Zhitong Financial APP learned that on the evening of May 10, Dongyao Pharmaceutical-B (01875) released its results for the first quarter of 2021. Data show that during the three-month period ended March 31, 2021, Dongyao Pharmaceutical's revenue was 14.584 million yuan, an increase of 99.8% over the same period last year. Behind this performance, in addition to CDMO, it is also related to the milestone grant income of Monoclonal Antibody TAB014 granted to Mega Ophthalmology (06622).
According to the Mega Ophthalmology prospectus, Mega Ophthalmology has established an ophthalmic drug product line for 25 drug candidates, including 13 innovative drugs and 12 generic drugs, covering most major ophthalmic indications affecting the anterior and posterior segments of the eye.
In terms of innovative drug research and development pipeline, Mega Ophthalmology mainly aims at 5 ophthalmic indications, including dry eye disease, wet age-related macular degeneration, diabetic macular edema, myopia and glaucoma. In addition to the popular anti-inflammatory cyclosporine eye gel, there are also anti-VEGF drugs, TAB014, which are popular in the market for the treatment of wet age-related maculopathy.
Zhitong Financial APP learned that Mega Ophthalmology's innovative drug TAB014 is China's first bevacizumab antibody used in the clinical stage for the treatment of wet age-related macular lesions. Although Avastin (bevacizumab) is currently only approved for tumor treatment, more and more Avastin is used outside the label to treat wet age-related maculopathy. Mega Ophthalmology expects to launch phase III clinical trials of TAB014 in the second quarter of 2021, which will be completed by 2023, and submit TAB014's new drug application to the State Drug Administration by 2024.
According to the materials, the drug was introduced from Dongyao Pharmaceutical Co., Ltd., Zhaoke Ophthalmology. Zhaoke Ophthalmology will be responsible for the commercialization and distribution of TAB014 in China. Dongyao is entitled to an one-time upfront payment from Mega Ophthalmology and a number of additional milestone payments related to TAB014's research and development progress and commercial sales, while Dongyao is also entitled to 30 per cent of TAB014's net sales in China.
Wet senile macular lesion is the main cause of severe visual loss and blindness in people over 50 years old in China and around the world. In China, the number of patients with wet age-related macular lesions increased from 3.4 million in 2015 to 3.9 million in 2019. Driven by the accelerated aging of the population, the number of patients with wet age-related macular disease is expected to further increase to 5.2 million by 2030. In addition, the diagnosis rate of wet age-related macular lesions is expected to increase from 2.6% in 2019 to 19.4% in 2030.
The size of China's wet age-related macular disease drug market has increased from US $91.4 million in 2015 to US $241.5 million in 2019, with a compound annual growth rate of 27.5%. It is expected to grow from 27.5% in 2019 to US $3.497 billion in 2030, becoming another track with a market size of more than 10 billion yuan.
At present, three anti-VEGF drugs for wet age-related macular diseases have been approved in China, namely, Lucentis (Lannizumab), Lumitin (Compaximab) and Eylea ((IVT), all of which are injected into the vitreous cavity. Together, the three drugs generated sales of about $395 million in China in 2019.
In addition, in China, doctors have prescribed Avastin for wet age-related macular disease, but sales are less than 5% of all wet age-related macular disease drugs in the past. The list of essential drugs of the World Health Organization also lists bevacizumab as an eye disease treatment. in the future, this drug will enter the market with high demand, so the market sales layout is particularly important.
According to the prospectus of Mega Ophthalmology, 300015.SZ is the cornerstone investor of Mega Ophthalmology, and Eye Ophthalmology has an absolute market share in domestic private ophthalmology, that is, in terms of sales channels, Mega Ophthalmology wins over its competitors. Therefore, although TAB014 was approved to be listed relatively late, the cooperation between Dongyao Pharmaceutical and Mega Ophthalmology is also indirectly close to the thighs of Ayre Ophthalmology, and its products can be released quickly after it is listed, so that Dongyao Pharmaceutical, Zhaoke Ophthalmology and Ayre Ophthalmology can achieve a win-win situation.