Exports of CKD·Dong-A ST's antianemic biosimilars increase

Chong Kun Dang’s exports rise 82% in 2 years…affected by Nesbell’s overseas sales

Cumulative exports of Dong-A ST’s ‘Darbepoetin α’ record ₩25.6 billion

The biosimilar products developed by Chong Kun Dang and Dong-A ST are starting to make their way into the overseas market, with its Nesp biosimilars starting to generate sales in earnest abroad.

 

Although the companies’ products did not show explosive growth upon entry, the products are increasing their presence in the market.

 

According to the Financial Supervisory Service, Chong Kun Dang’s export sales recorded ₩19.4 billion in Q1 this year, a 57.7% increase compared to sales made in the same period of the previous year.

 

Compared to the ₩10.6 billion it had made in Q1 2020, the scale of exports increase 82.3% in two years.

 

In the case of Chong Kun Dang, the company’s sales had been solely dependent on domestic demand.

 

Its exports in Q1 2019 were a mere ₩6.3 billion.

 

Chong Kun Dang’s ‘Nesbell’ is being highlighted as the driver of CKD’s recent growth in exports.

 

New drug products being developed by Hanmi Pharmaceutical have received a total of 20 orphan drug designations from regulatory authorities in Korea and abroad.

 

Hanmi Pharmaceutical announced on the 9th that the European Medicines Agency granted an orphan drug designation for its new triple action biologic drug LAPS Triple Agonist (HM15211) for the treatment of Idiopathic pulmonary fibrosis (IPF).

 

Idiopathic pulmonary fibrosis is a rare condition caused by an unknown pulmonary inflammatory process and fibroblast hyperproliferation.

 

Patients with IPF experience a rapid decline in lung function from tissue fibrosis and even death.

 

Although it occurs in less than 100 cases per 10,000, its treatment had been rendered difficult due to the lack of efficacy in its approved treatments.

 

LAPS Triple Agonist is a triple-action biologic drug that activates GLP-1, Glucagon, and GIP.

 

It simultaneously targets▲ Glucagon, which inhibits fibrosis ▲ GLP-1, which facilitates insulin secretion and helps suppress appetite, and ▲ GIP, which facilitates insulin secretion and anti-inflammatory effect.

 

Hanmi Pharmaceutical had confirmed its drug’s antiinflammatory and antifibrotic in animal models with idiopathic pulmonary fibrosis.

 

With the designation Hanmi Pharmaceutical received a total of 20 orphan drug designations for its 10 indications in 6 pipelines (9 FDA designations, 8 EMA designations, and 3 Korea MFDS designations).

 

LAPS Triple Agonist received a total of 6 orphan drug designations from both the FDA and EMA for the treatment of ▲primary biliary cholangitis, ▲primary sclerosing cholangitis, and ▲IPF.

 

The FDA and EMA grant orphan drug designations to facilitate smooth development and approval of drugs that treat rare, incurable, or life-threatening diseases.

 

In Europe, drugs that receive the designation pay reduced fees for marketing-authorization applications and may benefit from ten years of market exclusivity once they receive marketing authorization in the European Union (EU) An official from Hanmi Pharmaceutical said, “All the indications that the drug received orphan drug designation on induces fibrosis in specific tissues and has high unmet needs.

 

LAPS Triple Agonist’s designation has meaning in that the drug's innovativeness is receiving attention from regulatory agencies in advanced countries.

 

Nesbell is a biosimilar of the second generation anemia treatment ‘Nesp (darbepoetin-α).’ It is prescribed to treat ▲anemia in chronic kidney disease patients and ▲anemia in patients with solid cancer who receive chemotherapy.

 

Chong Kun Dang received marketing approval from Japan's Ministry of Health, Labor, and Welfare in September 2019.

 

The Japanese subsidiary of U.S.

 

global pharmaceutical company Mylan N.V.

 

is in charge of sales in Japan.

 

Analysts believe that the continued growth of Nesbell’s sales in Japan had driven the continued growth of Chong Kun Dang’s export in Japan.

 

Nesbell holds great significance for the company as it is the first biosimilar that it succeeded in developing.

 

Chong Kun Dang entered the biosimilar market after securing its own platform technology in 2008.

 

After initiating a Phase I trial on Nesbell in 2012, Chong Kun Dang succeeded in becoming the first company to commercialize a biosimilar of Nesp by receiving marketing approval for Nesbell from the Ministry of Food and Drug Safety at the end of 2018.

 

Nesbell is also set to enter the Middle East soon.

 

Chong Kun Dang signed an export agreement for Nesbell with an Oman company Menagene Pharmaceutical Industries in July last year.

 

Under the agreement, Menagene Pharmaceutical Industries will be acquiring the marketing authorization and own the exclusive rights to sell Nesbell in 6 countries in the Middle East, including Oman, Saudi Arabia, Chong Kun Dang starts supplying its finished Nesbell product to United Arab Emirates, Kuwait, Qatar, and Bahrain.

 

The drug is also increasing its presence in the Korean market.

 

According to the market research institution IQVIA, Nesbell’s sales last year amounted to ₩4.8 billion, which was a 150.9% YoY increase.

 

Its sales had only been ₩0.3 billion and ₩1.9 billion in the first year of its release and 2020, respectively.

 

Its sales has risen significantly last year to increase its market share in the same ingredient market to 18.5%.

 

Dong-A ST’s Nesp biosimilar ‘Darbepoetin-α’ is also slowly increasing its influence in the market.

 

After conducting a Phase 1 clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK).

 

Based on a Phase III trial conducted in Japan to compare the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare for the drug in September 2019 and launched the drug for sale in November of the same year.

 

Dong-A ST exports the finished products which were produced by DM Bio, a biosimilar company under Dong-A Socio Group, to SKK, after which SKK takes charge of its local sales.

 

Darbepoetin-α’s exports increased 13.8% YoY to record ₩3.3 billion in Q1 this year.

 

This is a decrease from the ₩6.1 billion made in Q4 last year, but still has been making ₩3 billion in sales every quarter.

 

Darbepoetin-α had first made ₩1 billion in the first year of its release, which increased to ₩8.8 in 2020.

 

Its sales then exceeded ₩10 billion in annual sales for the first time last year, recording ₩12.5 billion.

 

Darbepoetin-α’s cumulative sales totals at ₩25.6 billion.