Core Viewpoint - The company has announced mid-term data from a Phase II clinical trial of its dual-targeting bispecific antibody M701 for treating malignant pleural effusion caused by advanced non-small cell lung cancer (NSCLC), showing significant efficacy compared to the control group receiving cisplatin [1][4]. Group 1: Clinical Trial Overview - The Phase II trial (code name: M70103) is a randomized, controlled, multi-center study involving 54 eligible patients with symptomatic malignant pleural effusion after at least one line of systemic therapy [2]. - Patients were randomly assigned in a 1:1 ratio to receive either M701 or cisplatin after thoracentesis [1][2]. - The primary endpoint is puncture-free survival time (Pu FS), while secondary endpoints include objective response rate (ORR), time to next puncture (TTNP), and related symptoms [1]. Group 2: Patient Demographics - The trial included 26 patients in the M701 group and 28 in the cisplatin group, with median ages of 66.5 and 61.5 years, respectively [2]. - Female proportions were 57.7% in the M701 group and 50.0% in the control group, with ECOG performance status scores of 0-1 being 92.3% and 96.4% [2]. - Baseline characteristics were generally balanced between the two groups, with similar proportions of patients having prior thoracentesis and chemotherapy [2]. Group 3: Efficacy Results - M701 demonstrated a longer median puncture-free survival time compared to cisplatin (130 days vs. 85 days, HR=0.80, p=0.542) [3]. - In patients without driver gene mutations, the median survival was not reached for M701 compared to 44.5 days for cisplatin (HR<0.01, p<0.001) [3]. - The objective response rate for malignant pleural effusion was 72.7% for M701 versus 41.7% for cisplatin [3]. Group 4: Safety Results - The incidence of treatment-related adverse events was 3.7% for M701 compared to 10% for cisplatin, with only one serious adverse event related to M701 [3]. - Flow cytometry analysis indicated a significant reduction of Ep CAM+CD45- tumor cells in the pleural effusion after M701 infusion, which was not observed in the cisplatin group [3]. Group 5: Conclusion and Future Plans - M701 shows significant efficacy and good tolerability in treating malignant pleural effusion, particularly in NSCLC patients without driver gene mutations or those with prior chemotherapy [4]. - The ongoing Phase II trial indicates potential for preventing recurrence of pleural effusion, with plans for a pivotal Phase III trial to start in 2026 to validate efficacy and safety in a larger Chinese population [4].

疗效结果：试验组的无穿刺生存时间长于对照组(中位值130天对85天，HR(风险比)=0.80，p=0.542)，而 对于驱动基因阴性的患者(中位值未达到对44.5天，HR<0.01，p<0.001)或有胸腔内化疗史的患者(中位值 253天对72天，HR=0.31，p=0.076)，其获益更加显著。在上述人群中，试验组和对照组的恶性胸水客观 缓解率(MPE ORR)分别为72.7%和41.7%。随机分组98天后，只有试验组受试者的呼吸困难症状持续改 善。流式细胞术分析显示，输注M701后，胸水中的Ep CAM+CD45-肿瘤细胞显著减少，而在输注顺铂 的对照组中则没有这种现象。 安全性结果：M701治疗相关不良事件发生率为3.7%，顺铂组为10%，仅1例严重不良事件(2级发热)与 M701相关。 截至2025年3月7日，54名筛选合格的经至少一线全身治疗后病情进展、有症状性恶性胸水的晚期非小细 胞肺癌(NSCLC)患者，按照1:1随机分组，试验组26名，对照组28名。试验组的中位年龄为66.5岁，对照 组的中位年龄为61.5岁。试验组和对照组女性比例分别为57.7%和50.0%，体力状态评分(ECOG)处于0– ...

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部 或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 – 1 – WUHAN YZY BIOPHARMA CO., LTD. 武 漢 友 芝 友 生 物 製 藥 股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2496） 自願公告 M 701惡性胸水II期研究中期數據在2025年ESMO會議上公佈 本公告由武漢友芝友生物製藥股份有限公司（「本公司」）自願作出，以告知本公司 股東及潛在投資者本公司最新業務發展。 本 公 司 董 事 會（「 董 事 會 」）欣 然 宣 佈 ， 本 公 司 自 主 研 發 的 上 皮 細 胞 黏 附 分 子 （「Ep CAM」）和分化簇3（「CD3」）雙靶向的在研雙特異性抗體（「Bs Ab」）藥物M 701 在中國開展的治療晚期非小細胞肺癌(NSCLC)引發的惡性胸水的II期臨床研究（「本 研 究 」）的 研 究 中 期 數 據 已 ...