肿瘤免疫

Search documents
研究结果亮相国际会议!东阳光药2款创新药临床前研究登陆2025 AACR年会
智通财经网· 2025-04-30 07:47
智通财经APP获悉,2025年4月25日至30日,备受瞩目的第116届美国癌症研究协会(AACR)年会在美国 芝加哥盛大召开。作为全球肿瘤研究领域最具权威性和影响力的学术会议之一,AACR吸引了来自世界 各地的众多顶尖科学家分享和探讨前沿的癌症科学与医学成果。东阳光药2款创新药——靶向LY6G6D 阳性肿瘤细胞和免疫细胞表面激活型共刺激分子(4-1BB)双特异性抗体HEC-921、pan KRAS抑制剂 HEC211909的临床前研究亮相本次会议,旨在加速推动临床转化和全球合作,彰显公司研发实力获得国 际同行认可! 高效抗肿瘤活性的创新 LY6G6D/4-1BB免疫激动双抗 地点:Poster Session 37 时间:2025年4月29日 09:00 AM - 12:00 PM(当地时间) 讲者:梁绍勤博士 此次报告分子由经过筛选和优化设计的LY6G6D抗体,功能沉默的Fc结构域及4-1BB纳米抗体组成,是 一款具有First-in-class潜力的全人源LY6G6D/4-1BB双特异性抗体。其中,LY6G6D抗体靶向结合 LY6G6D阳性肿瘤细胞,在肿瘤部位富集并激活4-1BB阳性免疫细胞高效杀伤肿瘤。 ...
康方生物明星双抗药物OS数据不及预期?与“全球药王”的对决还未完
Di Yi Cai Jing· 2025-04-28 11:48
Core Viewpoint - The approval of the new indication for Ivosidenib (依沃西单抗) by Kangfang Biopharma (康方生物) did not positively impact the company's stock price, which fell by 11.83% on April 28 due to concerns over the overall survival (OS) data, which showed clinical benefits compared to Keytruda (K药) but lacked statistical significance [1][4][6]. Summary by Sections Drug Approval and Clinical Data - Ivosidenib received approval for a second indication as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positivity (TPS≥1%) and negative for EGFR and ALK mutations [4]. - The approval was based on positive results from the AK112-303/HARMONi-2 clinical trial, which demonstrated a median progression-free survival (PFS) of 11.14 months for Ivosidenib compared to 5.82 months for Keytruda, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [4][5]. Overall Survival Analysis - A mid-term analysis at 39% maturity showed that Ivosidenib reduced the risk of death by 22.3% compared to Keytruda, although this result did not achieve statistical significance [6][8]. - The total survival data is considered the gold standard for evaluating the efficacy of cancer therapies, and there are differing opinions on the interpretation of these results [6][9]. Market Reaction and Future Prospects - The market's reaction to the OS data has been viewed as misaligned with the essence of the clinical findings, according to Kangfang's chairman, Xia Yu [6][8]. - The ongoing competition with Keytruda is significant, as lung cancer remains the most prevalent and deadly cancer type in China, with Ivosidenib's performance in clinical trials being closely monitored [9][10]. Upcoming Research - The HARMONi-7 study, conducted by Summit, will further evaluate Ivosidenib against Keytruda in patients with high PD-L1 expression, with a focus on achieving statistically significant benefits in overall survival [10]. - This study is crucial for determining whether Ivosidenib can genuinely challenge Keytruda's dominant position in the market [10].
康方生物(09926):依达方®(依沃西,PD-1/VEGF)第二个适应症上市申请获得NMPA批准 用于一线治疗PD-L1阳性NSCLC
智通财经网· 2025-04-27 12:00
Core Viewpoint - The approval of the new indication for the bispecific antibody Iwosimab (PD-1/VEGF) for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) marks a significant advancement in cancer therapy in China, allowing patients to access a leading global treatment option [1][2]. Group 1: Drug Approval and Clinical Results - Iwosimab has received approval from the National Medical Products Administration (NMPA) for use in treating locally advanced or metastatic NSCLC with negative EGFR mutations and ALK [1]. - The approval is based on positive results from a randomized, double-blind, controlled Phase III clinical trial (AK112–303/HARMONi-2), where the median progression-free survival (PFS) for Iwosimab was 11.14 months compared to 5.82 months for Pembrolizumab, demonstrating a 49% reduction in the risk of disease progression or death (PFS HR=0.51, P<0.0001) [1][2]. - A mid-term analysis of overall survival (OS) at 39% maturity showed that Iwosimab significantly reduced the risk of death by 22.3% compared to Pembrolizumab (OS HR=0.777) [2]. Group 2: Future Plans and Ongoing Research - The company plans to hold a business highlights communication meeting on April 28, 2025, with details to be announced on its official website and public account [2]. - Iwosimab is currently undergoing 12 Phase III clinical studies, including 3 international multicenter trials, and has a total of 18 ongoing clinical trials covering various cancers such as lung cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and hepatocellular carcinoma [3].
三元基因:人干扰素1b治疗黑色素瘤获专家共识 细胞治疗临床研究取得积极进展
Bei Ke Cai Jing· 2025-04-27 09:11
创立30多年以来,三元基因围绕人干扰素α1b(商品名:运德素®)系列产品持续深耕,设计建立了第一条 通过国家GMP认证的基因工程药物生产线。人干扰素α1b作为全球独创基因工程药物,其独特的分子结 构和天然的生物学活性,在抗病毒的广谱性和临床用药的安全性等方面表现出显著的优势。 公司先后投资建立了五大技术平台,为持续的创新发展奠定了坚实的技术基础:一是建立了重组蛋白药 物高效表达与纯化技术平台;二是建立了蛋白质高稳定性水溶液技术平台,支持干扰素等细胞因子药物 的水针剂、喷雾剂、滴眼液、预充式注射剂、卡式笔多剂量注射剂、雾化吸入剂等的开发,并已获得中 国的发明专利;三是建立了高效、长效、安全新型干扰素制备技术平台,通过基因重组结合聚乙二醇定 点修饰技术,实现综合性能优越的新蛋白质药物,并已获得中国、美国、日本、韩国的发明专利;四是 建立了吸入制剂技术平台,通过建立雾化吸入制剂与干粉吸入制剂技术和特有的质量评价技术平台,支 持干扰素等吸入剂及与多种药物组合吸入方案的开发,并已获得中国的发明专利;五是设计了通用免疫 细胞治疗技术平台,开启了以天然γδT细胞联合人干扰素α1b为核心技术的新药开发。 2025年4月25日 ...
礼新医药完成3亿元C1轮融资,加快肿瘤免疫及肿瘤微环境领域临床管线推进
IPO早知道· 2024-10-19 02:30
本文为IPO早知道原创 作者|罗宾 微信公众号|ipozaozhidao 已启动C2轮融资。 礼新医药创始人、董事长兼首席执行官秦莹博士表示:"礼新医药自创立以来,一直坚持源头自主创 新,聚焦肿瘤微环境,专注于开发研发肿瘤特异性靶向ADC和免疫调节大分子创新药物,已建立了 一套完整覆盖从临床前直至临床III期的拥有自主知识产权并具有全球竞争力的差异化创新药管线。我 们将不负众望,加快推进LM-302和LM-108两个后期临床管线,争取早日实现产品上市。同时, 持续产出聚焦于肿瘤免疫及肿瘤微环境领域内尚未满足的治疗需求的早期源头创新管线,并继续积极 探索与各种伙伴以及各界展开多元化的紧密合作,通过BD合作进一步提升公司自我造血能力。" 中国生物制药有限公司董事会主席谢其润表示:"中国生物制药已上市了安罗替尼等众多重要的肿瘤 产品,并且正持续不断地投入创新药研发与合作。我们一直关注肿瘤免疫治疗和ADC药物的研发进 展,礼新医药是一家聚焦于肿瘤免疫及肿瘤微环境领域的创新药公司,其差异化的创新管线布局、扎 实的GPCR多次跨膜蛋白抗体发现平台、双抗技术平台和ADC技术平台、都给我们留下了深刻的印 象。我们坚定看好礼新 ...