Hsinchu-based Taiwan firm JHL Biotech won a nod for clinical trials of a biosimilar of Roche's MabThera (rituximab) to treat rheumatoid arthritis from the U.K.'s Medicines and Healthcare Products Regulatory Agency, marking what it says is a milestone for a monoclonal antibody biosimilar candidate from Greater China.
The trial for candidate JHL1101, the company said in a press release, was developed and manufactured at a Taiwan-based subsidiary and would be a first for the geographic area that includes Mainland China, Hong Kong, Taiwan and Macau. JHL also has offices in Mainland China.
|JHL Biotech CEO Racho Jordanov|
But other companies in Asia such as South Korea's Celltrion and India's Dr. Reddy's are well on the way. In the case of Celltrion, it has applied for biosimilar to the European Medicines Agency for the cancer indication of rituximab (Rituxan). Dr. Reddy's Laboratories already sells a biosimilar version in India.
In the Phase I trial slated to begin this year, JHL plans to recruit approximately 150 patients with severe rheumatoid arthritis for a randomized, double-blind trial at locations in Europe, the company said, adding the effort uses as "its reference product, Roche's ($RHBBY) MabThera."
"As a biosimilar with the same delivery mechanism and dosing as MabThera, JHL1101 is exempt from Phase II trial requirements and is eligible to undergo Phase III trial when the Phase I trial is concluded and similarity with the reference product is further validated," JHL said in the release.
In October, JHL listed an unspecified number of shares on the Taiwan Emerging Stock Board that were then valued around NTD$1.89 billion ($57.6 million). The emerging board on the Taipei Exchange is aimed at getting exposure through price discovery for companies that may eventually want to list on the main board.
In May, JHL Biotech said it had successfully completed the GMP manufacture and lot release of its first 500-liter scale batch from its Taiwan facility for a privately held Chinese biotech company of an unspecified oncology monoclonal antibody product for use in Phase I clinical trials in Australia.
And in the same month, the company announced it had closed on a Series C fundraising of $45.6 million under existing investor Milestone Capital and with new investors Sungent BioVenture and Liwick Investment Management.
- here's the release