Reimbursed Leclaza nears annual sales of 1T won

Yuhan’s Leclaza wins reimbursement listing within just six months of approval as a first-line treatment

Reimbursement listing took only six months following MFDS approval for both first-line and second-line treatments

Conditional approval lifted, and FDA approval attainable

Yuhan Corp.'s new cancer drug, Leclaza, swiftly wins reimbursement listing for its use as a first-line treatment.

 

Following success with its second-line treatment, Leclaza received reimbursement for the first-line treatment within just six months of approval.

 

The second-line treatment alone has generated quarterly sales of 6 billion won and continues to perform well.

 

Similar to the success of the anticancer immunotherapy Keytruda after its reimbursement expansion , Leclaza is also anticipated to considerably benefit from its inclusion as first-line treatment.

 

Recently, the Ministry of Health and Welfare (MOHW) held a meeting of the Health Insurance Policy Deliberation Committee and approved the reimbursement expansion for Leclaza and Tagrisso as first-line treatment options.

 

Beginning next month, National Health Insurance will begin reimbursement for the use of Leclaza and Tagrisso as the "first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations." Leclaza, which was approved in January 2021 as the 31st Korean-made new drug, is indicated for treating NSCLC.

 

Initially, Leclaza was approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who had developed chemical resistance to a specific genetic mutation (T790M) following the administration of first or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI).

 

In June 2023, the Ministry of Food and Drug Safety (MFDS) approved the use of Yuhan’s Leclaza for first-line treatment of NSCLC.

 

Within just six months, Leclaza successfully passed the National Health Insurance’s reimbursement review.

 

Originally, Leclaza was launched in the Korean market with a reimbursement listing in July 2021, just six months following its approval by MFDS as second-line treatment.

 

It only took six months for Yuhan to obtain reimbursement approval for Leclaza’s first-line and second-line treatment uses following its approval by the MFDS.

 

This timeline is unprecedented in comparison to AstraZeneca’s effort to list Tagrisso in the national insurance reimbursement scheme.

 

Tagrisso became reimbursable more than five years after its first-line treatment use was approved in 2018.

 

Furthermore, in March 2023, Yuhan received marketing approval only three months after applying to the MFDS for Leclaza’s first-line treatment.

 

Yuhan continues to benefit from the rapid approval of Leclaza, having had its conditional approval removed just three years after its initial regulatory approval.

 

As of November 28th, Leclaza secured full approval to change indications by meeting all the conditions for the second-line treatment indication.

 

Yuhan presented additional analysis data that demonstrated Leclaza’s statistically significant effectiveness as a second-line treatment when compared to platinum-based chemotherapy.

 

Yuhan submitted an application for converting from conditional to full approval in August.

 

Impressively, Leclaza secured full approval within two years and ten months after its initial conditional approval.

 

Leclaza received approval first as a first-line treatment after demonstrating statistically significant improvement in progression-free survival in a multinational Phase 3 clinical trial (LASER301 study) for EGFR mutation-positive NSCLC.

 

Just 2 years and 10 months after obtaining conditional approval as a second-line treatment, Leclaza is now officially approved for both first and second-line treatments in EGFR mutation-positive NSCLC.

 

Increased sales is expected following Leclaza’s reimbursement approval for a first-line treatment option.

 

MOHW explains that "patients with locally advanced or metastatic NSCLC had to bear an annual medication cost of approximately 68 million won per person.

 

With National Health Insurance coverage, a patient’s out-of-pocket expense will be limited to a 5% co-payment, which comes to about 3.4 million won per year." Even though Leclaza is only reimbursed as a second-line treatment, it continues to show strong performance in the prescription market.

 

IQVIA, a drug market research company, reported on December 22nd that Leclaza's sales in Q3 reached 6 billion won.

 

In 2021, Leclaza recorded sales of 1.5 billion won and 2.6 billion won in Q3 and Q4, respectively.

 

Last year, it accumulated sales of 16.1 billion won, surpassing 10 billion won in its second year.

 

In 2023, Leclaza recorded sales in the upwards of 5 billion won in both Q1 and Q2, with a notable increase in Q3.

 

Leclaza’s total sales amounted to 164 billion won in Q3 in 2023.

 

Leclaza is on track to surpass the 200 billion won mark within three years of launching.

 

The initial sales of Leclaza show a promising start.

 

Commercial success of a domestically developed anticancer drug is challenging as it must compete with new products from global pharmaceutical companies.

 

Before Leclaza, other domestically developed anticancer drugs approved in Korea include Il-Yang Pharm's Supect, Dong-A Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm’s Riavax, and Hanmi Pharm's Olita.

 

Among these, only Leclaza exceeded an annual sales of 100 billion won.

 

MOHW has estimated that the inclusion of Leclaza as a first-line treatment option will require an additional budget of 881 billion won.

 

Mathmatically, there is a potential for Leclaza’s sales to surpass 1 trillion won next year.

 

In turn, the competition will intensify with Tagrisso, a similar cancer drug in the same class.

 

MOHW has projected an additional budget of 920 billion won for the reimbursement of Tagrisso as a first-line treatment.

 

HK Inno.N’s K-CAB stands out as the only domestically developed new drug to have achieved annual sales surpassing 1 trillion won.

 

Approved in 2018 as the 30th Korean-made new drug, K-CAB is categorized as a 'potassium-competitive acid blocker (P-CAB)' in the anti-ulcer drug class.

 

Its competitively binds with the proton pump and potassium ions in gastric cells' final acid secretion step, thereby inhibiting acid production.

 

K-CAB, now in its third year of sales, surpassed 1 trillion won in prescription sales in 2021 and thereafter continued to exceed this milestone for two consecutive years.

 

K-CAB has already made its mark in the "1 Trillion Won Club" for prescription sales by recording 1.141 trillion won in prescription sales in Q3 of this year.

 

Leclaza is postulated to enter the U.S.

 

market shortly.

 

On December 21, 2023, Johnson & Johnson (J&J) submitted to the U.S.

 

Food and Drug Administration (FDA) a new drug application for Leclaza and supplemental biologics license application for Rybrevant’s use in combination with Leclaza.

 

Previously, in November 2018, Yuhan licensed Leclaza's technology to Janssen Biotech and received an initial non-refundable licensing fee of $50 million.

 

The recent FDA submissions are based on results from the Phase 3 MARIPOSA clinical study, which tested the efficacy of the combination therapy of Rybrevant and Leclaza.

 

Interim analysis data from this clinical trial were presented at the European Society for Medical Oncology Annual Meeting (ESMO 2023) in October 2023.

 

In the clinical trial, Rybrevant and Leclaza combination therapy showed improvement in the primary endpoint of progression-free survival (PFS) when compared to Tagrisso (osimertinib) monotherapy.

 

The median PFS was 23.7 months with Rybrevant and Leclaza combination therapy versus 16.6 months with Tagrisso monotherapy.

 

The combination therapy demonstrated a 30% reduction in disease progression and mortality risk compared to Tagrisso monotherapy.