Hanmi Pharmaceutical’s global biopharmaceutical drug Rolvedon (known as Rolontis in South Korea) has demonstrated clinical evidence that could revolutionize dosing convenience. A study published in a prestigious international medical journal reveals that administering the drug on the same day as chemotherapy produces effects comparable to the current standard of next-day administration. This breakthrough could eliminate the need for patients to return to the hospital 24 hours after chemotherapy, significantly improving their treatment experience.
Effective Even When Administered 30 Minutes After Chemotherapy… Convenience Secured
Assertio, Hanmi Pharmaceutical’s U.S. partner, announced on Monday that the phase 1 clinical trial results for Rolvedon, a neutropenia treatment, were recently featured in the latest issue of The Oncologist, a leading journal in the field of oncology.
Neutropenia is a serious side effect of chemotherapy that occurs when the treatment attacks not only cancer cells but also bone marrow cells, causing a rapid decrease in neutrophils crucial for fighting bacterial infections. Given the high risk of infection, preventing or treating neutropenia is essential for patient safety.
The study involved 53 early-stage breast cancer patients. Researchers administered Rolvedon, a granulocyte colony-stimulating factor (G-CSF) agent, just 30 minutes after chemotherapy. This approach differs from the typical practice of administering G-CSF agents 24 hours post-chemotherapy to avoid interference from cytotoxic drugs.
Results showed that patients receiving same-day administration of Rolvedon experienced neutrophil recovery in an average of 1.8 days, matching the recovery rate of the standard 24-hour post-therapy regimen. Only one patient (about 2%) developed febrile neutropenia, a key safety indicator, with no cases requiring hospitalization or antibiotic treatment.
Dr. Howard Franklin, Senior Vice President of Medical Affairs at Assertio, emphasized the significance of these findings: This study provides compelling scientific evidence that Rolvedon can offer patients a more convenient dosing schedule. The ability to maintain safety and efficacy when administered immediately after chemotherapy represents a potential paradigm shift in clinical practice.
The promising clinical results are expected to accelerate Rolvedon’s market share growth in the U.S. The drug has already shown impressive performance, establishing itself as a reliable revenue generator for Hanmi Pharmaceutical.
Assertio’s financial report reveals that Rolvedon achieved quarterly sales of approximately 38.6 million USD in the third quarter of 2025, more than doubling its performance compared to the same period last year and setting a new record since its launch. This rapid growth is particularly noteworthy given that initial quarterly sales were around 10 million USD.
The U.S. market for neutropenia treatments is valued at approximately 3 trillion KRW (about 2.04 billion USD). Historically dominated by Amgen’s Neulasta, the market has recently become more competitive with the introduction of biosimilars following patent expirations.
Neulasta currently holds about 30% of the market share, leveraging its on-body injector (OBI) technology, which automatically delivers medication over 45 minutes, 27 hours after being attached to the patient’s body.
If Rolvedon receives official approval for same-day administration, it could offer a compelling alternative to Neulasta’s OBI. Patients could potentially complete their entire treatment regimen on the same day as chemotherapy, eliminating the need for body-worn devices or next-day hospital visits.
Hanmi Pharmaceutical Expects Dual Benefits From Royalties and Raw Material Exports
Hanmi Pharmaceutical stands to benefit doubly from Rolvedon’s success through royalties and raw material exports. The company reportedly receives double-digit percentage royalties from Assertio based on Rolvedon sales. Additionally, Hanmi Pharmaceutical supplies the active pharmaceutical ingredients from its Pyeongtaek bio plant, ensuring that increased sales translate directly into higher manufacturing profits.
Assertio has identified Rolvedon as a cornerstone of its growth strategy and is investing heavily in marketing efforts. As this study represents early-stage clinical data, further large-scale trials and randomized controlled studies are anticipated to strengthen the drug’s position in the market.
An Assertio spokesperson stated that febrile neutropenia remains a serious risk for chemotherapy patients. It is committed to ongoing research and development to ensure that Rolvedon’s innovative dosing option can significantly enhance patients’ quality of life.
A pharmaceutical industry analyst noted that Rolvedon, which utilizes Hanmi Pharmaceutical’s proprietary LabDiscovery technology, represents a major advance in extending drug efficacy. With this new evidence supporting same-day administration, Rolvedon is poised to become an increasingly attractive option for healthcare providers and patients across the U.S.
