据介绍，YK012的研发依托益科思特"北京总部+美国全资子公司Excyte LLC"双中心布局，此次FDA IND获批后，公司将逐步启动国际多中心临床研究，与中国已开展的多中心试验(由北京大学第一医院 赵明辉教授牵头)形成数据互补，加速全球研发进程。 消息面上，据昭衍新药官微消息，近日，益科思特自主研发的靶向CD19/CD3的创新双特异性抗体 YK012.正式获得美国食品药品监督管理局(FDA)的临床试验批准(IND)，用于治疗原发性膜性肾病 (pMN)。这是全球首个针对该适应症获批临床的T细胞衔接器(TCE)类双抗药物，标志着中国原研双抗技 术在自身免疫病领域实现中美同步突破。昭衍新药作为益科思特的非临床CRO合作伙伴，全面参与了 YK012项目的药代动力学服务、毒理试验等非临床试验过程。 昭衍新药（603127）(06127)涨超3%，截至发稿，涨3.6%，报19.87港元，成交额2574.99万港元。 ...

Aclaris Therapeutics (NasdaqGS:ACRS) 2025 R&D Day October 14, 2025 08:00 AM ET Speaker0Hey, good morning, everyone. Good to see everybody here. My name is Will Roberts. I'm the Head of Comms for Aclaris Therapeutics. I'm thrilled to be the first person to welcome you to our 2025 R&D Day up here in New York. Thanks to everybody in the room. Really appreciate you showing up. It's early, we know it. The weather's not ideal, but it's good to see everybody here. To the folks attending on the webcast, thank you g ...

据介绍，IMM2510基于"mAb-Trap"技术平台研发，通过多重机制发挥抗肿瘤作用。I期临床研究显示， IMM2510治疗经免疫治疗的晚期鳞状非小细胞肺癌客观缓解率达35.3%，疾病控制率为76.5%，中位无 进展生存期为9.4个月，安全性可控;II期初步数据显示联合化疗一线治疗NSCLC效果显著。基于积极结 果，宜明昂科计划在III期临床试验中进一步验证IMM2510的疗效和安全性。 值得一提的是，国元国际指出，公司在2025年世界肺癌大会上公布IMM2510单药在晚期肺鳞状非小细 胞肺癌(sq-NSCLC)患者中的初步疗效与安全性数据，数据来源于I期临床研究的剂量递增及队列扩展阶 段。IMM2510此次公布单药治疗的ORR为35.3%，PFS为9.4个月，临床数据优秀，安全性良好。 （原标题：港股异动 | 宜明昂科-B(01541)涨超12% IMM2510两项III期注册临床试验已递交EOP2） 智通财经APP获悉，宜明昂科-B(01541)涨超12%，截至发稿，涨12.27%，报12.72港元，成交额2390.9万 港元。 消息面上，据动脉网报道，近日，宜明昂科自主研发的VEGF×PD-L1双特异 ...

Group 1 - The stock of Yiming Oncology-B (01541) increased by over 12%, reaching HKD 12.72 with a trading volume of HKD 23.9 million [1] - Yiming Oncology has submitted two EOP2 communication requests for its self-developed VEGF×PD-L1 bispecific antibody IMM2510 to the National Medical Products Administration for Phase III clinical trials targeting different types of lung cancer, marking a critical stage in its clinical development [1] - The IMM2510 is developed based on the "mAb-Trap" technology platform and demonstrates antitumor effects through multiple mechanisms [1] Group 2 - Phase I clinical trials showed that IMM2510 achieved an objective response rate (ORR) of 35.3% and a disease control rate of 76.5% in patients with advanced squamous non-small cell lung cancer (sq-NSCLC), with a median progression-free survival (PFS) of 9.4 months and manageable safety [1][2] - Preliminary data from the Phase I clinical study presented at the 2025 World Lung Cancer Conference indicated excellent clinical data and good safety for IMM2510 as a monotherapy in advanced sq-NSCLC patients [2] - Based on positive results, Yiming Oncology plans to further validate the efficacy and safety of IMM2510 in Phase III clinical trials [1]

Summary of the Conference Call for 康方生物 Company Overview - 康方生物 is a leading player in the field of bispecific antibodies, focusing on innovative drug development for cancer and autoimmune diseases. The company has over 50 drug candidates, with 24 in clinical or commercial stages and approximately 15 with first/best in class potential [2][5]. Key Points and Arguments Clinical Trial Success - **AK104** has shown outstanding results in clinical trials for cervical and gastric cancers, particularly in patients with low PD-L1 expression, demonstrating significant statistical differences in overall survival (OS) [2][4]. - **AK112** has entered the global market and is advancing in clinical trials for lung, colorectal, and biliary cancers, with promising data expected to be released at the upcoming CES conference [2][6]. Market Position and Sales Growth - Both **AK104** and **AK112** have been included in health insurance coverage, indicating strong market support. The sales figures are steadily increasing, driven by the expansion of indications and a snowball effect [2][7]. - The domestic sales peak for **AK112** is projected to reach 9 billion RMB, while the overseas market could see sales peak at 10 billion USD, contributing significantly to the company's valuation [16][17]. Research and Development - The **Harmony 6 study** is a pivotal head-to-head clinical trial comparing bispecific antibody combination chemotherapy with PD-1 monoclonal antibody combination chemotherapy, particularly focusing on central squamous cell lung cancer patients [2][8]. - **AK112** has successfully translated progression-free survival (PFS) into OS in the Harmony A study, indicating a significant breakthrough in treatment efficacy [9]. Addressing Market Concerns - 康方生物 has conducted extensive data analysis to demonstrate the consistency of its drugs across different populations, alleviating concerns regarding HR value discrepancies among various ethnic groups [3][10]. Future Development Directions - The company plans to continue enhancing its bispecific platform capabilities, expanding beyond oncology into autoimmune diseases, with multiple bispecific molecules entering Phase II clinical trials [11]. - The ongoing development of new first/best in class molecules is expected to elevate 康方生物's profile as a comprehensive platform company rather than a single-product entity [11]. Valuation and Financial Outlook - As 康方生物 progresses its Phase II clinical drugs, these will gradually be incorporated into the valuation framework, enhancing the overall stability of the company's operations [12]. - The long-term valuation potential for 康方生物 is estimated to reach 200 billion RMB, driven by the performance of AK104 and AK112, along with other drug candidates in the pipeline [18]. Additional Important Insights - The **AK104** drug has been approved for multiple indications, including first-line and second-line treatments for cervical cancer and first-line treatment for gastric cancer, achieving significant OS metrics [13][14]. - 康方生物 is conducting important global clinical trials for **AK104** across various indications, which are expected to further enhance its market position and sales potential [15]. This comprehensive overview highlights 康方生物's strong clinical performance, market positioning, and future growth potential, making it a significant player in the biopharmaceutical industry.

基石药业-B(02616)涨超4%，截至发稿，涨4.3%，报10.43港元，成交额1.09亿港元。 消息面上，基石药业今早宣布，公司自身免疫与炎症领域管线之一CS2015（OX40L/TSLP双特异性抗 体）入选2025年美国过敏，哮喘和免疫学会（ACAAI）年度科学会议，并将以"电子壁报演示+现场口 头汇报"的形式展出。本次大会将于11月6日至10日在美国奥兰多举行。据悉，CS2015是一款同时靶向 OX40L和TSLP的潜在同类首创/同类最佳双特异性抗体，通过双重抑制Th2介导炎症反应的关键调控因 子，为特应性皮炎（AD）、哮喘、慢性阻塞性肺病（COPD）等2型炎症性疾病提供新治疗策略。 国投证券此前指出，公司早期管线中，ADC产品管线CS5007（EGFR/HER3双特异性ADC）、CS5008 （DLL3/SSTR2双特异性ADC）、CS5005（SSTR2 ADC）、CS5006（ITGB4ADC）以及CS5009 （B7H3/PD-L1双特异性ADC）等，以及自免管线中CS2013（BAFF/APRIL双特异性抗体）、CS2015 （OX40L/TSLP双特异性抗体）等均为具备较高潜力的差异化品种 ...

基石药业-B(02616)涨超4%，截至发稿，涨4.3%，报10.43港元，成交额1.09亿港元。 国投证券此前指出，公司早期管线中，ADC产品管线CS5007(EGFR/HER3双特异性ADC)、 CS5008(DLL3/SSTR2双特异性ADC)、CS5005(SSTR2ADC)、CS5006(ITGB4ADC)以及 CS5009(B7H3/PD-L1双特异性ADC)等，以及自免管线中CS2013(BAFF/APRIL双特异性抗体)、 CS2015(OX40L/TSLP双特异性抗体)等均为具备较高潜力的差异化品种，后续的临床推进值得关注。 消息面上，基石药业今早宣布，公司自身免疫与炎症领域管线之一CS2015(OX40L/TSLP双特异性抗体) 入选2025年美国过敏，哮喘和免疫学会(ACAAI)年度科学会议，并将以"电子壁报演示+现场口头汇 报"的形式展出。本次大会将于11月6日至10日在美国奥兰多举行。据悉，CS2015是一款同时靶向 OX40L和TSLP的潜在同类首创/同类最佳双特异性抗体，通过双重抑制Th2介导炎症反应的关键调控因 子，为特应性皮炎(AD)、哮喘、慢性阻塞性肺病(COPD)等2型炎 ...

基石药业9月15日公告，公司自身免疫与炎症领域管线之一CS2015（OX40L/TSLP双特异性抗体）入选 2025年美国过敏、哮喘和免疫学会（ACAAI）年度科学会议。CS2015是一款同时靶向OX40L和TSLP的 潜在同类首创/同类最佳双特异性抗体，通过双重抑制Th2介导炎症反应的关键调控因子，为特应性皮炎 （AD）、哮喘、慢性阻塞性肺病（COPD）等2型炎症性疾病提供新治疗策略。 ...

人民财讯9月15日电，基石药业9月15日在港交所公告，公司自身免疫与炎症领域管线之一 CS2015(OX40L/TSLP双特异性抗体)入选2025年美国过敏，哮喘和免疫学会(ACAAI)年度科学会议，并 将以"电子壁报演示+现场口头汇报"的形式展出。本次大会将于11月6日至10日在美国奥兰多举行。 CS2015是一款同时靶向OX40L和TSLP的潜在同类首创/同类最佳双特异性抗体，通过双重抑制Th2介导 炎症反应的关键调控因子，为特应性皮炎(AD)、哮喘、慢性阻塞性肺病(COPD)等2型炎症性疾病提供新 治疗策略。 ...

根据披露，CS2015是一款同时靶向OX40L和TSLP的潜在同类首创/同类最佳双特异性抗体，通过双重抑 制Th2介导炎症反应的关键调控因子，为特应性皮炎(AD)、哮喘、慢性阻塞性肺病(COPD)等2型炎症性 疾病提供新治疗策略。 格隆汇9月15日丨基石药业-B(02616.HK)宣布公司自身免疫与炎症领域管线之一CS2015(OX40L/TSLP双 特异性抗体)入选2025年美国过敏，哮喘和免疫学会(ACAAI)年度科学会议，并将以"电子壁报演示+现 场口头汇报"的形式展出。本次大会将于11月6日至10日在美国奥兰多举行。 ...