Through strategic in-licensing and disciplined drug development, ObsEva has established a clinical pipeline with development programs focused on new therapies for the treatment of preterm labor and improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization.
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.Ībout ObsEva ObsEva is a biopharmaceutical company developing novel therapies to improve women's reproductive health and pregnancy. 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. ObsEva has sublicensed the exclusive rights to develop and commercialize nolasiban in the Peoples Republic of China to Yuyuan.
#Themen aktuell 1 trial
"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." "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. 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. Nolasiban is a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization. GENEVA, Switzerland - Octo ber 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.
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