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.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.