Sermonix Pharma Bags Chinese Nod of IND application For lasofoxifene

Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical firm developing cutting-edge therapeutics for the treatment of metastatic breast cancers (mBC), announced that China's National Medical Products Administration (NMPA) has approved the investigational new drug application (IND) for oral lasofoxifene (HLX78 in China), which was submitted with the help of Chinese development partner Shanghai Henlius Biotech, Inc. (2696.HK).

The IND approval enables Henlius to participate in the current global registrational ELAINE-3 clinical trial, with responsibility for China. The third evaluation of lasofoxifene in ESR1 mutations (ELAINE) trial, ELAINE-3 (NCT05696626), compares the efficacy of oral lasofoxifene and Eli Lilly and Company's CDK4/6 inhibitor abemaciclib (Verzenio) to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally progressing or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

This month, Henlius expanded its Sermonix license to include new Asia territories for upfront, milestone, and royalty payments. The agreement also permits Henlius to collaborate with Sermonix on the expedited development of oral lasofoxifene in Japan.

“With active ELAINE-3 enrollment already underway in the US, Canada, EU and Israel, we are pleased to announce that Henlius, our Chinese development partner for oral lasofoxifene, received approval for its investigational new drug application,” said Dr. David Portman, Sermonix founder and chief executive officer. “This milestone clears Henlius to enroll patients in ELAINE-3 in China, therefore further diversifying our patient population and potentially helping more people to better confront this terrible disease.”