration (NMPA) for the treatment of giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity in adults and skeletally mature adolescents (defined as having at least one mature long bone and with body weight ≥ 45 kg).
At the same time, Boan Biotech is working on the Biologics License Application (BLA) of Boluojia in China for the indications of bone metastases from solid tumors and multiple myeloma. The company is also conducting an international multicenter Phase 3 clinical trial for Boluojia in Europe, the U.S., and Japan, with a plan to launch the product in other countries as well.
Denosumab is a preferred treatment for GCTB, and Boluojia is highly similar to the reference product
GCTB is a primary borderline bone tumor that accounts for 13.7% to 17.3% of all primary bone tumors in China. GCTB is locally aggressive, and has a propensity for local recurrence and distant metastases, which can become life-threatening in severe cases1. Denosumab is a preferred treatment for GCTB. For patients whose tumor can be surgically resected, denosumab can be a downstaging therapy or even help avoid surgery. For patients whose tumor can’t be surgically resected, denosumab can effectively control it for a long period of time and improve their quality of life.
Boluojia is a biosimilar to XGEVA®. Its active ingredient is denosumab, a fully human IgG2 anti-RANKL monoclonal antibody. The development of Boluojia strictly followed relevant guidelines for biosimilars in China, the U.S., the EU, and Japan, and its overall similarity with the reference product XGEVA has been proven by comprehensive evidence from step-by-step comparative analytical, non-clinical, human pharmacokinetic and clinical efficacy studies. In particular, Boluojia is shown to be highly similar to the reference product in terms of quality, safety, and efficacy, with no clinically meaningful difference. Two pivotal clinical studies (Phase 1 and Phase 3) of Boluojia were completed in China comparing it with XGEVA head-to-head. The results of the Phase 1 clinical trial were published in the Journal of Bone Oncology2, and the results of the Phase 3 clinical trial were presented at the 2023 Annual Meeting of American Society of Clinical Oncology (ASCO) in the form of a poster.
Prof. Hu Xichun from the Fudan University Shanghai Cancer Center, principal investigator of the Phase 3 clinical trial for Boluojia in China, said: “Boluojia and the reference product met the endpoints for safety and efficacy in the Phase 3 trial. The results of the trial were presented as a poster at the 2023 Annual Meeting of ASCO. I believe that the approval of this product will further increase the accessibility of denosumab and provide a new and better option for patients.”
An international multicenter Phase 3 study is underway for Boluojia
In addition to GCTB, XGEVA has also been approved in many countries for the treatment of bone metastases from solid tumors, multiple myeloma, and hypercalcemia of malignancy. Denosumab has been in clinical use for over a decade, and abundant evidence has been accumulated. It is recommended by multiple authoritative guidelines in China and abroad, including those of European Society of Medical Oncology (ESMO)3,4 , National Comprehensive Cancer Network (NCCN)5,6, ASCO7, and Chinese Society of Clinical Oncology (CSCO)1,8,9.
Boluojia is being developed globally in addition to China. An international multicenter Phase 3 clinical trial is going on in Europe, the U.S. and Japan, and all subjects have been enrolled. After the completion of this study, Boan Biotech will submit a BLA to the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) respectively for all approved indications of the reference product.
Dr. Dou Changlin, Chief Operating Officer and President of R&D at Boan Biotech, said: “We are excited to see the swift approval of Boluojia in China. Taking advantage of the momentum built by our existing oncology products, we will be able to commercialize it quickly. Thanks to our robust R&D management system and technological strengths, we have launched three products since 2021 -- Boyounuo®, Boyoubei®, and Boluojia, and will launch more both in China and abroad over the next three years. By leveraging our existing products and those to be launched soon, we will further grow our team’s capabilities, enhance our technology platforms, and gain more financial resources. This will help to drive our sustainable growth and innovation in the long run and allow us to achieve the vision of becoming a leading global biopharmaceutical company earlier.”
Jiang Hua, Chairlady and CEO of Boan Biotech, said: “The biopharmaceutical industry is an emerging industry of strategic importance for China. As a ‘new quality productive force’, its growth is driven by innovation. As one of the few domestic biopharmaceutical companies with an integrated 'R&D-Manufacturing-Sales' system, we have built a balanced portfolio that includes biosimilars for short-term visibility and innovative biologics for long-term growth. Thanks to the launch of our first products, we are now on a fast track to reaping the benefits. We will move even faster to launch more products and serve more patients. We are ready to embrace a better future with the Chinese biopharmaceutical industry.”
References
1. Chinese Society of Clinical Oncology (CSCO). Guidelines for the Diagnosis and Treatment of Musculoskeletal Tumors 2023.
2.Ding Y, Liu Y, Dou C, Guo S. A randomized trial comparing LY01011, biosimilar candidate, with the reference product denosumab (Xgeva®) in healthy Chinese subjects. J Bone Oncol. 2023 Sep 1;42:100499.
3.Coleman R, Hadji P, Body JJ, et al. Bone health in cancer: ESMO Clinical Practice Guidelines [J]. Ann Oncol, 2020, 31(12):1650-1663.
4.Planchard D, Popat S, Kerr K ,et al.Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up [J]. Ann Oncol,2018,29(Suppl 4):192-237.
5.NCCN Guidelines for Patients, Bone Cancer. Version 2. 2024.
6.NCCN Guidelines for Breast Cancer. Version 2. 2024.
7.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.
8.Chinese Society of Clinical Oncology (CSCO). Guidelines for the Diagnosis and Treatment of Breast Cancer 2024.
9.Chinese Society of Clinical Oncology (CSCO). Guidelines for the Diagnosis and Treatment of Hematological Malignancies 2023.
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