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恒生港股通创新药指数即将修订;恒瑞医药斑秃药物获批上市丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-06-30 23:31
NO.1 恒生港股通创新药指数即将修订,明确剔除CXO公司 6月30日,恒生港股通创新药指数宣布修订编制方案,新增了剔除CXO(医药外包)公司的规则。根据 新的编制方案,修订后的指数成份股全部为创新药企,是目前ETF跟踪的指数中首批"纯度"达到100%的 创新药指数。 易方达基金指数研究部总经理庞亚平表示,CXO公司主要提供服务,并不直接获取创新药的核心知识 产权,一般也不参与创新药专利研发和商业化成功后获取的专利授权收益。因此,剔除CXO后,恒生 港股通创新药指数能够聚焦创新药核心公司,更纯粹地表征本轮创新药产业发展趋势。 点评:此次规则修订后,恒生港股通创新药指数拟剔除CXO企业,这一调整将提高港股创新药企业在 指数内的权重,使得该指数能更好反映创新药产业发展的核心趋势与估值逻辑。 NO.2 恒瑞医药斑秃药物获批上市 6月30日,恒瑞医药公告称,公司收到国家药品监督管理局的通知,批准公司自主研发的1类创新药硫酸 艾玛昔替尼片(SHR0302片)新增适应证,用于成人重度斑秃患者。硫酸艾玛昔替尼片是一种高选择性 的JAK1抑制剂,可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物学效应。除此次获批的斑秃外, ...
Roivant Sciences (ROIV) Update / Briefing Transcript
2025-06-17 18:00
Summary of Brepicitinib Investor Call Company and Industry - **Company**: Regan and Privyant - **Industry**: Pharmaceutical, specifically focusing on autoimmune diseases, particularly dermatomyositis (DM) Core Points and Arguments 1. **Brepicitinib Overview**: Brepicitinib is a dual selective Tyk2/JAK1 inhibitor, representing a new generation of treatments for inflammatory diseases, with potential to set a new standard of care for patients with high unmet medical needs, particularly in DM and other autoimmune conditions [4][5][6] 2. **Clinical Trials**: The VALOR study aims to improve treatment for over 40,000 patients with DM, with results expected in the second half of the year. The study is the largest DM trial ever conducted, enrolling 241 patients globally [4][22][45] 3. **Patient Burden**: DM is characterized by severe muscle weakness and debilitating skin conditions, leading to a high burden on patients. Current treatments, primarily high-dose steroids, are inadequate and carry significant side effects [10][12][14][16] 4. **Market Opportunity**: There is a significant commercial opportunity in DM, with several competitor programs in late-stage development, but brepicitinib is the only oral treatment in this space [49][50][51] 5. **Regulatory Engagement**: The company has had productive engagement with the FDA and plans to submit a New Drug Application (NDA) if the study results are positive [46] Important but Overlooked Content 1. **Steroid Burden**: The high use of steroids among DM patients leads to adverse health impacts, highlighting the need for new therapies that can reduce this burden while effectively treating the disease [14][15][40] 2. **Study Design**: The VALOR trial includes a strict steroid taper protocol to manage placebo response and demonstrate the drug's efficacy. A high success rate of 98% was achieved in tapering patients off steroids [40][41][86] 3. **Endpoints**: The primary endpoint of the study is the Total Improvement Score (TIS), which measures improvement rather than disease activity. This is crucial for understanding the drug's impact on patient quality of life [27][28][33] 4. **Patient Demographics**: The trial population is heavily treated, with many patients on multiple therapies, indicating a high level of disease severity and the need for effective new treatments [38][39] Conclusion - The upcoming results from the VALOR study are critical for establishing brepicitinib as a viable treatment option for DM, with the potential to significantly improve patient outcomes and address a substantial market need in the autoimmune disease space [44][58]