Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for its innovative drug, SHR0302, to treat severe alopecia areata in adults, addressing a significant unmet medical need in this patient population [1][2] Group 1: Product Information - SHR0302 is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [2] - The drug has already been approved for three indications in China, including active ankylosing spondylitis, moderate to severe active rheumatoid arthritis, and moderate to severe atopic dermatitis [2] Group 2: Market Context - The global lifetime prevalence of alopecia areata is as high as 2%, with approximately 3.49 million patients in China as of 2021, indicating a substantial disease burden [1] - Current treatments for severe alopecia areata, such as corticosteroids and immunosuppressants, have significant side effects and challenges, highlighting the need for effective and safe long-term treatment options [1] Group 3: Competitive Landscape - There are already oral JAK1 inhibitors approved globally for alopecia areata, including Pfizer's LITFULO®, Eli Lilly's OLUMIANT®, and Sun Pharmaceutical's LEQSELVI™, but no domestic JAK1 inhibitors have been approved in China [2] - The combined global sales of LITFULO® and OLUMIANT® are projected to reach approximately $1.047 billion in 2024 [2] - The total R&D investment for SHR0302 has reached approximately 1.091 billion yuan [2]
恒瑞医药(01276.HK):硫酸艾玛昔替尼片新增适应症获批 用于成人重度斑秃患者