Qletli®(BAT1406
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诺和诺德宣布计划裁员约9000人;派林生物控股股东拟变更为中国生物|医药早参
Mei Ri Jing Ji Xin Wen· 2025-09-10 22:19
Group 1 - Novo Nordisk plans to lay off approximately 9,000 employees to save 8 billion Danish kroner (about 1.26 billion USD) annually, aiming to streamline its organization and focus resources on diabetes and obesity business growth opportunities [1] - The company has lowered its earnings guidance multiple times this year due to increasing sales pressure on its core product, semaglutide, indicating a need for restructuring under profitability pressure [1] Group 2 - Pilin Biotech announced a share transfer agreement with China National Pharmaceutical Group, which will acquire approximately 200 million unrestricted shares, representing 21.03% of the company's total equity, leading to a change in the controlling shareholder and actual controller [2] - This move highlights the acceleration of central enterprises' integration in the biopharmaceutical sector, particularly in blood products, aiming to enhance the overall industry chain layout and resource synergy [2] Group 3 - Baillie Tianheng's drug, iza-bren, has been included in the breakthrough therapy list by the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [3] - Iza-bren has now received six breakthrough therapy designations from the NMPA and one from the U.S. FDA, which will expedite its market entry to meet urgent clinical needs [3] Group 4 - Baiyoutai's adalimumab injection, Qletli® (BAT1406), has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA), marking it as the first domestically approved biosimilar adalimumab in the UK with two specifications and eight indications [4] - This approval signifies a critical breakthrough for domestic biopharmaceuticals in the European mainstream market, opening up overseas growth opportunities and demonstrating that Chinese biosimilars have reached international standards in quality and registration capabilities [4] Group 5 - Zhixiang Jintai's GR1803 injection for systemic lupus erythematosus has received clinical trial approval from the NMPA, making it the first dual-specific antibody targeting BCMA×CD3 for this indication in China [5] - Currently, there are no marketed drugs targeting the same pathway for systemic lupus erythematosus in China, and GR1803's dual mechanism of action has the potential to fill a significant treatment gap in autoimmune diseases [5]
百奥泰:阿达木单抗注射液获得英国MHRA上市批准
Xin Lang Cai Jing· 2025-09-10 08:10
Core Viewpoint - The company, Baiotai (688177.SH), has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Qletli® (BAT1406, Adalimumab injection), which is expected to positively impact the company's long-term operational performance [1] Group 1 - The approval allows Qletli® to be sold in the UK, expanding the company's overseas product offerings [1] - The marketing authorization signifies a strategic milestone for the company in enhancing its market presence [1] - The introduction of Qletli® is anticipated to contribute positively to the company's revenue growth [1]