Nucala(Mepolizumab)

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太平洋医药日报:GSK抗体疗法MEPOLIZUMAB获FDA批准 用于治疗COPD
Xin Lang Cai Jing· 2025-05-24 12:26
Market Performance - The pharmaceutical sector rose by 0.42% on May 23, 2025, outperforming the CSI 300 index by 1.23 percentage points, ranking second among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical devices (+1.43%), medical research outsourcing (+0.98%), and offline pharmacies (+0.74%) performed well, while vaccines (-0.68%), blood products (-0.43%), and hospitals (-0.27%) lagged [1] - Top three gainers in individual stocks were Xintiandi (+20.02%), Haichen Pharmaceutical (+20.00%), and Duori Pharmaceutical (+20.00%), while the top three losers were Yahong Pharmaceutical (-5.86%), BeiGene (-4.15%), and Runduo Co., Ltd. (-3.94%) [1] Industry News - GSK announced that the FDA approved its first-in-class antibody therapy Nucala (Mepolizumab) for use as an adjunct maintenance treatment in adults with eosinophilic phenotype, poorly controlled chronic obstructive pulmonary disease (COPD) [2] - Nucala is a monoclonal antibody targeting IL-5, developed for a range of IL-5 mediated diseases, and is the first biologic approved for this specific COPD patient population characterized by blood eosinophil count (BEC) ≥150 cells/μL [2] Company News - Kelun Pharmaceutical (002422) announced that its subsidiary Kelun Botai received an upfront payment from Windward Bio as part of an exclusive licensing agreement for SKB378/HBM9378/WIN3781, including cash received in February 2025 and equity from Windward Bio's parent company, which will be delivered upon regulatory approval in China [3] - Jiuzhou Pharmaceutical (603456) reported that its subsidiary Drug Technology passed an FDA cGMP inspection conducted from March 17 to 21, 2025, and received the FDA's Establishment Inspection Report (EIR) confirming compliance [3] - Huate Dain (000915) announced that its subsidiary Dain Pharmaceutical received a drug registration certificate for sodium valproate oral solution from the National Medical Products Administration, confirming that the product meets registration requirements [3] - Dizh Pharmaceutical (688192) announced that it will present three latest research advancements on its two self-developed innovative drugs DZD8586 and DZD6008 at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, focusing on B-cell non-Hodgkin lymphoma (B-NHL) and non-small cell lung cancer (NSCLC) [4]