Successful year for Korean new drug, biosimilar and test kit

[2020 R&D Briefing] Part 2. Global sales performance of major new drug and biosimilars

The year 2020 was a fruitful year for the South Korean companies and their R&D outcomes showcased in the global market.

 

Yuhan Corporation licensed out its novel lung cancer treatment ‘lazertinib’ to Janssen for 100 billion won.

 

SK Biopharmaceutical put the gears in motion for its anti-epileptic drug Xcopri sales in the U.S.

 

market.

 

The previously neglected diagnostic testing kit manufacturers emerged amid COVDI-19 as the success cases of the infectious disease prevention in South Korea.

 

Samsung Bioepis and Celltrion broke the export record with their competitively priced biosimilars.

 

◆Yuhan’s Lazertinib confirms 100 percent response rate, the milestone pays out 100 billion won A number of new drugs developed by South Korean pharmaceutical companies have been impactful in the global market this year.

 

An image of Yuhan Corporation HQ

Yuhan met the development milestone for the novel lung cancer drug lazertinib, licensed to Janssen Biotech two years ago, and received a milestone payment of total USD 10 million paid out in April and November this year.

 

Lazertinib is a third generation epidermal growth factor receptor (EGFR) targeted therapy Yuhan licensed out to Janssen Biotech in November 2018.

 

The Korean company signed the deal with the 50 million-dollar upfront payment and maximum payment of 1.25 billion dollars including clinical, approval and sales milestones.

 

At the ‘European Society for Medical Oncology (ESMO) Virtual Congress 2020’ convened in last September, Janssen presented a Phase Ib interim report on confirming an outstanding response rate in lazertinib combined with amivantamab.

 

20 non-small cell lung cancer (NSCLC) patients with no previous treatment history, who have either EGFR exon 19 deletion or L858R mutation, have been treated with the lazertinib combination therapy and reached 100 percent objective response rate (ORR) in seven months.

 

Besides lazertinib, Yuhan has also inked five new drug technology license out deals in last two years.

 

When the non-alcoholic steatohepatitis (NASH) treatment candidate, licensed out to Boehringer Ingelheim, completed the non-clinical toxicity test in last April, Yuhan acquired 10 million dollars.

 

Within this year, Yuhan generated total of 77.9 billion won for the license out contracts, which vastly exceeds 57.1 billion won, the operating income accumulated up to third quarter.

 

As the value of licensing out new drug commercialization has gone up, the Korean company successfully overcame the risk of faltering sales with expanded R&D investment.

 

◆SK’s Xcopri commercialized in the U.S.

 

New drugs developed by SK Biopharmaceutical’s own technology are also seeing some satisfying commercialization outcomes.

 

SK Biopharmaceutical has generated 9.9 billion won as of the third quarter this year.

 

The statistic report found a narcolepsy treatment Sunosi (solriamfetol), licensed out to Jazz Pharmaceutical in 2011, generated 4.6 billion won and a partial-onset seizure treatment Xcopri (cenobamate) generated 5.3 billion won.

 

Although the figure is insignificant compared to last year’s sales 123.6 billion won, making almost 10 billion won from the license out sales was remarkable.

 

Currently, SK Biopharmaceutical has diversified commercialization strategy for Xcopri in respective regions.

 

For the world’s biggest U.S.

 

market, the Korean company’s subsidiary in the region SK LifeScience directly launched the product in last May.

 

Also the company plans to directly handle the Xcopri commercialization in Japan, China and South Korea, but for other regions like Europe, the company plans to seek a local partner.

 

◆COVID-19 testing kit '99.9 percent for export' Testing kit companies in South Korea had an unexpectedly successful year due to the pandemic.

 

One of the top companies who benefitted from the global pandemic is a molecular testing kit specialist company Seegene.

 

The company’s accumulated operating income up to the third quarter skyrocketed by 24 times from 17.3 billion won last year to 418.7 billion won this year.

 

During the three quarters, the company generated 683.5 billion won of sales revenue, which is more than eight-folds of last year’s.

 

Among all healthcare companies in South Korea, Seegene came in second with the operating income following Celltrion making 245.3 billion won.

 

The operating income against sales revenue marked 64.9 percent.

 

If the sales revenue actually exceeds the company’s projection for this year at 1 trillion won, the company would be making almost ten-folds of last year at 122 billion won.

 

Seegene COVID-19 test kit

Seegene had a record breaking performance by proactively developing COVID-19 testing kit to help diagnose the infectious disease in suspected patients during the early stage of COVID-19 outbreak.

 

The company exports the COVID-19 relevant products out to 70 countries.

 

As of the third quarter, the 94.4 percent, or 645.4 billion won, of the overall sales revenue was from the export.

 

Regardless of the swift distribution of COVID-19 vaccine in the U.S.

 

and other countries, the industry projects the worldly demand for the testing kit would remain high for a while.

 

◆Celltrion and Samsung Bioepis break quarterly revenue Amid COVID-19, South Korea’s top biosimilar companies continued to exceed top export records with successful portfolio.

 

Celltrion (left) and Samsung Bioepis R&D laboratory (Source: respective companies)

Celltrion Healthcare easily passed last year’s annual sales revenue at 1.10 trillion won by earning 1.24 trillion won as of the third quarter this year.

 

Celltrion Healthcare sells Celltrion’s biosimilar products to global distributors.

 

Basically, Celltrion Healthcare’s sales revenue indicates Celltrion’s antibody biosimilar export volume.

 

Mabthera’s biosimilar Truxima, prescribed to patients with blood cancer and rheumatoid arthritis, topped the leader board by selling 590.5 billion won as of the third quarter.

 

Celltrion’s U.S.

 

partner Teva reported Truxima’s market share reached 20.4 percent as of September, which was only 11 months after the U.S.

 

market launch.

 

The company also noted the drug is threatening the original’s top position with the drug’s strength of being the first rituximab biosimilar anticancer treatment.

 

Breaking its own top record, Samsung Bioepis’ third quarter sales revenue of 236.9 billion won grew 2.3 percent from last year at 231.6 billion won.

 

Although COVID-19 has slowed down the growth, the company made a new quarterly revenue record in a year as the biosimilar sales in Europe surged.

 

Samsung Bioepis’ European partner Biogen said three biosimilar products combined—Benepali, Flixabi and Imraldi—have earned 27.9 million dollars (approximately 235.7 billion won) in the last third quarter.

 

The Korean company’s Enbrel biosimilar Benepali was the first product to tap on the European market, and it made 124.20 million dollars, jumping 7.2 percent from last year same time.