Group 1 - Excyte Biopharma Ltd. has officially launched a Phase I clinical trial for its core product YK012, a bispecific antibody targeting CD3/CD19, for primary membranous nephropathy (pMN) in the United States [1] - The trial was registered on ClinicalTrials.gov on November 18, 2025, marking a significant step in Excyte's international research and development in the field of autoimmune diseases [1] - Excyte Biopharma, established in 2016, focuses on the development of bispecific antibody drugs and has a complete development platform with unique technical advantages in drug structure design, affinity optimization, and safety regulation [1] Group 2 - The Changchun New Area Government Investment Fund made a forward-looking investment in Excyte Biopharma in June 2024, providing critical resources for the early-stage development of YK012 and accelerating its clinical progress [2] - This investment reflects the fund's strategic support and precise layout in the field of biopharmaceutical innovation, which will also promote local talent cultivation, technological innovation, and industrial chain aggregation [2] - The ongoing wave of domestic innovative drugs entering international markets will see the Changchun New Area Government Investment Fund continue to support innovative enterprises, effectively promoting regional industrial structure optimization and upgrading [2]

Core 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]

Core 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]