RTTNews BiotechCodex · 实盘不做把握 7/10
北京时间·🕒 发布 16:55:21时区推断·⟳ 抓取 17:06:32·⚡ 决策 07-20 18:06:10 +59m38s·98.9 天前
康方生物AK146D1联合依沃西单抗启动晚期非小细胞肺癌II期研究首例给药
首例患者给药是临床推进里程碑，但仍处II期，距离注册和商业化收入较远。
📄 原文RTTNews Biotech↗ 原文
Akeso Doses First Patient In Phase II Study Of Novel Bispecific ADC In Advanced NSCLC
Akeso, Inc. (9926.HK) has dosed the first patient in its Phase II clinical study evaluating AK146D1, a novel TROP2/Nect…
不做 康方生物（09926.HK）
II期首例给药是早期管线进展，未披露疗效数据、监管突破或可量化商业化增量，且文本显示股价已同向上涨，不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
🔎 新鲜度:最早出现 2026-07-17 16:34 ET · 扩散 medium · price-in 风险 medium ↗
消息传播链
- RTTNews报道康方生物AK146D1-201研究完成首例患者给药。市场反应:报道文本称09926.HK周一收报93.35港元，上涨5.66%。
关键理由
- 首例患者给药是临床推进里程碑，但仍处II期，距离注册和商业化收入较远。
- 公司核心价值更多由依沃西单抗已读出的III期数据和商业化预期驱动，本次AK146D1组合尚未给出疗效数据或新增销售量级。
主要风险
- 若后续II期读出显示显著优于现有一线NSCLC疗法，事件级别会提高；当前仅启动研究无法估算近期收入增量。
原文全文
展开原文 · 2,537 字
Akeso, Inc. (9926.HK) has dosed the first patient in its Phase II clinical study evaluating AK146D1, a novel TROP2/Nectin-4 bispecific antibody-drug conjugate (ADC), in combination with Ivonescimab, the company's PD-1/VEGF bispecific antibody, for advanced non-small cell lung cancer (NSCLC).
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. Patients with advanced disease often face limited treatment options, particularly in the first-line setting, where response rate to existing therapies can vary depending on tumor biology.
The trial, designated AK146D1-201, is focused on exploring the therapeutic potential of this combination in the first-line treatment setting. Akeso highlights this milestone as part of its broader "IO2.0 + ADC2.0" strategy, which leverages proprietary bispecific and multispecific antibody technology to elevate the standard of care in oncology.
Ivonescimab has already demonstrated transformative benefits compared to PD-1 inhibitor-based therapies across multiple Phase III studies, while AK146D1 has shown potent antitumor activity with a favorable safety profile. Together, the combination aims to enhance efficacy, reduce toxicity, and expand treatment options for patients with NSCLC.
Akeso's pipeline includes several next-generation ADC candidates:
-AK138D1 (HER3 ADC)— in Phase I clinical development, designed with a novel cleavable linker and high drug-to-antibody ratio (DAR); targeting HER3-positive solid tumors.
-AK157D1 (ADC candidate)—entered early clinical stage under Akeso's ADC 2.0 platform; focused on solid tumor indications. -AK158D1 (a bispecific ADC) already in clinical development.
The initiation of the Phase II study underscores Akeso's commitment to advancing innovative immuno-oncology and ADC therapies, with the potential to reshape treatment paradigms for lung cancer patients worldwide.
9926.HK has traded between HKD 80.20 and HKD 179.00 over the past year. The stock closed Monday's trading at HKD 93.35, up 5.66%.
For comments and feedback contact: editorial@rttnews.com
Business News
July 17, 2026 16:34 ET A slew of U.S. data was released during the week that threw light on trends in prices and spending. Separately, survey data reflected the consumer mood amid easing inflationary pressures. In Europe, economic output figures from the U.K. were the main news. Meanwhile, China dominated the economics news scene in Asia as the country released the latest gross domestic product and external trade data.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. Patients with advanced disease often face limited treatment options, particularly in the first-line setting, where response rate to existing therapies can vary depending on tumor biology.
The trial, designated AK146D1-201, is focused on exploring the therapeutic potential of this combination in the first-line treatment setting. Akeso highlights this milestone as part of its broader "IO2.0 + ADC2.0" strategy, which leverages proprietary bispecific and multispecific antibody technology to elevate the standard of care in oncology.
Ivonescimab has already demonstrated transformative benefits compared to PD-1 inhibitor-based therapies across multiple Phase III studies, while AK146D1 has shown potent antitumor activity with a favorable safety profile. Together, the combination aims to enhance efficacy, reduce toxicity, and expand treatment options for patients with NSCLC.
Akeso's pipeline includes several next-generation ADC candidates:
-AK138D1 (HER3 ADC)— in Phase I clinical development, designed with a novel cleavable linker and high drug-to-antibody ratio (DAR); targeting HER3-positive solid tumors.
-AK157D1 (ADC candidate)—entered early clinical stage under Akeso's ADC 2.0 platform; focused on solid tumor indications. -AK158D1 (a bispecific ADC) already in clinical development.
The initiation of the Phase II study underscores Akeso's commitment to advancing innovative immuno-oncology and ADC therapies, with the potential to reshape treatment paradigms for lung cancer patients worldwide.
9926.HK has traded between HKD 80.20 and HKD 179.00 over the past year. The stock closed Monday's trading at HKD 93.35, up 5.66%.
For comments and feedback contact: editorial@rttnews.com
Business News
July 17, 2026 16:34 ET A slew of U.S. data was released during the week that threw light on trends in prices and spending. Separately, survey data reflected the consumer mood amid easing inflationary pressures. In Europe, economic output figures from the U.K. were the main news. Meanwhile, China dominated the economics news scene in Asia as the country released the latest gross domestic product and external trade data.
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