今日港股小幅飘红，T+0交易的港股通创新药ETF（159570）大涨3.88%，成交额快速突破5亿元！资金积极涌入，盘中狂揽净流入超2100万元，昨日更是巨 幅"吸金"超9100万元！ 格持续提升；（2）交易类型日益多元化；（3）管线BD阶段逐步前移。展望未来，中国创新药仍处于蓬勃发展期，建议重点关注国内拥有FIC/BIC管线的标 的。（来源：《医药行业周报：创新药BD高潮迭起，持续看好中国资产潜力》） 港股通创新药ETF（159570）标的指数成分股集体大涨：信达生物大涨超15%，石药集团、康方生物涨超3%，三生制药、中国生物制药涨超2%，百济神州 涨超1%。 消息面上，信达生物在2025年美国临床肿瘤学会（ASCO）年会上口头报告了全球首创（First-in-class）PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363治疗晚 期非小细胞肺癌的临床I期研究数据，这也是继结直肠癌和黑色素瘤之后IBI363今年ASCO大会的第三项口头报告。在免疫治疗耐药的鳞状非小细胞肺癌和野 生型肺腺癌中，都观察到了可控的安全性、令人鼓舞的疗效及长期生存获益趋势。值得一提的是，信达生物肿瘤管线在此次ASCO会议上 ...

截至2025年6月4日 09:53，信达生物(01801)上涨14.37%，再鼎医药(09688)上涨7.45%，诺诚健华(09969) 上涨5.43%，科伦博泰生物-B(06990)，中国生物制药(01177)等个股跟涨。香港医药ETF(513700)上涨 2.55%。 若投资者看好港股医药板块长期发展，可借助相关 ETF 布局。例如香港医药ETF(513700)，能有效跟踪 板块整体表现，分散个股风险。通过这类 ETF，投资者可一键打包众多优质港股医药标的，分享行业 发展红利。 香港医药ETF紧密跟踪中证港股通医药卫生综合指数，中证港股通医药卫生综合指数从港股通范围内选 取50只流动性较好、市值较大的医疗卫生行业上市公司证券作为指数样本，以反映港股通范围内医药卫 生上市公司证券的整体表现。 数据显示，截至2025年5月30日，中证港股通医药卫生综合指数(930965)前十大权重股分别为百济神州 (06160)、药明生物(02269)、信达生物(01801)、石药集团(01093)、康方生物(09926)、京东健康(06618)、 中国生物制药(01177)、三生制药(01530)、翰森制药(03692)、 ...

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO conference, demonstrating its potential efficacy in treating advanced non-small cell lung cancer (NSCLC) and other tumor types [1][2][11]. Group 1: Clinical Data and Efficacy - IBI363 has shown a manageable safety profile and encouraging efficacy in patients with immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma, with trends indicating long-term survival benefits [1][4][11]. - In a Phase 1 study, IBI363 monotherapy was administered to 136 NSCLC patients, with a focus on those with squamous cell carcinoma and EGFR wild-type adenocarcinoma [3][6]. - The confirmed overall response rate (ORR) for squamous NSCLC patients receiving IBI363 at different dosages was reported as 25.9% and 36.7%, with disease control rates (DCR) of 66.7% and 90.0% respectively [5][6]. Group 2: Long-term Survival Benefits - IBI363 demonstrated potential long-term survival benefits, with median overall survival (OS) of 15.3 months for the 1/1.5 mg/kg dose group and not reached for the 3 mg/kg group, alongside a 12-month OS rate of 70.9% [5][6][10]. - Among patients with PD-L1 TPS<1%, the ORR was 30.0% for the lower dose and 46.2% for the higher dose, indicating IBI363's effectiveness in low PD-L1 expression populations [7]. Group 3: Future Development Plans - Innovent plans to initiate a Phase 3 registration clinical study for IBI363 in locally advanced or metastatic squamous NSCLC patients who have failed prior treatments [11]. - The company has received Breakthrough Therapy Designation (BTD) from China CDE and Fast Track Designation (FTD) from the US FDA for IBI363 in treating squamous NSCLC [11][17]. Group 4: Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, with 15 products launched and multiple assets in clinical trials [18]. - The company collaborates with over 30 global healthcare companies to advance its innovative therapies [18].

Core Insights - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO Annual Meeting, demonstrating its potential to convert "cold tumors" into "hot tumors" in advanced colorectal cancer [1][2][10] Clinical Data Summary - IBI363 monotherapy showed a median overall survival (OS) of 16.1 months in patients with advanced colorectal cancer, significantly better than standard treatments which range from 6.4 to 9.3 months [6][10] - In Phase 1 studies, IBI363 combined with bevacizumab resulted in a confirmed objective response rate (cORR) of 15.1% and a disease control rate (DCR) of 61.6% among 73 participants [9] - The combination therapy showed a median progression-free survival (PFS) of 4.7 months, with a notable increase in efficacy for patients without liver metastases, achieving a cORR of 31.3% and a DCR of 81.3% [9] Mechanism of Action - IBI363 operates by blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway, specifically targeting tumor-specific T cells, which enhances its therapeutic efficacy in treating colorectal cancer [11][12] - Tumor immune cell infiltration analysis indicated that higher levels of CD8+ T cells were associated with improved clinical responses to IBI363, supporting its mechanism of action [8] Future Development - Innovent is conducting further clinical studies in multiple countries to explore IBI363's efficacy across various tumor indications, including immune-resistant and cold tumors [12] - The company has initiated a pivotal trial for IBI363 targeting unresectable locally advanced or metastatic mucosal or acral melanoma [12][13] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 15 products to date [14][15] - The company has received fast track and breakthrough designations from regulatory authorities for IBI363, indicating its potential in treating specific cancer types [13]

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, demonstrating breakthrough efficacy in treating "immune cold tumors" such as acral and mucosal melanoma, which are traditionally resistant to treatment [1][2][4]. Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [16]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline [16]. Clinical Study Insights - IBI363 is currently undergoing clinical studies in China, the United States, and Australia, targeting multiple tumor indications, particularly immune-resistant and cold tumors [2][14]. - The Phase 1/2 studies have shown a confirmed objective response rate (cORR) of 23.3% and a disease control rate (DCR) of 76.7% in patients with advanced melanoma [6][7]. - The median progression-free survival (PFS) for patients treated with IBI363 was reported at 5.7 months, significantly longer than previous studies [7][10]. Efficacy and Safety Profile - IBI363 has demonstrated durable responses with a median duration of response (DoR) of 14.0 months in patients with confirmed responses [7]. - The overall 12-month overall survival (OS) rate was 61.5%, with a median OS of 14.8 months [6][7]. - The treatment was generally well tolerated, with the most common treatment-related adverse events being arthralgia, rash, and hyperthyroidism, primarily Grade 1 or 2 [7]. Future Development Plans - A pivotal Phase 2 registrational study comparing IBI363 with pembrolizumab in patients with unresectable melanoma has been initiated, aiming to enroll 180 patients [8][9]. - The company is also exploring combination therapies with IBI363 across various cancer types, indicating a commitment to expanding its therapeutic applications [9][14]. Market Need and Potential - There is a significant unmet clinical need for effective treatments for advanced acral and mucosal melanoma in China, where current therapies have limited efficacy [10][12]. - IBI363 aims to address this gap by transforming "cold tumors" into "hot tumors" through dual activation of the PD-1 and IL-2 pathways, potentially establishing a new standard in immunotherapy for melanoma [10][13].

Core Viewpoint - Innovent Biologics has initiated a Phase 3 clinical study for picankibart, targeting psoriasis patients who have not responded adequately to anti-IL-17 treatments, aiming to provide robust clinical evidence for biologic switching strategies in psoriasis treatment [1][4][6]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focused on developing high-quality medicines for various diseases, including oncologic, autoimmune, cardiovascular, and metabolic conditions [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, including 3 new drug applications under regulatory review [10]. Clinical Study Details - The Phase 3 study (NCT06945107) will enroll approximately 310 participants, randomized in a 1:1 ratio to receive either picankibart or continued IL-17 monoclonal antibody treatment [2]. - The primary endpoint is the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16 [2]. Efficacy and Safety - Previous Phase 2 studies indicated that switching to picankibart resulted in a rapid clinical response, with 64.6% of patients achieving skin lesion clearance after 16 weeks [3][6]. - Nearly half (48.2%) of participants in the Phase 2 study reached the primary endpoint, with a stable response rate of 54.2% through week 44 [5]. Psoriasis Background - Psoriasis is a chronic inflammatory disease affecting 80%-90% of patients with plaque psoriasis, with nearly 30% classified as moderate-to-severe [7]. - Current systemic treatments include various agents, with biologics becoming a central focus since 2019 due to their efficacy and safety [7]. Picankibart Overview - Picankibart (IBI112) is a monoclonal antibody developed by Innovent, targeting the IL-23p19 subunit, which may offer a more effective treatment option for psoriasis and other autoimmune diseases [8]. - The first new drug application for picankibart for moderate-to-severe plaque psoriasis was submitted for review by the NMPA in September 2024 [9].

近日，由中国科研团队主导、信达生物深度参与的肥胖治疗新药——玛仕度肽III期临床研究（GLORY-1）成果在国际 顶级医学期刊《新英格兰医学杂志》（NEJM）全文在线发表。该药物是全球首个且唯一申报上市GCG/GLP-1双受体 激动减重降糖药物，其临床研究登顶医学权威学术期刊，标志着中国在内分泌代谢领域的创新成果得到了国际认可， 有望改写国内外超重和肥胖疾病的临床治疗路径，甚至纳入国际权威指南，为全球肥胖治疗提供"中国方案"。 聚焦GLORY-1：《新英格兰医学杂志》发表中国内分泌代谢领域首创新药治疗肥胖研究成果发布会现场。主办方供图 会上，NEJM副主编肖瑞平教授指出："该项研究验证了全球首个申报上市的GCG/GLP-1双受体激动剂在超重或肥胖管 理中的疗效与安全性，标志着中国自主开发的创新减重药物临床研究迈入国际领先行列。" 登顶NEJM："中国方案"为全球肥胖治疗提供新方向 5月27日，由NEJM医学前沿主办的"聚焦GLORY-1：《新英格兰医学杂志》发表中国内分泌代谢领域首创新药治疗肥 胖研究成果发布会"在北京举行。该研究牵头人北京大学人民医院内分泌科主任纪立农教授、北京医院国家老年医学 中心内分泌科 ...

机构：中金公司 研究员：张琎/刘雅馨/朱言音 IBI363 肠癌后线数据较大超我们预期。截至2024 年12 月6 日1：患者基线单药组和联合组分别有63.2% 和53.4%此前已经接受过3 线及以上的治疗。在疗效可评估患者中（单药组 n=63，联合组 n=68）整体 ORR为12.7%和23.5%。接受IBI363 单药治疗患者mOS达16.1 个月（95% CI： 10.1–未达到），IBI363 联合贝伐珠单抗组OS未成熟。三级及以上TRAE发生概率单药组和联合用药组 分别为23.5%和30.1%。尽管此前IBI363 披露的ORR数据已经显示出亮眼信号，我们认为此次首次披露 的OS数据仍较大超我们预期，IBI363 未来有潜力成为该领域的重磅品种。 IBI363 在IO经治肺癌持续展现领先的竞争力。截至2024 年12 月6 日2： 至少有1 次基线后肿瘤评估的鳞状NSCLC患者中，3mg/kg剂量组（n=30）ORR高达43.3%（cORR 36.7%），DCR 90.0%。mPFS 7.3 个月。在无可靶向基因组改变的PD-(L)1 经治患者中，3mg/kg剂量组 （n=30）ORR28.0%（c ...

机构：中信建投证券 研究员：贺菊颖/袁清慧 核心观点 公司公布IBI363 在ASCO 大会上的初步摘要数据，其中无论是热肿瘤NSCLC 还是冷肿瘤MSS CRC/黏 膜肢端黑色素瘤，公司均展现出极具突破性的疗效数据。其中NSCLC 上，sqNSCLC 3L 患者单药 3mg/kg 治疗后mPFS 达到7.3 个月，极其出色；同时MSS CRC后线混杂剂量单药下mOS 达到16.1 个 月，mOS 数据接近一线患者获益情况。综上来看，信达生物的IBI363 具备强大的对T 细胞增殖和激活 的能力，可以在冷/热肿瘤中均为患者带来超强获益，长期值得期待。 事件 5 月23 日，信达生物的IBI363（PD1/IL2）和IBI343（CLDN18.2ADC）两款产品亮相ASCO 大会，展示 摘要数据。（摘要数据是截止到2024 年12 月，正式会议数据预计截止到4-5 月）点评 肺癌数据优异，验证热肿瘤IO 耐药人群潜力，后续关注mDoR 及mOS在非小细胞肺癌上，公司的 IBI363 在临床试验中共计入组1 3 6人，所有患者均接受过标准疗法治疗，绝大部分患者前线接受过I O 治疗，72%的患者为三线及以后患者。 ...

此前，IBI363已被CDE纳入突破性治疗药物（BTD）品种名单，拟定适应症为既往未经过系统性治疗的 不可切除局部晚期或转移性肢端型及黏膜型黑色素瘤。 信达生物正在中国、美国、澳大利亚开展临床研究探索IBI363在针对各种恶性肿瘤的有效性和安全性。 IBI363已开出首个关键注册临床研究，用于治疗未经免疫治疗的粘膜型和肢端型黑色素瘤。IBI363已获 美国FDA两项快速通道资格认定，分别用于治疗晚期鳞状非小细胞肺癌和黑色素瘤。 由于新激活的肿瘤特异性T细胞同时表达PD-1和IL-2α，这一差异性策略可以更精确和有效地实现对该T 细胞亚群的靶向和激活。IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和 转移模型中也表现出了突出的抑瘤效力。 智通财经APP获悉，5月23日，国家药品监督管理局（NMPA）药品审评中心（CDE）官网显示，信达 生物（01801）的PD-1/IL-2双特异性抗体融合蛋白IBI363拟纳入突破性疗法，用于治疗经含铂化疗及抗 PD-1/PD-L1免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌。 据悉，IBI363是由信达生物自主研发的全球首创PD-1/IL-2α ...