Boan Biotech (06955): Dexumab injection 60 mg reached an authorized cooperation in Japan

Zhitong Finance App News, Boan Biotech (06955) announced that the company has reached a cooperation agreement with its partner on the Japanese market rights of desulumab injection 60 mg (BA6101). According to the agreement, the partner will receive exclusive commercialization rights for the product in Japan, including promotion, sales and registration declarations, and will be fully responsible for its development and entry into the Japanese market; the company will receive down payment, milestone payment and sales commission.

Dexumab is a RANK ligand (RANKL) inhibitor. ^{BA6101 is a biosimilar of the original drug Prolia ® (Japanese trade name: Pralia®) for didesumab injections. Pralia® has been approved in Japan to treat osteoporosis and inhibit the progression of bone erosion associated with rheumatoid arthritis.}

In Japan, there are approximately 15.9 million osteoporosis patients aged 40 and over, and about 825,000 people with rheumatoid arthritis. There is a long-term need for fracture prevention and bone erosion management. According to public data, Pralia ^® sales in Japan in 2025 were 45.8 billion yen, up 8.3% year over year. Furthermore, the Japanese government proposed a quantitative target. By the end of the 2029 fiscal year, at least 60% of the biosimilar varieties already available will have a biosimilar replacement rate of 80%. The combination of clinical demand and policy orientation has created a clear market space for high-quality and affordable biosimilars.

The company will work with partners to integrate resources and complement each other's advantages to jointly improve the accessibility of desulumab medication in Japan. This cooperation is another important step forward for the company to continue to promote self-developed products overseas.

BA6101 is independently developed based on the company's global R&D strategy. The development process strictly follows the biosimilar guidelines of the United States, the European Union, the United Kingdom, Japan and China. Through a series of progressive studies on pharmacy, non-clinical, human pharmacokinetics and clinical efficacy, it has been confirmed that it is highly similar to the original drug in terms of safety, purity, and efficacy, and there are no differences in clinical significance.

BA6101 was approved for marketing in China in 2022 as the first domestically produced suzumab. The company also continues to promote the registration and listing of this product in overseas markets: the product has now been approved for listing in Bolivia, and is in the review stage of listing license applications in the UK and US. It is expected that it will be approved one after another within the next year, and will expand to more countries and regions in the future. At the same time, the company has established commercial cooperation networks around this product in various countries and regions such as the United States, Southeast Asia and Latin America.