LEADS BIOLABS-B (09887.HK): Pivotal EP-NEC Study Selected as ESMO Late-Breaking Abstract

NewTimeSpace News: On 21 September 2026, Nanjing Leads Biolabs Co., Ltd. (stock code: 09887) published a voluntary announcement that, at the 2026 Annual Congress of the European Society for Medical Oncology (2026 ESMO), the pivotal registrational Phase IIb clinical study of its self-developed investigational drug LBL-024 (Oparilisumab, a PD-L1/4-1BB bispecific antibody) as monotherapy for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been selected as a late-breaking abstract (LBA) and granted a preferred oral presentation.

The study aims to evaluate the efficacy and safety of LBL-024 monotherapy in patients with advanced EP-NEC who have previously received at least second-line or later systemic therapy, with the data providing core support for the Company's new drug application (NDA) submissions to the relevant regulatory authorities. The principal investigator is Professor Shen Lin of Peking University Cancer Hospital, the presenter is Director Lu Ming of Peking University Cancer Hospital, and the presentation is scheduled from 10:15 a.m. to 10:25 a.m. local time on 26 October.

At 2026 ESMO, the Company has received preferred oral presentation status for three studies: the pivotal registrational Phase IIb study of LBL-024 monotherapy in advanced EP-NEC selected as an LBA, a Phase Ib/II study of LBL-024 in combination with chemotherapy as first-line treatment for EP-NEC, and a Phase I study of LBL-034 in relapsed or refractory multiple myeloma (RRMM). A further four studies have been selected for poster presentations at the congress.

LBL-024 is a bispecific antibody targeting both PD-L1 and 4-1BB and has entered clinical studies across 14 indications, covering seven cancer types with existing clinical data support, including EP-NEC, non-small cell lung cancer, small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, oesophageal squamous cell carcinoma and ovarian cancer. It obtained breakthrough therapy designation from the NMPA in October 2024, orphan drug designation from the US FDA in November 2024, and FDA fast track designation and EU orphan drug designation in January 2026; in July 2026 its innovative biologics marketing application was included in the NMPA's priority review and approval procedure and was formally accepted in August.

There is currently no therapy for EP-NEC with specific regulatory approval worldwide. First-line treatment for advanced EP-NEC is mainly platinum-based chemotherapy, with an objective response rate of approximately 30% to 50% and a median overall survival of only about one year; second-line treatment has limited efficacy, leaving a substantial unmet clinical need.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.