EQS-News: ReproNovo SA
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REPRONOVO ANNOUNCES CLINICAL TRIAL APPROVAL NOTICE FOR RPN-001 IN CHINA
Lausanne, Switzerland and Copenhagen, Denmark, September 30, 2025 - ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women's health, today announced that China's National Medical Products Administration (NMPA) has issued a clinical trial approval notice for RPN-001 (leflutrozole). This approval enables the initiation of a Phase 1 trial in China, marking a key regulatory milestone in the global development of RPN-001 as a potential treatment for male infertility associated with low serum testosterone. "Entering China with our first approved clinical study marks a meaningful geographic expansion for ReproNovo," said Joan-Carles Arce, MD, PhD, Chief Scientific & Medical Officer of ReproNovo. "With this approval, we will soon have active clinical programs in the U.S. and China, two of the world's largest healthcare markets, which reinforces our commitment to global development in reproductive medicine." RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis). The latest approval in China aligns with ReproNovo's global development strategy and follows recent progress in the U.S., where a Phase 2 trial is underway. "We are committed to expanding access to innovative therapies where few treatment options currently exist," said Jean Duvall, Chief Executive Officer of ReproNovo. "With clinical activities now advancing in both the U.S. and China, we are building the foundation for a truly global approach to reproductive medicine and women's health innovation." ABOUT REPRONOVO: ABOUT RPN-001 (leflutrozole): CONTACT INFORMATION: MEDIA CONTACT: 30.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. |
2205250 30.09.2025 CET/CEST
