SBP GROUP (01177.HK): LM-364 "Nectin-4ᵀᴹᴱ ADC" Obtains Clinical Trial Approvals from NMPA and FDA, Accelerating Global Clinical Development
NewTimeSpace News: On 28 August 2026, Sino Biopharmaceutical Limited (stock code: 01177) announced that LM-364 "Nectin-4ᵀᴹᴱ ADC", a national Class 1 innovative drug independently developed by LaNova Medicines (Shanghai) Co., Ltd., a wholly-owned subsidiary of the Group, had obtained implied clinical trial approval from the National Medical Products Administration (NMPA) of China, intended for the treatment of advanced solid tumors. The drug obtained clinical trial approval from the U.S. FDA in April this year and officially initiated clinical trials in Australia, and the Group is accelerating its global clinical development.
According to the announcement, LM-364 is a next-generation Nectin-4 ADC developed on LaNova Medicines' proprietary tumor microenvironment (TME)-responsive ADC platform, designed to circumvent the on-target/off-target toxicity common in traditional ADCs. Preclinical data disclosed at the 2026 AACR Annual Meeting showed significant tumor inhibition across multiple PDX models, with tumor growth inhibition (TGI) of 119.1% in triple-negative breast cancer and 168.79% in cervical cancer, and a highest non-severely toxic dose (HNSTD) of 60 mg/kg in cynomolgus monkeys.
Based on the approval, the Group will evaluate the safety, tolerability and preliminary antitumor activity of LM-364 as monotherapy and in combination in patients with advanced solid tumors, and explore the recommended dose for subsequent clinical development.
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