Leclaza costs 88 billion won for phase 3 in 3 years

challenging the first-line treatment,

Yuhan's development cost 104.8 billion won by the end of last year

Leclaza intangible assets increased by 26.6 billion won from the previous year to 88 billion won

Application for first-line treatment based on phase 3 clinical results

Last year, Yuhan invested a total of 88 billion won in phase 3 clinical trial of Leclaza, a new anti-cancer drug.

 

Yuhan Corporation is challenging the first-line treatment approval based on the efficacy and safety of Leclaza confirmed in clinical trials.

 

According to the Financial Supervisory Service on the 20th, as of the end of last year, Yuhan Corporation's development costs reflected as intangible assets totaled 104.8 billion won.

 

It increased by 33.1 billion won in one year from 71.7 billion won at the end of 2021.

 

In 2019, the Financial Supervisory Service set a standard that accounting assets can be treated only when there is technical feasibility of R&D tasks such as new drugs.

 

The Financial Supervisory Service suggested that R&D costs can be turned into assets by initiating phase 3 clinical trials for new drugs and approval of phase 1 clinical trials for biosimilars.

 

Generics can be capitalized after the BA test is approved.

 

Yuhan's R&D intangible assets are R&D costs invested in Leclaza and eight IMDs.

 

Among them, Leclaza's development cost intangible assets amounted to 88 billion won.

 

A total of KRW 88 billion was used for Leclaza's phase 3 clinical trial.

 

Leclaza accounted for 84.0% of Yuhan's development cost intangible assets.

 

Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January 2021.

 

Patients with locally advanced or metastatic non-small cell lung cancer who developed T790M resistance after administration of first- and second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are eligible for the treatment.

 

It acts as a mechanism to inhibit the proliferation and growth of lung cancer cells by interfering with the signal transduction involved in the growth of lung cancer cells.

 

Leclaza recognized development costs of 32.6 billion won as intangible assets for the first time in the fourth quarter of 2020.

 

As phase 3 clinical trials began in earnest, development costs were reflected as intangible assets.

 

Leclaza's development cost intangible assets increased to 61.4 billion won at the end of 2021, and 26.6 billion won was added last year.

 

As the cost of phase 3 clinical trials for Lecraza increased, the development cost that Yuhan Corp.

 

reflected as an asset exceeded 100 billion won for the first time.

 

Yuhan is challenging the first-line treatment approval based on the results of Leclaza's phase 3 clinical trial.

 

On the 17th, Yuhan Corporation applied for approval to use Lexraza as a first-line treatment for patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations in locally advanced or metastatic non-small cell lung cancer.

 

Leclaza demonstrated superior safety and efficacy compared to existing treatments in phase 3 clinical trial (LASER301) conducted on 393 patients with active EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer who had not previously received treatment.

 

The clinical results were recently unveiled at the Asian Congress of the European Society for Oncology held in Singapore.

 

If Leclaza's use as a first-line treatment expands, sales are projected to soar.

 

Although Leclaza is used on a limited basis as a second-line treatment, it is evaluated that it has successfully settled in the market.

 

According to IQVIA, a pharmaceutical research institute, Leclaza recorded sales of 16.1 billion won last year.

 

It increased by 4 times from 4.1 billion last year.

 

Leclaza entered the prescription market in earnest in July 2021 with its listing on the health insurance benefit list.

 

Sales of KRW 1.5 billion and KRW 2.6 billion occurred in the third and fourth quarters of 2021, respectively.

 

Leclaza sold 3.2 billion won and 3.7 billion won in the first and second quarters of last year, respectively, and expanded to 4.6 billion won and 4.5 billion won in the third and fourth quarters.

 

Leclaza recorded cumulative sales of 20.2 billion won for a year and a half after its release.

 

Leclaza has already broken the sales record for new anti-cancer drugs developed in Korea.

 

Domestically developed anti-cancer drugs approved prior to Leclaza include Ilyang Pharm's Supect, Dongwha Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm's Riavax, and Hanmi Pharm's Olita.

 

None of these products exceeded 10 billion won in annual sales.