Huadong Medicine(000963) announced on June 3 that the marketing authorization application for ranibizumab injection (R&D code HJY28) submitted by the company's wholly-owned subsidiary Hangzhou Sino-US East China Pharmaceutical Co., Ltd. was accepted.

Ranibizumab injection is indicated in adults for the treatment of wet (neovascular) age-related macular degeneration (AMD), the treatment of visual impairment caused by diabetic macular edema (DME), the treatment of diabetic retinopathy (DR) [proliferative diabetic retinopathy (PDR) and moderate to severe non-proliferative diabetic retinopathy (NPDR)], the treatment of visual impairment caused by macular edema secondary to retinal vein occlusion (RVO) (branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)), and the treatment of visual impairment caused by choroidal neovascularization (CNV, i.e. CNV secondary to pathological myopia (PM) and other causes).

Ranibizumab injection is indicated for premature infants for the treatment of retinopathy of prematurity (ROP) in zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) and AP-ROP (rapidly progressive posterior pole ROP).

The announcement shows that Ranibizumab Injection is independently developed by the company and has global rights. In April 2021, the company's application for clinical trials of Ranibizumab Injection for the treatment of wet (neovascular) age-related macular degeneration was approved. In November 2024, the company completed a multicenter, randomized, double-blind, parallel-controlled clinical trial comparing the efficacy, safety, and pharmacokinetic characteristics of HJY28 and Lucentis® in the treatment of Chinese patients with wet age-related macular degeneration. The results showed that in patients with wet age-related macular degeneration, the company's Ranibizumab Injection was equivalent to Lucentis® in terms of efficacy, including the number of letters of BCVA improvement from baseline at weeks 16 and 52 after the first dose in the target eye, as well as the improvement in central retinal lesion thickness, total lesion area, and total area of choroidal neovascular lesions at weeks 16 and 52.

As of now, the company’s total direct investment in the research and development of the ranibizumab injection project is approximately RMB 220 million.

The acceptance of the marketing application for ranibizumab injection is another important progress in the research and development process of this drug. It will not have a significant impact on the company's current performance, but will help further enhance the company's core competitiveness in this therapeutic field in the long run.

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