[Featured Stock] Hanmi Pharm Drops 13% on Concerns Over US FDA Approval of New Anticancer Drug

[Asia Economy Reporter Kwon Jae-hee] Hanmi Pharmaceutical's stock price is showing a sharp decline of over 10% in early trading. This is attributed to the plunge in Spectrum's stock price, which acquired the rights to Poziotinib technology from Hanmi Pharmaceutical.

As of 9:43 AM on the 21st, Hanmi Pharmaceutical is trading at 242,500 KRW on the KOSPI, down 13.39% from the previous trading day.

According to major foreign media on the 20th (local time), the U.S. Food and Drug Administration (FDA) raised concerns that Poziotinib is less effective than existing treatments. Poziotinib is a non-small cell lung cancer treatment targeting the HER2 exon 20 gene mutation. The FDA pointed out that Poziotinib's safety and treatment efficacy lack the duration of response compared to existing Enhertu by Daiichi Sankyo and AstraZeneca.

Additionally, concerns were expressed about its high toxicity. The FDA explained that 85% of patients taking 16 mg of Poziotinib once daily experienced serious side effects.

Some suggest that the FDA's concerns have also cast doubt on the approval review of Poziotinib scheduled for November 24.

Due to concerns over Poziotinib's safety relative to its efficacy, Spectrum's stock price plunged 37.46% the previous day.