智通财经网·2025-10-15 02:58Core Viewpoint - Zhaoyan New Drug (06127) has seen a stock price 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 development of innovative therapies for primary membranous nephropathy (pMN) [1] Group 1: Company Developments - YK012, a bispecific antibody targeting CD19/CD3, has received IND approval from the FDA for treating pMN, making it the first T cell engager (TCE) bispecific antibody 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] Group 2: Research and Development Strategy - The development of YK012 is supported by a dual-center strategy with a headquarters in Beijing and a wholly-owned subsidiary, Excyte LLC, in the United States [1] - Following the FDA 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, to accelerate global research progress [1]