科兴制药引进产品——地舒单抗注射液获中国澳门药监局批准上市

Core Viewpoint - The approval of the two biosimilar drugs, Deshu Single Antibody Injection, by the Macau Drug Regulatory Authority marks a significant milestone for the company, as it is the first major oncology drug from its collaborative products to gain market entry in the Hong Kong and Macau regions [1][2]. Group 1: Product Details - The two approved products are Deshu Single Antibody Injection in 60mg (brand name: Boyoubai) and 120mg (brand name: Boluoga), which are biosimilars of Prolia and Xgeva, respectively [1][2]. - Boyoubai is indicated for osteoporosis in postmenopausal women at high risk of fractures, while Boluoga is used for treating giant cell tumors of bone that cannot be surgically removed or where surgery may lead to severe functional impairment [2]. Group 2: Market Potential - The Chinese market for Deshu Single Antibody is projected to reach 3.741 billion yuan by 2025 and may exceed 10 billion yuan by 2030, driven by an aging population and increasing treatment rates [3]. - In Macau, the population aged 65 and above accounted for 13.66% in 2023, indicating a significant demand for treatments related to osteoporosis and cancer [3]. Group 3: International Strategy - The company has adopted a "global selection, global coverage" strategy, focusing on high-growth emerging markets and the EU, leveraging cost-effective high-end biosimilars [4]. - The establishment of local teams in various countries aims to enhance market responsiveness and competitiveness, facilitating the introduction of products into the European and American markets [4]. - The approval of Deshu Single Antibody in Macau, along with the existing product "Kuyang Capsule" in Hong Kong, enhances the company's market presence in the Guangdong-Hong Kong-Macau Greater Bay Area [4].