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医药行业周报：FDA接受Mesoblast现货型细胞疗法上市申请
Tai Ping Yang·2024-07-25 08:00

Investment Ratings - The report does not provide specific ratings for the chemical pharmaceuticals and traditional Chinese medicine sectors, while the biopharmaceutical sector is rated as Neutral [1][4]. Core Insights - 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 [4]. - Among the sub-industries, pharmaceutical circulation (+0.03%), blood products (-0.90%), and vaccines (-1.20%) showed better performance, while offline pharmacies (-2.30%), hospitals (-2.04%), and medical R&D outsourcing (-1.98%) lagged behind [4]. - Notable individual stock performances included KaiKai Industrial (+10.04%), Fudan Fuhua (+10.00%), and Saily Medical (+9.97%) on the gainers' list, while Ruiang Gene (-13.89%), Yahui Long (-10.00%), and Hehua Co. (-7.91%) were among the biggest losers [4]. Industry News - On July 24, 2024, Mesoblast announced that the FDA accepted its biologics license application for the cell therapy Ryoncil (Remestemcel-L) for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children, with a PDUFA date set for January 7, 2025 [5]. Company News - Warner Pharmaceuticals (688799) announced that its subsidiary received a GMP compliance inspection notice for its raw material drug lanthanum carbonate from the Hunan Provincial Drug Administration [6]. - China Resources Double Crane (600062) reported that its subsidiary received a drug registration certificate for paliperidone extended-release tablets, which is considered equivalent to passing the consistency evaluation [6]. - Haichuang Pharmaceutical (688302) received approval from the National Medical Products Administration for clinical trials of HP560 tablets for treating myelofibrosis [6]. - Luoxin Pharmaceutical (002793) announced that its subsidiary received approval for a supplemental application for injectable cefoperazone sodium and sulbactam sodium, which passed the consistency evaluation for generic drugs [6].