Boan Biotech Grants NKF Exclusive Rights to Commercialize Two Denosumab Drugs in the US

Yantai, Shandong, December 9 – Boan Biotech announced a licensing agreement with Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), granting NKF the exclusive rights to commercialize two denosumab injections in the U.S.: one is Boyoubei® code-named BA6101, and the other is Boluojia® code-named BA1102.

Under the agreement, NKF will be responsible for promoting and selling the two drugs in the U.S. and Boan Biotech will retain its status as the Marketing Authorization Holder (MAH) for both products, responsible for their manufacturing and supply. Boan Biotech shall receive upfront payment, milestone payments, and sales-based commissions.

Independently developed by Boan Biotech, BA6101 and BA1102 are biosimilars to Prolia® and Xgeva®, respectively. They were approved for marketing in China in 2022 and 2024 respectively, and have been well-received by physicians and patients in clinical practice ever since. Boan Biotech is actively advancing the international clinical development and registration for these two biosimilars, with plans to submit marketing authorization applications for them to major regulators such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The two products are also under regulatory review for marketing authorization applications in the UK.

Globally, Prolia is widely used for the treatment of osteoporosis, while Xgeva is indicated for bone metastases from solid tumors, multiple myeloma, giant cell tumor of bone, and hypercalcemia. Denosumab injections have strong global market potential, given clinical demand and value. Publicly available data shows that the combined global sales of Prolia and Xgeva reached approximately USD 6.6 billion in 2024, with roughly USD 4.4 billion in the U.S. alone.

To seize this opportunity, Boan Biotech has partnered with NKF to integrate their resources and complementary strengths. Boan Biotech will provide high-quality biologics by leveraging its R&D and manufacturing capabilities, while NKF will leverage its established U.S. commercial network to facilitate rapid market access for the two products.

NKF has well-established R&D, quality assurance, regulatory and sales teams in the U.S. To date, the company has supplied nearly100 products across the North American market, establishing itself as one of the suppliers with the most comprehensive injectable product portfolios for sales in the region. Through partnerships and acquisitions, NKF's U.S.-based commercial platform has rapidly expanded its product portfolio and established a biosimilar pipeline. NKF’s biologics manufacturing facility has successfully passed an on-site inspection by the FDA.

Boan Biotech is among the few fully-integrated biopharmaceutical companies in China with end-to-end R&D, manufacturing and commercial capabilities. It has successfully launched five products to date. To support its global commercialization goals, the company has established a comprehensive quality management system compliant with standards in China, the U.S., Europe, and Japan, ensuring the provision of high-quality biologics for international markets. Boan Biotech is actively building external partnerships with leading global players to drive its vision of becoming a leading biopharmaceutical company in the world. Developed under a global strategy, BA6101 and BA1102 are core assets of the company. In addition to the U.S. market, Boan Biotech has also established strategic partnerships for their commercialization in other markets such as Brazil, Hong Kong, and Macao.