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The top line results for the phase 3 clinical trial of the 3rd generation EGFR TKI ‘Lazertinib’ being developed by Yuhan Corporation have been announced. The results confirmed the efficacy of Lazertinib as a first-line treatment and Yuhan Corporation plans to submit an application for approval to expand indications in South Korea in Q1 of 2023. 

This phase 3 clinical trial (LASER301) randomly assigned Lazertinib (240mg) and Gefitinib (250mg) among 393 patients with locally advanced or metastatic NSCLC (Non-Small Cell Lung Cancer) with EGFR mutation (Ex19Del or L858R) to compare efficacy and safety (NCT04248829). Patients who had refractory or relapse in the Gefitinib administration group were allowed crossover to receive open label Lazertinib. The study was conducted at 119 institutions in 13 countries, including South Korea. 

In the Progression Free Survival (PFS) index set as the primary endpoint, Lazertinib was 20.6 months, whereas Gefitinib was 9.7 months. This statistically significant data results in Lazertinib reducing the risk of disease progression or death by 55% compared to Gefitinib (Hazard Ratio, HR 0.45, 95% Confidence Interval 0.34~0.58, p<0.001).  

Subgroup analysis also confirmed the superiority of Lazertinib over Gefitinib in all subgroups. First, significant efficacy was confirmed in patients with the EGFR L858R mutation. In general, the L858R mutation is known to have poor prognosis against existing EGFR TKIs. However, the PFS of the Lazertinib-administered group was 17.8 months and the Gefitinib-administered group was 9.6 months (HR 0.41), confirming the excellent antitumor effect even in L858R patients. Second, efficacy was also confirmed in patients with brain metastasis. In the patient group with CNS metastasis, the PFS of the Lazertinib-administered group was 16.4 months and the Gefitinib-administered group was 9.5 months (HR 0.42), demonstrating excellent efficacy even in CNS metastasis patients with poor prognosis. Third, when Lazertinib was administered in the Asian subgroup, PFS was 20.6 months and Gefitinib was 9.7 months (HR 0.46), demonstrating excellent antitumor effect in Asians as well. 

Interim analysis of the overall survival data, which is the secondary endpoint (data maturity 29%), showed a hazard ratio of 0.74 (95% CI 0.51~1.08, p=0.116), and the survival rate of patients who received Lazertinib at 18 months was 80% and Gefitinib was 72%. 

Safety data showed that adverse events were mostly mild or moderate.  Serious adverse effects of drug administration occurred at a level of 5% in  Lazertinib and Gefitinib. The rate of drug discontinuation was 10% for Lazertinib and 9% for Gefitinib, with  no significant difference between the groups. 

Yuhan licensed out Lazertinib to Janssen Pharmaceuticals in 2018. Phase 3 clinical trial is ongoing in combination with Janssen’s EGFRxMET bispecific antibody ‘Amivantamab’ for NSCLC as 1^st and 2^nd line treatments. This phase 3 trial of Lazertinib monotherapy mentioned in the article is independent study by Yuhan as a new primary therapeutic option for patients with EGFR mutant-positive NSCLC. 

Link to original articles:

https://tinyurl.com/yc7xh5c3 (Korean)

https://tinyurl.com/79y2kvm8 (Korean)

Processa Pharmaceuticals announced that positive gastric emptying results from its PCS12852 Phase 2A Proof-of-Concept trial 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). This Phase 2A trial was a 4-week placebo-controlled, randomized, dose-response trial designed to evaluate the effect of PCS12852 on gastric emptying, safety, pharmacokinetics, and gastroparesis symptoms. Adverse events associated with this Phase 2A trial were mild to moderate with no clinically significant cardiovascular or serious adverse events. Evaluation of the effect of PCS12852 on gastroparesis symptoms is expected before the end of this year. Processa plans to initiate a Phase 2B trial in 2023.

Article from BioSpace: PCS12852 Improves Gastric Emptying in Gastroparesis Patients | BioSpace

On 14 October, Yuhan announced top-line Phase 3 study data of Lazertinib as 1st line treatment that has significantly improved progression-free survival (PFS) as the primary endpoint. LASER301, comparing Lazertinib for the primary treatment of EGFR mutated non-small cell lung cancer (NSCLC) with the standard therapeutic agent gefitinib (Brand: Iressa), shows the risk of stage progression or death is reduced by 55%, which confirms statistically significantly improved the efficacy (HR: 0.45, 95% CI 0.34-0.58, p<0.001). PFS is a key evaluation indicator to confirm efficacy of anti-cancer drugs, which refers to the period where the disease does not progress or lead to death.

Dr. Byun-Chul Cho at Severance hospital, who is leading the LASER301 phase 3 clinical study, said “We are very excited about the multi-national, 13 countries including South Korea, phase 3 clinical trial results that show great potential of Lazertinib as a new primary therapeutic option for patients with EGFR mutant-positive NSCLC worldwide.” The detailed clinical trial results will be release at a professional conference in December. With the encouraging results, Yuhan will apply for a permit change to expand domestic (South Korea) indications in the first quarter of next year.

Yuhan signed a technology export and co-development agreement for Lazertinib with Janssen Pharmaceuticals in November 2018. Clinical development is actively underway in combination with Janssen’s EGFRxMET bispecific monoclonal antibody ‘Amivantamab’ for NSCLC as 1^st and 2^nd line treatments.

Link to original article (Korean): http://m.biospectator.com/view/news_view.php?varAtcId=17422

[채용 공고]
유한양행 미국 법인 - 유한 USA

Position:
Business Development Manager

Work location:
Boston, MA

Responsibilities:
1.개방형 기술혁신 및 In/Out Licensing Partnering 사업개발
2.유망 바이오 기업 발굴 및 전략적 투자활동
3.신약개발 연구 및 바이오 파마 동향 정보 수집

Qualifications: (Required)
1.해외 제약사/바이오텍 근무 혹은 그에 준하는 경력
2.영주권 또는 시민권 소지자
3.영어 능통
4.신약 개발 관련 전공 분야 석사 이상

Qualifications: (Preferred)
1.해외 제약사 사업개발(Business Development) 경험
2.신약개발 관련 전공분야 박사 학위 소지자
3.Venture Capital 근무 경력자
4.MBA 소지자

Documents for Application:
영문 또는 국문 이력서(CV/Resume) 및 자기 소개서 (cover letter)

Salary & Benefits:
Industry competitive Salary and benefit package including 401K

Contact Information:
info@yuhan-usa.com

Yuhan USA Corporation was established in January 2018 as a wholly-owned subsidiary of Yuhan Corporation, Korea’s largest pharmaceutical company with a 96-year heritage.

As an outpost of Yuhan’s globalization strategy, Yuhan USA is searching for business development and collaboration opportunities in new drug assets and companies that share our drive towards excellence in medicine.

The Business Development Manager will have the responsibility of exploring 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:
-Required
•MS in Life Sciences, Pharmacy, Biology, or related discipline
•Relevant biotech or pharmaceutical industry experience
•Fluent in English
•Excellent interpersonal, networking, and communication skills

-Preferred
•MBA, Ph.D., or other advanced degrees
•Experiences in drug research, development, and commercialization activities
•Fluent in Korean

Yuhan Corporation is working together with Gunpo City, South Korea to create a high-tech bio research base and CMC center in the industrial area of Dangjeong-dong, Gunpo. Yuhan Corporation will make an investment of approximately 80 billion Won ($66.7M USD) towards the bio research center and CMC center project. Through the establishment of this bio research center and CMC center, Yuhan Corporation expects to strengthen its research capabilities such as cell line development and process development of biologics, as well as development of protein and antibody drugs. Yuhan Corporation and Gunpo City also aim to develop the bio research center and CMC center into a hub for biopharmaceutical R&D centered on Yuhan Corporation by promoting the attraction of research facilities of other biopharmaceutical companies. Yuhan Corporation plans to start construction in the second quarter of 2023 and start operation from the second quarter of 2025. 

Link to original article (Korean): https://moneys.mt.co.kr/news/mwView.php?no=2022021714368022081&outlink=1 

Expected to receive 10 million USD as a milestone payment

Yuhan Corporation (000100. KS) announced on the 17^th 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

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

Learn more about our parent company “Yuhan Corporation by watching this video.