Ophthalmic Tetravalent Bispecific Antibody Product Being Granted an Approval for Drug Clinical Trial

Company News

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the tetravalent bispecific anti-VEGFA (vascular endothelial growth factor A) / ANG2 (angiopoietin 2) antibody for intravitreal injection (the “Tetravalent Bispecific Antibody Product”) has been granted an approval for drug clinical trials issued on 27 April 2023 by National Medical Products Administration of the People’s Republic of China (“China”) (NMPA) and agreed to conduct the clinical trials in neovascular age-related macular degeneration (nAMD). 

The Tetravalent Bispecific Antibody Product is a Class 1 Innovative Biological Product with a unique nano-antibody design bearing specific targeting VEGFA and ANG2, which can effectively inhibit abnormal neovascularization through two different pathways, for treatment of the ocular fundus neovascular diseases. The Tetravalent Bispecific Antibody Product enjoys the differentiation advantages of high affinity, strong inhibitory activity, high preparation concentration, good stability and low dosing frequency. It will provide a safer and more effective treatment option for patients with ocular fundus neovascularization, possessing important clinical implications.

Ocular fundus neovascular disease, such as nAMD, diabetic macular edema (DME), etc., is one of the main causes of blindness in the elderly. Intravitreal injection of anti-VEGF (vascular endothelial growth factor) drugs is the standard treatment for ocular fundus neovascular disease. The Tetravalent Bispecific Antibody Product has a vast market space in China. It is estimated that there are approximately 4 million nAMD patients and 5 million DME patients in Mainland China. According to IQVIA, the market size of mainstream anti-VEGF drugs in Mainland China was approximately RMB3.2 billion in 2022.

The Group obtained all the assets related to the Tetravalent Bispecific Antibody Product in the world from Wuhan YZY Biopharma Co., Ltd. on 26 July 2022. The Group is currently actively preparing for initiating the relevant clinical trials.

The announcement is made on a voluntary basis. Shareholders and investors are advised to exercise caution in dealing in the shares and other securities of the Company.