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新股前瞻|在港股“二次递表“浪潮中,解码维立志博的投资价值
智通财经网· 2025-06-05 01:01
今年以来,内地企业奔赴港股上市的热情不断高涨,形成了一股显著的潮流。在提交的450家备案申请企业中,计划赴港上市的企业多达248家,显示出对港 股市场的浓厚兴趣。在排队上市的各家企业中,不乏多家拟A+H上市的A股公司,以及各类明星企业。随着A+H上市正在进入高潮阶段,今年以来已有近60 家A股公司赴港上市。 据Wind数据显示,5月中国香港市场IPO累计募资金额超560亿港元,为2021年3月以来的历史新高水平,今年以来累计募资规模更是高达774亿港元,已接近 去年全年水平。 差异化布局优势凸显,多元化管线前景可期 智通财经APP了解到,作为下一代肿瘤免疫疗法的领跑者,维立志博持续专注于中国及全球肿瘤、自身免疫性疾病及其他重大疾病新疗法的发现、开发及商 业化。 其实在冲刺IPO前,维立志博就已是资本市场上的"香饽饽"。截至目前,维立志博已经完成8轮融资,累计融资总额10.84亿元(人民币,下同),当中不乏 恩然创投、汉康资本、深创投等知名医药投资机构。备受资本青睐的背后,是维立志博领先的技术能力及具备前瞻性的业务布局。 2025年6月,维立志博再次向港交所递交了招股书。与半年前相比,这次更新的不只是财务数据, ...
临床抗癌药流入市场?康方生物自查后回应:系医药代表伪造材料
近日,一则关于康方生物临床试验抗癌药物卡度尼利单抗流入市场的消息引发行业关注。根据大象新闻 报道,李某美以79320元购买了70支药物,其中大部分为"仅供临床研究使用"的药品。 对此,康方生物向21世纪经济报道回应道:系医药代表伪造材料,将全面排查并优化业务流程,配合监 管部门调查,维护患者和公司的合法权益。 这或是一波未平一波又起。数日前,康方生物与合作伙伴Summit Therapeutics公布的III期临床试验 HARMONi顶线结果又将企业推向另一争议焦点。研究虽在PFS上取得显著获益,但OS未达统计学显著 性,引发业内对临床价值的讨论。 就在舆论聚焦用药合规问题之际,康方生物与合作伙伴Summit Therapeutics近期公布的III期临床试验 HARMONi顶线结果,又将其推向另一个争议漩涡。 有接近康方生物方面的人士亦对21世纪经济报道坦言:"虽然数据解读存在复杂性,但在该治疗领域, 这个结果已经算是全球最佳水平。" 对于这一结果,业内不乏感慨新药不易。有业内人士表示,该治疗领域在美国等西方地区仍存在高度未 满足的临床需求,且获批治疗方案有限。 合规用药如何保障? 此次卡度尼利单抗注射液的 ...
Merck(MRK) - 2025 FY - Earnings Call Transcript
2025-06-03 00:02
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]
泽璟制药: 泽璟制药关于自愿披露ZG006和ZG005在2025年美国临床肿瘤学会(ASCO)年会发布临床数据及最新进展的公告
Zheng Quan Zhi Xing· 2025-06-02 08:26
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].
Cancer Cell:卡介苗通过造血重编程,促进抗肿瘤免疫
生物世界· 2025-06-02 02:42
撰文丨王聪 编辑丨王多鱼 排版丨水成文 卡介苗 (BCG) ,是一种由减毒 牛分枝杆菌悬浮液制成的活菌疫苗,被用于预防 肺结核 。此外,它还具有增强巨噬细胞活性及其杀灭肿瘤细胞的能力,活化 T 淋巴细胞,增强机体细胞免疫的功能,因此,还作为治疗 膀胱癌 的免疫疗法。 当通过静脉注射给药时,卡介苗会重新编程骨髓中的造血干细胞/祖细胞 (HSPC) ,从而对感染产生异源性保护作用。但目前尚不清楚膀胱内给药卡介苗的抗肿 瘤作用是否与其对 HSPC 的重编程有关。 2025 年 5 月 29 日,威尔康奈尔医学院的研究人员在 Cell 子刊 Cancer Cell 上发表了题为: Microbial cancer immunotherapy reprograms hematopoiesis to enhance myeloid-driven anti-tumor immunity 的研究论文。 该研究表明,微生物癌症免疫疗法—— 卡介苗 ,通过重编程的造血干细胞/祖细胞 (HSPC) ,增强抗肿瘤免疫。 经卡介苗重编程的造血干细胞/祖细胞 (HSPC) 足以通过生成中性粒细胞、单核细胞和树突状细胞来增强抗肿瘤免疫,这 ...
全球首个!维立志博攻克0成药肿瘤靶点,中国原研药领跑国际
Ge Long Hui· 2025-06-01 02:01
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 ...
创始人年薪千万,估值暴涨23倍,公司亏17亿
Guo Ji Jin Rong Bao· 2025-05-30 04:26
继谋求美股上市和首次申请港交所上市失效后,这是科望医药再一次递表。 IPO日报注意到,由"明星团队"创立的科望医药给创始人们带来的丰厚的薪资回报,公司估值三年半暴涨23倍,但公司尚未 盈利,三年累亏17.12亿元,现金及现金等价物的"血库"急需融资"补血",核心产品商业化最早要等到2028年。 近日,科望医药集团(下称"科望医药")向港交所递交招股书,拟在港交所主板上市,中信证券为独家保荐人。 AI制图 年薪千万,估值暴涨 科望医药成立于2017年,专注于肿瘤免疫与自身免疫这两大创新免疫疗法的产品开发,由纪晓辉、卢宏韬、沈文彦等科学 家和创业者共同创立。 资料显示,纪晓辉现年63岁,曾在罗氏制药担任Roche Partnering的亚洲和新兴市场全球负责人和副总裁,还担任过礼来亚 洲基金的风险合伙人,现任公司董事会主席、执行董事兼首席执行官,负责整体公司战略和业务运营。卢宏韬现年59岁,曾担 任葛兰素史克(GSK)的首任全球神经免疫部门负责人,现任执行董事兼首席科学官,负责制定和执行公司的科学战略和计 划。沈文彦是治疗心血管疾病的依洛优单抗(Repatha)的主要发明人,亦是治疗骨质疏松症药物罗莫单抗的发明人 ...
君实生物拟变更募投项目子项目 提高募集资金利用效率
Zheng Quan Ri Bao Wang· 2025-05-29 13:17
其中,JS207为君实生物自主研发的重组人源化抗PD-1和VEGF双特异性抗体,主要用于晚期恶性肿瘤 的治疗。君实生物公告称,当前,有多家生物医药企业围绕该靶点进行产品开发,已公布的临床研究数 据积极,在治疗肺癌、肝癌、乳腺癌、胃肠道肿瘤等多个实体瘤中的临床获益逐步得到验证,有望成为 下一代肿瘤免疫疗法中的潜在重磅产品。目前,JS207处于II期临床研究阶段。不久前,三生制药全资 附属公司沈阳三生制药有限责任公司、三生国健药业(上海)股份有限公司曾就PD-1/VEGF双特异性抗体 与辉瑞达成重磅许可协议。 本报讯(记者孙文青)5月29日晚间,上海君实生物医药科技股份有限公司(以下简称"公司")公告称,公司 拟对公司2022年度向特定对象发行A股股票募集资金投资项目之"创新药研发项目"中的部分临床试验子 项目及其募集资金投资金额进行调整,"创新药研发项目"的募集资金投资总金额保持不变。 公告显示,君实生物新增"JS207境内外研发""JS107境内外研发""JS125境内外研发"等多项子项目的募集 资金投入,同时调减了多款药物境内外研发资金投入。 君实生物在公告中表示,公司此次部分募投项目子项目变更及金额调整, ...
开辟TME抗癌新战线,科望医药能否征服港股投资者?
He Xun Wang· 2025-05-28 07:37
近日,科望医药集团(下称"科望医药")更新招股书,冲击港交所主板上市,独家保荐人为中信证券。 据悉,科望医药曾于2021年谋求美股上市,且提交了上市申请文件,但次年又撤回上市申请,并于2024 年6月转战港交所。而此次为公司第二次向港交所递表。 根据披露,科望医药成立于2017年,是一家处于临床阶段的生物医药公司。然而,这家成立不到十年的 新药公司却吸引了包括礼来、高瓴、腾讯、鼎晖等众多知名资本的青睐,并在经历多轮融资后估值达到 6亿美元。 礼来亚洲合伙人施毅博士,通过第一大股东LAVUSD持有公司22.93%的股份。不仅如此,公司创始人 纪晓辉此前还曾担任礼来亚洲基金的风险合伙人,施毅博士此前亦为公司的非执行董事。 成立不到十年,却与礼来有着深厚渊源的科望医药究竟有何独特之处? 聚焦肿瘤微环境的差异化创新 相比于行业内的在热门靶点上的扎堆竞争,科望医药选择以肿瘤微环境(TME)切入,打造以髓系细 胞为基础的癌症和自身免疫性疾病免疫疗法产品,开辟差异化研究赛道。 根据招股书介绍,公司凭借对肿瘤微环境的深刻理解和开创性研究,致力于以系统方法覆盖癌症生物学 中创新和有前景的靶点和通路,从而推动免疫肿瘤学的创新。 ...
英矽智能再登Nature子刊,以AI赋能创新免疫疗法研发
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 ...