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NANJING, China - Nanjing Leads Biolabs Co., Ltd. (9887.HK), a biotechnology company with a market capitalization of $819 million and impressive revenue growth of 22% over the last twelve months, announced Friday the dosing of the first patient in a Phase 1b/II clinical trial evaluating its bispecific antibody Opamtistomig for advanced melanoma treatment.
The multicenter trial (NCT07099430) will assess Opamtistomig, also known as LBL-024, as both monotherapy and in combination with other agents for first-line treatment of advanced melanoma. Professor Chen Yu from Fujian Cancer Hospital is leading the study. According to InvestingPro analysis, the company maintains a "GOOD" overall financial health score, suggesting strong operational stability as it advances its clinical programs.
Opamtistomig targets both PD-L1 and 4-1BB receptors, designed to simultaneously block immune suppression and enhance T-cell activation. The company reports the drug has shown promising results in previous trials for extrapulmonary neuroendocrine carcinoma (EP-NEC).
The drug received Breakthrough Therapy Designation from China’s National Medical Products Administration in October 2024 and Orphan Drug Designation from the U.S. FDA for neuroendocrine carcinoma in November 2024.
This melanoma trial represents an expansion of Opamtistomig’s clinical program, which currently includes nine clinical trials across more than 10 cancer indications. Patient enrollment was completed in August 2025 for a pivotal single-arm registration trial evaluating the drug as monotherapy in EP-NEC.
The company notes that melanoma in China presents different challenges than in Western populations, with a predominance of acral and mucosal subtypes that typically respond poorly to current immunotherapies.
According to the press release, Leads Biolabs is focusing on developing treatments for these "immunologically cold tumors" where current therapies show limited efficacy.
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