Moderna (MRNA) FY Conference June 11, 2025 08:40 AM ET Speaker0 So much for joining us. Really pleased to have Stephane Benzel, CEO of Moderna, with us. Maybe just start here, Stephane. You know, in the context of the current environment, both from a COVID demand and regulatory standpoint and the overall health care policy that we're seeing flow through from HHS and FDA and then there's the drug pricing dynamics. But just walk us through today where Moderna's business stands from a revenue and expenses stan ...

2025 年 06 月 11 日 行业周报 看好/维持 医药 医药 板块持续跑赢大盘，关注后续创新药催化（附 CD73 靶点研究）(2025.06.03-2025.06.08) 走势比较 (20%) (10%) 0% 10% 20% 30% 24/6/11 24/8/22 24/11/2 25/1/13 25/3/26 25/6/6 | 君实生物 | 买入 | | --- | --- | | 华领医药-B | 买入 | | 奥锐特 | 买入 | | 同和药业 | 买入 | | 阳光诺和 | 买入 | | 泓博医药 | 买入 | | 福元医药 | 买入 | | 三生制药 | 买入 | | 京新药业 | 买入 | | 共同药业 | 增持 | | 亿帆医药 | 买入 | | 诺诚健华 | 买入 | | 诺思格 | 买入 | | 奥翔药业 | 买入 | | 科伦药业 | 买入 | | 国邦医药 | 买入 | | 来凯医药-B | 买入 | | 百利天恒 | 买入 | | 益方生物 | 买入 | | 皓元医药 | 买入 | | 普洛药业 | 买入 | | 信达生物 | 买入 | | 加科思-B | 买入 | 子行业评级 ...

原料药——①2025-2030年，下游制剂专利到期影响的销售额为3900亿美元，相较2019-2024年总额增长 124%，同时，未来5年全球销售TOP15的小分子药物中有过半药物专利将到期，专利悬崖有望带来原料 药增量需求。②2024年，规模以上工业企业原料药产量为358.30万吨，同比增长4.6%，Q1受23年同期 高基数影响同比下降7.0%，Q2/Q3/Q4产量分别同比增长12.8%/14.9%/1.3%；2024年，印度原料药及中 间体从中国进口额为34.00亿元，同比增长4.9%，进口量为37.50万吨，同比快速增长11.1%，其中 Q1/Q2/Q3/Q4分别同比增长7.21%/22.18%/4.76%/11.18%，进口额及进口量均达到过去4年最高水平。结 合中印两国情况，原料药行业需求端边际改善明显，去库存阶段或已接近终结。建议关注：1）持续向 制剂、CDMO领域拓展、业绩确定性较强的个股，如奥锐特(605116)、普洛药业(000739)、奥翔药业 (603229)等；2）新产品业务占比较高或产能扩张相对激进的个股，如同和药业(300636)、共同药业 (300966)等；3）原有产品受去库存 ...

Financial Data and Key Metrics Changes - The company has achieved significant growth, reaching over 3.4 million patients treated globally with its oncology medicines, supported by strong commercial execution [56] - Keytruda is approved in 56 indications in the US, 44 in the EU, and 41 in Japan, showcasing its leadership in immuno-oncology [56][59] Business Line Data and Key Metrics Changes - The oncology portfolio has yielded 35 phase three trials with statistically significant overall survival and 56 FDA approved indications [7] - The development of subcutaneous pembrolizumab with barahyaluronidase alfa has shown comparability to IV Keytruda, with a median injection time of two minutes [17][19] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in earlier stage diseases, particularly in head and neck cancer, where there is a significant unmet medical need [60] - The anticipated peak uptake of subcutaneous pembrolizumab in the US is expected to reach between 30-40% within 18 to 24 months [62] Company Strategy and Development Direction - The company aims to diversify its oncology portfolio beyond Keytruda, focusing on additional therapeutic areas such as HIV vaccines, immunology, cardiovascular, and ophthalmology [6] - The strategy includes leveraging the proven track record of Keytruda to sustain leadership in oncology beyond its loss of exclusivity in 2028 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of innovative therapies and the potential for significant impact on cancer care through a diversified pipeline [55] - The company is committed to maximizing patient access and improving outcomes through its robust commercial engine and innovative product offerings [63] Other Important Information - The company has a strong focus on biomarker development, which is crucial for patient selection and optimizing treatment outcomes [36] - There are ongoing phase III studies for various agents, including MK1084 and Sac TMT, which are expected to read out in the near future [53][64] Q&A Session Summary Question: What is the company's perspective on the evolving market for PD-1, PD-L1, and VEGF bispecifics? - Management highlighted the consistent improvements in progression-free survival across multiple indications and expressed optimism about the ongoing trials in China, with plans to expand to the US [75][78] Question: How does the company view the market opportunity for head and neck cancer treatments? - Management clarified that patients receiving preoperative Keytruda did not lose the opportunity for surgery, and emphasized the safety and efficacy of the treatment [79]

Core Viewpoint - The announcement highlights the clinical data and latest progress of ZG006 and ZG005, which will be presented at the 2025 ASCO annual meeting, indicating the company's ongoing commitment to advancing its innovative oncology therapies [1]. Group 1: ZG006 Overview - ZG006, also known as Alveltamig, is a trispecific antibody drug developed by the company and its subsidiary, Gensun Biopharma Inc., targeting DLL3 and CD3, and has received orphan drug designation from the FDA [1][2]. - ZG006 is the first-in-class molecule targeting DLL3, showing potential to be a best-in-class therapy [1]. Group 2: ZG006 Clinical Data - In the ZG006-002 study, 48 patients with refractory advanced small cell lung cancer were randomized to receive either 10 mg or 30 mg Q2W treatment, with objective response rates (ORR) of 62.5% and 58.3%, respectively [2][3]. - The disease control rates (DCR) were 70.8% for the 10 mg group and 66.7% for the 30 mg group, with safety profiles showing no treatment-related adverse events leading to permanent discontinuation [3]. - In the ZG006-001 study, 47 patients received varying doses of ZG006, with confirmed ORR of 75.0% for 10 mg, 53.8% for 30 mg, and 58.3% for 60 mg, indicating strong anti-tumor activity [4][5]. Group 3: ZG005 Overview - ZG005, known as Nilvanstomig, is a recombinant humanized bispecific antibody targeting PD-1 and TIGIT, positioned as an innovative immunotherapy for various solid tumors [6][7]. - ZG005 is among the first of its kind to enter clinical research globally, with no similar mechanism drugs approved yet [6]. Group 4: ZG005 Clinical Data - In the ZG005-001 study, 55 patients with advanced cervical cancer were treated, showing an ORR of 40.9% and DCR of 68.2% in the 20 mg/kg group [7]. - The safety profile was favorable, with 83.6% of patients experiencing treatment-related adverse events (TRAE), predominantly grade 1-2 [7]. - In the ZG005-003 study, 60 patients with first-line cervical cancer were treated, with the 20 mg/kg group showing an ORR of 82.1% and DCR of 96.4% [8][9]. Group 5: ZGGS15 Overview - ZGGS15 is a recombinant humanized bispecific antibody targeting LAG-3 and TIGIT, representing a novel approach in tumor immunotherapy [10][11]. - It is the first of its kind to enter clinical research globally, with no similar mechanism drugs approved yet [10]. Group 6: ZGGS15 Clinical Data - In the ZGGS15-001 study, 22 patients were enrolled, with a DCR of 35.3% among evaluable patients [12]. - The safety profile showed that 90.1% of patients experienced TRAE, with no dose-limiting toxicities observed [12][13].

从二线单药治疗到一线联合化疗的临床数据连番释放，本质上亦映射出中国创新药企在双抗领域从"技术可行性验证"到"临床价值深挖"的进阶能力。 在全球创新药投资逻辑向"真创新、高壁垒"切换的背景下，中国创新药企在双抗等前沿领域持续突破，开始在国际顶级学术舞台展露锋芒。 继去年美国临床肿瘤学会（ASCO）年会以单药疗法惊艳亮相后，维立志博研发的抗PD-L1/4-1BB双抗LBL-024在2025年ASCO舞台再获突破性验证。 那么站在投资者的视角而言，应当如何来看待这一最新临床数据的表现？该数据对于维立志博又有何意义？ 潜在全球首创，真正源头创新锚定临床价值 不同于传统单抗疗法的线性突破逻辑，LBL-024通过PD-L1靶向锁定肿瘤微环境、4-1BB共刺激激活T细胞的"双引擎"设计，实现肿瘤微环境里的条件激活T 细胞，开创性地解决了4-1BB靶点系统性激活引发肝毒性的痛点。这种肿瘤微环境精准调控机制，使其成为全球首个有望实现4-1BB靶点商业化突破的免疫 疗法。 2024 ASCO大会，LBL-024单药在针对二线治疗、三线及以上治疗肺外神经内分泌癌（EP-NEC）的患者中，展现出良好的安全性和强有力的有效信号。 数据 ...

论文展示了前沿生成式人工智能平台及其集成工作流程在快速开发ISM5939中的赋能，验证了人工智能在药 物发现中的潜力。 不同于直接STING激动剂，ISM5939通过靶向ENPP1精准调控肿瘤组织内的STING信号通路，恢复局部免疫 激活，从而增强抗肿瘤免疫反应。 首次证实ENPP1抑制剂能够克服对免疫检查点抑制剂和化疗的双重耐药性，为难治性肿瘤患者带来新的治疗 希望。 自2025年以来，这已是英矽智能第三篇以AI驱动药物研发实践为主题、发表在Nature子刊的研究成果。 免疫检查点抑制剂为肿瘤治疗带来范式变革，使得多种恶性肿瘤患者获益。然而，接受免疫检查点抑制剂治 疗的患者中仅有10%-35%可以获得显著持久的治疗效果，亟需创新治疗策略。 | Received: 28 August 2024 | Congying Pu16, Hui Cui15, Huaxing Yu15, Xin Cheng', Man Zhang', Luoheng Qin', | | --- | --- | | Accepted: 7 May 2025 | Zhilin Ning', Wen Zhang', Shan Chen', Y ...

21世纪经济报道记者 唐唯珂 广州报道 5月23日，科望医药集团 Elpiscience Biopharmaceuticals, Inc. （以下简称"科望医药"）向港交所递交招股书，拟在港交所主板上市。 科望医药是一家专注于肿瘤免疫治疗领域研发的创新生物制药公司。目前科望医药没有被批准商业销售的产品，持续处于亏损状态。从2022年到2024年，科 望医药亏损额分别为7.71亿元、8.53亿元及0.88亿元，三年合计亏损17.12亿元。 与此同时，科望医药两位创始人纪晓辉、卢宏韬手拿千万年薪。 根据企业2024年6月递交的招股书，2022年，两人年薪分别达到1340.2万元和1084.8万元；2023年，两人年薪分别达到1234.7万元和1024.5万元。最新版招股 书则显示，2023年，两人年薪分别达到1244.5万元和1031.4万元；2024年，两人年薪分别达到1101.8万元和897.5万元。 "Biotech的生死线通常是账上现金能否支撑2-3年研发。"此前即有行业人士向21世纪经济报道记者分析，"科望的现金流勉强够到安全边际，但若IPO失败或 管线进展不及预期，压力将陡增。" 科学家与投资人的明星 ...

恒瑞医药公告，子公司广东恒瑞医药有限公司、上海盛迪医药有限公司收到国家药监局核准签发的关于 SHR-4712注射液的《药物临床试验批准通知书》，将于近期开展临床试验。SHR-4712注射液是公司自 主研发的1类治疗用生物制品，拟用于治疗晚期实体瘤。该药物能够与肿瘤相关抗原特异性结合，并诱 导激活肿瘤微环境中的免疫细胞，发挥靶向抗肿瘤作用。截至目前，SHR-4712注射液相关项目累计研 发投入约2492万元。 ...

2025 年 5 月 20 日，三生制药与辉瑞签订许可协议，授权辉瑞在全球（除中国外）对 707 的研发、生产和 商业化权益，本次授权的首付款为 12.5 亿美元，并可获得总额最多为 48.0 亿美元的潜在付款，包括开发、 监管批准及销售的里程碑付款，以及双位数百分比的销售分成。 国信医药观点：1）707 是三生制药研发的一款 PD-1xVEGF 双抗，研发进度较为靠前，早期临床数据优秀； 近日，707 单药头对头帕博利珠单抗针对一线 PD-L1 阳性的 NSCLC 的临床 3 期已经在 CDE 官网公示；2）707 目前单药在一线 PD-L1 阳性的 NSCLC、联合化疗在一线 NSCLC、结直肠癌、子宫内膜癌等实体瘤中开展临 床研究，其中一线 PD-L1 阳性的 NSCLC 适应症获得 CDE 突破性治疗认定，助力 707 的研发和商业化进程快 速推进；3）707 的商业化出海能力得到兑现，与辉瑞达成授权协议，协议总金额为 60.5 亿美元，其中首 付款 12.5 亿美元，里程碑付款 48.0 亿美元，以及双位数百分比的销售分成；此外，辉瑞将于生效日期根 据股份认购协议内容，认购公司 1.0 亿美元的三生 ...