‘Yuhan expects Leclaza’s FDA approval this year'

“Will also focus on global trials on the company’s 28 new drug candidates”

Wook-Je Cho, President, CEO & Executive Director of Yuhan Corp

“Expect FDA will approve the Rybrevant combination therapy within the year...Will also accelerate trials for second-line therapies"

“Will start clinical trials of its 28 candidates, including those for MASH and obesity, in earnest…on a smooth journey to discovering the company’s ‘next Leclaza’”

Wook-Je Cho (59), President, CEO & Executive Director of Yuhan Corp, has set global commercialization of its new anti-cancer drug Leclaza (lazertinib) as the company’s top priority this year.

 

Last year, the company focused on the challenge of securing first-line reimbursement coverage for Leclaza in Korea.

 

This year, he plans to move on to the global stage and focus on securing the U.S.

 

Food and Drug Administration (FDA) approval for its Leclaza+Rybrevant combination therapy.

 

In addition, he emphasized that the company will focus on global clinical trials of 28 drug candidates, including a treatment for metabolic dysfunction-associated steatohepatitis (MASH) and a treatment for obesity, to achieve the company’s goal of becoming a ‘top 50 global pharmaceutical company’ by 2026, the 100th anniversary of the company's founding.

 

" Expect FDA approval of Rybrevant-Leclaza combination...

 

results come out within the year"

Wook-Je Cho, President, CEO & Executive Director of Yuhan Corp

CEO Cho recently met with reporters and pointed to ‘FDA approval of Leclaza’ as his most anticipated achievement this year.

 

Leclaza is the 31st novel drug to be developed in Korea.

 

It had first received approval as a second-line treatment for patients with EGFR T790M mutation-positive, locally advanced, or metastatic non-small-cell lung cancer who were previously treated with an EGFR-TKI.

 

The past year, the company focused on expanding insurance reimbursement of Leclaza from second-line to first-line treatment.

 

The company received approval for the drug’s first-line use from the Ministry of Food and Drug Safety in June last year and passed through the health insurance reimbursement gateway in 6 months since then.

 

Leclaza has been reimbursed as a first-line treatment in Korea since January this year.

 

The company’s next goal is global commercialization.

 

Late last year, Johnson & Johnson (J&J) submitted a supplemental Biologics License Application (sBLA) and a New Drug Application (NDA) to the FDA for the approval of Leclaza in combination with its EGFR-positive non-small cell lung cancer drug Rybrevant (amivantamab) at the end of last year.

 

The industry expects a decision to be made within this year.

 

If Leclaza crosses the FDA threshold, it will be the first of Yuhan Corp's new drugs to enter the U.S.

 

market.

 

Cho said, "Together with Janssen, we look forward to pursuing U.S.

 

and European approvals for the Rybrevant+Leclaza combination within the year.

 

Also, we expect to see positive overall survival (OS) data following the progression-free survival (PFS) data we secured last year." The trial results for the use of the triple Rybrevant+Leclaza+chemotherapy combination therapy as a second-line treatment are also gaining attention.

 

Janssen is currently conducting 2 studies - MARIPOSA and MARIPOSA-2.

 

MARIPOSA is a study on the first-line use of the two-drug combination, Rybrevant+Leclaza, which the company had sought FDA approval for.

 

At the same time, the company started a trial on the use of the 3-drug Rybrevant+Leclaza+chemotherapy combination as a second-line treatment through the MARIPOSA-2 study.

 

The study enrolled patients who were previously prescribed Tagrisso.

 

The second-line treatment trials are expected to provide faster market penetration results than first-line treatment trials because there is currently no treatment available after Tagrisso in the indication.

 

Janssen and Yuhan are awaiting results on the recruitment of additional patients for the three-drug combination.

 

Cho said, "We expect results from the Janssen-led global Phase III second-line therapy study to be available within a year," Cho said.

 

"Will focus on discovering the next Leclaza, including treatments for MASH, allergies, and obesity" Cho also emphasized that the company will also speed up the discovery of its next Lekraza.

 

The company is currently running non-clinical and clinical trials on its 28 drug candidates.

 

One substance gaining particular attention is ‘YH25724,’ which is being developed as a treatment for MASH.

 

In 2019, the company signed an out-licensing agreement with Boehringer Ingelheim for YH25724, worth USD 870 million (approximately KRW 1 trillion).

 

Boehringer Ingelheim entered the Phase I trial for the substance in Europe in 2021.

 

A Phase 1b clinical trial is currently underway.

 

It has a mechanism of action that simultaneously inhibits liver fibrosis and steatohepatitis while improving metabolic function.

 

Boehringer Ingelheim and Yuhan Corp plan to first commercialize the product for MASH, and then expand its indication to diabetes and obesity.

 

Also of interest is ‘YH35324,’ a candidate for the treatment of allergic diseases.

 

This candidate has a mechanism of action that binds to immunoglobulin IgE and works on protein allergies.

 

It is expected to be used as a treatment for chronic urticaria, food allergies, and asthma.

 

Yuhan aims to complete the domestic Phase Ib study of YH35324 within the year and apply for approval of its Phase 2 trial plan by the end of the year.

 

‘YH32367,’ which is being developed as a bispecific antibody anticancer drug, is expected to enter Phase Ib clinical trials in the second half of the year.

 

It activates target tumor-specific T cell immunity, and Yuhan Corp expects to be able to acquire indications for breast, gastric, and biliary cancers in the future.

 

In addition, the company’s clinical development pipeline includes ‘YH14618’ for degenerative disc disease, ‘YH12852’ for gastrointestinal motility disorders, and ‘YH34160’ for obesity.

 

YH34160 is a novel, long-acting obesity treatment candidate that targets the GDF15 fusion protein.

 

It was approved for a Phase I clinical trial in the U.S.

 

last year, and the company is currently exploring partners to proceed with its global clinical development.

 

Cho plans to lay the foundation for long-term global expansion with the company’s broad clinical development pipeline.

 

Cho said, “We will focus on expanding our pipeline to next-generation anticancer drugs and metabolic, fibrosis, and immune-inflammatory therapies and speed up our entry into early clinical and non-clinical trials.

 

We want to secure a base to expand our late-stage pipeline in the long term." Cho added, "We will expand our pipeline by actively engaging in open innovation in Korea and abroad, in addition to our focus on in-house development.

 

We will strengthen partnerships with global pharmaceutical companies to speed up existing development projects and increase potential for technology exports." Yuhan Corp rises as an ‘M&A bigshot..." will further expand investment this year" Cho said the company will also diversify its business through active M&A with domestic and foreign companies.

 

The company has recently risen as a big M&A player in the domestic pharma and bio industry.

 

Last year, it acquired Progen for KRW 30 billion to work together for the development of multi-target antibody therapeutics.

 

It also invested KRW 5.7 billion in Fermentec to produce high-quality, low-cost probiotics.

 

In 2022, Yuhan also invested a total of KRW 32.6 billion in 9 projects, including acquiring the probiotics manufacturer AtoGen for KRW 17.5 billion.

 

The company's total investments in the last decade since 2014 totals almost KRW 602.4 billion in 54 companies.

 

Cho explained, “We are continuously promoting new businesses to secure future growth engines while making strategic investments to strengthen existing businesses and develop R&D.

 

We will continue to seek opportunities to become a total healthcare company this year."