IND Approval for Yuyuan Bioscience’s Phase I Clinical Trial of Nolasiban in China

On October 12, 2022, ObsEva SA (OBSV: NASDAQ), the listed biopharmaceutical company developing novel therapies for women’s health, that Yuyuan Bioscience’s IND application for a Phase I clinical trial of nolasiban has been approved by the Center for Drug Evaluation at the Chinese National Medical Products Administration. Nolasiban is a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization. Yuyuan plans to initiate a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of nolasiban in healthy adult female subjects in China.

ObsEva has sublicensed the exclusive rights to develop and commercialize nolasiban in China to Yuyuan. Under the sublicense agreement with Yuyuan, ObsEva is entitled to receive aggregate milestone payments of up to USD 17 million upon the achievement of specified development, regulatory, and first sales milestones, and aggregate milestone payments of up to USD 115 million upon the achievement of additional, tiered sales milestones. In addition, Yuyuan has agreed to pay tiered royalties on net sales at percentages ranging from high-single-digit to low-second digits, subject to specified reductions, until the later of expiration of the last valid claim covering the product in China and ten years from the first commercial sale of the product in China.

ObsEva is a biopharmaceutical company developing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a clinical pipeline with development programs focused on new therapies for treating preterm labor and improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization.