[Click eStock] "Hanmi Pharm Opposes US FDA Fast Approval of Poziotinib... Target Price Down 11%"

[Asia Economy Reporter Kwon Jae-hee] Daishin Securities on the 26th issued a 'Buy' investment rating on Hanmi Pharm but lowered the target price by 11.1% from the previous level to 320,000 KRW.

The U.S. Food and Drug Administration (FDA) Oncology Drug Advisory Committee concluded on the 22nd that the risk-benefit ratio of Poziotinib is not significant, with 9 out of 13 advisory members opposing expedited approval. The concerns include ▲lower response rate and shorter duration of response compared to existing treatments ▲safety concerns such as dose adjustments in 57% of clinical trial participants and grade 3-4 or higher adverse reactions in 85% ▲insufficient data for dose optimization ▲delays in subsequent clinical trials.

On the other hand, the competing drug 'Enhertu' received expedited approval from the FDA in August. The FDA is scheduled to make the final approval decision on Poziotinib on November 24, taking into account the advisory committee's opinions.

Yoonjin Lim, a researcher at Daishin Securities, stated, "Given the high proportion of opposition to expedited approval of Poziotinib, additional data on efficacy and safety through follow-up clinical trials seems necessary. However, Poziotinib is an oral drug, offering greater convenience compared to existing injectable therapies, and can provide an additional treatment option for patients with high unmet needs, so we maintained the reflection of its new drug value." She added, "Considering the high weighting of Poziotinib's new drug value, the stock price decline was excessive, and given the solid performance growth and 2023 research and development (R&D) momentum, we view this as a buying opportunity at a low price."

This content was produced with the assistance of AI translation services.