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特应性皮炎专题报告:掘金百亿AD蓝海:现有疗法仍可优化,双抗药物有望破局
SINOLINK SECURITIES· 2025-09-16 09:16
投资逻辑: 特应性皮炎以瘙痒作为重要标志,患者人群众多,疾病负担较重。特应性皮炎(AD)是一种慢性、复发性、炎症性皮 肤病,其特点为:反复发作、病程迁延,患者往往有剧烈瘙痒。影响日常生活,患者就诊意愿强烈,亟需疗效优异、 安全性良好的药物。AD 患者人数众多,全球约 6~7 亿患者、国内约 6700 万患者,未满足需求巨大。 近年来小分子和生物制剂逐步上市,AD 治疗迈入新阶段。传统疗法(如糖皮质激素、TCI 等)安全性不佳,近十年来 生物制剂和小分子靶向药等新兴产品逐渐涌现,目前新兴疗法上市产品不多,全球范围内约十余款不同作用机制的生 物制剂和小分子靶向药物获批用于治疗 AD,包括 JAK、IL-4R、IL-13 等靶点。 小分子 JAK 抑制剂疗效优异,但存在潜在安全性问题,TYK2 有望成为小分子新选择。AD 的小分子药物主要以 JAK 抑 制剂为主,目前已上市的获批 AD 适应症的包括乌帕替尼、艾玛昔替尼等,但以乌帕替尼为代表的多款 JAK 抑制剂均 被 FDA 添加黑框警告,在临床运用中也需要进行监测/评估,安全性存在一定风险。TYK2 作为 JAK 激酶家族的一员, 与 JAK1-3 家族成员参与 ...
我国科学家发现由单基因导致的红斑狼疮
Xin Hua She· 2025-09-11 02:17
浙江大学良渚实验室、国家肾脏疾病临床医学研究中心刘志红院士,浙江大学良渚实验室俞晓敏研究 员,以及浙江大学良渚实验室、浙江大学生命科学研究院周青教授为论文共同通讯作者。 据介绍,系统性红斑狼疮是一种异质性很强的自身免疫疾病,不管是临床症状还是遗传机制,都存在很 大的个体化差异。这对认识其发病机制构成了极大挑战。 研究团队通过全外显子组测序,发现5例系统性红斑狼疮肾炎患者存在PLD4基因突变,这种基因存在于 人体树突状细胞、B细胞和单核细胞中,PLD4基因突变属于隐性遗传。 新华社杭州9月11日电(记者朱涵)系统性红斑狼疮是一种常见的慢性自身免疫疾病,发病机制复杂。 我国科学家证实,人类单基因(PLD4)的缺陷可导致系统性红斑狼疮,为系统性红斑狼疮的精准诊疗 提供了重要理论依据。该成果10日发表在《自然》杂志上。 研究团队进一步发现,这一基因突变引发了机体长期炎症及自身免疫的致病机制,并通过小鼠实验证 实,某些靶向治疗药物JAK抑制剂可显著缓解缺陷小鼠体重下降、自身抗体产生及组织炎症等症状,可 为携带PLD4突变的系统性红斑狼疮患者提供潜在的精准治疗策略,也为未来开展基于基因分型的个体 化治疗提供了重要依据。( ...
创新药盘点系列报告(22):IBD治疗领域存在未满足的需求,关注新靶点、新机制
Guoxin Securities· 2025-06-17 11:19
Investment Rating - The investment rating for the industry is "Outperform the Market" (maintained) [1] Core Insights - There is an unmet demand in the IBD treatment field, with approximately 2.3 million patients in the US and five European countries suitable for biologic therapy, highlighting the significant patient population compared to other conditions like AD and PsO [2][5] - The global IBD drug market is valued at over $20 billion, with projections to reach approximately $28 billion by 2028, driven by the expiration of patents for first-line biologics and the rapid growth of new treatments [2][5] - Major multinational pharmaceutical companies are intensively exploring new targets and mechanisms for IBD treatment, focusing on dual pathways of inflammation and fibrosis, with several promising candidates entering late-stage clinical trials [2][5] Summary by Sections 01: Patient Population Comparison - The IBD patient population in the US and EU5 is approximately 4.1 million, with 2.3 million suitable for advanced therapies, comparable to populations for PsO and AD [5][6] 02: Unmet Needs in Current IBD Treatments - Existing IBD treatments have limitations, including slow onset of action and inadequate depth of remission, necessitating a shift in treatment goals towards deeper inflammation control [2][8] 03: MNCs' Focus on Next-Generation IBD Therapies - MNCs are actively pursuing new therapeutic targets, with TL1A and TYK2 being prominent areas of research, and several partnerships and acquisitions are underway to enhance their pipelines [2][8] 04: Investment Recommendations - The report suggests focusing on domestic opportunities in new IBD treatment targets and dual antibodies, indicating potential for international expansion [2][4]