BOAN BIOTECH (06955) has announced the submission of Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab injection, 60mg) and BA1102 (denosumab injection, 120mg). This submission marks a significant milestone in the company's strategy to accelerate the global expansion of its core products.
Denosumab is a RANK ligand (RANKL) inhibitor. BA6101 and BA1102 are biosimilars to the reference drugs Prolia® and Xgeva®, respectively. The applications in the U.S. cover all indications of the originator products: BA6101 for the treatment of osteoporosis and BA1102 for the treatment of bone metastases from solid tumors, multiple myeloma, giant cell tumor of bone, and hypercalcemia.
Developed independently under the company's global R&D strategy, BA6101 and BA1102 were developed in strict accordance with biosimilar guidelines from the U.S., EU, UK, Japan, and China. Through a comprehensive series of studies encompassing pharmaceutical quality, non-clinical, pharmacokinetic, and clinical efficacy assessments, the products have been confirmed to be highly similar to their reference products in terms of safety, purity, and potency, with no clinically meaningful differences.
Denosumab has accumulated substantial evidence-based medical data over more than a decade of clinical use, is recommended by numerous domestic and international authoritative guidelines, plays a crucial role in relevant therapeutic areas, and demonstrates broad market prospects. Public data indicates the combined global sales of Prolia® and Xgeva® are projected to reach approximately $6.498 billion in 2025, with U.S. sales accounting for roughly $4.333 billion.
To efficiently advance the commercialization of BA6101 and BA1102 in the U.S. market, in December 2025, the company entered into a cooperation agreement with a domestic global pharmaceutical company, granting it exclusive rights to promote these two products in the United States. The partner possesses established R&D, quality, regulatory, and sales teams in the U.S. and is one of the suppliers with the most comprehensive injectable sales pipeline in the region.
Beyond the U.S. market, the company is actively promoting the global deployment of BA6101 and BA1102. Currently, both products have received marketing approval in China, an application is under review in the UK, and BA6101 has been approved in Bolivia. The company will continue to expand the registration and commercialization process for denosumab in the EU, Japan, and other high-potential international markets.
Regarding the global promotion of the two denosumab products, the company has established a collaborative network across multiple countries and regions. In mainland China, BOAN BIOTECH collaborates with Qingdao Guoxin Pharmaceutical Co., Ltd. to enhance market penetration for BA6101. A commercialization agreement has been reached with Sinovac Biotech Ltd. for both denosumab products in Hong Kong and Macau. Overseas, the company partners exclusively with Shanghai Pharmaceutical Holding Co., Ltd. in certain Southeast Asian countries and with PHARMACARE in certain Latin American countries for the commercialization of these two products.
As the company's first products for international expansion, BA6101 and BA1102 are expected to become key drivers for the growth of its overseas business and lay the foundation for the internationalization of its subsequent series of biologics. Both products are already marketed in China and have received positive feedback from doctors and patients in clinical practice. The company will continue to collaborate with partners to refine its global commercialization system, accelerate the successful launch of these products in key overseas markets, and benefit more patients with high-quality, affordable biologics, thereby improving treatment accessibility in relevant therapeutic areas.