Yahong Pharmaceutical: APL-1202 and Bai Zean combined neoadjuvant therapy completed the world's first drug administration in the United States

On January 4, Yahong Pharmaceutical, a global innovation company focusing on genitourinary tumors, announced that its oral drug APL-1202 and BeiGene Bai zean (tirelizumab) combined with neoadjuvant treatment of muscle invasive bladder cancer (MIBC) completed the world's first clinical study of administering drugs in the United States. The clinical trial application was approved by the U.S. Food and Drug Administration (FDA) in June 2021 and by the Drug Review Center (CDE) of the State Drug Administration of China in October 2021.

According to the data, the study is an open-ended, multi-center international Phase I/II clinical study, and the main research objectives include: to evaluate the safety of combination drug treatment of PATIENTS WITH MIBC, the recommended dose of phase II clinical studies as a neoadjuvant treatment of MIBC, and the efficacy. APL-1202 is an oral reversible MetAP2 inhibitor with anti-angiogenic, antitumor activity and modulation of the tumor immune microenvironment. Phase III clinical trials of first-line monotherapy and second-line combination chemotherapy perfusion for patients with non-muscular invasive bladder cancer (NMIBC) are currently being conducted in China. Bezean (terelizumab injection) is a humanized lgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody designed to minimize binding to the Fcγ receptor in macrophages.

According to public information, Yahong Pharmaceutical was founded in 2010 as a global innovative pharmaceutical company focusing on genitourinary tumors and other major diseases. According to the announcement, the issue price of Yahong Pharmaceutical is 22.98 yuan / share, and it is expected to raise 2.38 billion yuan. Up to now, there is no relevant target for A shares, and Yahong Pharmaceutical is also known as the "first share of genitourinary tumors". (Wu Wenfeng)