Making news once again is the fast-growing Shanghai–based Henlius Biotech, with its recent announcement of a co-development and exclusive license agreement for commercialization of its phase-III bevacizumab biosimilar (HLX04) with Essex Bio-Tech Limited. As part of the agreement, the partners will co-develop the biosimilar for wet age-related macular degeneration (W-AMD) and Essex will be granted an exclusive license for developing, manufacturing and commercializing HLX04 in the field of ophthalmic diseases globally.
Henlius will mainly be responsible for the pre-clinical and clinical development of HLX04 and Essex will be responsible for regulatory filings and commercialization of HLX04 globally. Henlius is entitled to receive up to USD 43 million in upfront payment and regulatory and commercial milestone payments and USD 30 million for every USD 1 billion cumulative net sales of the product above the first USD 600 million. Additionally, it will also receive an annual royalty of 10% on product net sales. Sub-licensing rights have been granted to Essex and Henlius is also entitled to receive 20% of the related sublicensing revenue.
Bevacizumab has originally been approved for first-line treatment of several forms of cancer and has shown to be efficacious in off-label treatment for several conditions of the eye, including AMD, due to its anti-VEGF action that reduces the microvascular growth of blood vessels. With the rise in incidence of ophthalmic diseases, Henlius is developing the biosimilar for wAMD and Diabetic Retinopathy. In January 2019, the Chinese National Medical Products Administration (NMPA) approved the investigational new drug application for ophthalmic indications of HLX04. Essex and Henlius plan to conduct multi-centre global clinical trials in China, Australia, the European Union and the United States and apply for marketing authorization in different countries. Currently, no bevacizumab biosimilar is approved for use in ophthalmic indications, potentially making HLX04, one of the first to be approved for these indications.
HLX04 is also undergoing phase-III trial in metastatic colorectal cancer and Henlius recently announced that it successfully met primary and secondary endpoints and has submitted a New Drug Application to NMPA. Henlius recently became the first China-based biosimilar manufacturer to launch trastuzumab biosimilar in the European market through its partnership with Accord and is also pursuing to take it to other regulated markets such as the USA. It has been leading the league of emerging market companies that are establishing their foothold in the global biosimilars arena.
Essex Bio-Tech is one of the leading companies in China serving the Opthalmology and Dermatology therapeutic market. Last year it made its foray in the regulated market with the initiation of its first global clinical program in the USA for VISTA-1 targeting dry eye disease. With the recent partnership, it gets to leverage Henlius’ R&D capabilities and its in-house expertise in the commercialization of ophthalmic drugs in the global market.