From Factive to Rolontis, commercial success or failure

Hanmi Pharmaceutical's Rolontis enters the U.S. for the first time as a bio-new drug

Domestic new drugs, six U.S. permits since 2003 when they were active. There is little global achievement

Domestic development biosimilar and botulinum toxin drugs expand their influence in the U.S Hanmi Pharmaceutical's neutropenia treatment Rolvedon has succeeded in entering the U.S.

 

market.

 

Starting with LG Chem's Factual in 2003, a total of six new drugs made with domestic technology passed the U.S.

 

licensing gate.

 

However, it is evaluated that new domestic development drugs that have entered the U.S.

 

so far have a long way to go to achieve commercial success.

 

Although it is not a new drug, biosimilars and botulinum toxin drugs developed with domestic technologies are gradually expanding their market impact and writing a success story.

 

◆Hanmi Pharmaceutical's bio-new drug FDA's first approval, and domestic new drug's 6th commercial success is the key According to industries on the 13th, the U.S.

 

Food and Drug Administration (FDA) finally approved Rolontis (U.S.

 

product name Rolvedon), which Spectrum Pharmaceuticals applied for permission on the 10th (local time).

 

Rolvedon is a new bio drug that Hanmi Pharmaceutical transferred technology to Spectrum Pharmaceuticals in 2012.

 

It is administered to cancer patients subject to bone marrow-suppressing chemotherapy for the treatment or prevention of neutropenia.

 

In Korea, it was approved by the Ministry of Food and Drug Safety as the 33rd domestic new drug in March last year.

 

Rolvedon is produced at Hanmi Pharmaceutical's Pyeongtaek bioplant.

 

It is the first bio-new drug in Korea to be produced at a domestic factory that has passed FDA due diligence and enter the U.S.

 

market.

 

Rolvedon is the sixth new drug developed with the technology of a domestic company to pass the FDA approval gate.

 

In 2003, LG Chem's antibiotic Factive was the first to pass the U.S.

 

FDA among domestic new drugs.

 

In 2014, Factive, which was exported by Dong-A ST, obtained FDA approval.

 

In 2016, SK Chemicals' hemophilia treatment Afstyla passed FDA approval.

 

Afstyla is a genetically modified bio-new drug developed by SK Chemicals with its own technology.

 

In 2019, two products developed by SK Biopharm passed the U.S.

 

FDA.

 

In March 2019, SK Biopharm's new sleep disorder drug Sunosi, which was exported by technology, approved the FDA's final permission.

 

Sunosi is a product that SK Biopharm transferred its technology to Jazz Pharmaceuticals in 2011 after completing a phase 1 clinical trial after discovering candidate materials with its own technology.

 

In November 2019, SK Biopharm received FDA approval for XCOPRI, a new drug for epilepsy.

 

XCOPRI is the first new drug developed by a domestic company and carried out FDA approval directly.

 

The industry is eagerly looking forward to the commercial success of domestic development new drugs in the United States.

 

In Factive, its partner GSK suddenly took issue with clinical data, causing a setback in its overseas expansion.

 

More than 300 billion won has been invested in the development of Factual, but sales in the U.S.

 

are insignificant.

 

Last year, Factive's domestic production performance was only 10.5 billion won.

 

Sivextro, which was approved by the FDA in 2014, and Afstyla, which debuted in the U.S.

 

market in 2016, say that commercial performance fell short of expectations.

 

Sivextro disappeared from the market, withdrawing its permission due to low drug prices in Korea.

 

Two new drugs to develop SK Biopharm, which were recently approved by the U.S., are gradually expanding their influence in the market.

 

Sunosi made 25.3 billion won in profits to SK Biopharm last year, followed by 2.4 billion won in exports in the first half.

 

XCOPRI recorded 300.7 billion won in exports last year and 13.7 billion won in the first half of this year.

 

◆ Domestic development biosimilar accelerates its entry into the U.S.. Although it is not classified as a new drug, biosimilars and botulinum toxin drugs developed by domestic companies are rapidly penetrating the U.S.

 

market.

 

In the case of biosimilars, Celltrion and Samsung Bioepis have been approved for a total of eight products in the United States.

 

Celltrion was granted Remicade's biosimilar Inflectra in August 2016.

 

Celltrion received U.S.

 

permits from Truxima and Herzuma in 2018, respectively.

 

Truxima is a biosimilar product of the anti-cancer drug Mabthera.

 

Herzuma's original product is Herceptin.

 

The biosimilar developed by Celltrion recorded more than 7 trillion won in cumulative exports.

 

Celltrion Development's biosimilar posted 930.3 billion won in exports in the first half alone, with sales in the North American market accounting for 43% and 47% in the first and second quarters, respectively.

 

Samsung Bioepis, which was launched in 2012, has been approved by Europe and the United States for biosimilars of five products, including Enbrel, Remicade, Humira, Avastin, and Lucentis.

 

Since its launch, it has recorded sales of about 3.7968 trillion won until the first half of this year.

 

Sales of 431.9 billion won were recorded in the first half alone, of which sales in the U.S.

 

market account for 20-30%.

 

Recently, Nabota, a botulinum toxin drug developed by Daewoong Pharmaceutical, is doing well in the U.S.

 

market.

 

According to Daewoong Pharmaceutical, Nabota's sales in the first half were 67.5 billion won, up 74.9% from the previous year.

 

It recorded 52 billion won in export performance alone.

 

If this trend continues, Nabota is expected to record more than 100 billion won in exports alone this year.

 

Nabota has accumulated due to accumulation of experience in using the U.S., and export performance has begun to surge since the end of the Medy Tox and strain theft lawsuits conducted since 2019.

 

In February last year, Medy Tox signed a three-way agreement with Daewoong Pharmaceutical's U.S.

 

partners Evolus and AbbVie regarding the sale of Nabota (Jubo) to the U.S.

 

The key to Medy Tox and AbbVie is to grant Jubo's continuous sales and distribution rights to Evolus in the United States and receive a certain amount of money.

 

Earlier, at the end of 2020, the International Trade Commission (ITC) decided to ban Jubo from importing and selling in the U.S.

 

for 21 months.

 

With this agreement, Navota's hurdles for selling to the U.S.

 

are gone.

 

Of Nabota's overseas sales in the second quarter, exports to Evolus doubled from a year earlier to 21.1 billion won.