Tony Hagen is senior managing editor for The Center for Biosimilars®.
Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.
Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment, the company said in a statement.
The bevacizumab product will be codeveloped for the treatment of ophthalmic diseases such as wet age-related macular degeneration (wAMD). Henlius will handle preclinical and clinical development of the agent, and the Essex companies will collectively be responsible for regulatory filings and commercialization of the drug on global markets.
Financial Terms of the Deal
Henlius will receive up-front and regulatory and commercial milestone payments of $43 million and cumulative payments of $30 million for every $1 billion in net sales above the first $600 million.
The agreement, which also covers sublicensing fees, will help distribute the costs and risks associated with developing and marketing the biosimilar, while making use of the Essex companies’ marketing strengths.
Henlius said the market for this ophthalmic agent appears strong in China, as the incidence of wAMD is increasing year by year, especially among middle-aged and older individuals. The number of affected persons in China is about 5 million, and the globally affected population is close to 30 million, Henlius said.
HLX04 works by blocking the proliferation of blood vessels thought to contribute to macular degeneration, a process known as angiogenesis.
“Via specific binding with vascular endothelial growth factor (VEGF), HLX04 can block the interaction between VEGF and its receptors, thus inhibiting angiogenesis,” Henlius said. “Results from preclinical and clinical studies have demonstrated significant efficacy of VEGF inhibitors on ophthalmic diseases caused by fundus angiogenesis. Since bevacizumab has not been approved for the treatment of ophthalmic diseases globally despite of its broad use, HLX04 has the potential to be one of the first bevacizumabs approved for these indications.”
Hoping to secure indications in China for wAMD and diabetic retinopathy, Henlius has submitted an approval application to Chinese regulatory authorities. This was in January 2019. Global trials are planned to support similar regulatory submissions in Australia, the European Union, and the United States, Henlius said.