RTTNews BiotechCodex · 实盘不做把握 4/10
北京时间·🕒 发布 16:02:04·⟳ 抓取 16:15:20 +13m16s·⚡ 决策 08-21 16:16:25 +1m05s·67.1 天前
康方生物AK157D1获NMPA临床试验许可进入实体瘤I期研究
事件确认康方生物ADC管线继续扩张，但仅为I期临床许可，距离商业化和可量化收入仍远。
📄 原文RTTNews Biotech↗ 原文
Akeso's AK157D1 Cleared For Phase I Trial In Solid Tumors
Akeso, Inc. (9926.HK) announced that its next-generation antibody-drug conjugate (ADC), AK157D1 targeting B7-H3, has re…
不做 康方生物（09926.HK）
不做：AK157D1获NMPA I期临床许可方向偏正面，但属于早期管线例行推进，未披露授权金额、临床人体数据或可量化商业增量；康方生物已有更成熟ADC/双抗进展，单一I期许可对短线市值重定价edge不足。
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
消息传播链
- RTTNews报道康方生物AK157D1获NMPA临床试验许可，属于本次可见的最早转述节点。
- 公司此前已官方披露AK146D1和AK138D1进入II期并推进IO2.0+ADC2.0策略，说明本次AK157D1更多是既有平台管线延展。
- 公司近期已披露AK146D1联合依沃西单抗II期首例给药，ADC平台推进信息已有持续传播。
关键理由
- 事件确认康方生物ADC管线继续扩张，但仅为I期临床许可，距离商业化和可量化收入仍远。
- 康方生物已有依沃西单抗、卡度尼利单抗及多条临床管线，单个早期ADC进入I期对当前收入和市值增量有限。
- 量级上，本事件没有披露订单、授权、里程碑付款或销售预期，现阶段新增可触达量只能停留在研发期权，无法估算短期收入/利润贡献。
主要风险
- 早期IND/临床许可在生物医药公司中较常见，且AK157D1尚无人体疗效数据，短线容易被视为管线例行进展。
- RTTNews为转述源，未检索到康方官网同日一手公告页面，若后续公司公告口径或临床设计低于预期，催化强度会进一步下降。
反向证据
- 做多前查反向 · 来源 web · 日期 2026-03-24 · 影响 weakens
公司已有多条ADC及双抗管线处于更靠后阶段，本次AK157D1只是早期研发期权，边际基本面增量弱。
检索:Akeso ADC pipeline Phase I clearance materiality AK157D1 B7-H3 原文 ↗ - 做多前查反向 · 来源 web · 日期 2026-08-10 · 影响 weakens
更高阶段的AK146D1 II期进展近期已披露，市场对IO2.0+ADC2.0叙事已有预期。
检索:Akeso AK146D1 Phase II ivonescimab August 2026 ADC 原文 ↗
先例如何影响了这次决策
对本次决策的影响:先例证据不足叠加本事件量级不可量化，使最终从潜在利好降为不下单。
方向:早期IND/Phase I许可通常方向偏正面，但对已有多管线生物科技公司短线胜率和弹性不稳定。
涨幅量级:未取得同市场、同公司、同相位且首发锚点可靠的足够样本，不能用先例校准可交易涨幅。
形态:同类研发许可常见风险是利好确认但商业化周期长，若无授权金额、突破性疗法、关键临床数据或注册性进展，容易无反应。
原文全文
展开原文 · 1,747 字
Akeso, Inc. (9926.HK) announced that its next-generation antibody-drug conjugate (ADC), AK157D1 targeting B7-H3, has received clinical trial clearance from China's National Medical Products Administration (NMPA).
The clearance enables initiation of a Phase 1 study in patients with advanced malignant solid tumors. B7-H3 is highly expressed across a wide range of cancers— including lung, prostate, esophageal, colorectal, breast and glioblastoma— while showing limited presence in normal tissues, making it a promising broad-spectrum target.
AK157D1 is Akeso's third differentiated ADC candidate to enter clinical development, following AK146D1 (TROP2/Nectin-4 ADC) and AK138D1 (HER3 ADC). The company plans to explore AK157D1 in combination with its proprietary bispecific antibodies Ivonescimab and Cadonilimab, further advancing its IO2.0+ ADC2.0 strategy.
Preclinical studies demonstrated potent antitumor activity and a favorable safety profile, suggesting potential to overcome limitations of existing ADCs such as hematologic toxicity and interstitial lung disease.
Akeso continues to expand its innovative oncology pipeline, positioning AK157D1 as part of its broader effort to establish next-generation standards of care in cancer treatment.
9926.HK has traded between HKD 80.20 and HKD 179 over the past year. The stock is currently trading at HKD 90.45, down 3.67%.
For comments and feedback contact: editorial@rttnews.com
Business News
August 15, 2026 03:28 ET Inflation and consumer spending figures were the main economic news from the U.S. this week, along with some data on the housing market. In Europe, the second quarter economic growth figures were in focus. The Australian central bank policy decision drew attention in Asia.
The clearance enables initiation of a Phase 1 study in patients with advanced malignant solid tumors. B7-H3 is highly expressed across a wide range of cancers— including lung, prostate, esophageal, colorectal, breast and glioblastoma— while showing limited presence in normal tissues, making it a promising broad-spectrum target.
AK157D1 is Akeso's third differentiated ADC candidate to enter clinical development, following AK146D1 (TROP2/Nectin-4 ADC) and AK138D1 (HER3 ADC). The company plans to explore AK157D1 in combination with its proprietary bispecific antibodies Ivonescimab and Cadonilimab, further advancing its IO2.0+ ADC2.0 strategy.
Preclinical studies demonstrated potent antitumor activity and a favorable safety profile, suggesting potential to overcome limitations of existing ADCs such as hematologic toxicity and interstitial lung disease.
Akeso continues to expand its innovative oncology pipeline, positioning AK157D1 as part of its broader effort to establish next-generation standards of care in cancer treatment.
9926.HK has traded between HKD 80.20 and HKD 179 over the past year. The stock is currently trading at HKD 90.45, down 3.67%.
For comments and feedback contact: editorial@rttnews.com
Business News
August 15, 2026 03:28 ET Inflation and consumer spending figures were the main economic news from the U.S. this week, along with some data on the housing market. In Europe, the second quarter economic growth figures were in focus. The Australian central bank policy decision drew attention in Asia.
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