#ObsEva #Announces #IND #Approval #Yuyuan #Biosciences #Phase
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland – October 13, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing novel therapies for women’s health, today announced that Yuyuan Bioscience’s (Yuyuan) IND application for a Phase 1 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 1 clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of nolasiban in healthy adult female subjects in China.
“We are pleased to see Yuyuan’s progress with nolasiban in the Peoples Republic of China, as improving the birth rates of women undergoing IVF treatment is an incredibly important personal issue for millions of couples around the world affected by infertility,” said Brian O’Callaghan, CEO of ObsEva. “The Phase 1 clinical trial planned by Yuyuan, including testing varying dose levels and duration of dosing, will provide critical observations that will inform nolasiban’s future development in the United States and abroad.”
ObsEva has sublicensed the exclusive rights to develop and commercialize nolasiban in the Peoples Republic of China to Yuyuan. Under 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…
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