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(Yicai Global) Feb. 11 -- Shares of Innovent Biologics slumped after the Chinese drugmaker said advisors of the US Food and Drug Administration require a local trial of a new medicine against a common type of lung cancer that Innovent is developing with US pharmaceutical giant Eli Lilly.
Innovent's stock price [HKG: 0181] closed 7.5 percent lower at HKD31.60 (USD4.10). The shares are almost 30 percent down this year.
The Oncologic Drugs Advisory Committee is asking for clinical data which demonstrate that Sintilimab is applicable to the US population and medical practice before regulatory approval, the Suzhou-based company said in a statement today. The PD-1 inhibitor, used to treat nonsquamous non-small cell lung cancer, has exclusively been tested in China.
The news carries a lot of weight. The likeliness of the FDA's final decision to be the same as the ODAC's opinion is 90 percent, a medical industry insider said to Yicai Global.
"While we are disappointed by the ODAC outcome, we together with Lilly will continue to work with FDA as the agency completes its review of our Biologics License Application," said Yongjun Liu, president of Innovent.
Sintilimab is important to the Chinese company. In 2020, sales of the medicine tallied CNY2.3 billion (USD362 million) in China, making up nearly 60 percent of Innovent’s revenue that year, Yicai Global learned. The drug has been sold in the Asian county since December 2018.
Editors: Tang Shihua, Emmi Laine, Xiao Yi