Hanmi Pharm, Failing Consecutive Home Runs, Goes All In on 'Rollontis'... Critical Battle to Conquer US Market

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Hanmi Pharm's neutropenia treatment Rolontis.
Photo by Hanmi Pharm

[Asia Economy Reporter Lee Gwan-joo] Hanmi Pharmaceutical, which failed to obtain approval from the U.S. Food and Drug Administration (FDA) for the non-small cell lung cancer treatment ‘Poziotinib,’ has chosen to focus on the neutropenia treatment ‘Rolontis’ (U.S. name Rolvedon), which had previously received marketing approval. The future performance of Rolontis is expected to determine Hanmi Pharmaceutical’s success in entering the U.S. market.

According to the pharmaceutical industry on the 30th, Hanmi Pharmaceutical’s U.S. partner Spectrum decided to immediately lower the priority of the Poziotinib project and reduce research and development (R&D) personnel by 75% after receiving the FDA’s Complete Response Letter (CRL) on the 25th. The operational capital saved through this will be invested in the commercialization costs of Rolontis.

Hanmi Pharmaceutical has not officially announced the discontinuation of Poziotinib’s development. However, since Spectrum has decided to drastically reduce R&D personnel, further research has become difficult. A Hanmi Pharmaceutical official stated, “It is currently difficult to specify the timing for the Phase 3 clinical trial,” and added, “Spectrum plans to explore potential strategic alternatives for Poziotinib, such as partnerships.”

Hanmi Pharmaceutical’s plan, which aimed for a consecutive home run following the FDA approval of Rolontis in September, has thus resulted in partial success. Unlike Rolontis, which received a CRL last year due to production-related inspection supplements, Poziotinib faced questions regarding its efficacy, making immediate recovery unlikely. The company is now in a situation where it must ‘go all in’ on Rolontis, which has already been approved and launched.

Pyeongtaek Bio Plant producing Rollontis.
[Photo by Hanmi Pharm]

The market outlook is not unfavorable. The global market for neutropenia treatments is estimated to be about 7 trillion KRW. Among this, the U.S. market accounts for approximately 3 to 4 trillion KRW, making it the largest single-country market. Even targeting the U.S. market properly offers a chance of success. Local responses have also been positive, with ‘Nature Review Drug Discovery’ projecting Rolontis’ sales to reach $235 million (about 310 billion KRW) by 2026 in an analysis of FDA-approved drugs in the third quarter of this year.

However, the key issue is how much Rolontis can expand its territory against already established products in the market. A representative competitor is Amgen’s second-generation neutropenia treatment ‘Neulasta.’ Neulasta’s U.S. sales reached $1.514 billion (about 2 trillion KRW, according to IQVIA) last year. This underscores the need for a thorough marketing strategy to expand market influence.

Hanmi Pharmaceutical and Spectrum are increasing local sales and marketing personnel in line with the official launch of Rolontis. Spectrum’s specialized staff are reportedly intensifying sales efforts by increasing contact with major U.S. cancer centers. Since resources previously allocated to Poziotinib are now being redirected to Rolontis, the scale of marketing is expected to grow significantly. Hanmi Pharmaceutical expressed its determination, stating, “We will concentrate all our capabilities to support Spectrum so that Rolontis can achieve good results in the U.S. market.”

Rolontis’ push into the U.S. market is also attracting attention within the domestic pharmaceutical industry. It is the sixth Korean new drug to receive FDA approval and the first new drug manufactured in a domestic factory and sold in the U.S. An industry insider said, “It is meaningful that the drug passes FDA inspections and is directly produced domestically for export to the U.S.,” adding, “If Hanmi Pharmaceutical’s challenge succeeds, it will set a benchmark for other domestic pharmaceutical companies aiming to enter the U.S. market.”