理解市场 | 昭衍新药涨超 3% 近日助力益科思特创新双特异性抗体 YK012 获批美国 FDA IND

Zhitong
2025.10.15 02:58

JOINN rose over 3%, as of the time of publication, up 3.6%, reported at HKD 19.87, with a trading volume of HKD 25.7499 million. In terms of news, according to JOINN's official WeChat account, recently, Yikesi Technology's independently developed targeted CD19/CD3 innovative bispecific antibody YK012 officially received clinical trial approval (IND) from the U.S. Food and Drug Administration (FDA) for the treatment of primary membranous nephropathy (pMN). This is the world's first T cell engager (TCE) bispecific antibody drug approved for clinical use for this indication, marking a synchronized breakthrough in original Chinese bispecific antibody technology in the field of autoimmune diseases. JOINN, as Yikesi Technology's non-clinical CRO partner, fully participated in the pharmacokinetic services, toxicology tests, and other non-clinical trial processes of the YK012 project. It is reported that the development of YK012 relies on Yikesi Technology's "Beijing headquarters + wholly-owned subsidiary Excyte LLC in the U.S." dual-center layout. Following the FDA IND approval, the company will gradually initiate international multicenter clinical research, complementing the multicenter trials already underway in China (led by Professor Zhao Minghui from Peking University First Hospital) to accelerate the global R&D process

According to Zhitong Finance APP, JOINN (06127) has risen over 3%, with a current increase of 3.6%, priced at HKD 19.87, and a trading volume of HKD 25.7499 million.

In terms of news, according to JOINN's official WeChat account, recently, Yikesi Te's independently developed innovative bispecific antibody YK012 targeting CD19/CD3 has officially received clinical trial approval (IND) from the U.S. Food and Drug Administration (FDA) for the treatment of primary membranous nephropathy (pMN). This is the world's first T-cell engager (TCE) bispecific antibody drug approved for clinical use for this indication, marking a synchronized breakthrough in the field of autoimmune diseases for China's original bispecific antibody technology. JOINN, as Yikesi Te's non-clinical CRO partner, has fully participated in the pharmacokinetic services, toxicology tests, and other non-clinical trial processes of the YK012 project.

It is reported that the development of YK012 relies on Yikesi Te's dual-center layout of "Beijing headquarters + wholly-owned subsidiary Excyte LLC in the United States." Following the FDA IND approval, the company will gradually initiate international multicenter clinical research, complementing the data with the multicenter trials already underway in China (led by Professor Zhao Minghui from Peking University First Hospital) to accelerate the global research and development process