Boan Biotech Enters into Licensing Agreement for Denosumab Injection 60 mg in Japan

Yantai, China, October 30, 2026 – Boan Biotech announced today that it has entered into a licensing agreement with a partner for BA6101, a 60 mg denosumab injection, in Japan. Under the agreement, the partner will receive exclusive commercialization rights to BA6101 in Japan and will be responsible for its regulatory submissions, market access, promotion and sales in the Japanese market. Boan Biotech will receive an upfront payment, milestone payments and royalties on sales.

Denosumab is a RANK ligand (RANKL) inhibitor. BA6101 is a biosimilar to the reference denosumab product Prolia®, marketed as Pralia® in Japan for treating osteoporosis and inhibiting the progression of bone erosion associated with rheumatoid arthritis.

It is estimated that 15.9 million people aged 40 and older in Japan have osteoporosis,  while approximately 825,000 people have rheumatoid arthritis,  underscoring the substantial need for fracture prevention and management of bone erosion. Publicly available data shows that the sales of Pralia in Japan were 45.8 billion yen in FY2025, growing 8.3% YoY.  Japan aims to achieve a biosimilar replacement rate of 80% for at least 60% of existing Active Pharmaceutical Ingredients (APIs) by the end of FY2029.  Together, these clinical needs and supportive policies create favorable conditions for the adoption of high-quality, affordable biosimilars in Japan.

BA6101 was developed by Boan Biotech following the company’s global development strategy in strict compliance with the guidelines for biosimilars adopted in the U.S., the EU, the U.K., Japan, and China. A stepwise program of comparative quality, nonclinical, human pharmacokinetic and clinical efficacy studies demonstrated that BA6101 is highly similar to the reference product, having no clinically meaningful differences with the reference product in safety, purity or potency.

BA6101 was approved for marketing in China as the country’s first domestically developed denosumab injection back in 2022. Internationally, BA6101 has received marketing authorization in Bolivia, and its Marketing Authorization Application (MAA) in the U.K. and Biologics License Application (BLA) in the U.S. are currently under review, with approvals expected within the next year. Boan Biotech will seek marketing authorization for the drug in other countries and regions as well. It has put into place a network of partners to commercialize the drug in countries and regions including the U.S., Southeast Asia, and Latin America.

Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said: “Against the backdrop of an aging population, osteoporosis and other bone health conditions pose a significant healthcare challenge in Japan. We will work closely with our partner, bringing together our resources and expertise to make BA6101 more accessible to patients in Japan. This agreement marks another milestone in expanding the global reach of our products. We will continue to pursue regulatory approvals for our core products in key international markets, advance their commercialization and expand our global partnerships. This is in line with our mission to provide high-quality, affordable biologics for as many patients as possible.”
 

References:  
1. Japan Preventive Association of Life-Style Related Disease. https://seikatsusyukanbyo.com/statistics/disease/osteoporosis/. Accessed October 28, 2026.
2. Miyashiro M, Ishii Y, Miyazaki C, et al. A Real-World Claims Database Study Assessing Long-Term Persistence with Golimumab Treatment in Patients with Rheumatoid Arthritis in Japan[J]. Rheumatology and Therapy, 2023, 10(3): 615–634. DOI: 10.1007/s40744-023-00539-z.
3. Daiichi Sankyo Co., Ltd. Reference Data (Consolidated Financial Results for FY2025), https://www.daiichisankyo.com/files/investors/library/quarterly_result/2025/Q4/FY2025Q4_Reference_Data_Corrections_E.pdf. Accessed October 28, 2026.
4. Ministry of Health, Labour and Welfare, Japan. Promotion of Generic Drugs and Biosimilars https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/kouhatu-iyaku/index.html. Accessed October 28, 2026.