News Roundup: Bio-Thera, Henlius Advance Biologics Development

April 13, 2021
Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

Shanghai Henlius Biotech says the market for a checkpoint inhibitor in China is wide open, and Biogen and Bio-Thera stake out a global map for their tocilizumab biosimilar.

Biogen and Bio-Thera Solutions said they will work together to commercialize the tocilizumab biosimilar candidate BAT1806, which is in phase 3 clinical trials for the treatment of moderate to severe rheumatoid arthritis in adults and juveniles, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. The proposed product references Actemra, which had 2020 global sales of $3 billion, according to Biogen and Bio-Thera.

Bio-Thera, based in Guangzhou, China, is leading the development of the biosimilar candidate, and Biogen, based in Cambridge, Massachusetts, will help market BAT1806 in all countries outside China. Terms call for an upfront payment of $30 million from Biogen contingent upon satisfactory results from the phase 3 clinical trial. Biogen will also owe commercial milestone payments and royalties, based on market penetration.

“We are excited about this new transaction with Bio-Thera Solutions, a leading commercial-stage biopharmaceutical company in China, and how BAT1806 will augment our expanding portfolio of biosimilars assets,” said Chirfi Guindo, head of Global Product Strategy and Commercialization at Biogen.

Shanghai Henlius Biotech

Shanghai Henlius Biotech is a relatively young company with 3 biosimilars on the market in various countries, mainly China, but it is also developing products ranging from bio-betters, which represent improvements on originator drugs, to completely novel drugs, as well as combination therapies that may involve biosimilars and originators used together.

The company recently announced plans to file a new drug application (NDA) for a checkpoint inhibitor to the National Drug Products Administration (NMPA) in China: HLX10, which the company is not billing as a biosimilar, although the drug candidate has been compared to pembrolizumab and nivolumab, for the treatment of microsatellite instability–high and mismatch repair-deficient (MSI-H/dMMR) solid tumors.

HLX10 is a programmed death (PD) inhibitor that works by interfering with the tumor cell ability to “switch off” the immune system response. The expected filing is based on successful phase 2 clinical trial results with HLX10, which Henlius intends to present at upcoming medical conferences.

Patients with MSI-H tumors tend to respond better to immune checkpoint inhibitors, and the prevalence of MSI-H across all tumor types is 14%, according to Henlius. PD-1 inhibitors for MSI-H/dMMR are approved and in use in the United States but have yet to be introduced in China, so “treatment needs are far from being met,” Henlius said. The company has obtained clinical trial approvals for HLX10 in China, the United States, the European Union, and other countries and regions.

Henlius intends to evaluate the drug candidate's safety and efficacy in 10 planned immune-oncology therapies clinical trials across a range of MSI-H solid tumor types, including lung, hepatocellular, esophageal, head and neck, and gastric cancers. The company also intends an additional NDA filing with the NMPA later this year for HLX10 in combination with chemotherapy for first-line treatment of squamous non–small cell lung cancer.

For related reading on Henlius, click here.

For additional news from Bio-Thera, click here.