China Approves New Clinical Trial Targeting Advanced Colorectal Cancer

2026-08-03 companies

Nanjing, Monday, 3 August 2026.
China approved Nanjing Leads Biolabs to begin clinical trials for a novel therapy targeting advanced colorectal cancer, offering hope to the 95% of patients resistant to current immunotherapies.

Regulatory Milestone and Drug Mechanism

On August 2, 2026, China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) granted approval for Nanjing Leads Biolabs Co., Ltd. to commence an Investigational New Drug (IND) application [1]. This regulatory green light permits the company to initiate an open-label, multicenter Phase Ib/II clinical trial for Opamtistomig (LBL-024), specifically targeting metastatic colorectal cancer (mCRC) [5]. The announcement was formally made by the company, traded under stock code 9887.HK, on August 3, 2026, marking a significant expansion of their gastrointestinal oncology franchise [2]. Opamtistomig is a PD-L1/4-1BB bispecific antibody designed to block PD-1/PD-L1-mediated immunosuppression while conditionally activating 4-1BB co-stimulatory signaling [1]. This dual mechanism aims to restore T cell function in tumors that are typically resistant to standard immune checkpoint inhibitors [6].

Clinical Context and Unmet Medical Need

The strategic focus on metastatic colorectal cancer addresses a critical gap in current oncology treatments, where the 5-year survival rate remains below 13% [2]. Approximately 95% of patients with mCRC possess microsatellite stable (MSS) or mismatch repair proficient (pMMR) tumors, which do not respond well to conventional immunotherapies [1]. In contrast, only about 5% of patients possess microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors that are more responsive to existing treatments [6]. Globally, colorectal cancer accounted for approximately 1.926 million new cases and 904,000 deaths in 2022, making it the third most common cancer and the second leading cause of cancer-related death [1]. In China specifically, 2022 data indicated 517,100 new cases and 240,000 deaths, underscoring the regional burden of the disease [2].

Pipeline Progress and Market Position

This IND approval follows recent progress in other indications, including the completion of patient enrollment for a Phase II study in biliary tract cancer (BTC) on July 30, 2026 [3]. That study enrolled all 70 patients rapidly after entering an expansion phase in April 2026, driven by favorable safety profiles and efficacy exceeding expectations [4]. Opamtistomig has secured multiple regulatory designations, including NMPA Breakthrough Therapy Designation in October 2024 and FDA Fast Track Designation for EP-NEC in January 2026 [2]. Regarding market sentiment, the most recent analyst rating on the stock is a Buy with a price target of HK$100.50 [6]. The company maintains a current market capitalization of approximately HK$10.57 billion, reflecting investor interest in its immuno-oncology pipeline [4]. Opamtistomig is currently being evaluated in 13 solid tumor indications in China, positioning it as a potential cornerstone therapy in the IO 2.0 landscape [5].

Sources

Biotechnology Oncology