Marketability of homegrown drugs being tested in the US

Testing their global commerciality… 3 homegrown drugs released in the US in 2 years

GC Biopharma receives FDA approval for Korea’s first blood product…passes US gateways at its third try

Hanmi and Celltrion's biological drugs were granted FDA approval from last year

The commercial success of these US entrants to be tested...Xcopri’s cumulative sales in the US rose to KRW 45.21 billion

Domestic pharmaceutical and bio companies are entering the US one after another.

 

GC Biopharma succeeded in entering the US market with its blood product on its third try.

 

Since last year, 3 domestically developed drugs have passed the US market gateway, starting with Hanmi Pharmaceutical and Celltrion.

 

Until now, homegrown drugs that have entered the U.S.

 

were deemed to be far from market success.

 

In this sense, the success potential of homegrown drugs is now being tested in earnest in the US market.

 

GC Biopharma announced on the 18th that it received marketing authorization for its Alyglo from the US Food and Drug Administration on the 15th.

 

ALYGLO is a liquid solution containing immunoglobulin G for intravenous infusion, manufactured from pooled human plasma from US donors.

 

It is used to treat primary humoral immunodeficiencies such as congenital immune deficiency and Immune thrombocytopenia.

 

In Korea, the drug is being sold under the brand name, ‘IV-Globulin SN Inj.’ GC Biopharma was able to pass the barrier to US market entry and receive FDA approval on its third try.

 

GC Biopharma first applied for the approval of its IVIG-SN 5% product at the end of 2015.

 

In November 2016, the company was asked to supplement the manufacturing process data.

 

In September 2017, the authorities again requested GC Biopharma to submit supplementary material, delaying approval.

 

As a result, the company revised its strategy to introduce the more marketable 10% dosage to the U.S.

 

market first.

 

In 2020, it completed the North American Phase 3 clinical trial of IVIG-SN 10% Alyglo and submitted a biologics license application to the FDA in February 2021.

 

However, in February of last year, the company received a notice of delay from the FDA.

 

Due to the COVID-19 pandemic at the time, the review was conducted non-face-to-face in Q4 2021, but the FDA decided to postpone the drug’s approval due to the need for on-site inspection of the manufacturing facility.

 

In April, the FDA team conducted an inspection of the manufacturing facility and quality system, including the fractionation and finishing of IVIG-SN at GC Biopharma’s Ochang plant.

 

After completing the GMP inspection of the Ochang plant, GC Biopharma resubmitted the license application in consultation with the FDA and received final approval this time.

 

Among those made by Korean pharma and bio companies, three homegrown drugs from Hanmi Pharmaceutical, Celltrion, and GC Biopharma have entered the U.S.

 

market since last year.

 

In September last year, the FDA gave the final approval to Spectrum Pharmaceuticals' application for Rolontis (U.S.

 

brand name Rolvedon)

Rolvedon

Rolvedon is a biological drug Hanmi Pharmacuetical had licensed out to Spectrum in 2012.

 

is administered to prevent or treat neutropenia in cancer patients who receive myelosuppressive chemotherapy in Korea.

 

In Korea, the drug received approval as the 33rd homegrown novel drug in March 2021.

 

Rolontis is manufactured at Hanmi’s Pyeongtaek plant.

 

It is the first Korean biological drug to enter the US market after being produced in a domestic plant that passed the FDA’s on-site inspections.

 

Rolvedon became the 6th new drug developed by a domestic company to clear the FDA approval process.

 

In October, Celltrion received approval from the US FDA to market Zymfentra, a subcutaneous (SC) formulation of its antibody biosimilar Remsima as a new drug.

 

Remsima is a biosimilar product of Remicade.

 

Zymfentra is licensed and marketed in Europe under the name Remsima SC.

 

Zymfentra is Celltrion's first product licensed as a new drug in the United States.

 

Zymfentra

The FDA recognized the product's differentiated value from the approval discussion stage and recommended the company take the new drug approval process.

 

To obtain approval as a new drug, Celltrion conducted two new global Phase III clinical trials.

 

Based on the safe safety and efficacy results demonstrated through the clinical trial Celltrion submitted an application for approval in December of last year in accordance with the FDA's new drug approval process and obtained approval in 10 months.

 

LG Chem’s antibiotic Factive was the first among homegrown new drugs to pass the US gates in 2003.

 

Then, Sivextro that Dong-A ST licensed-out was approved by the FDA in 2014.

 

Then, in 2016, SK Chemical’s hemophilia drug Afstyla received FDA approval.

 

Afstyla is a new genetic recombinant drug that was developed by SK Chemical with its proprietary technology.

 

SK Chemical licensed the drug candidate to Australia’s CSL Behring in the preclinical stage in 2009, and CSL Behring conducted the clinical trials and received approval for the drug in the US and Europe.

 

In 2019, two of SK Biopharmaceuticals’ drugs - the narcolepsy drug Sunosi and the new epilepsy drug Xcopri - received FDA approval.

 

In 2019, Sunosi, SK Biopharmaceuticals’ sleep disorder drug that the company licensed out, received final approval from the FDA.

 

SK Biopharmaceuticals completed Phase I trials for the candidate drug after discovery and licensed-out the candidate Jazz Pharmaceuticals in 2011.

 

Jazz acquired the global commercialization rights for Sunosi, including those for the US and Europe, completed Phase III trials, and reached the commercialization stage.

 

In November 2019, the company also received FDA approval for its epilepsy treatment Xcopri.

 

Xcopri is the first new drug to be solely developed and applied and granted FDA approval by a domestic company.

 

Xcopri is a positive allosteric modulator of the y-aminobutyric acid (GABAA) ion channel, which blocks the voltage-gated sodium currents, causing the reduction in repetitive neuronal firing, and reducing seizures.

 

As such, the industry believes this is the time to test the potential for commercial success of homegrown drugs in the United States.

 

So far, domestic drugs that have received US approval have been far from conquering the global stage.

 

Factive’s overseas expansion was hindered when its partner GlaxoSmithKline withdrew from the deal over clinical data.

 

More than KRW 300 billion was invested in its development, but its sales in the U.S.

 

have been negligible.

 

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

 

market in 2016, have not performed as well commercially as expected.

 

The company voluntarily withdrew the license for Sivextro, citing low drug prices in Korea.

 

Quarterly Sales of Xcopri in the US (Unit: KRW 10 million, Data SK Biopharm).

On the other hand, SK Biopharm's Xcopri is gradually expanding its share in the US market.

 

Since its launch in the US, Xcopri has continued to renew its sales record every quarter.

 

After posting initial sales of KRW 2.1 billion in the US in 2020, the drug generated sales of KRW 75.7 billion in Q3 this year.

 

Xcopri’s cumulative sales in the US last year were KRW 169.2 billion, and in Q3 of this year alone, Xcopri surpassed last year's sales with KRW 193 billion.

 

Xcopri’s cumulative sales in the U.S.

 

over the past 3 years totaled at KRW 452.1 billion.

 

Rolvedon, a drug licensed out by Hanmi Pharmaceutical, has also continued to grow in the US market, with sales of $15.6 million (KRW 20 billion) and $21 million (KRW 28 billion) in Q1 and Q2 respectively.

 

Rolvedon was developed by Assertio Holdings, a pharmaceutical company specializing in central nervous system, pain, and inflammation, which acquired Spectrum Pharmaceuticals in April.