HONG KONG – Taiwan's JHL Biotech Inc. has received approval to start clinical trials of a biosimilar to Roche AG's Rituxan (rituximab), marking the first European clinical trial approval for a monoclonal antibody biosimilar developed in the Greater China region.
"There are a lot of biosimilar developers [in the Greater China region], but we are the first one to have received approval from Europe via the biosimilar pathway where the biosimilar 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's Chief Financial Officer Max Chan told BioWorld Asia. "The key is to provide state-of-the-art analytical methods to prove the similarity between the biosimilar and the originator drug, otherwise companies will still have to go through the new drug pathway, which takes longer time, more money and has lower probability of success."
Following the approval, the randomized, double-blind, multinational phase I trial will aim to establish the similarity of Zhubei City-based JHL's biosimilar rituximab, JHL1101, with its reference drug, Roche's Mabthera. Mabthera is a monoclonal antibody (MAb) for the treatment of rheumatoid arthritis. It is marketed as Rituxan in the U.S., Canada and Japan and is one of the best-selling drugs in the world with 2014 annual sales at $6.9 billion worldwide.
The clinical studies aim to prove that JHL1101 has the same safety and efficacy levels as well as similar pharmacokinetic and pharmacodynamics to Mabthera. The company will recruit around 150 patients with severe rheumatoid arthritis in locations across Europe. JHL is also aiming to work with local Taiwanese hospitals to enroll more patients to speed up the study. The enrollment will begin sometime this this year.
The next step for JHL1101 is to look for an approval in Mainland China. The company plans to file its clinical trial application to the CFDA in the second half of this year.
JHL is working on four other biosimilars referencing Roche's Avastin (bevacizumab), Herceptin (trastuzumab), Abbvie Inc.'s Humira (adalimumab) and Roche's orphan drug Pulmozyme (dornase alfa) for the treatment of cystic fibrosis.
"Countless international pharmaceutical companies have attempted to develop a rituximab biosimilar. Rituximab has a complex structure, and JHL had to develop a product identical in quality, safety and efficacy to its Roche reference," said JHL's CEO Racho Jordanov.
Unlike biosimilar rituximab, JHL sees no competition in developing biosimilars of the orphan drug.
"Pulmozyme was approved in 1993 and the patent has already expired," said Chan. "No one has launched biosimilar Pulmozyme because it's very difficult to manufacture and the annual sales of the originator is only around $700 million, so there's hardly any competition."
Last October, JHL went public on Taiwan's Emerging Stock Board, which provides an introductory listing pathway for companies before listing on larger Taipei Exchange or the Taiwan Stock Exchange (TWSE). The company was valued at NT$1.9 billion (US$57 million) at the time of the IPO. Before that the company received $46 million series C financing in support of its biosimilar filing in Europe.
"The money will be used for our first two biosimilar products' filing. The construction of our Wuhan facility also needs some money," said JHL's co-founder and general manager in Taiwan, Rose Lin. "And the extra money will be used to recruit some management; we will also continue to expand in Taiwan." (See BioWorld Today, May. 13, 2015.)
The stock price of JHL has seen steady growth over the four month of listing.
"We're listed in the Emerging Market of Taiwan. A lot of biotech stocks have dropped in past January," said Chan. "But we have been holding up strongly at the end of last month and steadily moving up in the last couple of weeks compared with our peers."
On Feb. 17, JHL's stock price closed at NT$124.5.
JHL is planning the grand opening of JHL Wuhan, which is built to coordinate with China filing issues. The facility has a modular Kubio biologics plant that is designed for scalable and cost-efficient production of MAbs and what the company claims is the world's largest single-use bioreactors.