Major Events - Zijin Mining International (02259) is conducting an IPO from September 19 to September 24, with expected listing on September 29 [1] - Xipuni (02583) is also conducting an IPO from September 19 to September 24, with expected listing on September 29 [1] - China National Nuclear Corporation (01735) plans to establish a strategic partnership with Ant Blockchain in the fields of new energy digital assets and AI ecology [1] - Huajian Medical (01931) has officially completed the world's first RWA building - ETHK building, marking a new era of physical and scalable technology for ETHK's financial ecosystem [1] - Hong Kong Broadband (01310) received a placement of 47.925 million existing shares from its controlling shareholder, China Mobile Hong Kong [1] - Jieli Trading Treasure (08017) launched DeepTrade AI Agent, an intelligent trading system [1] - Fuhong Hanlin (02696) received approval from the European Commission for HLX14 (dazhu single antibody) for specific osteoporosis treatment indications [1] - Changying Group (Holdings) (00689) underwent a major shareholder change, with VCYBER acquiring 13.92% of the company's shares [1] - Zhaojin Mining Industry (01818) plans to invest $30 million to subscribe for cornerstone shares of Zijin International [1] - Boya Interactive (00434) established a strategic partnership with New Fire Technology to jointly explore Web3 ecological development opportunities [1] - Yangtze Optical Fibre and Cable (06869) experienced abnormal trading fluctuations in A-shares, with no significant impact on financial data from the hollow fiber-related business [1] - Baiguoyuan Group (02411) plans to issue a total of 279.5 million placement shares, aiming to raise approximately HKD 325 million [1] - Youbao Online (02429) plans to issue up to 157.5 million placement shares at a discount of approximately 16.95% [1] Operating Performance - SF Holding (06936) reported a total revenue of CNY 24.787 billion from its express logistics, supply chain, and international businesses in August, representing a year-on-year growth of 7.86% [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international presence and product influence in the market [1][2] Group 1: Product Approval - BILDYOS and BILPREVDA have received centralized marketing authorization in all EU member states and EEA countries, which includes Iceland, Liechtenstein, and Norway [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for bone loss related to prostate cancer and long-term systemic glucocorticoid therapy [1] - BILPREVDA is indicated for the prevention of skeletal-related events in adults with advanced bone malignancies and for the treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Group 2: Regulatory and Clinical Background - The approval was based on a comprehensive review of comparative studies demonstrating the high similarity of HLX14 (the active ingredient in BILDYOS and BILPREVDA) to its reference drug, Prolia, in terms of quality, safety, and efficacy [2] - The company received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products in June 2025, confirming compliance with EU GMP standards for the production line of HLX14 [2] - In July 2025, HLX14 received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending the approval of the marketing authorization applications for BILDYOS and BILPREVDA [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international market presence and product influence [1][2]. Product Approval - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women and men, bone loss in prostate cancer patients undergoing hormone ablation, and bone loss related to long-term systemic glucocorticoid treatment in high-risk adult patients [1]. - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in adults with advanced bone malignancies and treating patients with giant cell tumors of bone that cannot be surgically removed or may lead to severe functional impairment [1]. Regulatory Basis - The approval is based on comprehensive reviews of comparative studies between HLX14 (the biosimilar) and its reference drug Prolia, demonstrating high similarity in quality, safety, and efficacy [2]. - The European Medicines Agency's guidelines allow extrapolation of clinical safety and efficacy data to other approved indications of the reference drug [2]. International Recognition - Following the approval in the United States, the EU approval of BILDYOS and BILPREVDA represents further recognition of the company's products in major international markets, supporting its globalization strategy [2].