BOAN BIOTECH (06955) surged more than 4% in afternoon trading, reaching HK$10.34 with a turnover of HK$31.69 million. The company announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorization applications for two self-developed denosumab injections: BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology.

BOAN BIOTECH considers BA6101 and BA1102 as core products in its global development strategy and plans to submit marketing applications to international regulatory agencies, including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Given the broad clinical demand and strong therapeutic value, denosumab demonstrates significant global market potential. Public data shows that Prolia and Xgeva, two existing denosumab products, generated combined global sales of approximately $6.6 billion in 2024.

To support its global commercialization goals, BOAN BIOTECH has established a comprehensive quality management system compliant with Chinese, European, US, and Japanese standards, ensuring the successful international expansion of denosumab and future biologics.