Mabwell(SH:688062) Zheng Quan Zhi Xing·2025-08-31 10:13Core Viewpoint - Maiwei Biotech has received registration approval for two biosimilar drugs, 9MW0311 and 9MW0321, from the Drug Regulatory Authority of Pakistan, marking a significant milestone in the company's global commercialization strategy [1][4]. Drug Information - 9MW0311 (Rexeva) is approved for osteoporosis treatment in postmenopausal women at high risk of fractures, with a specification of 60mg and registration number 127267 [1]. - 9MW0321 (Denosu) is approved for treating giant cell tumor of bone (GCTB) in adults and adolescents, with a specification of 120mg and registration number 127268 [2]. Market Potential - Pakistan, with a population of 240 million, represents a significant emerging market for pharmaceuticals, driven by increasing medical demand [1]. - The global market for denosumab drugs for osteoporosis treatment is projected to reach $1.317 billion in 2024 [2]. International Expansion - The company has signed formal cooperation agreements with 30 countries, including Brazil, Colombia, and Indonesia, to expand the market for 9MW0311 and 9MW0321 [3]. - Registration applications for these drugs have been submitted to five additional countries, including Jordan and Egypt, with more applications in preparation [3]. Competitive Advantage - The approval of these biosimilars enhances the company's core competitiveness and supports its ongoing efforts to penetrate emerging markets [4].