Domestic New Drugs Rushing to US FDA... Aiming for Approval Within the Year

Yuhan's 'Lazertinib' and Hanmi's 'Poziotinib'
Pushed for Approval Within the Year

'Blockbuster' New Drugs Expected
Variable: Delayed Inspections Due to COVID-19

[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Domestic pharmaceutical and bio companies preparing for the post-COVID-19 era are gearing up for a surge of new drug approvals from the U.S. Food and Drug Administration (FDA) this year. Among these, the emergence of 'blockbuster' products with annual sales exceeding 1 trillion won is anticipated, while the ongoing COVID-19 pandemic remains a significant obstacle.

Yuhan, Hanmi, and Green Cross Awaiting One After Another

According to the pharmaceutical industry on the 16th, the drugs currently preparing for FDA approval within the year include Yuhan Corporation's non-small cell lung cancer treatment 'Lezotininib', Hanmi Pharmaceutical's non-small cell lung cancer treatment 'Poziotinib' and neutropenia treatment 'Rolontis', GC Green Cross's blood fractionation product 'ALYGLO (IVIG-SN 10%)', and Medison's treatment for Fontan surgery patients with single ventricle defect 'Udenafil'.

FDA approval in the U.S. is an essential stepping stone for new drugs to expand globally. It is the largest pharmaceutical market in the world and also conducts the most stringent approval reviews. So far, only seven domestic new drugs (five synthetic new drugs and two bio new drugs) have received FDA approval. Moreover, since SK Biopharm's epilepsy treatment 'Xcopri' (active ingredient cenobamate) in 2019, there has been no further progress.

Yuhan Corporation is aiming for FDA approval of Lezotininib within this year. The drug was introduced from Oscotec in 2015 and licensed out to Janssen in 2018. If the product license is successful, additional milestone revenues are expected on top of the 200 billion won milestone already received from Janssen. Notably, there is currently no FDA-approved treatment for non-small cell lung cancer. If it becomes the world's first approved treatment, it is expected to become a blockbuster new drug.

Hanmi Pharmaceutical is also pursuing approval within the year for Poziotinib, which was licensed to Spectrum in the U.S. in 2015. Last month, the FDA accepted the New Drug Application (NDA) and entered the process for market approval, with the final decision expected by November 24. Hanmi is also pushing for the U.S. market entry of Rolontis. It was already approved domestically in March last year and is scheduled for release this year. Although the FDA received the approval application in August last year, it requested additional supplements due to manufacturing facility defects. Rolontis is also licensed out to Spectrum, which is reportedly planning to resubmit the approval application in the first quarter of this year.

On-site Inspections Delayed Due to COVID-19 Are Key

However, it is uncertain whether all these products will receive approval within the year as planned. On-site inspections, such as the 'pre-approval inspection' conducted by the FDA for new drugs or generic drugs, have not been properly carried out since the COVID-19 pandemic. According to the Korea Bio Association, the FDA conducted 977 overseas inspections in 2009, but only 21 inspections were conducted from March 2020 to April last year. Due to travel restrictions imposed by the U.S. government amid COVID-19, inspections abroad were almost halted.

A representative new drug affected by inspection delays is GC Green Cross's ALYGLO. The FDA's approval announcement, originally scheduled for the 25th of last month (local time), was postponed as the FDA issued a Complete Response Letter (CRL). GC Green Cross submitted the Biologics License Application (BLA) to the FDA in February last year, but on-site inspections could not be conducted due to the COVID-19 situation. As a last resort, a remote evaluation of the Ochang production facility was conducted in the fourth quarter of last year, but the FDA deemed this insufficient and ultimately requested additional supplements.

Medison's Udenafil, whose approval deadline is approaching in about 10 days, is also reported to have not undergone on-site inspection. If this situation continues, it is highly likely that Udenafil will also receive a request for additional supplements.

An industry insider said, "However, the FDA has announced plans to resume overseas inspections starting this year," adding, "Since the global spread of the Omicron variant has peaked worldwide, if inspections resume, approvals could be granted in a short period."

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