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生物医药行业周报:行业周报礼来替尔泊肽全线爆发,2025年合计贡献365亿美元-20260208
Ping An Securities· 2026-02-08 10:09
Investment Rating - The industry investment rating is "stronger than the market" indicating an expected performance that exceeds the market by more than 5% over the next six months [32]. Core Insights - Eli Lilly's total revenue for 2025 is projected to reach $65.179 billion, representing a significant year-on-year growth of 45%. The revenue for 2026 is expected to be between $80 billion and $83 billion. The two key products, Tirzepatide, are anticipated to contribute a combined global sales of $36.5 billion, with the diabetes version Mounjaro generating $22.965 billion (up 99% year-on-year) and the weight loss version Zepbound achieving $13.542 billion (up 175% year-on-year) [3]. - Eli Lilly's drug approval progress for 2025 includes the FDA approval of the multi-dose prefilled pen for Tirzepatide and the approval of a new indication for the drug Jaypirca. Applications for obesity indications of Orforglipron have been submitted to U.S. and Japanese regulatory agencies, along with submissions to the EU for both obesity and type 2 diabetes indications [3]. - The pipeline progress for Eli Lilly in 2025 includes positive results from Phase 3 clinical trials for the combination of Taltz and Tirzepatide in adult patients with active psoriatic arthritis and obesity. Orforglipron has shown positive clinical results in studies transitioning from injectable to oral incretin therapy, and Retatrutide has also shown positive results in studies involving obesity with knee osteoarthritis [3]. Summary by Sections Industry Overview - The biopharmaceutical industry is rated as stronger than the market, maintaining a positive outlook [3][4]. - The investment strategy emphasizes the increasing global competitiveness of Chinese innovative pharmaceutical companies, focusing on potential therapeutic areas such as metabolic diseases, chronic diseases, and central nervous system disorders [4]. Market Performance - The pharmaceutical sector saw a slight increase of 0.14% last week, while the Shanghai and Shenzhen 300 Index decreased by 1.33%. The pharmaceutical industry ranked 14th among 28 industries in terms of performance [8][18]. - The valuation of the pharmaceutical sector is currently at 29.57 times (TTM), with a premium of 10.50% over the overall A-shares excluding financials [23]. Notable Company Developments - Cloudtop announced the approval of Velsipity® for treating moderate to severe ulcerative colitis in China, marking a significant advancement in treatment options [12]. - BMS reported a total revenue of $48.194 billion for 2025, with the drug Opdivo generating $10.049 billion, reflecting an 8% increase [13]. - Innovent Biologics achieved a total product revenue of approximately 11.9 billion yuan for 2025, maintaining a strong growth rate of about 45% [15]. - Saintin Biotech announced a strategic collaboration with Genentech for RNAi drug development, highlighting ongoing innovation in the sector [16].
云顶新耀:治疗成人患者中重度溃疡性结肠炎新药维适平®获中国上市批准
Cai Jing Wang· 2026-02-06 08:31
(云顶新耀公告) 2月6日,云顶新耀发布公告称,其新药维适平®(精氨酸艾曲莫德片)在中国获得新药上市申请批准,用于治疗对传 统治疗或生物制剂应答不充分的中度至重度活动性溃疡性结肠炎成人患者。 公司将积极筹备维适平®的商业化上市,努力将该疗法尽快带给国内患者,并推动纳入国家医保目录。此次获批是公 司2030年发展战略的重要组成部分,战略明确提出以"BD合作+自研"双轮驱动,实现商业化和研发的双重价值。公司 计划到2028年实现收入规模超过100亿元人民币,到2030年超过150亿元人民币,收入年复合增长率预计在2025至2030 年超过50%。 此次批准基于亚洲多中心III期注册临床ENLIGHTUC研究及全球III期注册研究ELEVATEUC的结果,ENLIGHTUC研究 纳入340名患者,在治疗中达到了统计学显著性和良好的安全性特征。 ...
云顶新耀(01952):维适平用于治疗成人患者中重度溃疡性结肠炎的新药上市申请在中国获批
智通财经网· 2026-02-06 04:25
云顶新耀(01952)发布公告,中国国家药品监督管理局(NMPA)已批准维适平®(精氨酸艾曲莫德片, VELSIPITY®)的新药上市申请(新药上市申请),在中国用于治疗对传统治疗或生物制剂应答不充分、失 应答或不耐受的中度至重度活动性溃疡性结肠炎(UC)成人患者。 作为新一代高选择性鞘氨醇-1-磷酸(S1P)受体调节剂,维适平®每日一次口服,可实现快速起效和强效 深度黏膜癒合,并具有良好的安全性特征,为成人溃疡性结肠炎患者提供新的一线治疗选择。维适平® 此次获批,是基于亚洲多中心III期注册临床ENLIGHT UC研究(ES101002)的结果和全球III期注册研究 ELEVATE UC(包括ELEVATE UC 52和ELEVATE UC 12研究)的结果。ENLIGHT UC研究是迄今完成的最 大规模亚洲中重度活动性溃疡性结肠炎患者的III期注册临床研究,总计纳入340名患者。在12周诱导期 及40周维持期治疗中,维适平®治疗组在所有主要和次要疗效终点上均达到统计学显著性与临床意义, 且安全性良好,安全性特征与既往研究一致。ELEVATE UC III期注册研究中的ELEVATE UC 52和 ELEV ...