药物临床试验登记信息显示，深圳信立泰药业股份有限公司的评价不同剂量SAL0140片治疗2种或3种及 以上药物治疗且未控制的高血压患者的有效性和安全性的随机、双盲、安慰剂对照、多中心的Ⅱ期临床 研究已启动。临床试验登记号为CTR20254681，首次公示信息日期为2025年11月25日。 该药物剂型为片剂，用法为口服。本次试验主要目的为评价不同剂量SAL0140片治疗未控制的高血压患 者的有效性；次要目的为评价不同剂量SAL0140片治疗未控制的高血压患者的安全性，以及评价 SAL0140在未控制的高血压患者中的药代动力学特征。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现 的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不 构成个人投资建议。受限于第三方数据库质量等问题，我们无法对数据的真实性及完整性进行分辨或核 验，因此本文内容可能出现不准确、不完整、误导性的内容或信息，具体以公司公告为准。如有疑问， 请联系biz@staff.sina.com.cn。 责任编辑：小浪快报 本次试验主要终点指标包括双盲治疗期结束平均诊室坐位 ...

药物临床试验登记与信息公示平台数据显示，漳州片仔癀药业股份有限公司的评价PZH2113胶囊治疗以 弥漫性大B细胞淋巴瘤为主的复发性/难治性B细胞非霍奇金淋巴瘤受试者的安全性、耐受性、药代动力 学特征和初步疗效的开放、多中心、I期临床研究已启动。临床试验登记号为CTR20254688，首次公示 信息日期为2025年11月25日。 目前，该实验状态为进行中（尚未招募），目标入组人数72人。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现 的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不 构成个人投资建议。受限于第三方数据库质量等问题，我们无法对数据的真实性及完整性进行分辨或核 验，因此本文内容可能出现不准确、不完整、误导性的内容或信息，具体以公司公告为准。如有疑问， 请联系biz@staff.sina.com.cn。 责任编辑：小浪快报 该药物剂型为胶囊，用法为口服，每日1次，用药时程为多次给药，21天为一个给药周期。本次试验 Part A1/A2主要目的为评价PZH2113胶囊在以DLBCL为主的r/r B - NHL受试者中 ...

24 November 2025 | 12:15PM GMT Equity Research Novo Nordisk (NOVOb.CO): EVOKE/EVOKE+ miss in Alzheimer's - disappointing but not significantly impactful This morning (November 24th), Novo announced that the EVOKE/EVOKE+ trials of semaglutide in Alzheimer's disease did not hit the primary endpoint, as no efficacy difference was seen between the treatment and placebo arms, leading to the 1-year extension study to be discontinued. Topline results will be presented at the CTAD conference on December 3rd, and No ...

药物临床试验登记信息显示，广东恒瑞医药有限公司的评价SHR - 2173注射液在原发性膜性肾病患者中 的安全性、有效性、药代动力学和药效学的随机、开放、多中心的II期临床研究已启动。临床试验登记 号为CTR20254655，首次公示信息日期为2025年11月24日。 该药物剂型为注射液，规格为0.15 g/瓶，用法用量按方案规定使用。本次试验主要目的是评价SHR - 2173治疗原发性膜性肾病（PMN）患者的安全性和耐受性；次要目的是评价其疗效、药代动力学 （PK）特征和药效学（PD）特征。 SHR - 2173注射液为生物制品，适应症为原发性膜性肾病。原发性膜性肾病是一种自身免疫性肾小球疾 病，主要表现为大量蛋白尿、低蛋白血症等，诊断依赖肾活检。 本次试验主要终点指标包括52周内的安全性评价（不良事件、生命体征、体格检查、实验室检查、12导 联心电图）；次要终点指标包括第12、24、36、52周达到总体缓解、完全缓解、部分缓解、完全免疫学 缓解的受试者比例等多项有效性指标及免疫原性评价。 目前，该实验状态为进行中（尚未招募），目标入组人数75人。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方 ...

PresentationOperator Hello, and welcome to the Protara Update Call. We ask that you please hold all questions until the completion of the formal remarks at which time you will be given instructions for the question-and-answer session. Also, as a reminder, this conference is being recorded. If you have any objections, please disconnect at this time. With that, I would now like to turn the call over to Justine O'Malley, Senior Vice President, Investor Relations and Corporate Affairs. ...

登录新浪财经APP 搜索【信披】查看更多考评等级 股票简称：华海药业 股票代码：600521 公告编号：临2025-119号债券简称：华海转债 债券代码： 110076 浙江华海药业股份有限公司 评价HB0017注射液治疗中重度斑块状银屑病的疗效和安全性的多中心、随机、双盲、安慰剂对照的III 期临床研究已顺利完成揭盲，总计共纳入408例中国中重度斑块状银屑病患者。研究结果显示，研究达 到预设的所有主要疗效终点（第12周时达到PASI 75（PASI评分较基线改善≥75%）的受试者比例、第12 周时达到sPGA 0/1（sPGA评分为0分或1分）的受试者比例）和关键次要疗效终点（第12周达到PASI 90 （PASI较基线改善≥90%）的受试者比例）。维持治疗期给药方案有望实现同类产品给药间隔最长，且 各种疗效指标在维持治疗期持续升高并保持稳定。相较于同靶点已上市产品，HB0017的核心治疗期 （前12周）和维持治疗期（12-52周）疗效数据均展现有力的竞争优势。安全性方面，HB0017整体安全 性和耐受性良好，与前期临床研究数据及同靶点药物相比，常见的不良事件类型和严重程度均在预期范 围，未发现新的安全性风 ...

BGM1812注射液是公司优化设计的新型长效Amylin类似物，具有良好的分子活性和药学稳定性。 Amylin(胰淀素)作为一种由37个氨基酸组成的饱腹感多肽激素，由胰腺β细胞与胰岛素协同释放入血。 它通过激活大脑饱腹感通路抑制食欲，同时延缓胃排空、抑制胰高血糖素分泌，具有多重减重机制。截 至公告披露日，BGM1812注射液减重适应症在美国已获得FDA的药品临床试验批准，首例临床入组已 完成。截至公告披露日，全球尚无同类靶点制剂减重适应症获批上市。 博瑞医药(688166.SH)发布公告，公司全资子公司博瑞制药(苏州)有限公司(简称"博瑞制药")近日收到国 家药品监督管理局签发的《药物临床试验批准通知书》，同意博瑞制药BGM1812注射液开展超重或肥 胖的临床试验。 ...

Core Viewpoint - Jinfang Pharmaceutical-B (02595) experienced a significant stock price increase, rising over 8% towards the end of trading, with a current price of 31.1 HKD and a trading volume of 28.08 million HKD [1] Group 1: Clinical Trial Announcement - On November 11, Jinfang Pharmaceutical announced the initiation of a Phase III clinical trial comparing the efficacy and safety/tolerability of GFH375 monotherapy versus investigator-selected chemotherapy for patients with KRAS G12D mutated metastatic pancreatic cancer [1] - The company’s prospectus indicates that GFH375 is being developed as a first-in-class oral G12D inhibitor, with plans for the monotherapy to enter Phase I/II trials by June 2024 [1] - GFH375/VS-7375 has received FDA Fast Track designation this year, allowing it to be used for first-line and subsequent treatment of locally advanced and metastatic KRAS G12D mutated PDAC patients [1] Group 2: Previous Data Presentation - Early data on GFH375 monotherapy for solid tumors was presented at prestigious international academic conferences such as ASCO and WCLC this year, through late-breaking abstracts and oral presentations [1]

Upstream Bio Conference Call Summary Company Overview - **Company**: Upstream Bio (NasdaqGS:UPB) - **Event**: First annual I&I Summit - **Date**: November 12, 2025 Key Industry Insights Drug Development and Efficacy - Upstream Bio presented positive Phase 2 data for **verekitug**, an antibody targeting the **TSLP receptor**, showing long pharmacodynamic activity with a dosing schedule of Q12 weeks [3][5][6] - The drug demonstrated a **76% reduction** in systemic corticosteroid use and surgery needs in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) [9][10] - The data indicated that there was no plateau in efficacy at 24 weeks, suggesting potential for continued improvement in longer studies [4][8] Clinical Trial Progression - Upstream Bio is advancing towards Phase 3 trials for both CRSwNP and severe asthma, with plans to analyze data from both indications contemporaneously to inform dose selection [11][12] - The company aims to initiate Phase 3 programs as quickly as possible, contingent on data analysis and regulatory feedback [31] Competitive Landscape - Upstream Bio differentiates itself from competitors by targeting the **TSLP receptor** rather than the ligand, which is the approach taken by other companies [34][35] - The competitive landscape includes drugs from GSK and ILOS, which are reportedly behind Upstream Bio in development timelines [32][34] Additional Important Points Pharmacodynamics and Dosing - The pharmacodynamic profile of verekitug suggests that it maintains receptor occupancy for up to **24 weeks** after the last dose, which is critical for sustained efficacy [24][22] - The company is exploring the potential for extended dosing intervals (Q24 weeks) while ensuring that efficacy is not compromised [17][22] Regulatory Considerations - Upstream Bio is focused on obtaining robust data to support regulatory negotiations, with a primary endpoint of asthma exacerbation reduction set at **50% or greater** [26][28] - The company is preparing for potential discussions with regulators regarding the design of future trials, including considerations for secondary endpoints like lung function improvement [30][31] Future Data Releases - Upcoming data from the Phase 2 trials is expected in Q1, with plans to present findings at major medical meetings such as QuadAI and ATS in the first half of the following year [38] This summary encapsulates the critical insights and developments discussed during the Upstream Bio conference call, highlighting the company's strategic direction and competitive positioning within the biotech industry.

TG Therapeutics Conference Call Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Event**: Conference Call on November 12, 2025 Key Points Product Performance and Market Position - **Briumvi Launch Success**: Briumvi has established itself as a trusted product among physicians, with many moving it to the first IV slot due to its data and patient convenience [3][5] - **Patient Support Programs**: TG Therapeutics maintains the most generous patient support programs, unlike competitors who have cut back, contributing to its market position [5][6] - **Crossover Patients**: A significant portion of Briumvi's patients are switching from other therapies, with a stable distribution among naive patients, switches from non-CD20 therapies, and switches from other CD20 therapies [9][10] Clinical Trials and Future Expectations - **Enhanced Trial Enrollment**: Impressive enrollment rates in the enhanced trial combining initial doses, with expectations for a successful outcome based on area under the curve measures [12][13] - **Subcutaneous (SubQ) Version**: The company is optimistic about the SubQ version of Briumvi, targeting non-inferiority to IV dosing, with enrollment expected to complete in the first half of next year and data anticipated in late 2026 or early 2027 [29][32] Competitive Landscape - **Ocrevus and BTK Inhibitors**: Current market dynamics show limited impact from Ocrevus SubQ on Briumvi's uptake. The company believes BTK inhibitors will compete more in the oral category rather than against CD20 therapies [17][19][20] - **Market Dynamics for SubQ**: The SubQ version is expected to capture a significant market share, potentially doubling the total addressable market, with a competitive edge in convenience over existing products [33][34] Revenue and Growth Expectations - **Q4 Guidance**: The company is confident in meeting or exceeding Q4 guidance, citing positive dynamics typically seen in the fourth quarter [23][24] - **2026 Growth Initiatives**: Plans to expand direct-to-consumer (DTC) campaigns and enhance field team effectiveness to drive growth in 2026 [26][27] Pipeline and Future Projects - **Exploratory Programs**: The company is cautiously optimistic about ongoing exploratory programs, including MG trials and azer-cel, with potential for clearer direction in 2026 [35][36] Additional Insights - **Patient Awareness**: The DTC campaign has reportedly raised awareness, with patients actively requesting Briumvi after seeing commercials, indicating a positive trend for future sales [26][27] - **Team Performance**: The field team has received positive feedback, and the company is considering adding more personnel to strengthen market presence [27][28] This summary encapsulates the key insights from the TG Therapeutics conference call, highlighting the company's strategic positioning, product performance, competitive landscape, and future growth initiatives.