Core Viewpoint - Maiwei Biotech (688062.SH) has received registration approval from the Drug Regulatory Authority of Pakistan (DRAP) for its two biosimilar products, 9MW0311 and 9MW0321, marking a significant milestone in the company's global commercialization strategy [1] Group 1: Product Approval - The two biosimilar products, known domestically as Mai Li Shu® and Mai Wei Jian®, are the first biosimilars of de-sumumab approved by the DRAP [1] - This approval represents the company's first overseas registration for its products, enhancing its competitive edge in the global market [1] Group 2: Market Potential - Pakistan, with a population of 240 million, is identified as a key emerging market with growing pharmaceutical demand, aligning with the company's strategic focus on expanding in such regions [1] - The approval is expected to positively impact the company's efforts to expand into new markets and improve its core competitiveness [1] Group 3: Global Strategy - As of the announcement date, the company has signed formal cooperation agreements covering dozens of countries in overseas markets [1] - The company aims to continue promoting the commercialization of its products in more countries, further enhancing the global accessibility of its de-sumumab injection [1]

人民财讯8月31日电，迈威生物(688062)8月31日晚间公告，公司近日收到合作客户The Searle Company Limited的通知，公司两款地舒单抗注射液9MW0311和9MW0321(国内商品名：迈利舒和迈卫健)已获得 巴基斯坦药品监管局的注册批准。这是巴基斯坦药品监管局首次批准的地舒单抗生物类似药，也是公司 首个获得海外注册批件的产品。迈威生物同日公告，公司近日收到国家药品监督管理局签发的《受理通 知书》，9MW3811注射液用于病理性瘢痕适应症的II期临床试验申请已获正式受理。 ...

Core Viewpoint - The company has received regulatory approval for two biosimilar products in Pakistan, marking a significant milestone in its international expansion efforts [1] Group 1: Product Approval - The Searle Company Limited has notified the company that its two biosimilar injections, 9MW0311 and 9MW0321, have been approved by the Drug Regulatory Authority of Pakistan (DRAP) [1] - This approval represents the first registration of a biosimilar drug for denosumab by the DRAP [1] - The products are the company's first to receive overseas registration, indicating a successful entry into the international market [1] Group 2: Product Details - 9MW0311, marketed as "迈利舒" in China, is indicated for osteoporosis in postmenopausal women at high risk of fractures [1] - 9MW0321, marketed as "迈卫健" in China, is used for the treatment of giant cell tumor of bone (GCTB) that cannot be surgically removed or where surgery may lead to severe functional impairment [1]