ObsEva : China Approves Yuyuan Bioscience's IND Application For Phase 1 Trial Of Nolasiban

(RTTNews) - ObsEva SA (OBSV) said that the Center for Drug Evaluation at the Chinese National Medical Products Administration has approved Yuyuan Bioscience's IND application for a Phase 1 clinical trial of nolasiban.

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 1 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 the Peoples Republic of China to Yuyuan.

As per the sublicense agreement with Yuyuan, ObsEva is entitled to receive aggregate milestone payments of up to $17 million upon the achievement of specified development, regulatory, and first sales milestones, and aggregate milestone payments of up to $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 the expiration of the last valid claim covering the product in China and ten years from the first commercial sale of the product in China.