Zhi Tong Cai Jing·2025-10-15 03:02Core Viewpoint - Zhaoyan New Drug (603127) has seen a stock increase of over 3%, currently trading at 19.87 HKD, following the FDA's approval of YK012 for clinical trials, marking a significant milestone in the treatment of primary membranous nephropathy (pMN) [1] Company Summary - YK012, a bispecific antibody targeting CD19/CD3, has received IND approval from the FDA, making it the first T cell engager (TCE) drug approved for this indication globally [1] - Zhaoyan New Drug is a non-clinical CRO partner for YK012, participating in pharmacokinetic services and toxicology testing during the non-clinical trial phase [1] - The development of YK012 is supported by a dual-center strategy involving Excyte LLC, a wholly-owned subsidiary in the U.S., and the Beijing headquarters of Yikost [1] Industry Summary - The FDA's approval of YK012 represents a breakthrough for Chinese-origin bispecific antibody technology in the field of autoimmune diseases, achieving a synchronized advancement with the U.S. [1] - Following the IND approval, the company plans to initiate international multi-center clinical studies, complementing ongoing multi-center trials in China led by Professor Zhao Minghui from Peking University First Hospital [1]