RTTNews BiotechDoubao · 实盘不做把握 5/10不做原因:已被定价
北京时间·🕒 发布 19:02:09·⟳ 抓取 19:15:13 +13m04s·⚡ 决策 09-14 19:18:31 +3m18s·43.0 天前
维立志博LBL-024(opamtistomig)WCLC口头报告：一线NSCLC二期更新数据ORR 71%、鳞癌87.1%
核心临床数据(ORR约65%)已于2026-08-20随WCLC摘要公开并当日推动股价涨超10%，本次口头报告仅是延长随访更新(ORR 71%、鳞癌87.1%)，属预期内的学术确认；且通稿在9月14日港股盘前发布，当日盘中一度下探至56.8港元、收涨仅2.16%，在WCLC催化下创新药板块普涨(诺诚健华+10.8%、康方+5.4%)中明显落后，显示增量利好已被消化、缺乏正向edge。
📄 原文RTTNews Biotech↗ 原文
Leads Biolabs' Opamtistomig Shows Robust Response And PFS Benefits In First-Line NSCLC
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不做 维立志博-B（09887.HK）
数据虽正面但核心结果8月20日WCLC摘要已披露并涨过，9月14日口头报告仅延长随访微调(ORR 65%→71%)，盘前明牌后当日仅收涨2.16%、盘中创阶段新低、显著落后WCLC驱动的创新药板块，增量利好已price-in，无正向edge；单臂II期+两日后FOMC进一步降低短线赔率。
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
结论摘要
LBL-024一线NSCLC二期数据强劲(ORR 71%、鳞癌87.1%)且NDA优先审评在途，但关键数据8月20日摘要已披露并已驱动一波上涨，9月14日口头报告更新在创新药板块大涨背景下仅收涨2.16%、盘中还创阶段新低，增量预期差不足，不值得追多。
消息传播链
- WCLC摘要全文发布，首次披露联合化疗一线NSCLC延长随访数据(ORR约65%)，公司当日午后涨超10%，核心数据首次公开市场反应:8月20日盘中涨超10%
- WCLC口头报告给出更新：63例、ORR升至71.0%、鳞癌87.1%、6个月PFS 70.6%；通稿港股盘前已可获得市场反应:9月14日开60.15、盘中最低56.8、收61.5(+2.16%)，大幅落后同日创新药板块
- WCLC催化下创新药概念股全线走高(诺诚健华+10.8%、康方+5.4%)，反衬维立志博个股增量反应温和
关键理由
- 数据质量正面：ORR从8月摘要的约65%提升至71%、鳞癌87.1%、6个月PFS 70.6%，支持NDA注册和best-in-class潜力
- NDA已获NMPA优先审评并受理，监管路径清晰，平台14个适应症、约800例安全性数据降低后续开发风险
主要风险
- 数据为单臂II期、无对照，PFS仅6个月率而非成熟mPFS/OS，疗效优劣仍需III期验证
- 核心数据8月20日已公开并涨过，9月14日盘中下杀至56.8港元显示资金分歧，剩余edge高度依赖9月15日情绪，FOMC在两日后也压制风险偏好
反向证据
- 做多前查反向 · 来源 web · 日期 2026-08-20 · 影响 weakens
核心数据8月20日已公开并当日涨超10%，本次更新预期差有限
检索:opamtistomig 8月20日 WCLC摘要 ORR 65 股价 涨超10 原文 ↗ - 做多前查反向 · 来源 kb_search · 影响 none
未发现新增安全性恶化或下修；无新增安全信号，但单臂II期、无对照构成方法论局限
检索:维立志博 LBL-024 利空 砍单 安全性 下修
先例如何影响了这次决策
对本次决策的影响:进一步支持不追多：增量数据温和且已被部分定价，不出ENTER
方向:未构建可锚定首发的对齐先例；同期WCLC数据事件方向偏正面但幅度有限(翰森Ris-Rez III期达终点当日+3.24%、康方III期胆道癌达标盘中+3.5%)
涨幅量级:缺乏高相似、锚干净的同市场同相位先例，不用以校准tp/sl
形态:会议口头报告多为摘要数据的确认，新增超预期有限，配合8月已涨过与当日板块beta，倾向利好兑现而非新驱动
工具执行结果 · 成功 8 · 降级 0 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 28 ms
{"result": "search_processed_events:agent query=`leads biolabs 9887 opamtistomig nda priority review nmpa 2026 | leads biolabs opamtistomig lbl-024 first-line nsclc phase 2 wclc 2026 orr pfs | 康宁杰瑞 9887.hk opamtistomig 非小细胞肺癌 wcl`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 0.0/72 小时、0 条本臂决策(完整)，返回 0 条候选。未命中只表示这些 agen - fetch_decision_experience 成功 stock_tools HTTP · 34 ms
{ - stock_quote 成功 stock_tools HTTP · 127 ms
{ - web_search 成功 doubao_search · 2,507 ms
豆包搜索结果（原始查询:Leads Biolabs opamtistomig WCLC 2026 abstract NSCLC Phase 2 shares jump；API SearchType:web） - web_search 成功 doubao_search · 2,529 ms
豆包搜索结果（原始查询:opamtistomig WCLC abstract August 2026 NSCLC ORR 63 patients ORR PFS cutoff；API SearchType:web） - kb_search 成功 stock_tools HTTP · 7,110 ms
{ - search_case_library 成功 stock_tools HTTP · 48 ms
{"result": "search_case_library「09887.HK」—— 与这些标的相关的自家决策案例(本页 10 条,该标的全历史相关记录共 21 条；ENTER 只按该标的自己的腿统计):\n◆ 09887.HK：相关历史决策 21 条 · 其中该标的 ENTER 0 条(0.0%) · 我们从没在这只票上 ENTER 过\n【对所查标的真 ENTER 过的:0 条 —— 相关案例里没有该标的自己的 ENTER 腿】\n【最近 10 条其它决策(多为「不做」,用来看这票最近在被什么消息刷屏)】\n• 2026-08-24 UTC(CST 2026-08-25) 不做 · 事件 - web_search 成功 doubao_search · 1,419 ms
豆包搜索结果（原始查询:港股 18A biotech WCLC oral presentation updated data stock reaction next day 双抗 临床数据 股价；API SearchType:web）
原文全文
展开原文 · 9,646 字
Leads Biolabs' Opamtistomig Shows Robust Response And PFS Benefits In First-Line NSCLC
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Biotech Daily Dose
Leads Biolabs' Opamtistomig Shows Robust Response And PFS Benefits In First-Line NSCLC
By
RTTNews Staff Writer
✉
Published:
9/14/2026 7:02 AM ET
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Leads Biolabs Co., Ltd. (9887.HK) announced updated Phase II data for opamtistomig (LBL-024), its proprietary PD-L1/4-1BB bispecific antibody, plus chemotherapy in first-line non-small cell lung cancer (NSCLC), presented in an oral session at the 2026 World Conference on Lung Cancer (WCLC).
As of July 1, 2026, 63 treatment-naïve patients had been enrolled, including 31 with non-squamous and 32 with squamous NSCLC.
More than 90% had Stage IV disease, while a considerable proportion had multiple metastases, including brain and liver metastases.
Among 62 efficacy-evaluable patients, the objective response rate (ORR) was 71.0%, disease control rate (DCR) was 95.2%, and the six-month progression-free survival (PFS) rate was 70.6%.
In squamous NSCLC, opamtistomig plus chemotherapy achieved an ORR of 87.1%, DCR of 96.8% and six-month PFS rate of 86.7%.
Efficacy was consistent regardless of PD-L1 expression, with ORRs of 84.6% in PD-L1-positive patients and 88.2% in PD-L1-negative patients.
Among PD-L1-positive patients with non-squamous NSCLC, the combination achieved an ORR of 81.8%, DCR of 100% and six-month PFS rate of 90.0%.
The treatment demonstrated a manageable safety profile generally consistent with PD-(L)1 antibody-based chemotherapy combinations, with no new safety signals observed.
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said the updated data showed continued tumor shrinkage and increasing response rates with longer follow-up, supporting the durability of opamtistomig's antitumor activity.
He highlighted the consistent efficacy across PD-L1 expression levels in squamous NSCLC and the deep responses observed in PD-L1-positive non-squamous NSCLC.
About Opamtistomig
Opamtistomig is a PD-L1/4-1BB bispecific antibody designed to simultaneously block PD-L1-mediated immune suppression and conditionally activate 4-1BB.
The drug is being evaluated across 14 solid tumor indications, with clinical evidence emerging across seven tumor types.
Approximately 800 patients with solid tumors have been treated with opamtistomig to date.
Opamtistomig has received Breakthrough Therapy Designation from China's NMPA, Orphan Drug Designation from the U.S. FDA and European Commission, and Fast Track Designation from the FDA.
In July 2026, its NDA received priority review designation from the NMPA, followed by NDA acceptance in August 2026.
9887.HK has traded between $44.7 and $97.5 over the past year. The stock closed Monday's trading (September 14, 2026) at $61.5, up 2.16%.
For comments and feedback contact: editorial@rttnews.com
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Biotech Daily Dose
Leads Biolabs' Opamtistomig Shows Robust Response And PFS Benefits In First-Line NSCLC
By
RTTNews Staff Writer
✉
Published:
9/14/2026 7:02 AM ET
Follow Us
Join Us
Add
as your preferred news source on Google
Add Now
Leads Biolabs Co., Ltd. (9887.HK) announced updated Phase II data for opamtistomig (LBL-024), its proprietary PD-L1/4-1BB bispecific antibody, plus chemotherapy in first-line non-small cell lung cancer (NSCLC), presented in an oral session at the 2026 World Conference on Lung Cancer (WCLC).
As of July 1, 2026, 63 treatment-naïve patients had been enrolled, including 31 with non-squamous and 32 with squamous NSCLC.
More than 90% had Stage IV disease, while a considerable proportion had multiple metastases, including brain and liver metastases.
Among 62 efficacy-evaluable patients, the objective response rate (ORR) was 71.0%, disease control rate (DCR) was 95.2%, and the six-month progression-free survival (PFS) rate was 70.6%.
In squamous NSCLC, opamtistomig plus chemotherapy achieved an ORR of 87.1%, DCR of 96.8% and six-month PFS rate of 86.7%.
Efficacy was consistent regardless of PD-L1 expression, with ORRs of 84.6% in PD-L1-positive patients and 88.2% in PD-L1-negative patients.
Among PD-L1-positive patients with non-squamous NSCLC, the combination achieved an ORR of 81.8%, DCR of 100% and six-month PFS rate of 90.0%.
The treatment demonstrated a manageable safety profile generally consistent with PD-(L)1 antibody-based chemotherapy combinations, with no new safety signals observed.
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said the updated data showed continued tumor shrinkage and increasing response rates with longer follow-up, supporting the durability of opamtistomig's antitumor activity.
He highlighted the consistent efficacy across PD-L1 expression levels in squamous NSCLC and the deep responses observed in PD-L1-positive non-squamous NSCLC.
About Opamtistomig
Opamtistomig is a PD-L1/4-1BB bispecific antibody designed to simultaneously block PD-L1-mediated immune suppression and conditionally activate 4-1BB.
The drug is being evaluated across 14 solid tumor indications, with clinical evidence emerging across seven tumor types.
Approximately 800 patients with solid tumors have been treated with opamtistomig to date.
Opamtistomig has received Breakthrough Therapy Designation from China's NMPA, Orphan Drug Designation from the U.S. FDA and European Commission, and Fast Track Designation from the FDA.
In July 2026, its NDA received priority review designation from the NMPA, followed by NDA acceptance in August 2026.
9887.HK has traded between $44.7 and $97.5 over the past year. The stock closed Monday's trading (September 14, 2026) at $61.5, up 2.16%.
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HP Partners With Red Hat For AI Workloads; Shares Up
September 09, 2026 15:46 ET
Apple Unveils New AirPods And Apple Watch Lineup With Enhanced Audio, Health And AI Features
September 09, 2026 16:47 ET
Macy's Stock Drops On Cautious Q3 View, Despite Positive Q2 Results, Raised FY26 Outlook
September 10, 2026 08:38 ET
Blackstone To Buy Flow Control Holdings From Audax For Undisclosed Terms
September 10, 2026 11:20 ET
Atlantic HPC Group To Go Public Via Aperture AC Merger
September 11, 2026 08:16 ET
SEALSQ H1 Loss Widens From Higher Expenses; Reaffirms FY26 Outlook
September 11, 2026 13:24 ET
Ageas Completes Sale Of 30.95% Maybank Ageas Stake To Maybank For EUR 1.1 Bln
September 11, 2026 01:43 ET
Sasol Agrees To Sell Nitrates Business To Enaex Africa; Retains 23% Stake
September 09, 2026 03:49 ET
Holcim Invests In Cloud Cycle
September 09, 2026 03:16 ET
E79 Gold Mines Limited Full Year Sales Increase
September 09, 2026 01:00 ET
ASE Technology August Revenues Rise 34.6% Y-o-Y
September 09, 2026 03:18 ET
Everpure To Join S&P 500
September 09, 2026 01:09 ET
Victrex Plc Raises FY26 Underlying PBT View; Appoints Interim CFO; Stock Rises 12.8%
September 09, 2026 03:28 ET
Scientex Berhad Q4 Income Climbs
September 09, 2026 01:12 ET
Autohellas S.A. Reveals Fall In H1 Profit
September 09, 2026 03:33 ET
Chime To Acquire Stride Bank
September 09, 2026 01:26 ET
Sasol Agrees To Sell Nitrates Business To Enaex Africa; Retains 23% Stake
September 09, 2026 03:49 ET
Antin Infrastructure Partners SAS Profit Drops In H1
September 09, 2026 01:29 ET
TENPOS HOLDINGS Co Ltd. Reveals Retreat In Q1 Profit
September 09, 2026 05:03 ET
Vallourec, Aramco Ink Agreement For Supply Of Oil Country Tubular Goods
September 09, 2026 01:45 ET
Editors Pick
CPSC Recalls: 2.3 Mln Candy Bottles, Motorcycles, Dressers, Dual Fuel Ranges, Fire Spray Canisters
September 11, 2026 10:17 ET
Kroger Q2 Profit Rises, Backs FY26 Adj. Earnings View, Cuts Sales Growth Forecast; Stock Drops
September 11, 2026 07:40 ET
Macy's Stock Drops On Cautious Q3 View, Despite Positive Q2 Results, Raised FY26 Outlook
September 10, 2026 08:38 ET
Apple Unveils IPhone Duo, Its First Foldable IPhone
September 09, 2026 14:42 ET
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