Collaboration with Sponsor 丨Clinical Trial of Fudan Zhangjiang Obeticholic Acid Tablets for Primary Biliary Cholangitis Treatment Completes First Subject Enrollment

On December 13, 2021, Shanghai Fudan Zhangjiang Biomedical Co., Ltd (hereinafter referred to as "Fudan Zhangjiang") announced that the clinical trial of Obeticholic Acid Tablets (size: 5mg, 10mg) (hereinafter referred to as "the drug") developed by the company's subsidiary Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd for treatment of primary biliary cholangitis (PBC) has successfully completed the first patient enrollment in the clinical trial.

The drug is a Farnesoid X receptor (FXR) agonist, a nuclear receptor expressed at high levels in the liver and intestine that plays a key role in the regulation of bile acid metabolism. The drug is a class 3 generic chemical drug with primary biliary cholangitis as its first target indication. This clinical study is a multicenter, randomized, double-blind, double-model, placebo-controlled bridging clinical trial evaluating the efficacy and safety of obeticholic acid tablets in the treatment of primary biliary cholangitis.

As a CRO partner for this project, Panacro facilitates the full lifecycle management of the project and is involved in CRO services such as medical R&D strategy development, medical surveillance, project operation management, data management and statistics, and pharmacovigilance. In spite of the difficulty of the project and the small number of people eligible for program enrollment, the project team of Panacro actively responds to the pressure and adhered to the core value of "customer-centric & striver first" to propose practical solutions for the sponsors. At the same time, the project team maintains close communication with the study center, closely follows up with patients and conducts careful screening to ensure the patient pool. The Panacro project team were highly recognized by the sponsor by virtue of the rigorous working attitude and strong execution abilities.

"This project is a breakthrough made by Fudan Zhangjiang in the patent restriction of the original drug, and the Panacro team is honored to contribute to its clinical trial. In the next project process, Panacro team will rise to the challenge and make leap progress through daily accumulations. We look forward to the early NDA submission of this drug to the market for the benefit of more people suffering from hepatobiliary diseases. Panacro will also continue to uphold its customer-centric philosophy and facilitate new local drugs at full speed to serve the patients as soon as possible.