LeadsBiolabs-B (09887.HK): LBL-024 (Opatisumab) Receives CDE IND Approval for Metastatic Colorectal Cancer; IO 2.0 Portfolio Expands to Gastrointestinal Tumors

NewTimeSpace News: Nanjing Leads Biolabs Co., Ltd. (stock code: 9887) announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its self-developed candidate drug WeilixinTM (PD-L1/4-1BB bispecific antibody opatisumab, LBL-024) for the treatment of metastatic colorectal cancer (mCRC).

According to the announcement, the approved clinical trial is an open-label, multi-center Phase Ib/II study designed to evaluate the safety and efficacy of WeilixinTM in combination therapy for mCRC. This milestone marks an important step in expanding WeilixinTM's indications into the gastrointestinal tumor space, extending the company's immuno-oncology portfolio from biliary tract cancer (BTC), gastric cancer (GC), and esophageal squamous cell carcinoma (ESCC) to colorectal cancer (CRC), a cancer type with highly unmet clinical needs.

The announcement noted that mCRC is difficult to treat with extremely poor prognosis, and the 5-year survival rate for patients is less than 13%. Although immunotherapy has achieved breakthroughs in the microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) subtype, these patients account for only about 5% of mCRC cases. For the remaining approximately 95% of patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) status, traditional immune checkpoint inhibitors offer limited clinical benefit, and first-line and second-line standard treatments remain chemotherapy combined with targeted therapy, leaving an urgent need for more effective treatment options.

WeilixinTM can simultaneously block the PD-1/PD-L1 immune suppression pathway and conditionally activate the 4-1BB co-stimulatory pathway. Through this dual mechanism of action, WeilixinTM aims to restore T-cell function while promoting T-cell proliferation and long-term immune memory formation. The clinical activity of therapies based on WeilixinTM has been validated in multiple tumor types including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC). The company believes that these mechanistic advantages are expected to translate into clear efficacy benefits in the colorectal cancer (CRC) field as well, further solidifying WeilixinTM's positioning as a cornerstone IO 2.0 therapy.

As the world's first molecule targeting the co-stimulatory receptor 4-1BB to have reached the single-arm pivotal registrational clinical stage, WeilixinTM is expected to become the first drug approved for the treatment of EP-NEC. WeilixinTM has initiated clinical studies for 13 solid tumor indications in China, including one pivotal registrational trial and eight proof-of-concept studies, covering EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma, among other areas with high unmet clinical needs. In October 2024, WeilixinTM received Breakthrough Therapy Designation from the CDE, and in November 2024, it received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). In January 2026, WeilixinTM received FDA Fast Track designation for the treatment of EP-NEC and European Union Orphan Drug designation.

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