Gene therapy product in Anhui approved for clinical tests

Biotech group Heifei Xingmou Biotechnology Co Ltd, based in the Hefei National High-Tech Industry Development Zone – in Hefei, capital of East China's Anhui province – recently obtained approval from China's National Medical Products Administration for its innovative gene therapy drug, the XMVA09 injection, to undergo clinical tests.

It marks the first gene therapy product made in Anhui and is one of the rare gene therapy products that were developed by using new AAV shells in China.

The drug is intended for the treatment of wet age-related macular degeneration.

XMVA09 is the company's first gene therapy drug and it has already undergone clinical studies at the First Affiliated Hospital of the University of Science and Technology of China in Hefei.

The study showed significant clinical benefits without any drug-related adverse events or serious adverse events.

The safety of XMVA09 is being attributed to its low immunogenicity, due to the dual-antibody design and the use of a new shell for vitreous injections.

Recognizing the difficulties and safety concerns associated with subretinal injections, the company focused on developing a shell for intravitreal injections that could effectively deliver the drug to the area around neovascular lesions while ensuring safety.

Xingmou Biotechnology is a high-tech enterprise focused on the development of gene therapy products for ophthalmic diseases using cutting-edge gene editing technologies.