China's Innovent Biologics Inc. plans to release biosimilars of blockbuster drugs Humira, Avastin and Rituxan by 2021.
The Hong Kong-listed company submitted an application with Chinese regulators in January to release IBI-305, a biosimilar of Roche Holding AG's Avastin, or bevacizumab. The non-small cell lung cancer and colorectal cancer therapy is shortlisted for priority review in China, and the company expects to hear back from the regulator on the final decision soon, CEO Michael Yu said at a Hong Kong press event to discuss full-year earnings March 15.
The company filed an application for IBI-303, a copycat of AbbVie Inc.'s Humira, in November 2018. The medicine, also known as adalimumab, is used to treat rheumatoid arthritis, Crohn's disease and other illnesses and is the best-selling drug in the world. Chinese regulators have granted priority review to Innovent's biosimilar, which is a term used to describe a biological medicine that is highly similar to and has no clinically meaningful differences from an existing brand-name drug already on the market.
IBI-301 is a biosimilar of Roche's rituximab, which is sold under the brand of Rituxan in the U.S. and MabThera in Europe. The company plans to file an application for the cancer and autoimmune drug in the fourth quarter.
The three brand-name drugs combined garnered $32.25 billion in sales for AbbVie and Roche in 2018, according to S&P Global Market Intelligence data.
Closer to home
Meanwhile, more trials are underway for immuno-oncology treatment Tyvyt, which Innovent licenses from Eli Lilly and Co. The CEO said the drug, which was approved for release by Chinese regulators in December 2018 to treat classical Hodgkin's lymphoma, is undergoing 20 clinical trials for indications including non-small cell lung cancer and gastric cancer.
Yu said the company is testing Tyvyt as a second- and first-line treatment for non-small cell lung cancer in a phase 3 study, and aims to announce the results of the study for second-line treatment later this year, and first-line in 2020.
Innovent has started selling Tyvyt in China with a sales team of more than 300 people and plans to expand that to about 500 by the end of the year, according to the company's chief commercial officer, Liu Min.
Never say never
The Hong Kong-listed company, which IPOed in October 2018, reported a loss of about 1.48 billion yuan for 2018, compared to a loss of 635.7 million yuan in 2017 due to higher research and development expenses, which roughly doubled to 1.22 billion yuan in 2018, as well as other expenses.
CFO Ronnie Ede said in an interview with S&P Global Market Intelligence that the company believes its spending will increase as more products go into phase 3 trials.
Ede also said the money that Innovent raised in the IPO likely will not be enough to last until it posts a profit, and that the company will look for additional financing.
"At this time we still have a lot of cash, but I will never say never to [a new round of financing]," Ede said.
As of March 14, US$1 was equivalent to about 6.72 Chinese yuan.