On May 17, 2019, Sunshine Guojian’s antibody drug YISAIPU was officially granted the GMP certificate in Indonesia. This milestone marked that YISAIPU's production quality system has met the requirements of PIC/S, one of the highest international standards. Indonesia is a member country of PIC/S, which is an organization with internationally recognized high standards, covering developed countries such as European countries, the United States, Japan and a few emerging markets.
In addition, in 2018 and 2019, the company also achieved significant overseas market expansion for YISAIPU, including marketing approval in Thailand (PIC/S), Phase III head-to-head comparative trial getting approved in Ukraine (PIC/S) and head-to-head PK/PD clinical trial wrapping up in Mexico.
All these important advances marked the high quality of YISAIPU, which has been recognized by broader international markets. The data of its overseas registration and clinical trials will surely provide more professional reference and trust endorsement for YISAIPU to continuously realize the goals of exploring international markets and benefiting global patients.