Hanmi's 'Rollontis' Approved by FDA... 6th Korean New Drug to Receive FDA Approval

New Anticancer Drug for Neutropenia Treatment
First Among Hanmi's Independently Developed Drugs
Applying Proprietary Platform 'LabScovery'

[Asia Economy Reporter Chunhee Lee] Hanmi Pharmaceutical's neutropenia treatment 'Rolontis' has succeeded in crossing the threshold of the U.S. market by receiving approval from the U.S. Food and Drug Administration (FDA).

On the 9th (local time), Spectrum Pharmaceuticals, the U.S. partner company to which Hanmi Pharmaceutical licensed Rolontis, announced that it had received a notification from the FDA approving the marketing authorization for 'Rolvedon' (Rolontis' U.S. product name).

With this, Rolontis became the first new drug developed independently by Hanmi Pharmaceutical to pass the FDA threshold. It is also the first bio-drug applying Hanmi Pharmaceutical's proprietary platform technology 'Lapscovery' to receive global market approval. Lapscovery is a technology that extends the duration of a drug's presence in the body, overcoming the short half-life, which is considered a drawback of biopharmaceuticals.

As a Korean pharmaceutical and bio industry achievement, it is the first FDA-approved anticancer new drug and the first bio new drug produced in a domestic factory that passed FDA inspection to enter the U.S. market. It is also the sixth FDA approval in three years since SK Biopharm's 'Xcopri' in November 2019, reviving the lineage of FDA new drug approvals that had been interrupted. Previously approved drugs include ▲LG Chem's 'Pactiv' ▲Dong-A ST's 'Cibextro' ▲SK Chemicals' 'Abstila' ▲SK Biopharm's 'Sunosi' and 'Xcopri'.

Success on the Third Attempt

Exterior view of Hanmi Pharm Bio Plant in Pyeongtaek-si, Gyeonggi Province (Photo by Hanmi Pharm)

Rolontis' success in obtaining U.S. approval came on the third attempt. Spectrum, the U.S. partner that licensed Rolontis in 2012, applied for a Biologics License Application (BLA) to the FDA in 2018 but voluntarily withdrew the application after the FDA requested additional data. The following year, they reapplied for the license, but in August last year, the FDA issued a Complete Response (CR) letter. They reapplied for approval in March this year and succeeded.

The problematic manufacturing facility inspection was delayed due to the COVID-19 pandemic and other factors, but the FDA's inspection of the Pyeongtaek bio plant was completed in June without major issues ahead of this approval, leading to expectations that approval would be granted this time. Hanmi Pharmaceutical and Spectrum were also rushing to complete preparations for sales in the U.S. Spectrum recently finalized the U.S. launch name Rolvedon for Rolontis and has completed preparations for launch, including hiring sales and marketing personnel nationwide.

Hanmi Pharmaceutical CEO Kwon Se-chang said, “This is not only the first FDA approval case among Hanmi Pharmaceutical's new drugs but also has great significance in proving the commercialization potential of our proprietary platform technology Lapscovery.” He added, “We expect this to be a decisive turning point for the commercial success of Rolontis and the future value increase of Lapscovery-based bio new drugs.”

Tom Lee, CEO of Spectrum, also stated, "The approval of Rolvedon marks Spectrum's transformation into a commercial-stage company capable of competing in the market," calling it "an important milestone in our collaboration with Hanmi Pharmaceutical."

Can It Catch the Blockbuster 'Neulasta'?

Korea Kyowa Kirin's neutropenia treatment 'Neulasta'

Rolontis is a treatment for neutropenia. Neutrophils play a role in defending against bacterial and fungal infections within white blood cells. However, cancer patients frequently experience neutropenia, a severe reduction in neutrophils, during chemotherapy, which significantly lowers immunity. Rolontis is used for the treatment or prevention of neutropenia. It has already been approved and marketed domestically as the 33rd Korean new drug since March last year.

The global neutropenia treatment market is dominated by Amgen's 'Neulasta,' a blockbuster drug with annual sales of about $5 billion (approximately 6.815 trillion KRW). It has maintained the number one position domestically for several years, generating sales of 24.4 billion KRW last year. However, sales have been declining recently due to the launch of various biosimilars (biopharmaceutical generics).

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