Wet Age-Related Macular Degeneration Drug Market Risk Analysis Brief - Anti-VEGF Drugs.

Old age macular degeneration, also known as age-related macular degeneration (AMD), is a change in the aging of the structure of the macular region, the formation of glass warts or veins on the macular retina, which can eventually lead to irreversible visual loss.
AMD is divided into wet AMD (wAMD) and dry AMD, wetness is about 10%-15%, resulting in 80%-90% of blinding cases, dry AMD may also be converted to wet AMD.
currently no effective therapeutic drug for dry AMD, wAMD is dominated by anti-vascular endothormic growth factor (VEGF) drugs, rejuminant, abersip and compassip (Figure 1).
Chart 1. Currently approved the main wAMD drug name time-to-market adaptive manufacturer Lei Zhu single anti-2006 (FDA) wAMD, macular edema, retinal vein occistic diabetic macular edema, vascular newborn blood vessels caused by vision impairment Novarian Abersip 2011 (FDA) wAMD, diabetic macular edema German Bayer Compassip 2013 (NMPA pulse) wAMD, Vision impairment caused by membrane new blood vessels, diabetic macular edema Kanghong Pharmaceutical Data Source: State Drug Administration SGRCR finishing AMD incidence is mainly age-related and more than 45 years of age, according to the China Health Statistics Yearbook 201 In 2018, China's population aged 65 and over reached 167 million, accounting for 11.9% of the total population, and the prevalence of AMD and the number of patients will continue to increase as China's aging degree continues to increase.
Abersip entered the Chinese market late and was approved for listing on February 13, 2018, and the market is still dominated by Leizhu monoantigen and Compaqsip, with a strong market share, with sales growth increasing after the two drugs entered the National Health Insurance Directory in 2017.
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2019 Compaq's full-year sales revenue was RMB1,155 million, an increase of 30.98 percent over 2018, with a gross margin of 94.99 percent.
1. Insufficient ophthalmology medical resources are currently able to independently carry out anti-VEGF drug injection ophthalmology department mainly concentrated in the capital cities such as North Shanghai, large-scale integrated three-level hospitals, other hospitals are gradually being promoted, the current anti-VEGF drugs can not be extended to primary hospitals, which is also the main reason for the current low penetration rate of such drugs.
2. Biosimilar drug competition is fierce wAMD biosimilar drug entry enterprises more, although at present only Kanghong Pharmaceuticals Compaqsip listed, but the layout of this kind of drug enterprises, such as Xinda Biological, Sansheng Guojian, Qilu Pharmaceuticals, Baiotai Bio, Rongchang Bio, such as more than ten (Figure 2), which has no shortage of sales promotion capacity of the advantages of enterprises, the existing market pattern will have a great impact.
Chart 2. At present, China wAMD in the research drug profile drug code-named clinical stage production enterprises IBI302 clinical I phase I Xinda biorecomcomment anti-VEGF humanized monoclonal antibody clinical phase I and IIa phase sansheng Guojian QL1205 clinical phase I Qilu pharmaceutical BAT5906 Clinical Phase I Bio-Otai BioRC28-E Clinical Phase I Rongchang Biodoty Source: National Drug Administration Review Center SGRCR finishing 3. The pressure of centralized procurement of national drugs increases Although there are only three drugs in wAMD now, but with the deepening of centralized procurement of national drugs, the downswing pressure on product prices will gradually increase.
Compaqsip's 2019 health care negotiations, the price of 4160 yuan (0.2 ml / branch), while the current price of imported Leizhu single resistance is 3950 yuan (0.2 ml / branch), it can be seen that imported drugs in order to consolidate the market, the initiative in the national drug centralized procurement of price reduction will be greatly increased.
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