Prestige BioPharma, a Singapore-based company, listed on the Kospi market, said it failed to get marketing approval for its Herceptin biosimilar product in Europe. The company’s stock price tanked immediately after the announcement.

In a public disclosure on Friday, Prestige BioPharma said it received a negative opinion on the marketing authorization for HD201 (brand name: Tuznue), a Herceptin biosimilar from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Thursday.

The company did not elaborate on why the CHMP recommended the refusal of the permit.

“As soon as we confirm details, we will correct or supplement the announcement,” it said.

In April 2019, Prestige BioPharma applied to the EMA for the license for HD201 to treat breast cancer and metastatic gastric cancer.

The biotech firm said it would challenge to obtain the permit for HD201 in Europe again.

“The company plans to apply for a re-examination of HD201 to the EMA,” Prestige BioPharma said. “We are waiting for the results from applications submitted to Korea’s Ministry of Food and Drug Safety and Health Canada. We will file the results as soon as we get them.”

The company went on to say that it also planned to apply to the U.S. FDA for HD201 approval.

However, the Korean stock market reacted widely to the news of the CHMP’s negative opinion on Prestige BioPharma’s Herceptin biosimilar