On April 7, 2023, Suzhou Puhe Biopharma Science and Technology Co., Ltd. has achieved a notable milestone with the successful enrollment of the first patient in the Phase III clinical study of its self-developed Class 1 new drug, YK-029A. This pivotal study, conducted at the Union Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, targets locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations, comparing YK-029A to first-line platinum-based doublet chemotherapy. Led by Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences, this large-scale Phase III study involves collaboration across 60 centers nationwide.

Suzhou, China, February 10, 2023- Suzhou Puhe Biopharma announced today that its application for Phase III clinical trial for a small molecule innovative drug (PH001) in the field of lung cancer has been accepted and approved by the National Medical Products Administration for use in advanced NSCLC patients with EGFR Ex20ins who have not undergone systematic treatment.