Yipurun (Shanghai) Biotechnology’s Corina Intrauterine Drug-Eluting System, a drug-device-combination therapy, has received approval in China for treating moderate-to-severe intrauterine adhesions (IUA).
The system is designed for treating patients with IUA who undergo transcervical resection of adhesions (TCRA) and offers a new therapeutic option in the field of female reproductive health.
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This approval follows a randomised controlled clinical trial that demonstrated Corina’s efficacy in comparison to the standard-of-care.
IUA, which result from damage to the uterus’s endometrial basal layer, can lead to severe reproductive health issues, including infertility and recurrent miscarriage.
With an incidence rate of up to 25% in Chinese women who have undergone certain uterine procedures, the condition represents a significant health concern.
Despite the high incidence of intrauterine adhesions and the common use of transcervical resection of adhesions as a treatment, the recurrence rate remains alarmingly high, the company said.
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By GlobalDataThe approval for Corina introduces an approach to reducing this rate and improving pregnancy outcomes post-surgery.
Corina combines a non-degradable medical-grade material with estradiol, leveraging Yipurun’s proprietary technology to release the drug over a 60-day period.
This promotes endometrial growth and acts as a physical barrier to prevent re-adhesion.
The clinical trial results for Corina have shown a statistically significant reduction in intrauterine adhesion and an improvement in endometrial thickness at 60 days post-procedure, marking a significant advance in the treatment of this condition.
Yipurun is a wholly-owned subsidiary of Puyi (Shanghai) Biotechnology (Puyi Biotech).
Puyi Biotech and YPR have developed an R&D pipeline of high-end implantable therapeutics leveraging knowhow in biomedical material science and proprietary drug-eluting technology.
