FDA接受Mesoblast现货型细胞疗法上市申请

Investment Ratings - The report does not provide specific ratings for the chemical pharmaceuticals and traditional Chinese medicine sectors, while the biopharmaceutical and other medical sectors are rated as neutral [1][2]. Core Insights - The report maintains a positive outlook on the pharmaceutical sector, indicating that the FDA has accepted Mesoblast's application for a cell therapy product, which could significantly impact the market [2][6]. - The pharmaceutical sector experienced a decline of 1.45% on July 24, 2024, underperforming the CSI 300 index by 0.82 percentage points, ranking 18th among 31 sub-industries [5]. - Notable performances within sub-industries include pharmaceutical circulation (+0.03%) and blood products (-0.90%), while offline pharmacies (-2.30%) and hospitals (-2.04%) lagged behind [5]. Summary by Sections Market Performance - On July 24, 2024, the pharmaceutical sector's performance was -1.45%, underperforming the CSI 300 index by 0.82 percentage points, ranking 18th among 31 sub-industries [5]. - The best-performing sub-industries were pharmaceutical circulation (+0.03%) and blood products (-0.90%), while offline pharmacies (-2.30%) and hospitals (-2.04%) performed poorly [5]. Industry News - On July 24, 2024, Mesoblast announced that the FDA accepted its application for the cell therapy Ryoncil (Remestemcel-L) for treating steroid-refractory acute graft-versus-host disease in children, with a PDUFA date set for January 7, 2025 [6]. Company News - Warner Pharmaceuticals announced that its subsidiary received a GMP compliance notice for a raw material drug [7]. - China Resources Double Crane received a drug registration certificate for a new medication, indicating successful compliance with evaluation standards [7]. - Haichuang Pharmaceuticals received approval for clinical trials of a new drug for treating myelofibrosis [7]. - Luoxin Pharmaceutical announced the approval of a supplemental application for a generic drug, confirming its quality and efficacy [7].