Corina Intrauterine Drug-Eluting System receives approval in China for the treatment of intrauterine adhesions

Shanghai-based Yipurun Biotech (YPR) announced the approval of its Corina Intrauterine Drug-Eluting System (“Corina”) in China, a device designed to advance the treatment of patients with moderate to severe intrauterine adhesions (IUA) undergoing transcervical adhesion resection (TCRA). The approval was based on a randomized, controlled clinical trial that demonstrated superior efficacy of Corina compared to current standard treatments.

Intrauterine adhesions (IUA) are scar tissue that forms in the uterine cavity and often leads to reduced menstrual bleeding, amenorrhea, infertility, and recurrent miscarriages. The condition poses a significant threat to the reproductive health of women of childbearing age, particularly in China, where the incidence rate of IUA is alarmingly high, affecting up to 25% of women who have previously undergone abortion or curettage.

The standard treatment for IUA, TCRA, is surgical separation of the adhesions to restore the anatomical shape of the uterine cavity. However, despite this intervention, the recurrence rate of IUA remains at 62.5% and the pregnancy success rate after surgery is disappointingly low, ranging from 22.5% to 33.3%. Although various adjuvant therapies have been developed to improve outcomes, their effectiveness has been limited.

According to YPR, Corina is the world's first intrauterine drug delivery system specifically designed to meet the challenges of IUA treatment. Corina is made of non-degradable, medical-grade material and contains the active ingredient estradiol. It is designed to conform to the unique shape of the female uterus. When inserted, it acts as a physical barrier to prevent re-adhesion and allows targeted delivery of estradiol directly to the endometrium.

Using YPR's proprietary controlled release technology, Corina can continuously release estradiol for up to 60 days after the procedure. This sustained release is critical for promoting endometrial growth and reducing the risk of re-adhesion and represents a significant improvement over standard therapies.

The pivotal study for Corina demonstrated statistically significant and clinically meaningful reductions in intrauterine adhesions 60 days after the procedure compared to standard of care. In addition, Corina demonstrated a significant improvement in endometrial thickness from baseline, further highlighting its potential to improve reproductive outcomes in women with IUA.

YPR is a wholly owned subsidiary of Puyi Biotech, a company dedicated to developing innovative, implantable therapeutics for various medical fields, including women's health. Since its establishment in 2012, Puyi Biotech has leveraged its expertise in biomedical materials science and drug delivery technology to address unmet clinical needs. The company has attracted investments from investors such as Goldman Sachs Alternatives, Legend Capital and Northern Light VC.