(Health Korea News / Lee Soon-ho) Hanmi Pharmaceutical’s new drug for the treatment of neutropenia, ‘Rolvedon’ (Eflapegrastim, domestic product name: Rolontis), has completed its phase 1 clinical trial for same-day therapy in the United States. As promising results were confirmed in the interim safety evaluation conducted in the early stages of the clinical trial, attention is being paid to whether it will also receive a passing grade in the final data evaluation.
According to Clinical Trials, a clinical information site operated by the U.S. National Institutes of Health (NIH), Spectrum Pharmaceuticals (now Assertio Holdings), a partner of Hanmi Pharmaceutical and the developer and marketer of Rolvedon in the U.S., recently changed the status of its ongoing local phase 1 clinical trial of Rolvedon from “Active, not recruiting” to “complete.”
The actual clinical trial ended on the 16th of last month, and a total of 59 subjects were recruited. These subjects received a total of 4 cycles of docetaxel and cyclophosphamide chemotherapy, and 30 minutes after chemotherapy, ‘Rolvedon’ was administered to evaluate the time for the absolute neutrophil count (ANC) to recover.
In an interim safety evaluation conducted in the early clinical phase in 2021, subjects who received ‘Rolbedone’ 30 minutes after the first cycle of chemotherapy showed rapid recovery of ANC and also met the pre-specified safety evaluation criteria. The overall safety profile was similar to the existing chemotherapy administration regimen 24 hours after chemotherapy.
Assultio, which acquired Spectrum in April last year, expects to have the final data analysis results from this clinical trial within this year.
‘Rolvedon’ is a third-generation bio-new drug administered to cancer patients receiving myelosuppressive chemotherapy for the purpose of treating or preventing neutropenia. It is a member of the ‘G-CSF’ (granulocyte colony stimulating factor) series that stimulates granulocytes and increases the number of neutrophils, and has a similar mechanism of action to Amgen’s blockbuster drug ‘Neulasta’ (ingredient name: pegfilgrastim).
It is characterized by extending the duration of efficacy and reducing the number of administrations by applying Hanmi Pharmaceutical’s proprietary platform technology, ‘Labscovery’ technology, and received sales approval from the US FDA in 2022. In Korea, it received product approval from the Ministry of Food and Drug Safety in 2021.
The US neutropenia treatment market is worth 3 trillion won, and Amgen’s ‘Neurlasta’ dominates it. ‘Neurlasta’ is a subcutaneous injection formulation that was approved by the US FDA in 2002 and has been sold for 20 years. Sales once exceeded 5 trillion won, but the size quickly decreased after the introduction of biosimilars in 2018, but it still shows off its power in the relevant market.
In particular, Neulasta Onpro, a patch formulation of Neulasta that Amgen launched in 2017 to prepare for the market entry of biosimilars, accounts for about half of the US neutropenia treatment market despite the launch of a subcutaneous injection biosimilar.
‘Neurast Onpro’ is a dosage form that, when attached to the body, automatically administers the drug after a certain period of time.
Existing subcutaneous injection-type neutropenia treatment drugs can be administered at least one day after chemotherapy. Because of this, patients had to visit the hospital again after receiving rigorous chemotherapy to receive neutropenia treatment drugs, or else had to be hospitalized for at least one day.
‘Neurasta Onpro’ is designed to be attached to the body on the day of receiving chemotherapy and automatically administer the drug the next day. Since there is no need to visit the hospital separately, the burden of outpatient treatment for patients is greatly reduced, and it has secured over 60% of the market share as soon as it was launched, replacing the subcutaneous injection formulation.
In order for Hanmi Pharmaceutical’s ‘Rolbedone’ to succeed in the US market, it is crucial to take away the market share of ‘Neurlasta Onpro’. This is why attention is focused on the results of the clinical trial of ‘Rolbedone’ same-day treatment.
Meanwhile, neutropenia is a symptom in which the number of neutrophils, a type of white blood cell, decreases as a side effect of anticancer chemotherapy. When the number of neutrophils in the blood decreases, the patient becomes extremely vulnerable to infectious diseases. To treat this, G-CSF, which induces neutrophil production, is administered after anticancer chemotherapy.
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Source: www.hkn24.com
