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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.







Yuhan USA Corporation was established in January 2018 as a wholly-owned subsidiary of Yuhan Corporation, Korea’s largest pharmaceutical company with a 94-year heritage.






As an outpost of Yuhan’s globalization strategy, Yuhan USA is seeking new opportunities to expand its business domain through searching new drug materials and companies that match with Yuhan’s targeted therapeutic areas under its open innovation platform.






Business Development Manager will have the responsibility for exploring the new business opportunities and In-licensing novel assets that align with Yuhan USA’s focused therapeutic areas.





Responsibilities:
- Build relationships with potential business partners, outside counsel, and other key external parties
- Attend conferences, seminars, meetings, and industry events as a representative of Yuhan USA
- Act as a liaison between external partners and internal R&D team; facilitate meetings in regards to product development, R&D collaboration, and other issues
- Perform research and analysis for focused therapeutic areas; report to the management and R&D department





Qualifications:
1. Required
- MS in Life Sciences, Pharmacy, Biological areas, Business or related discipline
- Relevant biotech or pharmaceutical industry experience





2. Preferred
- MBA, Ph.D. or other advanced degree
- Experiences in drug research, development, and commercialization activities





3. Others
- Excellent interpersonal, networking and communication skills
- Fluent in both English and Korean preferred



Yuhan and AbClon have joined the list of pharmaceutical companies that are in the race to develop a therapeutic antibody for COVID-19. They have identified a multifariously adaptive candidate for COVID-19 therapy, which they plan to begin testing on humans before the end of this year.





According to Yuhan and Abclon, their antibody in a laboratory setting has shown neutralizing effects, not only for the “S-strain”, which was widespread in Asia, but also for the “G-strain” mutations of COVID-19, which is prevalent in the US, Europe, and now in South Korea as well.





Since February, AbClon had been running its Novel Epitope Screening Technology platform to identify antibody candidates that block the binding of human ACE2 protein with the spike protein of the COVID-19 virus. Among 20 candidates, the company selected a final and optimal antibody drug candidate for further development.





Based on its extensive experience with clinical development and commercialization, Yuhan Corporation plans to take initiative in AbClon’s pre-clinical evaluation for the COVID-19 neutralizing antibody treatment, apply for clinical trial plans, and conduct clinical design and implementation.





The two companies are operating a Task Force team comprised of experienced scientists and are making all-out efforts for the rapid development of a cell line and the sample drugs for animal and human tests.





  • Related Article from Biospectator (Korean): http://m.biospectator.com/view/news_view.php?varAtcId=10918&ref=https%3A%2F%2Fwww.googleapis.com%2Fauth%2Fchrome-content-suggestions




  • Related Article from The Korea Herald (English): http://www.koreaherald.com/view.php?ud=20200727000502


Yuhan Corporation has in-licensed GI Innovation's allergy treatment pipeline (GI-301) from GI Innovation in a deal that could potentially total $1.2 billion.






Yuhan and GI Innovation’s collaboration to develop next-generation allergy treatment will cover all four major allergic diseases, which are allergic asthma, chronic urticaria, atopic dermatitis, and food allergy.





Under this license and co-development agreement, Yuhan has global rights, excluding Japan, to develop and commercialize GI-301, while GI Innovation will collaborate on the development.






According to GI Innovation, GI-301 can be competitive in the market, since it has 1) higher inhibition of IgE in animal testing compared to Xolair, which is the only existing IgE antibody approved by the FDA, and 2) less risk of anaphylaxis, the most common side effect of anti-IgE drugs.






In September, GI 301 will enter phase 1 clinical trials in Korea.





  • Related Article: http://www.koreaherald.com/view.php?ud=20200701000846






Yuhan Corporation's global R&D and open innovation strategy - in which they introduce early assets from the startups, conduct preclinical & early clinical studies, then license them out to the pharmaceutical giants – is now reaping its benefits. Yuhan, which formerly led the Korean pharmaceutical industry with its sales force, has transformed itself into an innovative drug developer through investment in its R&D program and in & out-license deals with biotech startups and multinational pharmaceutical companies.
As a result, Yuhan has received upfront payments of USD 134 million (KRW 165 billion) through the out-licensing of new drug candidates. The amount includes upfront payments with no obligation to return and a portion of milestone payments for each stage of development.
Yuhan Corporation clinched four technology export agreements since they first licensed out the global sales rights of degenerative disc disease treatment “YH14618” to Spine Biopharma for USD 218 million. In November 2018, Lazertinib (YH25448) was out-licensed to Janssen Pharmaceuticals. Inc for a total amount of USD 1.25 billion, including the upfront, milestone payments, and royalties. In 2019, Yuhan marked a licensing and collaboration agreement worth USD 785 million with Gilead Sciences, and another USD 870 million with Boehringer Ingelheim for its nonalcoholic steatohepatitis (NASH) drug candidate. The total of four technology exports amounted to USD 3 billion (KRW 3,819.4 billion).
Yuhan has recently received a milestone payment of USD 10 million from Boehringer Ingelheim upon the completion of the preclinical toxicity test (GLP-Tox) of YH25724; under the terms of the agreement, Yuhan received upfront of USD 40 million and was eligible to receive USD 10 million after GLP-Tox. YH25724 is now expected to enter clinical trials soon.
Yuhan also received USD 35 million from Janssen Pharmaceuticals Inc. for its first milestone payment, since JNJ-6372 in combination with Lazertinib (YH25448) had received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA). 
Yuhan's successive license out deals and receipt of milestone payments are the result of their global R&D and open innovation strategy. Yuhan has already earned USD 45 million this year, including the 1st milestone payment for Lazertinib and the remainder of the upfront for YH25724. The annual milestone payment revenue from those licensing-out deals may reach up to USD 70 to 80 million (approximately 860 billion to 980 billion won) this year.
Yuhan Corporation has been actively promoting open innovation since its CEO Jung-Hee Lee took office in 2015. So far, a total of KRW 200 billion (USD 165 million) has been invested in 25 biotech/pharmaceutical companies. Yuhan has strengthened its global R&D program by establishing a Global Operations team to manage its overseas subsidiaries, and a Global Business Development team to discover novel drug materials from biotech startups.







Here’s an update from our business partner Janssen Biotech that JNJ-6372 in combination with Lazertinib (YH25448), a novel third-generation EGFR TKI for advanced NSCLC that Yuhan Corporation out-licensed to them in November 2018, received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).





- Article from Johnson & Johnsonhttps://lnkd.in/gFMri6P





- Article from BioSpacehttps://lnkd.in/gjNTGqh