Hengrui Pharmaceuticals subsidiary gains approval for the first mRNA gene drug phase II clinical trial

Recently, the clinical trial application of RGL-2102, an mRNA gene therapy product independently developed by Shanghai Ruihongdi Pharmaceutical, a subsidiary of Jiangsu Hengrui Pharmaceuticals, has been officially approved by the U.S. Food and Drug Administration (FDA). A Phase II clinical study on the efficacy and safety for ischemic diseases of the lower limbs will be conducted.

This drug uses lipid nanoparticles (LNP) to encapsulate and deliver therapeutic mRNA, which can translate and express specific human proteins after entering the body's cells. It is expected to improve blood flow perfusion in ischemic regions by promoting angiogenesis and collateral circulation in the lower limbs, offering a new treatment option for patients with ischemic diseases of the lower extremities who do not respond to traditional treatments and are unable to undergo revascularization surgery.

Phase I clinical trial results show that RGL-2102 has good safety and tolerability and can significantly alleviate lower limb ischemia in patients.Blood symptoms.The upcoming Phase II clinical trial will further evaluate its efficacy and safety.

It is reported that the product has received the implied permission for clinical trials from China's National Medical Products Administration (NMPA) in April 2024 for the treatment of lower limb ischemic diseases. In December of the same year, the IND for its topical formulation RGL-2102, used to treat chronic wounds such as diabetic foot ulcers and pressure ulcers, also obtained implied permission from the NMPA. By locally administering the drug to the wound and surrounding tissues, it can efficiently deliver the mRNA of human hepatocyte growth factor (hHGF) to target cells, achieving high expression and secretion of HGF protein. This promotes new blood vessel formation, facilitates granulation tissue development, and accelerates the wound healing process.

Hengrui Pharmaceuticals' (600276) subsidiary, Shanghai Ruihongdi Pharmaceutical, was established in August 2021, focusing on the research and development of gene and cell therapy drugs. It is advancing the industrialization and clinical application of innovative therapies, including AAV gene therapy, therapeutic mRNA drugs, and cell-based medicines. The company’s core technology platform integrates a full-chain technical development and production system encompassing plasmids, viruses, mRNA, and cell therapy, providing robust technical support for the R&D and industrialization of CGT innovative drugs. Currently, the company's R&D pipeline primarily concentrates on several major disease areas, including neurology, metabolic diseases, ophthalmology, and oncology.

Source: Cell and Gene Therapeutics Field