近日，长春新区政府投资基金投资的创新型生物制药企业益科思特（ExcyteBiopharmaLtd.）宣布，其核 心产品YK012——一款靶向CD3/CD19的双特异性抗体药物，已在美国正式启动针对原发性膜性肾病 （pMN）的一期临床试验。该试验已于2025年11月18日在ClinicalTrials.gov完成注册（编号： NCT07234474），标志着益科思特在自身免疫疾病领域的国际化研发迈出关键一步，也成为长春新区政 府投资基金在生物医药前沿领域投资布局的重要里程碑。 益科思特成立于2016年，是一家专注于双特异性抗体药物研发的创新型生物制药企业，公司建立了完整 的双抗药物开发平台，在药物结构设计、亲和力优化和安全性调控方面具有独特技术优势。研发团队由 具有国际药企丰富经验的核心科学家领衔，围绕CD3/CD19、BCMA/CD3等双抗管线，系统性布局肿瘤 与自身免疫疾病治疗，其技术平台和临床进展已吸引多家国际药企关注。近年来，国产双抗药物海外授 权交易频发，益科思特在自免领域的先行者地位，有望成为下一个具有国际影响力的合作标的。 长春新区政府投资基金于2024年6月便前瞻性地投资益科思特，为公司的早期研 ...

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]