Good news! Yidu Zhengkang assisted Jiangsu Yahong in obtaining the Phase III International Multi-center Clinical Trial Approval Letter for APL-1702 Project
Recently, Yahong Medical Technology Co., Ltd. ("Yahong Pharmaceutical") announced that its international multicenter phase III clinical study of APL-1702 (Cevira ®), a photodynamic drug-device combination product for non-surgical treatment of cervical precancerous lesions, has been approved and issued by China Food and Drug Administration (hereinafter referred to as"CFDA"). In addition to China, Yaron Pharmaceutical has simultaneously initiated this international registration clinical trial in the United States and European countries such as Germany, Romania, Hungary, Russia, and Ukraine, and the results will be used to support registration applications in China, the United States, the European Union, and other countries. Yahong Pharmaceutical is a global innovative drug development company focused on urogenital anti-tumor and related diseases. Dr. Chengfeng Zhuang, chief operating officer and project leader of APL-1702, said. There is currently a high treatment need for women of childbearing age for therapies that can preserve cervical function. APL-1702 is expected to be the world's first non-surgical broad-spectrum treatment for cervical precancerous lesions, filling the important and unmet medical needs and bringing good news to the majority of female patients. "
About APL-1702 (Cevira ®)
About also the degree of health
APL-1702 (Cevira ®) is a photodynamic drug device combination product that combines a photosensitizer with light activation at a specific wavelength to produce a therapeutic effect based on photodynamic principles. The goal is to treat patients 18 years of age and older with histopathologically confirmed high-grade squamous intraepithelial lesion (HSIL) of the cervix, including all HPV subtypes. APL-1702 is easily placed on the cervix by the gynecologist and can be removed by the patient after the treatment without affecting the patient's daily activities during the treatment. Typically, patients only need to receive one to two doses of APL-1702. APL-1702 breakthrough product will provide a new treatment option for Chinese and global patients, so that some patients are free from the pain and side effects of surgical treatment, especially avoiding the impact of surgery on future reproductive function. APL-1702 (Cevira ®) was also awarded the internationally renowned Fierce Life Sciences Innovation Award 2019 Best Medical Device Innovation Award. To date, no non-surgical treatment products have been approved worldwide in the treatment of cervical precancerous lesions.
Established in 2010, Beijing Yidu Zhengkang Health Technology Co., Ltd is committed to providing customers with CRO services throughout the life cycle from project evaluation, research and development, registration management, clinical trials to post-marketing studies. It has provided 350 + new drug clinical trials, registration and other related services for 160 + customers at home and abroad. In particular, the operation proportion of innovative drug projects ranks among the top in the CRO industry. Yidu Zhengkang has also participated in the registration clinical trials of multiple imported originators in China and has undergone strict quality audit and audit by originators and NMPA. At the same time, Yidu Zhengkang also has rich experience in BE research of generic drugs. More than 50 BE trials have been successfully carried out between 2017 and 2019, helping many large state-owned enterprises and listed companies to pass the consistency evaluation of their products. After many years of accumulation, Yiduzhengkang has established and improved an integrated service platform for project operation management, clinical study, drug registration, biological sample analysis, data management and statistics, aiming to help pharmaceutical companies shorten R & D time, provide value-added technical services and bring products to the market as soon as possible.
