Leads Biolabs-B (09887.HK): Core Bispecific Antibody Initiates Phase Ib/II Trial for Triple-Negative Breast Cancer
NewTimeSpace News: Nanjing Leads Biolabs Co., Ltd. (09887.HK) announced that the first patient dosing has been completed in the Phase Ib/II clinical trial of its core product Velixin™ (LBL-024) for the treatment of relapsed or metastatic triple-negative breast cancer, marking new progress in the development of this drug for breast cancer indications.
NewTimeSpace News: Nanjing Leads Biolabs Co., Ltd. (09887.HK) issued a voluntary announcement on February 10, 2026, stating that the first patient has been successfully dosed in the Phase Ib/II clinical study of its core productVelixin™ (PD-L1/4-1BB Bispecific Antibody, Opatisumab, LBL-024)for the treatment of relapsed or metastatic triple-negative breast cancer.
This open-label, multicenter study is led by Professor Yin Yongmei from Jiangsu Provincial People’s Hospital, aiming to evaluate the efficacy and safety of Opatisumab monotherapy or in combination with chemotherapy in patients with advanced triple-negative breast cancer. The announcement noted that triple-negative breast cancer accounts for approximately 15% to 20% of all breast cancer cases, representing a significant unmet medical need.
Velixin™ is an innovative bispecific antibody independently developed by the company, featuring a 2:2 structural design intended to relieve immunosuppression and activate T cells. Previously, the drug has achieved several important regulatory milestones for the indication of extrapulmonary neuroendocrine carcinoma, includingBreakthrough Therapy Designationby China NMPA,Orphan Drug DesignationandFast Track Designationby the U.S. FDA.
The company issued a warning statement in accordance with the Listing Rules, reminding shareholders and potential investors that there is no guarantee that Velixin™ can be successfully developed or eventually commercialized, and that caution should be exercised when dealing in the company’s shares.
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