Nanjing Leads Biolabs Achieves Major Milestone in Phase II Study of LBL-024 for Advanced Biliary Tract Cancer
Nanjing Leads Biolabs Co., Ltd. (Stock Code: 9887) has announced a significant development in its oncology pipeline, completing full patient enrollment for its pivotal Phase II clinical study of Opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for first-line treatment of advanced biliary tract cancer (BTC).
Key Highlights
- Full Enrollment Achieved: The Phase II clinical study enrolled all 70 targeted patients, marking an important step forward for LBL-024’s clinical development. Rapid enrollment was achieved, demonstrating both high clinical demand and operational execution.
- Expansion Phase Progression: The study entered its expansion phase in April 2026 after demonstrating a favorable safety profile and efficacy data that exceeded expectations. This advancement underscores the significant therapeutic promise of LBL-024 in BTC.
- Strong Competitive Position: Opamtistomig showed highly competitive efficacy in BTC—a recognized “immune-cold” tumor where existing immunotherapy plus chemotherapy regimens offer limited benefit (objective response rate [ORR] <30%, median overall survival [OS] ~12–13 months). LBL-024’s performance signals potential for improved outcomes over current standards.
- Broad-Spectrum Anti-Cancer Potential: The antibody’s efficacy is being validated across multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), small cell lung cancer (SCLC), and now BTC. Notably, it has shown efficacy in both adenocarcinoma and squamous cell carcinoma, indicating broad application potential.
Clinical and Scientific Details
- Study Leadership and Scope: The trial is led by Academician Zhou Jian of Zhongshan Hospital, Fudan University, and is being conducted at multiple top-tier hospitals across China. Safety run-in data indicate favorable tolerability and no new safety signals. Early efficacy signals are positive, with notable tumor shrinkage trends.
- Upcoming Data Disclosure: Detailed results are set to be presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain, scheduled for October 23–27, 2026—a potential catalyst for further investor attention.
- Biliary Tract Cancer Market Opportunity: BTC is a highly aggressive disease (majority adenocarcinoma), with poor prognosis and a five-year survival rate below 5%. Global incidence is rising, particularly in Asia, and current therapies offer only marginal improvement in survival, highlighting a significant unmet need.
About LBL-024 (Opamtistomig)
- Innovative Mechanism: LBL-024 is a bispecific antibody developed using the proprietary X-body™ platform, targeting PD-L1 and the co-stimulatory receptor 4-1BB. It offers conditional 4-1BB activation, aiming to boost T-cell activity while relieving PD-1/PD-L1 immunosuppression for synergistic anti-tumor effects.
- Favorable Safety and Efficacy: Comparable safety profile to established PD-(L)1 therapies, with potential for greater efficacy across a broad range of solid tumors.
- First-In-Class Potential: LBL-024 is the first molecule targeting 4-1BB to reach pivotal single-arm registrational clinical stage globally, and may become the first approved drug for EP-NEC. It is also being tested in 13 solid tumor indications, including one pivotal and eight proof-of-concept studies (e.g., NSCLC, SCLC, BTC, ovarian cancer, esophageal squamous cell carcinoma, HCC, gastric cancer, TNBC, melanoma).
- Regulatory Designations: Received Breakthrough Therapy Designation (BTD) from China’s CDE (NMPA) in October 2024, Orphan Drug Designation from the US FDA for NEC in November 2024, Fast Track Designation from the US FDA for EP-NEC in January 2026, and Orphan Drug Designation from the EU.
- Potential for “Cold Tumors”: 4-1BB agonism can reactivate apoptotic T-cells, making LBL-024 suitable for tumors resistant to existing checkpoint inhibitors.
Price Sensitive and Shareholder-Relevant Information
- Milestone Achievement: Completion of full patient enrollment and progression to expansion phase in a pivotal Phase II trial is a significant inflection point, potentially accelerating the path to registration and commercialization.
- Upcoming Catalysts: Data presentation at a major international conference (ESMO) in October 2026 could be a major share price catalyst, depending on the full results.
- Regulatory Advancements: Multiple regulatory designations enhance the likelihood of expedited development and approval, which could significantly increase the company’s value proposition.
- Strong Unmet Need: BTC is an area of high unmet medical need with rising incidence, offering a large market opportunity.
Shareholders and potential investors should note: While the latest results are promising, there is no guarantee that LBL-024 will ultimately be successfully developed or approved. The company advises exercising caution when dealing in its shares.
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Biotechnology investments are subject to significant risks, including clinical and regulatory uncertainties. Investors should conduct their own due diligence or consult professional advisors before making investment decisions.
南京樂迪生物 LBL-024 （Opamtistomig）治療晚期膽道癌 II 期臨床試驗全體入組完成，迎來重要里程碑
南京樂迪生物（股份代號：9887）公佈，其自主研發的 PD-L1/4-1BB 雙特異性抗體 Opamtistomig（LBL-024）用於晚期膽道癌（BTC）一線治療的關鍵性 II 期臨床研究，已成功完成全部 70 例患者入組，標誌著產品開發進程邁向新階段。
重點內容
- 全體患者快速入組： 該 II 期臨床研究已完成 70 名患者的全部入組，顯示臨床推進效率高、需求強勁。
- 進入擴展階段： 基於安全性良好及療效超預期，臨床於 2026 年 4 月進入擴展階段，進一步驗證 LBL-024 的潛力。
- 療效具競爭力： 在膽道癌這類免疫冷腫瘤中，現有聯合免疫治療 ORR 低於 30%，中位總生存僅約 12-13 個月，LBL-024 展示出顯著優於現有標準的潛力。
- 廣譜抗腫瘤潛力： 除膽道癌外，LBL-024 在外肺神經內分泌癌（EP-NEC）、小細胞肺癌（SCLC）等多種腫瘤中亦展現療效，無論腺癌或鱗癌亞型均見成效。
臨床及科學細節
- 專家領銜、多中心開展： 由復旦大學中山醫院周健院士帶領，於國內多家大型醫院進行。安全性數據顯示耐受性良好，無新不良信號，初步療效鼓舞人心。
- 重磅數據將披露： 詳細數據將於 2026 年 10 月 23-27 日西班牙馬德里 ESMO 年會上發佈，或成股價催化劑。
- 膽道癌市場機會： BTC 以腺癌為主，五年生存率低於 5%，全球發病率持續上升，亞洲尤為嚴重，現有治療提升有限，未被滿足的醫療需求巨大。
關於 LBL-024（Opamtistomig）
- 創新機制： 基於自主 X-body™ 平台，LBL-024 同時靶向 PD-L1 及 4-1BB 協同激活 T 細胞，解除免疫抑制，發揮協同抗腫瘤效應。
- 安全性與療效兼備： 安全性可比 PD-(L)1 單抗，展現更廣泛腫瘤治療潛力。
- 同類首創： 全球首個進入關鍵單臂註冊臨床階段的 4-1BB 靶向分子，有望成為首個獲批治療 EP-NEC 的藥物。目前已開展包括 BTC 在內的 13 種實體瘤適應症臨床研究。
- 監管認可： 2024 年 10 月獲中國 NMPA 突破性治療藥物資格，2024 年 11 月獲美國 FDA 孤兒藥資格，2026 年 1 月再獲美國 FDA 快速通道資格及歐盟孤兒藥資格。
- “冷腫瘤”潛力： 4-1BB 激動劑可重振凋亡 T 細胞，對 PD-1/PD-L1 抑制劑耐藥腫瘤具潛力。
對股東及潛在投資者的重要及敏感信息
- 重大里程碑： II 期關鍵臨床完成入組並進入擴展階段，有望加快註冊及商業化進程。
- 即將到來的催化劑： 2026 年 ESMO 年會數據披露，有望成股價重大催化劑。
- 監管推進： 多項監管認可提升加速開發和審批的可能性，或顯著增強公司估值。
- 龐大市場機會： BTC 高發病、高未被滿足需求，市場空間廣闊。
須注意： 雖然目前結果令人鼓舞，但公司無法保證最終開發或上市成功，投資者應審慎行事。
免責聲明：本文僅供資訊參考，並不構成投資建議。生物醫藥投資風險較高，臨床及監管不確定性大，請投資者在投資前進行獨立調查或諮詢專業顧問。
