[eDisclosure Notice] Hanmi Pharm: "US FDA Advisory Committee Expresses Negative Opinion on 'Pogziotanib' Approval" etc.

[Image source=Yonhap News]

[Asia Economy Reporter Myunghwan Lee] Hanmi Pharmaceutical announced on the 23rd that the Oncology Drugs Advisory Committee (ODAC), an advisory committee of the U.S. Food and Drug Administration (FDA), has determined that the benefits of the new drug for non-small cell lung cancer treatment, 'Poziotinib,' do not outweigh the risks in relation to its accelerated approval.

ODAC is an independent advisory body that provides comprehensive opinions on the quality, safety, and cost-effectiveness of drugs under FDA review. According to Hanmi Pharmaceutical, ODAC voted 9 to 4 that the benefits of Poziotinib do not outweigh the risks.

The FDA will review all circumstances, including ODAC’s recommendation, and decide whether to approve Poziotinib for marketing by November 24.

Below are Hanmi Pharmaceutical’s disclosure and other major disclosures released during the morning trading session today.

▲ Daewoo Engineering & Construction = Signed a contract with DCR Co., Ltd. for the construction of City OCELE Phase 5 (private rental) Prugio residential complex worth 300.5 billion KRW.

▲ Chong Kun Dang = Submitted a domestic product approval application to the Ministry of Food and Drug Safety for the diabetes treatment drug 'Duvimet-S Extended Release (CKD-393)'.

▲ Namkwang Construction = Won a contract worth 59.659 billion KRW for the street housing maintenance project in the area of 149-1 Birae-dong.

▲ JSND = Signed a contract with Dongseo Noblesse Co., Ltd. for the construction of a residential-commercial complex in Gwanyang-dong, Dongan-gu, Anyang City, worth 38.048 billion KRW.

▲ Camu E&C = Signed a contract with SK Ecoplant for the PC construction work of the SK Hynix M15 WWT project worth 49.5 billion KRW.

▲ DA Technology = Signed a supply contract with LG Electronics for manufacturing equipment for secondary battery assembly processes worth 6.2 billion KRW.

▲ Genomictree = Announced acquisition of a patent for a methylated DNA multiplex detection method. The company stated, "This patented technology is currently applied to our colorectal cancer, bladder cancer, and lung cancer diagnostic products, and will be incorporated into various future cancer molecular diagnostic products under development, contributing to revenue growth through expansion of the product pipeline."