Aiming at ‘2nd Leclaza,’ Yuhan quickens steps to develop new drugs in 2023

Yuhan Corp. is hastening its steps to develop new drugs that can succeed Leclaza (lazertinib), which is cruising as a homegrown blockbuster for cancer treatment.

In a recent interview with reporters covering the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Yonhan Corp. CEO Cho Wook-je disclosed the company’s business goals and plans for this year, including major new drug pipelines under development.

“We will expand R&D investment and upgrading pipelines to grow into global pharmaceutical companies and establish future growth engines,” Cho said. “This year, we will focus on expanding clinical pipelines and securing and applying promising new platform technologies.

Yuhan continued to increase R&D investment from 110.5 billion won ($89.7 million), 7 percent of its revenue, in 2018 to 139.9 billion won in 2019 (9.5 percent) and 225.6 billion won in 2020 (13.7 percent) before falling to 178.3 billion won in 2021 (10.6 percent).

Behind the relatively impressive performance of Leclaza, the 31st homegrown new drug released in 2021, amid global blockbusters, are such vigorous investments into research and development, the company said. Aside from Leclaza, Yuhan has also secured 29 new drug pipelines and 16 incrementally modified new drug pipelines.

CEO Cho said the company would further develop these new drugs this year.

More specifically, the company targets to win approval for lazertinib as the primary treatment and its global phase 3 clinical trial; phase 1 b clinical trial for the technology export concerning non-alcoholic steatohepatitis (NASH); phase 2 clinical trial for the tech export concerning gastrointestinal mobility diseases; continue or begin clinical trials for other tech export tasks; and strengthen open innovation and promote research cooperation with global pharma companies, Cho said.

Yuhan is conducting a global phase 3 clinical trial regarding the primary treatment for Leclaza, the third-generation mutant EGFR (epidermal growth factor receptor)-inhibiting lung cancer treatment, and another global phase 3 trial to combine it with Yanssen’s antibody cancer therapy, Amivantamab. Leclaza is prescribed as the secondary treatment for non-small cell lung cancer (NSCLC) patients in Korea.

In the case of YH2572, another rising candidate of Yuhan, Yuhan seeks to expand its indications to diabetes and obesity in addition to the ongoing phase 1 clinical trial as NASH treatment. This new drug candidate is expected to have a dual effect on liver fibrosis, inhibition of fatty hepatitis, and metabolic function improvement. The technology was exported to Boehringer Ingelheim for around 1 trillion won.

Besides, Yuhan is conducting a phase 3 clinical trial of YHI14168, a degenerative herniated intervertebral disc treatment, in the U.S.; phase 2 b clinical trial for YH12852, a gastrointestinal mobility disorder treatment, in the U.S.; and preclinical trial for NASS/fibrosis treatment being developed jointly with Gilead.

“The company, even amid the difficult business environment due to prolonged Covid-19, Russia’s war in Ukraine, U.S.-China trade conflict, and global inflation and unstable prices, has set this year’s sales growth 9 percent higher than last year by focusing on innovative cancer treatment Leclaza, probiotics and incrementally modified new drugs by Addpharma,” CEO Cho said.

In addition, Yuhan will upgrade the clinical phase of the existing task to develop a second or third Leclaza and introduce new pipelines amid continuous investment into research and development, he emphasized.

“We have invested in R&D, existing businesses, and new businesses to become global companies for many years. We will seek various investment methods and partnerships this year to introduce new pipelines, secure infrastructure, and create synergy with existing businesses,” Cho said, “In addition, we will make efforts to build infrastructure for the sustainable growth of existing businesses. We will move past the 100th anniversary and open another 100 years through these and other efforts.”