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🇭🇰 港交所LEADS BIOLABS-BDoubao · 实盘不做把握 5/10不做原因:风险收益比不佳
北京时间·🕒 发布 19:40:00时区推断·⟳ 抓取 19:41:15·⚡ 决策 10-19 19:44:42 +3m27s·8.0 天前

维立志博-B自愿公告:LBL-024与LBL-034共六项研究摘要上线2026 ESMO官网,含1篇LBA与3项口头报告

这是临床读出链条上的'摘要上线'阶段而非新数据:关键数据截止2026年3-4月,LBL-034数据2025 ASH已做过突破性口头报告、LBL-024 EP-NEC为关键注册研究已知数据,BTC仅20例短期随访,真正可能超预期的更新数据要等10月23-27日现场。标的近20日累计-25.9%、距52周高点-57.6%、13周轨迹持续下行,中期亏损2.22亿、新任CBO履历争议、早期股东解禁与港股创新药板块走弱构成逆风;在无新数据的情况下提前4个交易日左侧接飞刀,赔率与时效均不支持。

📄 原文LEADS BIOLABS-B↗ 原文
VOLUNTARY ANNOUNCEMENT ABSTRACTS OF SIX STUDIES PUBLISHED AT 2026 ESMO
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
不做 南京维立志博生物科技股份有限公司(09887.HK)
会前摘要上线的自愿公告无新增数据(关键数据截止2026年3-4月且多在WCLC/ASH披露过),真正催化LBA/口头更新在10月23-27日;个股近20日-25.9%、距高点-57.6%的下行趋势中,且有中期亏损、CBO争议和解禁逆风,提前4个交易日左侧抢跑风险收益不足;等现场更新数据与市场承接后再评估,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

结论摘要

维立志博公告ESMO六项摘要上线,数据方向积极但多为旧数据复述,实质性更新(LBA与口头报告)在10月23-27日才披露;个股处于-26%/20日的明确下跌通道并有基本面与解禁逆风,会前抢跑风险收益不佳,回避,等现场数据再评估。

🔎 新鲜度:最早出现 2026-10-19 · 扩散 low · price-in 风险 medium ↗ ↗ ↗

消息传播链

  1. 2026-10-19 19:41 HKT首发HKEXnews公司自愿公告一手源原文 ↗
    公司盘后发布自愿公告,确认六项摘要已在2026 ESMO官网公开,完整更新数据待10月23-27日口头报告;公告时港股已收盘,下一交易日10月20日才可交易
    市场反应:公告在收盘后发布,尚无交易反应;最近收盘(10月16日)41.30港元,近5日-9.35%、近20日-25.92%

关键理由

  • 若交易,唯一逻辑是LBL-024 EP-NEC长尾生存信号(mOS近17个月未成熟 vs 历史化疗约12个月)与LBL-034在重度经治RRMM的15.8个月mPFS在ESMO现场更新后催化估值修复
  • 但本公告本身只复述官网摘要,不含更新数据,不构成新的预期差

主要风险

  • 摘要到口头报告间隔4个交易日,BTC队列仅20例、EP-NEC mOS未成熟,现场更新数据若不及标题乐观将高开低走
  • 公司中期亏损2.22亿、CBO任命争议、H股全流通后解禁存仓压力与港股创新药板块beta走弱,可能淹没个股正面催化

反向证据

  • 做多前查反向 · 来源 web · 日期 2026-09-28 · 影响 weakens
    中期亏损2.22亿、新任CBO履历引争议、早期股东解禁与存仓异动、港股创新药板块自2025年9月走弱,近20日-25.9%为持续阴跌而非事件前抢跑
    检索:维立志博 9887 中期亏损 CBO 争议 解禁 股价下跌 原文 ↗
  • 做多前查反向 · 来源 kb_search · 影响 none
    内部KB检索服务连接失败(ConnectError),未取得研报/纪要层面的预期与反方观点;不以此作为看多或看空依据
    检索:维立志博 LBL-024 LBL-034 ESMO 临床数据 进展 风险
  • 做多前查反向 · 来源 web · 日期 2026-09-26 · 影响 weakens
    新浪财经9月报道显示LBL-024 NSCLC II期更新已于WCLC 2026口头公布、EP-NEC关键注册IIB已披露,LBL-034数据2025 ASH做过开场口头报告,本次摘要含大量旧信息
    检索:LBL-034 2025 ASH 数据 / LBL-024 EP-NEC 关键IIB 既往披露 原文 ↗

先例如何影响了这次决策

对本次决策的影响:先例证据不足叠加下行趋势与左侧时点,直接支持AVOID而非小仓试探

方向:未取得同市场、同相位(会前摘要上线公告)且锚定首发的干净对齐先例,不以记忆中的biotech会议表现代替统计

涨幅量级:无高相似对齐样本校准幅度,不据此刻画tp/sl

形态:市场常识层面,biotech会前摘要上线多为弱催化、现场LBA才定价且常见见光死,但该模式未经本轮首发级先例面板验证,仅作风险提示

工具执行结果 · 成功 7 · 降级 0 · 失败 1 · 取消 0
  1. search_processed_events 成功 stock_tools HTTP · 11 ms
    {"result": "search_processed_events:agent query=`lbl-034 gprc5d cd3 multiple myeloma esmo 2026 | opamtistomig pd-l1 4-1bb ep-nec btc esmo abstract | 维立志博 leads biolabs 9887 esmo 2026 lbl-024 lbl-034`;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 agent query 表达式没有召回候选,不能据此证明消息首发或不是
  2. fetch_decision_experience 成功 stock_tools_inprocess · 1 ms
    {
  3. stock_quote 成功 stock_tools HTTP · 952 ms
    {
  4. web_search 成功 doubao_search · 1,748 ms
    豆包搜索结果(原始查询:ESMO 2026 annual meeting dates abstracts published online;API SearchType:web)
  5. web_search 成功 doubao_search · 1,541 ms
    豆包搜索结果(原始查询:维立志博 9887 ESMO 2026 LBL-024 LBL-034 摘要;API SearchType:web)
  6. search_case_library 成功 stock_tools HTTP · 13 ms
    {"result": "search_case_library「9887.HK」无历史决策命中(我们过去没在这些标的上决策过,或历史尚未回填)。\n◆ 9887.HK:相关历史决策 0 条 · 其中该标的 ENTER 0 条(0.0%) · 我们从没在这只票上 ENTER 过"}
  7. kb_search 失败 stock_tools HTTP · 56 ms
    kb_search 服务暂不可用;这不是一条知识库命中。
  8. web_search 成功 doubao_search · 1,364 ms
    豆包搜索结果(原始查询:维立志博 9887 股价 下跌 原因 2026年10月;API SearchType:web)

原文全文

展开原文 · 12,406 字
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited
take no responsibility for the contents of this announcement, make no representation as to
its accuracy or completeness and expressly disclaim any liability whatsoever for any loss
howsoever arising from or in reliance upon the whole or any part of the contents of this
announcement.

Nanjing Leads Biolabs Co., Ltd.
南京 維立志博生物科技股份有限公司
(A joint stock company established in the People’s Republic of China with limited liability)

(Stock Code: 9887)

VOLUNTARY ANNOUNCEMENT
ABSTRACTS OF SIX STUDIES PUBLISHED AT 2026 ESMO
This announcement is made by Nanjing Leads Biolabs Co., Ltd. (the “Company ”, together
with its subsidiaries, the “Group”) on a voluntary basis to inform shareholders and potential
investors of the Company about the latest business development of the Company.
The Company is pleased to announce that the full abstracts of six studies of its self-developed
LBL-024 (Opamtistomig, an anti-PD-L1/4-1BB bispecific antibody) and LBL-034 (GPRC5D/
CD3 bispecific T-Cell engager, TCE), covering clinical studies, translational research and
meta-analyses, have been published on the official website of 2026 Annual Meeting of the
European Society for Medical Oncology (“ 2026 ESMO”). The data collectively demonstrate
trends of durable responses and long-tail survival benefits with LBL-024 across multiple
immunologically “cold tumors,” supporting its potential as a pan-tumor therapy, and highlight
the differentiated capabilities of the Company ’s X-body and TCE technology platforms.
Notably, three studies of LBL-024 and LBL-034 have been selected for Proffered Paper
presentations at 2026 ESMO, including one study selected as a Late-Breaking Abstract
( “ LBA ” ). Detailed and updated data from these studies will be presented during the oral
presentations at the 2026 ESMO.

LBL-024 AS FIRST-LINE TREATMENT FOR EP-NEC (ABSTRACT NO. 5836)
As of April 3, 2026, the study had enrolled 69 patients with advanced extrapulmonary
neuroendocrine carcinoma (“EP-NEC”) who had not received prior systemic therapy. Sixtyfive patients were evaluable for efficacy, and the median follow-up for the overall population
was 16.9 months.
Across all dose levels, the median duration of response (“ mDoR”) was 10.2 months and the
median overall survival ( “ mOS ” ) had not yet matured. In the 6 mg/kg and 15 mg/kg dose
groups, the mDoR was 15.5 months and 10.2 months, respectively, and the 15-month overall
survival (“OS”) rates were 63.6% and 58.4%, respectively.

–1–

Among patients with PD-L1-positive disease (combined positive score (“ CPS ” ) ≥1), the
15-month OS rate was 66.7% in each of the 6 mg/kg and 15 mg/kg dose groups. Among patients
with PD-L1-negative disease (CPS <1), the corresponding 15-month OS rates were 57.1% and
53.6%, respectively.
No dose-limiting toxicities ( “ DLTs ” ) were observed. Treatment-related adverse events
( “ TRAEs ” ) were primarily chemotherapy-induced myelosuppression, and no severe
hepatotoxicity was observed.
EP-NEC is a rapidly progressing disease with a poor prognosis, and historical data indicate
an mOS of approximately 12 months with first-line platinum-based chemotherapy. In this
study, the median follow-up was approaching 17 months while the mOS had not been reached,
suggesting that survival benefit continued to accrue and that the survival curve exhibited a
long-tail trend.

LBL-024 AS FIRST-LINE TREATMENT FOR BTC (ABSTRACT NO. 5649)
As of April 1, 2026, 20 patients with advanced biliary tract cancer (“BTC”) had been enrolled
in the safety lead-in phase. The median age was 61 years. The cohort included two patients
with gallbladder cancer, 13 with intrahepatic cholangiocarcinoma and five with extrahepatic
cholangiocarcinoma; 85.0% of patients had metastatic disease.
The overall objective response rate (“ORR”) was 55.0% and the disease control rate (“DCR”)
was 100.0%. Among patients with PD-L1-positive disease (CPS ≥1), the ORR was 100.0%.
TEAEs primarily comprised chemotherapy-related hematologic toxicities, including
leukopenia, neutropenia and anemia. No new safety signals were observed.
Patients with PD-L1-negative disease (CPS <1) accounted for 60% of the study population,
compared with generally less than 30% in comparable first-line BTC studies, while other
baseline characteristics were broadly comparable. Follow-up for the abstract data was limited,
and updated follow-up data are expected to be presented at 2026 ESMO.

TRANSLATIONAL STUDY OF LBL-024 IN MSS COLORECTAL CANCER
(ABSTRACT NO. 5512)
In a preclinical translational study of microsatellite-stable (“ MSS ”) colorectal cancer, LBL024 demonstrated dose-dependent tumor growth inhibition. Tumor growth inhibition by tumor
volume was 69.27%, 94.53% and 99.84% in the 2 mg/kg, 8 mg/kg and 30 mg/kg groups,
respectively. In the 30 mg/kg group, complete tumor regression was achieved in two of five
mice. At molar-equivalent doses, LBL-024 demonstrated greater antitumor activity than
pembrolizumab.

–2–

The study further demonstrated that intratumoral soluble 4-1BB levels were several dozen
times higher than peripheral levels, consistent with the design of conditional activation within
the tumor. Tumor-infiltrating T cells increased in a dose-dependent manner: the proportion
of CD3+ cells increased from 30.84% in the control group to as high as 68.92%, while the
proportion of CD8+ cells increased from 56.05% to as high as 88.72%. The proportion
of immunosuppressive regulatory T cells decreased from 9.58% to as low as 1.71%, and
intratumoral cytokines, including TNF-α and IFN-γ, increased in a dose-dependent manner.
These findings indicate that LBL-024 induces intratumoral immune activation and reshapes
the tumor microenvironment by conditionally activating local CD8+ T cells and reducing
immunosuppressive regulatory T cells. The mechanism is consistent with the efficacy signals
and safety profile observed in clinical studies of LBL-024 and supports further clinical
development in MSS colorectal cancer and other immunotherapy-resistant solid tumors.

LBL-034 FOR RELAPSED OR REFRACTORY MULTIPLE MYELOMA
(ABSTRACT NO. 4727)
As of March 31, 2026, 56 heavily pretreated patients with relapsed or refractory multiple
myeloma (“RRMM”) had been enrolled. The median number of prior lines of therapy was five.
Of the patients enrolled, 73.2% were triple-class exposed, 57.1% were penta-drug exposed,
28.6% had previously undergone autologous stem cell transplantation, 16.1% had previously
received BCMA CAR-T therapy and 23.2% had extramedullary disease (“EMD”).
Among 55 efficacy-evaluable patients, the median follow-up was 16.0 months, the median
progression-free survival (“ mPFS”) was 15.8 months and the mDoR had not been reached.
At doses of 400–1,200 μg/kg, the 18-month progression-free survival (“PFS”) rate was 58.0%.
Among 23 patients who achieved a complete response or better, the 18-month PFS rate was
87.7%, the median time to complete response or better was 3.94 months and the minimal
residual disease-negative rate at a sensitivity of 10^-5 was 72.7%.
Among high-risk patients with EMD, the ORR was 75.0%, the median time to response was
3.07 months, the mPFS was 11.5 months and the 18-month PFS rate was 46.9%.
LBL-034 demonstrated a favorable safety profile. There was only one event of Grade 3 or
higher cytokine release syndrome (“CRS”), and no treatment-related deaths occurred.
The results demonstrate deep and durable responses in heavily pretreated and high-risk patients
with RRMM while maintaining a low incidence of severe CRS, supporting the effectiveness and
safety of the conditional T-cell redirection and activation mechanism of the Company’s TCE
technology platform.

–3–

ABOUT LBL-024 (OPAMTISTOMIG)
LBL-024 is a bispecific antibody simultaneously targeting PD-L1 and 4-1BB, with the potential
to become a pan-tumor IO 2.0 cornerstone therapy that offers survival benefits. To date, LBL
024 has been evaluated in clinical studies for 14 indications, including one pivotal single arm
registrational clinical study, one confirmatory Phase III clinical study and nine proof-of concept
studies, covering multiple major cancer types and “cold tumors. ” Among the seven tumor
types in which LBL-024 has been clinically validated, LBL-024 has demonstrated outstanding
clinical value and broad therapeutic prospects, including extrapulmonary neuroendocrine
carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC),
biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell
carcinoma (ESCC) and ovarian cancer (OC).
Leveraging our self-developed X-body™ platform with full intellectual property rights, LBL
024 achieves conditional activation of 4-1BB, relieving PD-1/PD-L1 immunosuppression while
enhancing 4-1BB-regulated T-cell activation, achieving a synergistic effect in eliminating
tumors. LBL-024 demonstrates a safety profile comparable to PD-1/PD-L1 inhibitors and
greater potential for broad-spectrum cancer treatment. In particular, activation of 4-1BB can
reactivate exhausted T cells and substantially promote their proliferation, making 4-1BB
targeted therapies potentially suitable for the treatment of immunologically “cold tumors” that
are resistant or unresponsive to PD-1/PD-L1 inhibitors, and may bring long-lasting survival
benefits.
In October 2024, LBL-024 was granted Breakthrough Therapy Designation by the NMPA,
and in November 2024, it received Orphan Drug Designation from the U.S. Food and Drug
Administration (the “FDA”). In January 2026, LBL-024 was granted Fast Track Designation
by the FDA and Orphan Drug Designation in the European Union. In September 2026, LBL024 was granted Orphan Drug Designation by Japan’s Ministry of Health, Labour and Welfare
(“MHLW”). In October 2026, it received Fast Track Designation from the FDA for the firstline treatment of advanced BTC.
In July 2026, the Marketing Authorization Application of LBL-024 as an innovative biological
product was included in the NMPA’s priority review and approval procedure and was formally
accepted in August 2026. LBL-024 is expected to become the world ’s first approved 4-1BB
antibody drug, the world’s first approved agonistic antibody drug and the world ’s first approved
therapy targeting EP-NEC.

–4–

ABOUT LBL-034
LBL-034 is a humanized bispecific T-cell engager (TCE) targeting GPRC5D and CD3,
developed using the Company ’s proprietary LeadsBody™ platform. LBL-034 employs a 2:1
structural design comprising two high-affinity Fab domains targeting GPRC5D and one singlechain variable fragment targeting CD3. It is designed to selectively target GPRC5D-positive
tumor cells and conditionally activate T cells, thereby reducing the risks of cytokine release,
systemic toxicity and T-cell exhaustion while enabling potent, sustained antitumor activity.
LBL-034 has demonstrated encouraging efficacy signals in preclinical and clinical studies.
Breakthrough clinical data for LBL-034 monotherapy in RRMM were presented in the opening
oral presentation at the 2025 American Society of Hematology Annual Meeting, and further
updated clinical data have been selected for a Proffered Paper presentation at 2026 ESMO.
LBL-034 received Orphan Drug Designation from the FDA in October 2024 and Fast Track
Designation from the FDA in January 2026. A Phase III clinical study of LBL-034 is currently
in preparation.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee
that it will be able to develop, or ultimately market, LBL-024 and LBL-034, successfully.
Shareholders and potential investors of the Company are advised to exercise due care when
dealing in the shares of the Company.
By order of the Board
Nanjing Leads Biolabs Co., Ltd.
南京維立志博生物科技股份有限公司
Dr. KANG XIAOQIANG
Chairman, Executive Director and
Chief Executive Officer
Nanjing, PRC, October 19, 2026
As at the date of this announcement, the board of directors of the Company comprises: (i)
Dr. Kang Xiaoqiang (Chairman of the Board), Dr. Lai Shoupeng and Mr. Zuo Honggang
as executive Directors; (ii) Mr. Zhang Yincheng, Dr. Chen Renhai and Dr. Wu Fenglan as
non-executive Directors; and (iii) Dr. Zhang Hongbing, Mr. Du Yilong and Ms. Du Jiliu as
independent non-executive Directors.

–5–

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  1. e5a0e05ff3 · 2026-10-19 19:44 · doubao / doubao-seed-evolving-latest-version · 策略包 658c0c1e2ba5当前