Hanmi's new bio drug 'Rolvedon' sales 88%↑ in the US mkt

Recorded the sales of KRW 21 billion in Q3…rebounded since Q4 of 2023

Has completed the Phase 1 clinical trial for the same-day administration…will present the data at the U.S. conference next month

The U.S.

 

sales of Rolvedon (Korean product name: Rolontis) have substantially increased.

 

Hanmi Pharmaceutical's U.S.

 

partnering company, Assertio, plans to expand market share by securing Rolvedon's indication for the same-day administration.

 

According to Assertio on Novermber 14, Rolveron's sales in the U.S.

 

market in Q3 were US$ 15 million (about KRW 21 billion), up 87.5% Year-over-Year (YoY).

 

Rolvedon has recorded cumulative sales of US$110.30 million (about KRW 155 billion) since its launch in Q4 of 2022.

 

Rolvedon is a treatment for neutropenia developed by Hanmi Pharmaceutical.

 

It is Korea's 33rd new drug, approved in March 2021.

 

After that, Hanmi Pharmaceutical and its U.S.

 

partnering company Spectrum (now Assertio) obtained U.S.

 

Food and Drug Administration (FDA) approval in September of the same year.

 

Rolvedon was outlicensed to the U.S.

 

Spectrum in 2012.

 

After Assertio acquired Spectrum in April last year, it secured the licensing of sales and development of Rolvedon and lung cancer therapy Poziotinib.

 

Rolvedon

Since its release in the United States in October 2022, Rolvedon has recorded sales of $10 million within three months.

 

After the product launch, 70 distributors purchased Rolvedon.

 

It was then utilized by the top three community oncology networks, accounting for 22% of the clinic market share.

 

It continued to show strong sales up to Q2 last year.

 

Rolvedon generated sales of $15.6 million in Q1 last year, and in Q2, it recorded $21 million (approx.

 

KRW 28 billion), an increase of 34.6% from the previous quarter.

 

Rolvedon’s sales in Q3 last year slowed down since its launch.

 

It recorded $8 million in Q3 last year, a decrease of 62% from the previous quarter.

 

Regarding sales reduction, Assertio explained that the demand for Rolvedon after applying the reimbursement system was below expectations.

 

Rolvedon successfully rebounded in Q4 last year, generating US$11 million in sales.

 

Rolvedon's sales in Q1 amounted to US$14.50 million and maintained recovery in Q2, recording sales of US$15.10 million.

 

Assertio has high hopes for Rolvedon's same-day administration clinical trial.

 

Currently, Neulasta, jointly developed by Amgen and Kyowa Kirin, is recording over half of the market share in the U.S.

 

market for neutropenia treatment.

 

However, conventional treatments for neutropenia, such as Neulasta, can only be administered 24 hours after cancer therapy, thereby prolonging hospitalization.

 

Assertio plans to gain a competitive edge with its strategy of Rolvedon's same-day administration method.

 

Assertio has recently completed the Phase 1 clinical trial for Rolvedon's same-day administration.

 

The company plans to present the clinical results at the 2024 San Antonio Breast Cancer Symposium (SABCS 2024), held for four days, starting December 10.