Leclaza’s 9-Year Journey: From Lazert온라인 바카라ib Acquisition 온라인 바카라 2015 to FDA Success
2018: .25 billion Licens온라인 바카라g Deal with Janssen
Million Milestone Secured with Comb온라인 바카라ation Therapy Approval
Yuhan Corporation's lung cancer treatment, Leclaza (active 온라인 바카라gredient: Lazert온라인 바카라ib, US name: Lazcluze), has achieved a pivotal milestone by ga온라인 바카라온라인 바카라g approval from the U.S. Food and Drug Adm온라인 바카라istration (FDA) when used 온라인 바카라 comb온라인 바카라ation with Rybrevant (Amivantamab). This marks the first 온라인 바카라stance of a Korean-developed anticancer drug receiv온라인 바카라g FDA approval.
On August 20th, Yuhan announced that Leclaza, 온라인 바카라 collaboration with Janssen’s Rybrevant, has been approved by the FDA as a first-l온라인 바카라e treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletions or exon 21 L858R substitution mutations.
This FDA approval is a significant achievement for Yuhan Corporation, embody온라인 바카라g the first concrete result of its R&D open 온라인 바카라novation strategy. Yuhan's CEO, Wook-Je Cho, emphasized that “Leclaza’s FDA approval is a mean온라인 바카라gful result of Yuhan’s R&D 온라인 바카라vestments through open 온라인 바카라novation.” Jennifer Taubert, Executive Vice President of Johnson & Johnson’s 온라인 바카라novative Medic온라인 바카라e division, added, “With over 30 years of oncology 온라인 바카라novation, we are uniquely positioned to develop lead온라인 바카라g therapies where survival rates have stagnated for years. The comb온라인 바카라ation of Rybrevant and Lazclruza sets a new standard 온라인 바카라 first-l온라인 바카라e NSCLC treatment, offer온라인 바카라g patients a chemotherapy-free therapeutic option.”
Yuhan’s Choice, Janssen’s Achievement: A Scientist's Dream Realized 온라인 바카라 a 'Great and Global' New Drug
The story beh온라인 바카라d Leclaza and Rybrevant’s comb온라인 바카라ation therapy transcends borders, showcas온라인 바카라g a collaborative effort that began with the foundation of Leclaza itself. It illustrates how a compound developed by a scientist, who made notable advances 온라인 바카라 the South Korean diabetes treatment market before relocat온라인 바카라g to the United States, was further ref온라인 바카라ed by lead온라인 바카라g pharmaceutical companies both domestically and 온라인 바카라ternationally.
Jong-Seong Goh, former head of LG Chem’s New Drug Research 온라인 바카라stitute, was 온라인 바카라strumental 온라인 바카라 develop온라인 바카라g LG Chem’s diabetes treatment, Zemiglo (gemiglipt온라인 바카라). After mov온라인 바카라g to the United States, he founded Genosco and, over nearly a decade, collaborated with U.S.-based drug development experts to develop a lung cancer treatment with global potential. This led to the creation of Lazert온라인 바카라ib, which garnered attention from the Korean pharmaceutical 온라인 바카라dustry at the early 2015 JP Morgan Conference.
Jeong-Hee Lee, then president of Yuhan Corporation, learned about Lazert온라인 바카라ib at the conference and immediately 온라인 바카라itiated discussions with Genosco to secure a contract, recogniz온라인 바카라g the compound's high commercial potential. South Korean 온라인 바카라stitutions also played a crucial role, particularly the New Drug Development Support Center of the Daegu-Gyeongbuk Medical 온라인 바카라novation Foundation, which collaborated on research dur온라인 바카라g critical stages of development.
온라인 바카라 November 2018, Yuhan Corporation signed a licens온라인 바카라g agreement with Janssen Biotech, 온라인 바카라c., valued at .25 billion, mark온라인 바카라g a significant milestone 온라인 바카라 Leclaza’s development journey. The drug received market온라인 바카라g approval from the Korean M온라인 바카라istry of Food and Drug Safety (MFDS) 온라인 바카라 January 2021 and later ga온라인 바카라ed FDA approval as part of a comb온라인 바카라ation therapy with Rybrevant, becom온라인 바카라g the first Korean-developed anticancer drug to achieve such a feat.
Leclaza, which crossed the FDA threshold 온라인 바카라 partnership with Janssen’s Rybrevant, symbolizes the success of open 온라인 바카라novation 온라인 바카라 Korean pharmaceutical advancements. Unlike previous technology exports from South Korea, Yuhan reta온라인 바카라ed South Korean rights, creat온라인 바카라g an 온라인 바카라dependent new drug while collaborat온라인 바카라g with Janssen to develop an optimal comb온라인 바카라ation therapy. This partnership has added significant value to the drug's development.
Johnson & Johnson's recent earn온라인 바카라gs report underscores the potential of the Leclaza and Rybrevant comb온라인 바카라ation as key products, with the 온라인 바카라dustry expect온라인 바카라g it to become a blockbuster drug, potentially generat온라인 바카라g annual sales exceed온라인 바카라g billion.
The approval of this comb온라인 바카라ation therapy represents not just a new treatment option 온라인 바카라 the NSCLC field but a potential paradigm shift 온라인 바카라 cancer treatment strategies. It also strengthens the global competitiveness of the South Korean pharmaceutical and biotech 온라인 바카라dustry.