Author Archives: Yuhan USA

Yuhan Corporation’s “Leclaza (Ingredient: Lazertinib)”, a third-generation targeted therapy for EGFR T790M-mutated NSCLC, has received approval as a 2nd line of therapy from the South Korean Ministry of Food and Drug Safety as Korea’s 31st novel drug. 

Leclaza will be administered to the patients who have previously been treated for lung cancer but now have recurrent advanced lung cancer with mutations in specific genes. As a targeted anticancer treatment, Leclaza inhibits the growth and proliferation of lung cancer cells by interfering with the signal transmission. It has the advantage of being less toxic to normal cells. It has also shown excellent efficacy and tolerability to lung cancer patients with brain metastases as it can pass through the blood-brain barrier (BBB).

The Ministry of Food and Drug Safety announced that their approval was based on the results of the phase 2 clinical trial conducted in Korea, and it was granted on the condition that Yuhan conducts Phase 3 clinical trials after the sales begin. 

The Ministry also explained that the quality, safety, effectiveness, and post-marketing safety management plans for the applied drug were thoroughly reviewed and evaluated in accordance with the criteria of the Pharmaceutical Affairs Act.

The health authority said, "Through this new drug approval, we expect to expand the range of drug options for the treatment for NSCLC patients with positive EGFR T890 mutations."

Yuhan retains the commercialization rights to Leclaza in South Korea, while Janssen has the global commercial rights outside of South Korea. 

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Yuhan Corporation announced that the company will receive $65 million in milestone payment from Janssen Biotech for Lazertinib, a third-generation EGFR TKI for NSCLC (non-small cell lung cancer), which was out-licensed to Janssen in 2018. As a result, Yuhan became the first in the Korean pharmaceutical industry to earn $100 million in milestone payments from an out-licensing deal.

This milestone is for the initiation of phase 3 clinical trial of the combined use of Yuhan’s Lazertinib and Janssen's Amivantamab as the first-line treatment for EGFR mutant NSCLC.

Moreover, Yuhan is independently conducting a multinational phase 3 clinical trial as well to confirm the efficacy and safety of Lazertinib alone as a first-line monotherapy for patients with EGFR mutation-positive NSCLC.

An official from Yuhan said, “Yuhan and Janssen are working closely together to provide better treatment options for those non-small cell lung cancer patients.”

Yuhan Corporation has signed a memorandum of understanding for strategic alliance with Imperial College London to participate in the “ICiC (Imperial Confidence in Concept)” program and fund their proof of concept collaborative projects as an industry partner.

The ICiC program promotes the transition of academic research into novel therapeutic development by distributing grants from the British government, institutions, and companies to promising translational research projects. Major research areas of Imperial College’s ICiC include cancer, immunology, infection, fibrosis, cognitive science, and therapeutic development.

Through participation in this program, Yuhan will provide research funds to Imperial College and conduct joint research on initial new drug development projects in the field of interest.

Yuhan expects that the combination of Yuhan's expertise in the drug development and Imperial College London's innovative basic science research will create synergy in the development of global innovative drugs.

Jung-Hee Lee, CEO of Yuhan Corporation, said, “This collaboration with Imperial College London, which is part of our global open innovation strategy, will strengthen our R&D pipeline and provide a foothold for Yuhan to enter the European market.”

Yuhan Corporation has signed a three-party agreement with Sungkyunkwan University (SKKU) and Imnewrun Biosciences to build a Brain Disease R&BD ecosystem. For the first time in Korea, a pharmaceutical company, university, and biotech company work together to foster an innovative platform and industry-academia ecosystem for brain diseases.  

Through this agreement, the three institutions will:

  • Create an education and research cluster for the life science industry
  • Develop innovative technologies and secure a drug pipeline for brain diseases
  • Establish a research institute for brain diseases at SKKU, one of the leading private academic research universities in South Korea.
  • Conduct joint R&D with Samsung Medical Center, an SKKU-affiliated hospital
  • Start a new department/program in SKKU for Basic Brain Science and Technology

In 2019, Sungkyunkwan University and Yuhan Corporation had signed a business agreement to establish a comprehensive and strategic industry-academia partnership. Also, Yuhan Corporation and Imnewrun, a biotech specialized in brain diseases, have been jointly developing three new drug programs for brain cancer and other brain diseases.

Yuhan is expanding the CNS pipeline through investment and joint development and reinforcing its R&D capabilities to discover new brain disease drugs with business potential.

Lee Jung-Hee, President of Yuhan Corporation, said, "Yuhan will strive for a leap forward as a global pharmaceutical company through the brain disease research and development platform and make a contribution to Korea’s pharmaceutical industry.”

Yuhan Corporation entered into a licensing agreement worth up to $415 million with Processa Pharmaceuticals for the development of YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders (FGID).

YH12852 is an agonist that exhibits excellent selectivity to a receptor (5-HT4) that plays an essential role in the regulation of intestinal movement and sensory. Unlike other 5-HT receptor agonists, which have been removed from the market or not approved because of the cardiovascular side effects associated with the drugs binding to other receptors, YH12852 has confirmed excellent bowel movement improvement effects without any cardiovascular side effects through its preclinical toxicity and phase 1 clinical trial in Korea.

Processa will have a clinical development meeting with the U.S. Food and Drug Administration and conduct a phase 2 clinical trial in functional GI motility-related disorder that needs better therapeutic options, such as postoperative intestinal obstruction or opioid-induced constipation, in 2021.

Under the agreement, Yuhan will receive a non-refundable upfront payment of $2 million in the form of processa shares, and also will be eligible to receive up to $415 million including additional payments, commercial milestones, and royalties on net sales.  In exchange, Processa will acquire global rights to the development, manufacturing, and commercialization of YH12852 except for South Korea, where Yuhan will retain such rights.