China Approves Corina IUD for Treating Moderate-to-Severe Intrauterine Adhesions

Corina Intrauterine Drug-Eluting System (Corina), developed by Yipurun (Shanghai) Biotechnology Co., Ltd. (YPR), has received approval in China for treating moderate-to-severe intrauterine adhesions (IUA) in patients undergoing transcervical resection of adhesions (TCRA). This approval is founded on a randomized controlled clinical trial which showed Corina's superior efficacy over the current standard treatments. Corina aims to promote female reproductive health by preventing the risk of intrauterine re-adhesion after TCRA and enhancing endometrial growth.

Intrauterine adhesions (IUA) occur when scar tissues form in the endometrial cavity due to damage to the endometrial basal layer. This leads to partial or complete blockage of the cervical canal and uterine cavity, causing symptoms such as reduced menstrual flow, amenorrhea, infertility, and recurrent miscarriage. These adhesions pose a significant threat to the reproductive health of women of childbearing age.

The incidence rate of IUA in China is high and continues to rise, primarily due to an increasing number of intrauterine interventions. Research indicates that up to 25% of women who have undergone prior abortions or curettage procedures develop IUA. This high incidence rate is a major cause of reduced menstrual flow and secondary infertility among women of childbearing age.

Transcervical resection of adhesions (TCRA) is the standard surgical procedure to treat IUA. It separates the adherent tissues and restores the anatomical structure of the uterine cavity. Despite its widespread use, surveys indicate that TCRA has a high recurrence rate of 62.5% and a relatively low pregnancy success rate of 22.5% to 33.3%. Over the years, various adjuvant therapies like uterine cavity isolation barriers and hormonal treatments have been developed, but their efficacy remains limited.

Corina is an innovative therapy combining a drug and a device, made from non-degradable, medical-grade material and containing the active ingredient estradiol. It is designed to fit the shape of the uterus, acting as a physical barrier upon insertion. It also enables targeted delivery of estradiol to the endometrium. With YPR's proprietary controlled-release technology, Corina can continuously release estradiol for up to 60 days post-procedure, promoting endometrial growth.

Clinical trial results for Corina have demonstrated a statistically significant and clinically meaningful reduction in intrauterine adhesions at 60 days post-procedure compared to standard-of-care treatments. Additionally, Corina has shown a meaningful improvement in endometrial thickness from baseline at 60 days post-procedure.

Yipurun (Shanghai) Biotechnology Co., Ltd. (YPR) is a wholly-owned subsidiary of Puyi (Shanghai) Biotechnology Co., Ltd. (Puyi Biotech). Located in the Zhangjiang Hi-Tech Park in Shanghai, Puyi Biotech focuses on developing innovative solutions to address unmet clinical needs in women's health, ENT (ear, nose, and throat), and medical aesthetics. Since its founding in 2012, the company has been leveraging its expertise in biomedical material science and proprietary drug-eluting technology to develop a high-end R&D pipeline of implantable therapeutics. The Group has notable investors including Goldman Sachs Alternatives, Legend Capital, and Northern Light VC.