[팍스넷뉴스 민승기 기자] Indigenous new drugs, whose entry into the US market was delayed somewhat due to the effects of Corona 19 last year, are raising expectations that they will be able to obtain approval this year. The U.S. pharmaceutical market is large enough to account for 40% of the global market, and success in the U.S. market leading global technology standards can soon lead to success in the global market.
According to industry sources on the 7th, local new drugs that are expected to be approved by the US Food and Drug Administration (FDA) within this year are Hanmi Pharmaceutical’s long-lasting neutropenia treatment biologic drug’Rolontis’ and Mezion’s Fontan surgery treatment’Udenafil’. .
Rollontis, which Hanmi Pharm licensed out of the spectrum, expected FDA approval last year, but the schedule was postponed due to the global spread of Corona 19. The FDA’s Pyeongtaek bioplant due diligence, originally planned for March last year, was rescheduled twice due to the spread of Corona 19 at home and abroad.
However, as the spread of Corona 19 around the world did not subside, in the end, the due diligence in Korea could not be completed within the FDA review deadline on October 24. This is due to restrictions on overseas business trips for US officials.
In addition to the Pyeongtaek bioplant inspection, the FDA inspections for the finished product producers, finished packaging sites, and Spectrum headquarters in the US are all over. All data related to the approval process requested by FDA for review of the permit document have also been submitted.
An official in the pharmaceutical industry explained, “Although the variable called Corona 19 remains, vaccines and treatments are being developed. If this is the case, a due diligence will be scheduled in Korea this year, and the approval process will start quickly afterwards.”
He said, “As the FDA due diligence for drugs with new manufacturers outside the United States as well as Rolontis has been unsuccessful, cases of delayed approval of new drugs are occurring all over the world.” It has been approved, but there are no approved drugs in 2020,” he added.
The possibility of approval of Mezion’s Fontan surgery treatment’Udenafil’ within this year is also high. The industry predicted that Mezion would submit a new drug approval application within the first quarter as early as possible.
Mezion submitted an application for new drug approval for udenafil last year, but was asked to revise and supplement the data from the FDA. Afterwards, Mezion submitted a request for a Type A meeting to the FDA, explaining’how to solve the problem’ in response to FDA’s request for data revision and supplementation, and requesting a meeting as soon as possible.
The FDA replied, “Mezion has explained the solution accurately and sincerely and fully agrees with it,” and “Prepare a new drug application without having to hold a meeting.”
An official from the investment industry said, “I know that Mezion is currently working on revising and supplementing necessary matters,” he said. “It was a little delayed due to the influence of Corona 19, but we expect to submit a permit application soon.” In particular, he added, “Udenafil was designated as a priority screening item,” he added. “If you look at the cases of drugs that received priority screening, it was decided whether or not to approve it within 8 months from the time the application was submitted.”
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