Organon China has announced a licensing and supply agreement with Shanghai Bao Pharmaceutical (BaoPharma) and its wholly-owned subsidiary, Suzhou Centergene Pharmaceuticals. Through this partnership, Organon acquires the exclusive commercialization rights to Centergene’s investigational asset, SJ02, in Mainland China.
SJ02, developed by Centergene, is a long-acting recombinant human follicle-stimulating hormone carboxyl-terminal peptide fusion protein (FSH-CTP). It is designed for controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist to facilitate the development of multiple follicles in women undergoing assisted reproductive technology (ART) programs.
Positioned to potentially become the first long-acting FSH available in China, SJ02 is currently under review by China’s regulatory agency. The current COS regimen in ART requires daily FSH injections until the day of human chorionic gonadotropin (hCG) administration. SJ02 is designed to initiate and maintain follicular growth in the ovaries for one week. If approved, a single-dose injection of SJ02 has the potential to offer an alternative to the current treatment regimen.
“As a company who focuses on health of women, Organon has extensive experience and a widely recognized portfolio in reproductive health, and we are also committed to increasing our investment in reproductive technology innovation,” said Zafer Unluer, President of Organon China. “This partnership aligns perfectly with our ‘In China, for China’ strategy and our broader growth strategy focused on expanding our fertility portfolio. We believe that by collaborating with China’s leading innovators, we can accelerate advancements in ART, offering additional fertility options to millions of Chinese families.”
According to the World Health Organization’s report Estimates of Infertility Prevalence (1990-2021), approximately 17.5% of the global population—about one in six people—are affected by infertility, with the prevalence continuing to rise.
Liu Yanjun, Chairman of BaoPharma, stated, “Through the collaboration with Organon, we believe that, if approved, SJ02 will have the potential to benefit those suffering from infertility in China, offering a new treatment option to those in need. BaoPharma remains dedicated to the innovative development of recombinant protein drugs and cutting-edge therapies. We look forward to our partnership with Organon to help deliver therapies that address urgent clinical needs to patients.”
Under the terms of the agreement, BaoPharma and its wholly-owned subsidiary Centergene will receive a $12 million upfront payment with additional development and commercial milestone payments.