Monthly Archives: July 2020

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 & Johnson

- Article from BioSpace

In 2020, Yuhan Corporation is going to invest the largest amount in history for its R&D program to speed up the development of Lazertinib (YH25448) – the first-line treatment for non-small cell lung cancer (NSCLC) that has entered a phase-3 global study, and the expansion of Yuhan’s presence overseas.
The company has announced to increase its annual R&D expenditure by up to 14% of its sales, which is expected to exceed $168 million, as their sales projection for 2020 is approximately $1.3 billion. It is a drastic increase from last year’s R&D expenses, which was $117 million (9% of sales).
Yuhan has been steadily increasing its gross R&D expenditures as well as the ratio of R&D investment to sales since their CEO Jung-hee lee took office in 2015. Yuhan invested $73 million (6.5% of sales) in 2016, $87 million in 2017 (7.1% of sales), and $ 94 million in 2018 (7.4% of sales) for its R&D program.
Mr. Lee said, “We are not only focusing on short-term profit growth but putting more weights on achieving our long-term goals. We strongly believe that new drug development is the primary focus for our company’s future, thus plan to strengthen our R&D program further.”

Lazertinib’s Phase-3 global study this year
2020 will be a pivotal year for Yuhan’s novel therapeutic candidate ‘Lazertinib (YH25448)’. Lazertinib, which was out-licensed to Janssen Biotech for a total amount of $ 1.25 billion in November 2018, is a targeted drug under development as a third-generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) for NSCLC.
Yuhan launched a global Phase 3 study and started recruiting patients since the first quarter of 2020 to confirm the efficacy and safety of Lazertinib compared to gefitinib. Aside from this Phase 3 trial, Yuhan and Janssen are also testing the efficacy of Lazertinib in combination with Janssen’s EGFR-cMet bispecific antibody ‘JNJ-61186372’ as well, to further extend the use of Lazertinib in patients with NSCLC.

US, Australia and now to Europe for global open innovation
Yuhan Corporation has been a “bridge” between biotech startups and multinational pharmaceutical companies, by introducing early assets from the startups, conducting preclinical and early clinical studies, then license them out to the pharmaceutical giants. 
The number of Yuhan’s innovative new drug pipeline, which was nine in early 2015, has now grown to 27, more than half of which came from external research projects. Through this open innovation, the company was able to ink around $3 billion-worth of license-out deals in total over the last two years.
Yuhan has been stepping up and expanding its platform internationally. So far, the company had established a subsidiary with two offices (San Diego and Boston) in the United States and one in Australia. This year, they are planning to extend their global reach to Europe.