After Enduring Hardships, the Korea-US 'Rolontris' Crosses the US Threshold... What Is the Next Global New Drug?

FDA Approval for Neutropenia Treatment
First Hanmi Pharmaceutical Self-Developed New Drug

First Commercialization Success Among 10 Technology Exports Since 2011... Half Experienced Returns

Hanmi Pharmaceutical's neutropenia treatment 'Rolontis'

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's neutropenia treatment 'Rolontis' has crossed the threshold of approval in the United States, marking a milestone in Hanmi Pharmaceutical's research and development (R&D) history. This is a remarkable achievement not only for Hanmi Pharmaceutical but also for the entire Korean pharmaceutical and bio industry, as it signifies the revival of FDA new drug approvals after a three-year hiatus. Despite Hanmi Pharmaceutical's focus on R&D investment, it had only succeeded in technology transfers until now, with no drugs achieving final approval and successful commercialization in the global market.

According to industry sources on the 13th, on the 9th (local time), Spectrum Pharmaceuticals, Hanmi Pharmaceutical's U.S. partner to which Rolontis was licensed out, announced that it had received a notification of approval from the U.S. Food and Drug Administration (FDA) for the marketing authorization of 'Rolvedon' (Rolontis' U.S. product name).

With this, Rolontis became the sixth drug to receive FDA approval after SK Biopharm's 'Xcopri' in November 2019, continuing 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' 'Apstila', and SK Biopharm's 'Sunosi' and 'Xcopri'.

Rolontis is also the first Hanmi Pharmaceutical-developed new drug to successfully cross the FDA threshold. It is significant as a biopharmaceutical produced directly at the Pyeongtaek bioplant, which passed FDA inspection and is exported to the U.S. In terms of technology platform, it is the first biopharmaceutical using Hanmi Pharmaceutical's proprietary platform technology 'Lapscovery' to receive global market approval. Lapscovery is a technology that extends the drug's duration in the body, overcoming the short half-life, which is a common drawback of biopharmaceuticals.

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

However, the more than 10 years it took for Rolontis to gain FDA approval was also a period of endurance for Hanmi Pharmaceutical. Despite signing a series of large technology transfer contracts and rising as a star in technology licensing, most of the substances were returned, causing setbacks.

Hanmi Pharmaceutical's technology transfers peaked in 2015. At that time, Hanmi Pharmaceutical succeeded in licensing out three diabetes drug candidates, including the GLP-1 class long-acting diabetes drug 'Epeglenatide', to global big pharma Sanofi for a total of 3.9 billion euros (approximately 5.4325 trillion KRW), which was regarded as rewriting the history of the Korean pharmaceutical and bio industry. In addition, Hanmi Pharmaceutical signed technology transfer contracts with Janssen (a Johnson & Johnson subsidiary) for the long-acting obesity and diabetes treatment candidate 'HM12525A' worth a total of $915 million (approximately 1.2576 trillion KRW), as well as with Eli Lilly (immune disease treatment), Boehringer Ingelheim (Olmutinib), and Zai Lab (Olmutinib).

However, all the candidate substances exported in 2015 were returned, starting with the return of long-acting insulin and insulin combo among the three diabetes drugs from Sanofi in the following year, culminating in the return of Epeglenatide in September 2020, marking a painful experience of all licensed substances being returned.

Prior to Rolontis, the oral metastatic breast cancer anticancer drug 'Oracsol', licensed out to Athenex in 2011 and attempting FDA approval, received a Complete Response Letter (CRL) in March last year, resulting in a temporary halt to commercialization in the U.S. However, it has applied for marketing authorization (MAA) in the UK, and development may continue depending on the UK approval status.

Since 2011, out of a total of 10 technology transfer contracts, as many as five?half?were returned, and one faced difficulties, casting doubts on Hanmi Pharmaceutical's R&D achievements. However, the FDA approval of Rolontis is expected to largely dispel these doubts.

Hanmipharm Headquarters Building Exterior

Following the success of Rolontis, Hanmi Pharmaceutical plans to maintain momentum through FDA approval of the non-small cell lung cancer treatment 'Poziotinib'. Like Rolontis, it was licensed out to Spectrum, and the FDA has set a decision deadline for marketing authorization on November 24. On the 22nd, the FDA will hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss whether to recommend approval, with procedures steadily progressing.

Hanmi Pharmaceutical is also attempting to revive the potential of returned substances through business diversification such as re-licensing and indication discovery. HM12525A, returned from Janssen, was successfully re-licensed to Merck (MSD) in the U.S. in 2020, and Epeglenatide is currently undergoing global Phase 3 clinical trials.

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