Baili Tianheng's Yizekang Added to Breakthrough Therapy Designation List
核心洞察
Baili Tianheng (搜索) said China's Center for Drug Evaluation has included Yizekang (搜索) on its breakthrough therapy designation list for recurrent or metastatic biliary tract cancer (搜索) after platinum-based chemotherapy failure.
Yizekang (搜索), also known as BL-B01D1 or iza-bren (搜索), is described by the company as the only approved EGFR (搜索)×HER3 (搜索) bispecific antibody-drug conjugate.
The designation brings Yizekang (搜索) to nine breakthrough therapy indications in China, with one indication also holding breakthrough status from the U.S. Food and Drug Administration (搜索).
Baili Tianheng (搜索) (688506.SH) announced that the Center for Drug Evaluation of China's National Medical Products Administration has included Yizekang (搜索) on its list of breakthrough therapy designations for patients with recurrent or metastatic biliary tract cancer (搜索) who have previously failed platinum-based chemotherapy. The public notice for the designation has been completed.
Yizekang (搜索), also referred to as lunconyilongtou monoclonal antibody, BL-B01D1 or iza-bren (搜索), is an EGFR (搜索)×HER3 (搜索) bispecific antibody-drug conjugate developed independently by the company. Baili Tianheng (搜索) describes it as the only approved EGFR×HER3 bispecific ADC.
With this addition, Yizekang (搜索) has now been granted breakthrough therapy designation for nine indications by the Center for Drug Evaluation. One indication has also received breakthrough therapy designation from the U.S. Food and Drug Administration (搜索).
Source: Baili Tianheng (688506.SH): Yizekang included in the list of breakthrough therapy designations