Core Viewpoint - China Antibody-B (03681) has received approval from the National Medical Products Administration (NMPA) for its clinical trial application (IND) for the innovative treatment product SM17, expanding its use from atopic dermatitis (AD) to inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC) [1] Group 1 - The stock price of China Antibody-B increased by over 5%, reaching 2.1 HKD with a trading volume of 9.53 million HKD [1] - The IND approval marks a significant milestone for the company, addressing a substantial unmet medical need in chronic and debilitating diseases [1] - The company has completed follow-up for the Phase I bridging study of the subcutaneous injection formulation of SM17 in healthy volunteers, with data to support the advancement of IBD indications into Phase II clinical development [1] Group 2 - In addition to advancing the IND, the company is completing a bridging study transitioning from intravenous to subcutaneous injection, expected to be finished by the first quarter of this year [1] - The company anticipates initiating Phase II clinical trials for AD in the second quarter of this year [1] - The expansion of SM17's indications from AD to IBD is viewed as a significant opportunity to address unmet medical needs in a clinically and commercially valuable area [1]
港股异动 中国抗体-B(03681)午前涨超5% 预计最早于二季度启动针对SM17 AD的II期临床试验