PD-1 (pucotenlimab) is a novel humanized monoclonal antibody differentially designed to target PD-1, belonging to human IgG4/Kappa subtype, with the introduction of S254T/V308P/N434A mutation in the Fc of IgG4 to extend the half-life. Its gains an advantage due to its design strategy of extended half-life and introduction of mutations in the Fc region using innovative differential antibody engineering technology, which is expected to reduce the number of doses, lower the cost of treatment, and further improve patient compliance with the drug.

Panacro has partnered with Lepu Biopharma since 2019, provide whole-process services for the PD-1 pucotenlimab Phase II clinical study. 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 formulation, operation management, data statistics, pharmacovigilance and preparation of NDA filings.

During the project process, Panacro’s project team adhered to the core values of "customer-centric & striver first", and united as one from top to bottom to overcome all challenges during project execution to ensure that the project was completed as scheduled. The Panacro project team were highly recognized by the sponsor by virtue of its scientific and rigorous attitude, project support expertise and operational efficiency and quality in the project implementation process.

“NDA of PD-1 pucotenlimab by Lepu Biopharma was accepted by the CDE, and congratulations!Panacro is honored and proud to be involved in NDA of Lepu Biopharma’s first innovative drug.We wish the drug will be available soon and bring benefits to the patients with second-line and above melanoma.At the same time, Panacro will continue to work hard and practice its customer-centric philosophy to improve and accelerate the clinical projects for the sponsors,” said Mr. Zhao Min, Founder & CEO of Panacro.