HONG KONG – The China Food and Drug Administration (CFDA) has approved the first novel monoclonal antibody (MAb) in China with global intellectual property rights. Compaq Sipp ophthalmic injection (conbercept), a VEGF receptor antagonist, for wet age-related macular degeneration (AMD), joins similar biologics – such as Avastin (bevacizumab) and Lucentis (ranibizumab) with blockbuster sales potential.

“Conbercept represents the very first novel MAb that has global intellectual property rights,” said Michael Yu, the inventor and developer of the drug and now president and CEO at Innovent Biologics Inc., of Suzhou, China.

Yu developed the drug between 2005 and 2010 while working at Chengdu Kanghong Pharmaceuticals Group Co., which now manufactures Conbercept. He left the company in 2010 and launched his own start-ups Innovent Biologics and Allbright Biotech PTE Ltd., of Singapore.

The CFDA has categorized Conbercept as a Class I therapeutic biological product.

AMD is a common eye disease among people aged 45 and above. It causes damage to the macula and leads to irreversible loss of vision. There are two types of AMD, dry (atrophic) and wet (exudative). Conbercept targets wet AMD. As the Chinese population ages, wet AMD is becoming a common eye disease.

“We did a survey a few years ago, and it showed there are 10 million to 30 million potential patients in China who may benefit from this drug,” Yu told BioWorld Asia.

There are three stages of AMD, early, intermediate and advanced. Conbercept ophthalmic injection is used to treat advanced AMD. Conbercept inhibits the vascular endothelial growth factor to stop the choroidal neovascularization which is one of the major pathological features of AMD. Studies have shown that Caucasians have a higher risk of AMD than other races.

Similar drugs like Avastin (bevacizumab) and Lucentis (ranibizumab) have had impressive sales in the global market for the past few years.

Avastin is an angiogenesis inhibitor developed by Genentech Inc., of South San Francisco, (a subsidiary of Roche) that slows the growth of new blood vessels. It is used to treat AMD and various cancers such as colorectal, lung and breast cancer.

Lucentis, also developed by Genentech, is a monoclonal antibody fragment for the treatment of diabetic macular edema (DME).

Roche said global Lucentis sales were $4 billion in 2012 and Avastin earned $5.98 billion.

Another AMD drug comes from Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Eylea (aflibercept), was approved in November 2011 for AMD and has become the company’s best seller. Regeneron raised its 2013 sales estimate for Eylea to between $1.30 billion and $1.35 billion from its earlier estimate of $1.25 billion to $1.33 billion. It has been taking market share from Lucentis over time.

Earlier this year, Piper Jaffray analyst Edward Tenthoff predicted U.S. Eylea sales will hit $1.89 billion in 2014, accompanied by growing sales of the product in Europe, where sales are split with Bayer AG.

KANGHONG AIMS FOR IPO

China’s Kanghong has been planning an initial public offering since 2010, plans that could be spurred along by the recent approval of Conbercept. Regulators in China had a long-standing freeze on new issues that was lifted earlier this year, so the company’s offering is now pending.

Conbercept is expected to be the biggest contributor to Kanghong’s revenue. Attracted by the huge market abroad, the company is considering out-licensing the drug.

This first novel MAb in China also is generating interest among multinational companies.

Based in Chengdu, Kanghong develops, manufactures and markets traditional Chinese medicines, as well as a wide pipeline of small molecules and biological drugs. It has nine subsidiaries such as Sichuan Jishengtang Pharmaceutical Co. Ltd., Chengdu Hongda Pharmaceuticals and Chengdu Kanghong Biological Science & Technology Co.