Nanjing-based Leads Biolabs successfully completed its initial public offering on the Hong Kong Stock Exchange on July 25, 2025, raising approximately $189 million to advance its pipeline of immuno-oncology therapeutics. The clinical-stage biotechnology company priced its IPO at HKD 35 per share, offering 36.86 million shares under stock code "09887."
The company plans to allocate approximately 65% of proceeds toward ongoing and planned clinical trials and regulatory affairs, with the remainder supporting preclinical asset advancement, manufacturing capacity upgrades, and general corporate purposes. Morgan Stanley and CITIC Securities served as joint sponsors for the transaction.
Breakthrough 4-1BB Platform Shows Clinical Promise
Leads Biolabs' most advanced asset, LBL-024, represents a significant milestone as the world's first 4-1BB-targeted molecule to reach registrational trials. The PD-L1/4-1BB bispecific antibody utilizes the company's proprietary X-body™ platform, which employs a 2:2 configuration designed to restrict 4-1BB activation to the tumor microenvironment while minimizing systemic toxicity, particularly hepatotoxicity that has limited earlier 4-1BB approaches.
At the 2025 ASCO Annual Meeting, the company presented compelling Phase Ib/II data for LBL-024 in combination with etoposide and platinum-based chemotherapy for first-line advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC). Among 52 efficacy-evaluable patients, the combination achieved a 75.0% objective response rate and 92.3% disease control rate. In the 15 mg/kg cohort, response rates reached 83.3% with 100% disease control. Overall, 57.7% of patients achieved tumor reduction exceeding 50%.
These results substantially outperformed historical benchmarks for chemotherapy alone in EP-NEC, which typically demonstrate response rates in the 30-55% range. The data supported China's National Medical Products Administration (NMPA) approval on April 30, 2024, for a pivotal single-arm registrational trial, potentially establishing LBL-024 as the first approved therapy for this rare and aggressive cancer with no current second-line treatment options.
Comprehensive Technology Platform Portfolio
Founded in 2012, Leads Biolabs has developed an integrated pipeline of 14 innovative drug candidates, including six clinical-stage assets. The company operates three core technology platforms: LeadsBody™ for CD3 T-cell engagers, X-body™ for 4-1BB engagers, and a linker-payload platform for antibody-drug conjugates (ADCs).
The LeadsBody™ platform enables precise affinity modulation between T-cell engagers and both CD3 and tumor-associated antigens through spatially optimized molecular architecture. This design enables conditional T-cell activation exclusively within the tumor microenvironment, significantly reducing cytokine release syndrome risk and systemic toxicity. The platform has generated six differentiated therapeutic candidates spanning hematologic malignancies, solid tumors, and autoimmune diseases.
Key pipeline assets include LBL-034, a GPRC5D/CD3 bispecific antibody for multiple myeloma; LBL-033, a MUC16/CD3 bispecific targeting gynecologic cancers; and LBL-051, a first-in-class CD19/BCMA/CD3 trispecific antibody for autoimmune diseases developed through collaboration with Aditum Bio portfolio company NewCo.
Regulatory Recognition and Broad Therapeutic Potential
LBL-024 has earned significant regulatory recognition, receiving Breakthrough Therapy Designation from China's NMPA for relapsed/refractory EP-NEC and Orphan Drug Designation from the U.S. FDA for neuroendocrine neoplasms. The candidate has secured regulatory approvals to investigate multiple additional indications including small cell lung cancer, biliary tract cancer, ovarian cancer, non-small cell lung cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, and gastric cancer.
Early clinical data have demonstrated promising antitumor activity across several tumor types, supporting LBL-024's potential as a broad-spectrum oncology therapeutic. As the first 4-1BB-targeted agent to reach registrational stage, LBL-024 could establish 4-1BB as the fourth approved immuno-oncology target following PD-1/PD-L1, CTLA-4, and LAG-3.
Accelerated Development Timeline
Leads Biolabs has demonstrated exceptional development efficiency, achieving investigational new drug (IND) submission within three years of target selection, significantly outpacing the industry average of 5-6 years according to Frost & Sullivan data. The company has built end-to-end capabilities spanning target screening, discovery, preclinical research, clinical development, chemistry manufacturing and controls, and pilot manufacturing.
Dr. Xiaoqiang Kang, Founder, Chairman, and CEO, stated: "Our HKEX debut represents a major leap from laboratory innovation to global capital markets, accelerating our innovation-driven international expansion. Through strengthened global execution and accelerated translation of breakthrough therapies from bench to bedside, we will deliver paradigm-shifting treatments to patients across the globe."
The company is exploring strategic collaborations to accelerate clinical development and commercialization, positioning itself to capitalize on market opportunities through out-licensing agreements, co-marketing partnerships, and other strategic alliances as its clinical-stage assets progress toward potential commercialization.
