答：LZM012 III 期临床入组患者基线较重，PASI 评 分达 21，与 UCBIII 期临床相当，既往生物制剂用药比例 不高。 | 3. 抗凝药物 H001：适应症为骨科大手术术后静脉血 | | --- | | 栓栓塞症，II 期临床试验已顺利完成入组。该项目具有靶 | | 点创新、用药安全性更佳、剂型便利等优势，II 期初步数 | | 据显示其抗凝效果与依诺肝素相当，出血风险呈现低于达 | | 比加群酯的趋势。 | | 4. 抗癫痫药物 NS-041 片：新一代 KCNQ2/3 激活剂， | | 已完成癫痫适应症 I 期临床并启动 II 期研究。公司 NS-041 | | 片已展现出同类最佳潜力，目前全球尚无同靶点抗癫痫药 | | 物上市。此外，重度抑郁适应症临床前研究已基本结束， | | 计划近期申报 IND。 | | 抗感染 片：适应症为侵袭性真菌病，目 5. SG1001 | | 前已完成 I 期临床，未来有望解决侵袭性曲霉菌感染耐药 | | 以及一线治疗效果不佳的难题。目前全球尚无同靶点药物 | | 获批上市。 | | 消化道药物 产品，其片剂已顺 6. JP-1366：P-CAB | | ...

丽珠医药集团股份有限公司投资者关系活动记录表 编号：2025-09 | | √特定对象调研 □分析师会议 | | --- | --- | | | □媒体采访 □业绩说明会 | | 投资者关系活动类别 | □新闻发布会 □路演活动 | | | 现场参观 | | | 其他 | | 活动参与人员 | 丽珠集团——董事会秘书 刘宁 | | | 丽珠生物——常务副总经理 杨嘉明 | | | 丽珠集团——研究院院长助理 汪永星 | | | 丽珠集团——投资者关系总监 陈文霞 | | | 丽珠集团——投资者关系经理 彭婷 | | | 参会投资机构共计 18 家，详见附件。 | | 时间 | 月 日 7 24 9:30-11:00，13:30-15:00 | | 地点 | 本公司会议室 | | 形式 | 现场调研及电话会议 | | 交流内容及具体问答 | 一、公司重点研发项目最新进展介绍 1. 双靶点， 期临床试验 | | | IL-17A/F 项目 LZM012：靶向 IL-17A/F | | | 适应症覆盖中重度银屑病及强直性脊柱炎。近日公司已公 | | | 布其与司库奇尤单抗（可善挺®）头对头的 III | | | ...

Market Overview - The current market is characterized by volatility, with the Nasdaq reaching a historical high primarily driven by Nvidia, while other sectors remain lackluster, indicating a sentiment-driven market rather than a solid fundamental basis [1] - The Hong Kong stock market experienced a slight decline of 0.29% today, reflecting the overall cooling of market conditions [1] Trade and Tariff Developments - President Trump announced upcoming tariffs on smaller countries, expected to be "slightly above 10%" [1] - NATO Secretary General warned that Brazil, China, and India could face secondary sanctions from the U.S. if Russia does not reach a peace agreement with Ukraine [1] - The Chinese Foreign Ministry stated that there are no winners in a trade war, emphasizing that coercion will not resolve issues [1] Semiconductor and AI Developments - Nvidia's CEO Huang Renxun highlighted the demand for H20 orders, noting its superior ecosystem efficiency compared to domestic alternatives [2] - InnoScience, a leader in GaN power devices, plans to increase its monthly production capacity from 13,000 to 20,000 wafers by the end of 2025, with a long-term goal of 70,000 wafers [2] - Huang acknowledged China's AI models as "world-class," suggesting that U.S. restrictions on high-end chips could accelerate China's AI development [2] Pharmaceutical Sector Insights - The pharmaceutical market is currently benefiting from innovative drugs that are not subject to centralized procurement, thus protecting profit margins [3] - Lijun Pharmaceutical's innovative drug H001 has completed its Phase II clinical trials, showing promise in preventing venous thromboembolism after orthopedic surgeries [3] - The latest centralized procurement list includes several Hong Kong-listed pharmaceutical companies, indicating potential market share growth for those that secure bids [4] Entertainment and Media Sector - The summer box office has reached 3.3 billion yuan, with notable films leading the ticket sales [5] - Companies like Huayi Brothers and Maoyan Entertainment are positioned to benefit from the summer film season, with significant contributions expected to their revenues [5] - The short video industry is experiencing explosive growth, with global in-app purchases nearing $700 million in Q1 2025, a nearly fourfold increase year-on-year [6] Precious Metals Investment - Major financial institutions are advising investors to seek refuge in precious metals due to potential tariffs, with gold, silver, and copper identified as favorable investments [7] - Morgan Stanley and Goldman Sachs have raised their gold price targets, predicting prices could reach $3,800 and $3,700 per ounce, respectively, by year-end [7] Travel and Tourism Sector - Tongcheng Travel reported a 13.2% year-on-year revenue growth in Q1 2025, driven by a strong performance in its core OTA business [8] - The company is expanding its international business, with significant growth in international ticket sales and hotel bookings [9] - Tongcheng's acquisition of Wanda Hotels is expected to enhance its high-end hotel management capabilities, contributing to future revenue growth [9]

国联民生证券表示，创新药或将逐步进入成果兑现阶段。2025年预计是国内创新药授权出海的重要年 份，自2018年"4+7"集采以后，国内企业纷纷开始从仿制药向创新药转型，至今已达7年时间，部分细分 赛道的集采影响已经出清，预计将陆续进入兑现期。 就港股整体表现，近日迎来持续回暖，海外积极信号频现，有望进一步支撑港股反弹走势。 隔夜美国劳工统计局最新公布的数据显示，剔除波动较大的食品和能源后，美国6月CPI较5月上涨 0.2%，同比上涨2.9%，连续5个月低于预期，特朗普随之再度催促美联储降息，港股有望成为美联储开 启宽松周期的主要受益者之一。 7月16日，港股冲高回落，恒指一度涨近4个月高位，尾盘翻绿微跌。港股科技双雄——创新药、科网龙 头走势活跃，科网板块开盘走强，重仓港股互联网龙头的港股互联网ETF（513770）场内价格一度大涨 2.7%，后涨幅有所回落，收涨0.72%，全天成交额9.31亿元，维持高位。快手-W、哔哩哔哩-W涨幅居 前。 板块个股大面积飘红，丽珠医药两位数领涨，最新消息，公司心血管领域1类创新药H001胶囊II期临床 试验患者完成入组；绿叶制药涨超9%，复星医药涨超7%，康方生物再刷新高 ...

Core Insights - GH Research PLC has submitted a complete response to the FDA regarding the clinical hold of its Investigational New Drug Application (IND) for GH001, ahead of schedule [1][2] - The company is focused on developing GH001, a treatment for treatment-resistant depression (TRD), utilizing a proprietary inhalation method [3] Company Developments - The response to the FDA includes comprehensive data and completed toxicology studies, demonstrating the company's commitment to regulatory compliance and patient care [2] - GH001 has shown promising results in the Phase 2b GH001-TRD-201 trial, achieving a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by -15.5 points compared to placebo on Day 8 (p<0.0001) [3]

丨证券研究报告丨 行业研究丨专题报告丨制药、生物科技与生命科学 [Table_Title] IL-25：II 型炎症通路创新靶点，剑指百亿美元特 应性皮炎市场 报告要点 [Table_Summary] IL-25 为 II 型炎症通路细胞因子，研究发现其在特应性皮炎 (AD)、银屑病和接触性皮炎这几种 皮肤炎症疾病的病变组织中均有上调，表明其与这几种疾病的发展有关。由中国抗体开发的 SM17 是全球 FIC 的 IL-25 受体 IL-17RB 单抗，针对特应性皮炎（AD）的 Ib 期顶线数据展现 出了优异的 PoC 数据，在保证不弱于 IL-4 单抗等疗法的皮损改善能力前提下，实现了比现有 创新疗法更快速和深度的瘙痒改善，有望成为特应性皮炎市场的下一个重磅靶点，并且还具有 拓展至其他 II 型炎症适应症的潜力。 分析师及联系人 [Table_Author] 彭英骐 刘长洪 SAC：S0490524030005 SFC：BUZ392 请阅读最后评级说明和重要声明 %% %% %% %% research.95579.com 1 制药、生物科技与生命科学 cjzqdt11111 [Table_Title2] I ...

Core Insights - GH Research PLC announced the acceptance of a Pharmaceutical Pipeline Presentation at the ASCP Annual Meeting, where clinical data from a Phase 2b trial of GH001 for treatment-resistant depression will be presented [1][7] - The Phase 2b trial results indicate robust evidence of GH001's efficacy and safety, potentially transforming treatment for patients with treatment-resistant depression [2][10] - Additional late-breaking posters will present safety and tolerability data from the Phase 2b trial and a proof-of-concept trial for postpartum depression [3][4] Company Overview - GH Research PLC is a clinical-stage biopharmaceutical company focused on developing innovative treatments for depression, particularly targeting treatment-resistant depression with its lead product candidate, GH001 [9][10] - GH001 is administered via a proprietary inhalation method and has shown promising clinical activity in trials, meeting primary endpoints with significant reductions in depressive symptoms [10] Clinical Trial Highlights - The Phase 2b trial (GH001-TRD-201) demonstrated a mean reduction of 15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo on Day 8, with a p-value of less than 0.0001, indicating strong efficacy [10] - In a proof-of-concept trial for postpartum depression, all ten participants achieved remission by Day 8, highlighting GH001's potential as an effective treatment option [4][8] - A separate Phase 2a trial for bipolar II disorder showed a 52% mean reduction in depressive symptoms by Day 8, suggesting rapid onset and substantial efficacy [6][9]

Core Insights - GH Research PLC reported financial results for Q1 2025, highlighting significant advancements in its clinical trials for GH001, a treatment for treatment-resistant depression (TRD) [1][9]. Business Updates - The Phase 2b trial of GH001 in 81 patients with TRD has completed, achieving its primary endpoint with a significant placebo-adjusted reduction of -15.5 on the Montgomery-Åsberg Depression Rating Scale (MADRS) by Day 8 [2][3]. - A 57.5% remission rate was observed in patients treated with GH001 on Day 8, compared to 0% in the placebo group [3]. - Safety analysis for the open-label extension (OLE) has not been completed, but as of January 22, 2025, no serious adverse events (SAEs) were reported [4]. - In the OLE, 77.8% of completers were in remission at the 6-month visit, with a 91.7% remission rate for those who achieved remission on Day 8 [4]. - The company is preparing to submit a full response to the FDA regarding the clinical hold on the Investigational New Drug Application (IND) for GH001, with submission expected in mid-2025 [6][7]. Financial Highlights - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $315.3 million, up from $182.6 million as of December 31, 2024 [10]. - Gross proceeds from a public offering in Q1 2025 amounted to $150 million [10]. - Research and development expenses for Q1 2025 were $7.9 million, a decrease from $8.7 million in the same quarter of 2024 [11]. - General and administrative expenses increased to $4.9 million in Q1 2025 from $2.9 million in Q1 2024 [12]. - The net loss for Q1 2025 was $10.8 million, or $0.19 loss per share, compared to a net loss of $7.7 million, or $0.15 loss per share, in Q1 2024 [12]. Clinical Development - GH001 is being developed for various indications, including bipolar II disorder and postpartum depression, with ongoing proof-of-concept trials [5]. - The Phase 1 clinical pharmacology trial for GH001 using a proprietary aerosol delivery device is ongoing in the UK [8].

Core Insights - GH Research PLC reported financial results for the year ended December 31, 2024, and provided updates on its clinical programs and financial position [1] Business Updates - GH001, an inhalable mebufotenin product candidate, is in a Phase 2b trial for treatment-resistant depression (TRD) involving approximately 80 patients [2] - The trial met its primary endpoint with a significant placebo-adjusted reduction of -15.5 in the Montgomery-Åsberg Depression Rating Scale (MADRS) on Day 8 (p<0.0001) [3] - A 57.5% remission rate was observed in patients treated with GH001 on Day 8 compared to 0% in the placebo group (p<0.0001) [3] - Safety analysis for the ongoing open-label extension (OLE) has not been completed, but as of January 22, 2025, 77.8% of OLE completers were in remission at the 6-month visit [4] - The Phase 1 trial for the proprietary aerosol delivery device is ongoing in the UK [5] Regulatory Updates - The Investigational New Drug Application (IND) for GH001 was placed on clinical hold by the FDA, which requested additional inhalation toxicology studies and device design verification [6] - The company has completed the requested inhalation toxicology studies, showing no adverse findings in the respiratory tract of dogs [7][9] - A full response to the IND hold is on track for submission in mid-2025 [10] Clinical Trials - Two Phase 2a proof-of-concept trials for GH001 in postpartum depression (PPD) and bipolar II disorder (BDII) have been completed [11] - The PPD trial met its primary endpoint with a MADRS reduction of -35.4 points (96.3%) on Day 8, with 100% of patients in remission [12] - The BDII trial also met its primary endpoint with a MADRS reduction of -16.8 points (51.9%) on Day 8, with 33.3% of patients in remission [13] Financial Highlights - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $182.6 million, down from $222.7 million in 2023 [14] - Research and development expenses increased to $35.0 million in 2024 from $29.8 million in 2023, primarily due to clinical development activities [15] - General and administrative expenses rose to $15.3 million in 2024 from $11.4 million in 2023, driven by higher professional fees and increased headcount [16] - The net loss for 2024 was $39.0 million, or $0.75 loss per share, compared to a net loss of $35.6 million, or $0.68 loss per share, in 2023 [17]