每经记者｜陈星 每经编辑｜魏官红 点评：截至目前，iza-bren已有6项适应证被CDE纳入突破性治疗品种名单，1项适应证被美国食品药品 监督管理局授予突破性疗法认定。突破性治疗认定将加速上市进程，满足迫切临床需求。 NO.4 百奥泰阿达木单抗注射液获得英国MHRA上市批准 诺和诺德表示，公司将进行内部重组，并裁员约9000人，以每年节省80亿丹麦克朗（约合12.6亿美元） 的开支。诺和诺德公司在一份声明中指出，将对公司进行全面改革，以简化组织架构、加快决策速度， 并将资源重新分配至糖尿病和肥胖症领域的业务增长机会上。 点评：今年以来，诺和诺德已经几度下调业绩指引，因为其核心产品司美格鲁肽的销售压力与日俱增。 此次裁员计划亦是公司面临盈利压力之下的调整之举。 NO.2 派林生物控股股东拟变更为中国生物 派林生物发布公告称，公司控股股东共青城胜帮英豪投资合伙企业（有限合伙）与中国生物技术股份有 限公司签署了《股份转让协议》，胜帮英豪拟向中国生物转让其合计持有的公司约2亿股无限售流通股 股份，占公司总股本的21.03%。若本次权益变动实施并完成，公司的控股股东及实际控制人将发生变 更。中国生物将成为公司的控股股东 ...

BAT1406是百奥泰自主研发的阿达木单抗生物类似药，是由CHO细胞表达的重组全人源单克隆抗体，通 过与TNF-α特异性结合并中和其生物学功能，阻断其与细胞表面TNF-α受体的相互作用，从而阻断TNF- α的致炎作用。Qletli获得英国MHRA上市批准后可在英国进行销售，公司海外销售产品品类得到进一步 扩充，将进一步提升公司产品的国际影响力，有望对公司长期经营业绩产生积极影响。 成人适应症：类风湿关节炎、多关节型幼年特发性关节炎、与附着点炎症相关的关节炎、强直性脊柱 炎、无强直性脊柱炎影像学证据的中轴型脊柱关节炎、银屑病关节炎、银屑病、化脓性汗腺炎、克罗恩 病、溃疡性结肠炎、葡萄膜炎；儿童适应症：多关节型幼年特发性关节炎、与附着点炎症相关的关节 炎、儿童斑块状银屑病、儿童克罗恩病、儿童溃疡性结肠炎、儿童葡萄膜炎。 （原标题：百奥泰(688177.SH)：Qletli®（阿达木单抗注射液）获得英国MHRA上市批准） 格隆汇9月10日丨百奥泰(688177.SH)公布，公司于近日收到了英国药品和健康产品管理局（称"英国 MHRA"）签发的关于Qletli（BAT1406，阿达木单抗注射液）上市批准通知。 ...

百奥泰(688177.SH)公告称，公司近日收到英国药品和健康产品管理局签发的关于Qletli®（BAT1406， 阿达木单抗注射液）上市批准通知。Qletli®获得英国MHRA上市批准后可在英国进行销售，公司海外 销售产品品类得到进一步扩充，有望对公司长期经营业绩产生积极影响。 ...

Core Viewpoint - The company, Maiwei Biotech, is focused on enhancing the quality and investment value of listed companies through its "Quality Improvement, Efficiency Enhancement, and Return to Investors" initiative, with significant progress in innovative drug development and commercialization strategies. Group 1: Innovative Drug Development - The company has 14 key products in various stages of development, including 10 innovative drugs and 4 biosimilars, primarily targeting oncology and age-related diseases [1][2] - Three clinical studies have advanced to Phase III, including treatments for urinary tract cancer and cervical cancer, with potential mid-analysis submissions for NDA expected in 2026 and 2027 [2][3] - The company is also developing a novel antibody-drug conjugate (ADC) targeting CDH17, which has shown promise in overcoming drug resistance in gastrointestinal cancers [2][3] Group 2: Commercialization and Sales Growth - In the first half of 2025, the company's drug sales revenue reached 100.79 million yuan, a 51.59% increase from the previous year [6][7] - The company has received necessary production licenses and is actively promoting new products, including its first innovative drug, which has optimistic market prospects [6][7] - A partnership with Qilu Pharmaceutical has been established to enhance the commercialization of long-acting white blood cell-boosting drugs [6][7] Group 3: Global Market Expansion - The company is pursuing international collaborations and has signed agreements with 30 countries for product registration and sales [8][9] - The company has successfully registered its products in Pakistan, marking a significant step in its global expansion strategy [8][9] - Ongoing negotiations with international pharmaceutical giants aim to broaden the company's product reach and enhance its market presence [9][10] Group 4: Production and Quality Management - The company has established production facilities compliant with international standards, enabling the commercial production of its drug candidates [11][12] - The production base has completed clinical trial sample preparations for 12 products and commercial production for 2 products as of June 30, 2025 [11][12] - The company is also expanding its production capacity to meet growing demands for its innovative drugs [12][13] Group 5: Corporate Governance and Investor Relations - The company emphasizes strong governance structures and internal controls to safeguard shareholder interests [14][15] - A commitment to enhancing information disclosure quality and investor communication has been established to foster transparency [16][17] - The company plans to repurchase shares to boost investor confidence and align interests among shareholders, employees, and the company [17][18]