PharmaResearch wins CE MDR certification for Rejuran products, plans clinical trial for knee injection

PharmaResearch, a Korean biopharmaceutical company specializing in regenerative medicine, said Thursday that it has obtained CE MDR certification under the European Union’s enhanced Medical Device Regulation (MDR) for three of its products: Rejuran, Rejuran i (eye), and Rejuran s (scar).

Rejuran is designed to temporarily improve facial wrinkles, while Rejuran s targets scar reduction and skin elasticity, and Rejuran i focuses on enhancing the eye area by treating dark circles and fine lines.

All three products are made using PharmaResearch's proprietary DNA Optimizing Technology (DOT) and contain polynucleotide sodium (NP), a regenerative substance derived from salmon DNA that promotes collagen and elastin production.

The MDR, implemented in 2021, replaced the earlier Medical Device Directive (MDD) and introduced stricter quality, safety, and performance standards for medical devices in the European Union. CE MDR certification is a critical requirement for entering the European market and is widely recognized as a key global accreditation.

“With this CE MDR certification, we have significantly enhanced the competitiveness of Rejuran in the international aesthetics market,” a PharmaResearch official said. “We will focus on expanding into Europe and other global markets, including the U.S. as a longer-term goal, alongside ongoing efforts in Asia and the Middle East.”

In addition to the CE MDR certification, PharmaResearch plans to initiate a confirmatory clinical trial for its next-generation NP knee joint injection, NPNP-001, in January 2025.

The trial will involve 260 patients with knee osteoarthritis across seven hospitals in Korea, including Seoul St. Mary’s Hospital. The study aims to evaluate the treatment’s effectiveness in reducing knee pain and its overall safety.

NPNP-001, developed as a next-generation product of Conjuran, is an intra-articular injection utilizing NP. It is designed to reduce friction by protecting damaged cartilage, thereby alleviating pain in arthritis patients.

“NPNP-001 has viscosity and elasticity most similar to human synovial fluid, enabling long-term pain relief from repetitive joint stress,” a company official said. “It offers a promising new solution for patients suffering from knee pain.”