Yuhan Corp. said it is accelerating its efforts to develop the next breakthrough therapies following its success with Leclaza (ingredient: lazertinib), the company's flagship treatment for non-small cell lung cancer (NSCLC).

The company hosted a press conference in Yeouido, Seoul, on Friday, to outline its strategic direction, following the recent U.S. FDA approval of Leclaza in combination with Johnson & Johnson (J&J) 's Rybrevant (ingredient: amivantamab-vmjw) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with specific EGFR mutations on Tuesday, local time.

During the event, Yuhan Corp. Chief Strategy Officer Oh Se-woong said the company is focusing on its strongest areas to develop second and third therapies that can follow Leclaza's steps.

These include targeted therapies and immunotherapies in the oncology sector and metabolic and cardiovascular disease treatments.

Yuhan currently has a total of 33 drug candidates in its pipeline, with six in the clinical stage, according to Oh.

"We expect to have over 12 clinical-stage pipelines by next year, as more than four additional candidates are anticipated to enter clinical trials in the latter half of this year and next year."

Prominent candidates for becoming the next Leclaza include the YH32367 (immunotherapy), YH35324 (allergy treatment), and YH35995 (Gaucher disease treatment).

YH32367 is a bispecific antibody drug that targets the HER2 protein while simultaneously stimulating the immune system.

In preclinical trials, YH32367 demonstrated superior anti-cancer effects compared to control antibodies, even showing efficacy against cancer cells with low HER2 expression.

Currently, the drug is in phase 1/2 clinical trials, having completed the dose-escalation and is now progressing to the dose-expansion phase.

YH35324, an allergy treatment, was licensed from the Korean biotech company GI Innovation in 2020, with Yuhan holding global rights, excluding Japan.

The drug is currently in phase 1 clinical trials, and with additional data, Yuhan plans to initiate multinational phase 2 trials alongside active discussions for technology transfer.

Previous results from the phase 1 trial indicated that YH35324 significantly reduced blood levels of Immunoglobulin E (IgE), an allergy-causing antibody, more rapidly than placebo or active control groups.

YH35995, a newly developed Gaucher disease treatment, has just entered clinical trials.

Gaucher disease is a rare genetic disorder currently treated with enzyme replacement therapy administered via injection.

To improve patient convenience, Yuhan is developing YH35995 as an oral synthetic drug capable of crossing the blood-brain barrier (BBB), which is notoriously difficult for medications to penetrate.

In disease models, YH35995 extended survival periods, and its safety and tolerability are now being evaluated in a phase 1 trial involving 108 adults in Korea, with completion expected by June 2026.

"Existing therapies like Sanofi's show limited efficacy," Oh noted, "but YH35995 has shown promising clinical results, so we are accelerating its development."

During the conference, Yuhan Corp. Head of Global R&D Innovation Lee Young-mi also stressed that the company, which developed Leclaza through its open innovation strategy, intends to maintain this approach moving forward.

Lee emphasized the focus on diseases such as cancer, cardiovascular, renal, metabolic, and immuno-inflammatory diseases.

"In oncology, we are leading with Leclaza and targeting solid tumors, particularly those where we can develop best-in-class therapies," Lee said. "We are also actively reviewing new modalities that can address unmet medical needs in existing treatments."

Lee also mentioned that Yuhan is exploring new targets related to metabolic diseases, particularly obesity and associated comorbidities, and is seeking drug delivery systems that enhance patient convenience.

Meanwhile, regarding questions from reporters about the future direction of the Leclaza and Rybrevant, Yuhan refrained from commenting on the milestone payments or clinical development plans.

Yuhan Corp. President and CEO Cho Wook-je stated that since Johnson & Johnson, which holds global rights, has been responsible for the clinical development plans and FDA approval, the company's information is limited.

"Our goal is to continuously create global blockbusters, and we hope to eventually manage the entire process independently," Cho said.