湖南科伦第二代抗精神病药获批,多款首仿领跑布局精神神经疾病领域!

Core Viewpoint - Hunan Kelun Pharmaceutical has received approval for its generic drug Paliperidone Palmitate Injection, marking its sixth first generic drug approval this year, which enhances its product lineup in the field of mental health treatment [1][15]. Group 1: Product Approval and Market Impact - The approval of Paliperidone Palmitate Injection is significant as it is a second-generation antipsychotic that offers a long-acting formulation, improving patient compliance and reducing hospitalization rates [5][15]. - The sales forecast for Paliperidone Palmitate Injection is projected to exceed 800 million yuan in 2024, representing a year-on-year growth of 199.61%, with sales in the first half of 2025 expected to reach 453 million yuan [5][15]. - The market for Paliperidone drugs includes both injection and tablet forms, with four injection products successfully approved, indicating a competitive landscape [8][12]. Group 2: Competitive Landscape - Hunan Kelun Pharmaceutical is the fourth company to receive approval for Paliperidone Palmitate Injection, joining other companies like Qilu Pharmaceutical and Green Leaf Pharmaceutical, which have also successfully navigated the approval process [12][15]. - In addition to Hunan Kelun, seven other pharmaceutical companies are currently under review for the same product, indicating a growing interest in this therapeutic area [12][15]. - The company has successfully passed over 200 drug evaluations, with more than 50 being first generic approvals, showcasing its strong position in the pharmaceutical market [15][18].