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Expected to receive 10 million USD as a milestone payment





Yuhan Corporation (000100. KS) announced on the 17th of November that the new drug candidate (YH25724) for the treatment of non-alcoholic steatohepatitis (NASH), which was licensed-out to Boehringer Ingelheim, has entered a phase 1 clinical trial in Europe.





The two companies plan to evaluate safety, tolerability, and pharmacokinetics after one subcutaneous administration of YH25724 to about 80 healthy overweight male subjects. The phase 1 clinical trial is expected to be completed by June, 2022.





With the start of the phase 1 clinical trial, Yuhan will receive 10 million USD from Boehringer Ingelheim. This is part of the $870 million USD licensing deal. At the time of the contract in 2019, Yuhan had received a non-refundable upfront payment of 40 million USD.





YH25724 is a fusion protein developed by combining South Korean biotech company Genexine’s Hybrid Fc (Hy Fc) antibody fusion protein platform technology and Yuhan's own protein engineering technology. In preclinical studies, it has been shown to relieve steatohepatitis and have anti-fibrotic effects, preventing hepatocellular damage and reducing liver inflammation.





Non-alcoholic steatohepatitis is a condition in which liver damage progresses from non-alcoholic fat liver disease (NAFLD) that refers to more than 5% of fat accumulating in the liver even though little to no alcohol is consumed. It is a chronic, progressive disease that greatly hinders liver functionality by causing damage or fibrosis.





Link to original article (Korean): https://m.mk.co.kr/news/it/view/2021/11/1078112/







Yuhan USA strengthens its role as a 'venture capital'. They purchased 750,000 shares of Processa Pharmaceuticals this year.





Yuhan Corporation is spurring overseas open innovation expansion and strengthening its global position by continuously investing in 'Yuhan USA', a leading edge for global advancement. 





According to industry sources on October 11th, Yuhan Corporation acquired 1.5 million shares by investing 1.667 billion Won (1.4 million USD) in Yuhan USA, a wholly-owned subsidiary incorporated in the US, in the second quarter of this year. As a result, Yuhan's holdings in Yuhan USA increased to 9,318,180 shares. 





Yuhan Corporation provides financial support to Yuhan USA every year. In 2019, it invested 3.557 billion Won (2.988 million USD) to secure 3 million shares, and in 2020 also invested 3.546 billion Won (2.979 million USD) to increase 3 million shares. 





The goal is to quickly acquire advanced information through active network activities in the United States, and to promote technology transfer or R&D collaboration by discovering promising technologies or new drug candidates in the United States. 





Recently, Yuhan USA is strengthening its role as a 'venture capital' by directly investing in US biotech companies. 





This year, it purchased 750,000 shares of US biotech company Processa Pharmaceuticals making Yuhan USA a 7.3% stakeholder. 





Previously, Yuhan USA played a role as an intermediary in signing a license-out contract for Yuhan Corporation's 'YH12582', a functional gastrointestinal disease treatment, with Processa Pharmaceuticals in August of last year. 





An official from Yuhan Corporation said, "Yuhan USA will continue to strengthen its role in expanding overseas open innovation by discovering promising biotech companies and technologies in the United States and exploring new business opportunities." 





Yuhan USA is currently headed by Taewon Yoon as Chief Executive Officer, a former Senior Manager of Business Development team of Yuhan USA. He holds a Ph.D in biochemistry and molecular genetics.





Article from MTN News (Korean): https://news.mtn.co.kr/news-detail/?v=2021100815262329812   



Processa Pharmaceuticals announced that they have been cleared by the FDA to proceed with a Phase 2a clinical trial of PCS12852 in patients with moderate to severe gastroparesis. PCS12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist, originally developed by Yuhan Corporation in South Korea, and exclusively licensed to Processa Pharmaceuticals in August 2020 (https://bit.ly/30iKnMR). Non-clinical toxicology studies show that there are no cardiovascular side effects associated with PCS12852, making it a potentially safe treatment option for gastroparesis and other GI motility disorders. The Phase 2a study will be conducted in up to eight centers in the United States.





Article from GlobeNewsWire: https://www.globenewswire.com/news-release/2021/10/12/2312599/0/en/Processa-Pharmaceuticals-Cleared-by-FDA-to-Proceed-with-Phase-2a-Trial-for-the-Treatment-of-Gastroparesis.html



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Job description





Responsibilities:





  • Provide administrative support to include arranging travel plans and meetings; interact and liaise with members of the functional team, management and external clients
  • Perform office duties that include ordering supplies and maintaining an organized filing system of paper and electronic documents
  • File and retrieve corporate records, documents, and reports.
  • Accurately record minutes from meetings
  • Handle basic bookkeeping tasks
  • Assist in other ad-hoc tasks and projects as requested




Qualifications:





  • Administrative experience preferred, but not required
  • Ability to proactively troubleshoot problems, prioritize competing requirements and ask questions for clarification
  • Proficiency in Microsoft Office, Web-based research skills, and ability to learn accounting applications
  • Fluent in English and Korean preferred
  • Bachelor's Degree in biology or business-related majors preferred
  • Great professionalism and communication (oral/written) skills




Benefits:





  • Health Insurance PPO Packages
  • Dental + Vision
  • 401(k) Plan
  • Paid Time Off














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.