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石药集团再涨超4% 司库奇尤单抗注射液III期临床试验取得顶线分析数据
Zhi Tong Cai Jing· 2025-12-19 02:22
石药集团(01093)再涨超4%,截至发稿,涨4.37%,报8.36港元,成交额5.79亿港元。 消息面上,12月18日,石药集团发布公告,本公司附属公司石药集团巨石生物制药有限公司开发的司库 奇尤单抗注射液(该产品)在用于治疗中度至重度斑块状银屑病的等效性III期临床试验中获得顶线分析数 据。 该产品是本集团开发的全人源IgG1单克隆抗体药物,为司库奇尤单抗注射液(可善挺)的生物类似药。可 善挺在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺 炎,其疗效与安全性已获得广泛认可。 该项关键研究已达到预设主要终点,并取得积极的顶线结果。统计分析表明,该产品与可善挺具有临床 等效性,且安全性良好,未出现新的或非预期的安全性信号,有望能满足患者长期用药的安全性需求。 该研究的有关详细数据将于后续学术会议及期刊上发布。 ...
石药集团:司库奇尤单抗注射液III期临床试验获得顶线分析数据
Zhi Tong Cai Jing· 2025-12-18 10:26
石药集团(01093)发布公告,本公司附属公司石药集团巨石生物製药有限公司开发的司库奇尤单抗注射 液(该产品)在用于治疗中度至重度斑块状银屑病的等效性III期临床试验中获得顶线分析数据。 银屑病是一种免疫相关的慢性、炎症性、系统性疾病。目前,中国约有超700万银屑病患者。全人源白 介素(IL)-17A(IL-17A)主要由活化T细胞产生,是银屑病发病机制中的关键分子。司库奇尤单抗可特异性 结合IL-17A,阻断IL-17受体的信号传导,从而抑制银屑病炎症。 该产品是本集团开发的全人源IgG1单克隆抗体药物,为司库奇尤单抗注射液(可善挺)的生物类似药。可 善挺在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺 炎,其疗效与安全性已获得广泛认可。 本集团遵循生物类似药的研究指导原则开展该产品的研发,并与可善挺进行了"头对头"等效性研究。该 研究是一项多中心、随机、双盲、平行、阳性对照等效性Ⅲ期临床试验,旨在验证该产品与可善挺治疗 中度至重度斑块状银屑病患者疗效的一致性。该研究的入组人群为中度至重度斑块状银屑病患者,按照 1:1比例随机分配至试验组(该产品)和对照组(可善挺),其主 ...
石药集团(01093.HK):司库奇尤单抗注射液III期临床试验获得顶线分析数据
Ge Long Hui· 2025-12-18 10:20
集团遵循生物类似药的研究指导原则开展该产品的研发,并与可善挺进行了"头对头"等效性研究。该研 究是一项多中心、随机、双盲、平行、阳性对照等效性Ⅲ期临床试验,旨在验证该产品与可善挺治疗中 度至重度斑块状银屑病患者疗效的一致性。该研究的入组人群为中度至重度斑块状银屑病患者,按照 1:1比例随机分配至试验组(该产品)和对照组(可善挺),其主要研究终点为在第12周达到银屑病皮损面积 和严重程度指数(PASI)评分较基线改善75%(PASI-75)的患者比例。 该项关键研究已达到预设主要终点,并取得积极的顶线结果。统计分析表明,该产品与可善挺具有临床 等效性,且安全性良好,未出现新的或非预期的安全性信号,有望能满足患者长期用药的安全性需求。 该研究的有关详细数据将于后续学术会议及期刊上发布。 该产品是集团开发的全人源IgG1单克隆抗体药物,为司库奇尤单抗注射液(可善挺)的生物类似药。可善 挺在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺炎, 其疗效与安全性已获得广泛认可。 格隆汇12月18日丨石药集团(01093.HK)公告,公司附属公司石药集团巨石生物制药有限公司开发的司库 奇尤 ...
新诺威(300765.SZ):控股子公司司库奇尤单抗注射液III期临床试验获得顶线分析数据
Ge Long Hui A P P· 2025-12-18 08:01
格隆汇12月18日丨新诺威(300765.SZ)公布,控股子公司石药集团巨石生物制药有限公司(简称"巨石生 物")开发的司库奇尤单抗注射液于近日在 III 期临床试验中获得顶线分析数据。该产品是巨石生物开发 的全人源IgG1单克隆抗体药物,为可善挺?的生物类似药。可善挺?在中国获批的适应症包括6岁及以上 斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺炎,其疗效与安全性已获得广泛认可。银屑 病是一种免疫相关的慢性、炎症性、系统性疾病,目前中国约有700万银屑病患者。全人源白介素 (IL)-17A主要由活化T细胞产生,是银屑病发病机制中的关键分子。司库奇尤单抗可特异性结合IL- 17A,阻断IL-17受体的信号传导,从而抑制银屑病炎症。 巨石生物遵循生物类似药的研究指导原则开展该产品的研发,并与可善挺?进行了"头对头"等效性研 究。该研究是一项多中心、随机、双盲、平行、阳性对照等效性Ⅲ期临床试验,旨在验证该产品与可善 挺?治疗中度至重度斑块状银屑病患者疗效的一致性。入组人群为中度至重度斑块状银屑病患者,按照 1:1比例随机分配至试验组(该产品)和对照组(可善挺)。主要研究终点为第12周达到银屑病皮损面 积和 ...
新诺威子公司司库奇尤单抗注射液III期临床试验获得顶线分析数据
Zhi Tong Cai Jing· 2025-12-18 07:54
新诺威(300765)(300765.SZ)发布公告,公司的控股子公司石药集团巨石生物制药有限公司(简称"巨石 生物")开发的司库奇尤单抗注射液于近日在III期临床试验中获得顶线分析数据。 该产品是巨石生物开发的全人源IgG1单克隆抗体药物,为可善挺的生物类似药。可善挺在中国获批的 适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺炎,其疗效与安全性 已获得广泛认可。 该项关键研究已达到预设主要终点,并取得积极的顶线结果,统计分析表明,该产品与可善挺具有临床 等效性,且安全性良好,未出现新的或非预期的安全性信号,有望能满足患者长期用药的安全性需求。 有关详细数据将于后续学术会议及期刊上发布。 ...
新诺威:司库奇尤单抗注射液III期临床试验获得顶线分析数据
Guo Ji Jin Rong Bao· 2025-12-18 07:48
新诺威公告,控股子公司巨石生物开发的司库奇尤单抗注射液(该产品)于近日在III期临床试验中获得顶 线分析数据。该产品是巨石生物开发的全人源IgG1单克隆抗体药物,为可善挺 的生物类似药。可善挺 在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺炎,其 疗效与安全性已获得广泛认可。银屑病是一种免疫相关的慢性、炎症性、系统性疾病,目前中国约有 700万银屑病患者。全人源白介素(IL)-17A主要由活化T细胞产生,是银屑病发病机制中的关键分子。司 库奇尤单抗可特异性结合IL-17A,阻断IL-17受体的信号传导,从而抑制银屑病炎症。 ...
免疫疗法的下一波创新浪潮:全球技术趋势与行业展望
科尔尼管理咨询· 2025-12-09 03:59
科尔尼医疗与生命科学团队 近期在《Nature Reviews Drug Discovery》发表论文,分析了自身免疫疾 病领域的发展趋势。过去几十年,通过 细胞因子靶向 实现的 免疫调节 进展推动了治疗创新,据IQVIA 数据,全球自身免疫药物市场在2023年已达到1560亿美元,年复合增长率为15%。这个时代的标志是 肿瘤坏死因子α抑制剂的成功 (现已成为许多疾病的标准治疗)以及 白细胞抑制剂 的出现。然而,推 动此轮增长的明星产品,如修美乐(UMIRA (anti-TNF))和喜达诺(STELARA (anti-IL-12/23)),如今 面临生物类似药的竞争,而其他领先产品,如达必妥(DUPIXENT (IL-4/13))和喜开瑞(SKYRIZI (IL- 23)),则在各自适应症中设定了很高的"疗效天花板"。下一个突破性创新时代将与今天大不相同。 未来三到五年,我们预计市场将继续增长,主要驱动力是JAK抑制剂和IL抑制剂在多疾病领域的上市, 以及首创药物(尤其是TNFα以外的TNF靶点)的涌现——这些都将试图提高自身免疫疾病的疗效标 准。 本文探讨自身免疫疾病的研发技术趋势,并分析其影响。 自身免疫 ...
新药销售抵消Entresto专利到期影响 诺华制药(NVS.US)Q3营业利润增长6%
智通财经网· 2025-10-28 07:59
Core Insights - Novartis has initiated a wave of acquisitions this year, with a focus on enhancing its drug pipeline and compensating for revenue declines from key therapies due to patent expirations [1][2] - The company reported a 6% increase in operating profit, reaching $5.46 billion in Q3, slightly above analyst expectations of $5.4 billion [1] - Q3 revenue was $13.91 billion, representing an 8.4% year-over-year growth, exceeding forecasts, while adjusted EPS was $2.25, falling short of expectations by $0.06 [1] Financial Performance - Novartis' Q3 operating profit adjusted for special items increased to $5.46 billion, surpassing analyst expectations [1] - The company has raised its annual performance outlook twice this year, maintaining its 2025 financial guidance with projected sales growth in the "mid-high single digits" and adjusted operating profit growth in the "low double digits" [1] Product Performance - The heart drug Entresto, which lost patent protection this year, generated $1.88 billion in sales during Q3, with total sales expected to reach $7.82 billion globally in 2024 [1] - Analysts had anticipated Q3 sales for Entresto to be $1.77 billion [1] - The psoriasis treatment drug Cosentyx faced competition from AbbVie's Bimzelx, with sales remaining flat at $1.7 billion year-over-year [2] - The breast cancer drug Kisqali, launched last year, achieved sales of $1.33 billion [2] Acquisition Strategy - Novartis is actively pursuing acquisitions and licensing deals valued at $30 billion, including a $12 billion acquisition of U.S. biotech company Avidity [1]
美股前瞻 | 三大股指期货涨跌不一,“恐怖数据”今晚揭晓,奈飞(NFLX.US)盘后公布财报
智通财经网· 2025-07-17 12:19
Market Overview - US stock index futures showed mixed performance ahead of the market opening, with Dow futures down 0.19% and S&P 500 futures down 0.08%, while Nasdaq futures rose 0.02% [1] Economic Data and Predictions - The US is set to release June retail sales data, with expectations of a 0.1% month-over-month increase, which could influence interest rate cut expectations for September [2] - Atlanta Fed President Raphael Bostic indicated rising inflation pressures and supported maintaining current interest rates, noting that recent inflation data shows signs of increasing price pressures [3][4] Corporate Earnings and Performance - Netflix is expected to report its Q2 earnings, with analysts predicting a 24% year-over-year increase in EPS to $6.70 and a 15% increase in revenue to $11.3 billion [5] - PepsiCo reported Q2 organic sales growth of 2.1% and EPS of $2.12, exceeding analyst expectations, while facing ongoing supply chain cost pressures [6] - GE Aerospace exceeded Q2 earnings expectations, raising its full-year guidance with adjusted EPS projected between $5.60 and $5.80, driven by a 30% increase in commercial aircraft revenue [7] - Alcoa reported Q2 revenue of $3.018 billion, a 4% increase year-over-year, with net income of $164 million, despite over $100 million in cost increases due to tariffs [8] - TSMC raised its revenue growth forecast for 2025 to approximately 30%, driven by strong demand in the AI sector, with Q2 profits reaching a record $13.5 billion [9] - Novartis reported a 12% increase in Q2 revenue to $14.054 billion, with a 24% increase in profit, despite challenges from its psoriasis treatment [10] Corporate Actions - NVIDIA CEO Jensen Huang sold $37 million worth of shares as part of a planned stock sale, having sold a total of $190 million worth of shares this year [11] - OpenAI announced a shift to using Google Cloud for its ChatGPT services, moving away from exclusive reliance on Microsoft [12]
海外制药企业2025Q1业绩回顾:美国药品价格改革叠加不确定的宏观环境
Guoxin Securities· 2025-05-21 05:58
Investment Rating - The investment rating for the pharmaceutical industry is "Outperform" [2] Core Insights - Overall revenue growth for pharmaceutical companies has slowed down, with Eli Lilly and Novo Nordisk showing significant increases of 45% and 18% respectively in Q1 2025, while other companies like GSK and Merck faced low single-digit growth or declines [3][5] - The U.S. drug price reform and uncertain macroeconomic environment are impacting the industry, with the Trump administration's executive order promoting "Most Favored Nation" pricing potentially reducing the pricing power of large pharmaceutical companies [3][7] - The next five years will see several blockbuster drugs facing patent expirations, prompting pharmaceutical companies to pursue business development (BD) transactions to enhance revenue and fill pipeline gaps [3][13] Summary by Sections 01 Overview of Q1 2025 Performance - The top 15 pharmaceutical companies had a combined R&D expenditure of $31.8 billion in Q1 2025, reflecting a year-on-year increase of 0.6% [8] 02 Revenue and Guidance - Eli Lilly reported Q1 2025 revenue of $12.7 billion, a 45% increase year-on-year, with a full-year guidance of $58.0 billion to $61.0 billion [5] - Pfizer's revenue decreased by 6% to $13.7 billion in Q1 2025, with a full-year guidance of $61.0 billion to $64.0 billion [6] 03 Drug Price Reform and Macro Environment - The Trump administration's executive order aims to provide U.S. patients with "Most Favored Nation" pricing, which could pressure drug prices downward [7] - A proposed budget plan by the Republican party includes significant cuts to Medicaid, potentially impacting pharmaceutical revenues [7] 04 Upcoming Patent Expirations - Several key products are approaching patent expiration, including Eli Lilly's Tirzepatide and JNJ's Invega Sustenna, which could lead to increased competition and revenue challenges [13][14] 05 Recent Business Development Projects - Notable recent BD transactions include JNJ's acquisition of IntraCellular for $14.6 billion to enhance its pipeline in mental health treatments [15][16]