"All five new drug candidates that Yuhan Corporation (000100.KS) is currently developing as 'post-Lazcluze' assets will reach a conclusion on technology transfer or co-development within one to two years. We are also actively pursuing 'package technology transfers' with global companies seeking new drugs to combine with Yuhan's products."
Kim Yeol-hong, president of R&D at Yuhan Corporation, outlined the company's drug development plans at an "R&D Day" held at Yuhan's headquarters in Seoul on the 28th. Yuhan has narrowed down its pipeline of follow-up candidates to Lazcluze — the first Korean cancer drug to receive U.S. Food and Drug Administration (FDA) approval and commercialization — to five compounds: allergy treatment "Resigercept," metabolic dysfunction-associated steatohepatitis (MASH) treatment "YH25724," solid tumor treatment "YH42946," bispecific antibody solid tumor treatment "Nesprotamic (YH32367)," and bispecific antibody solid tumor treatment "YH32364."
Yuhan plans to actively pursue a "combination technology transfer" strategy by leveraging its experience commercializing Lazcluze. After being licensed out to Johnson & Johnson (J&J), Lazcluze received FDA approval as a combination therapy with J&J's "Rybrevant." In November last year, it was listed in the National Comprehensive Cancer Network (NCCN) guidelines as a "preferred regimen" for first-line treatment of EGFR-mutated non-small cell lung cancer, establishing itself as a standard of care. Kim believes the new drugs currently under development can also be co-administered with major products from global pharmaceutical companies. "Even if approved as second- or third-line treatments prescribed after cancer recurrence, the market size only reaches a few hundred billion won," he said. "We are targeting the multi-trillion-won market that opens up the moment a drug becomes a first-line standard treatment through combination with immuno-oncology agents."
Yuhan has placed particular hope on Nesprotamic, a bispecific antibody cancer drug. Nesprotamic is a bispecific antibody targeting HER2 and 4-1BB for the treatment of HER2-positive solid tumors. According to Yuhan, HER2-targeted cancer drugs can be used for various solid tumors including breast cancer, gastric cancer, and lung cancer, with the market expected to grow from 17.4 trillion won in 2022 to 26 trillion won in 2028. "We have completed Phase 1a trials targeting biliary tract cancer, and more than half of the target patients have been enrolled in Phase 1b," Kim said. "We previously disclosed data showing one complete response (CR) in Phase 1a, with response duration lasting between one-and-a-half to two years."
Expectations are also high for YH42946, an oral cancer drug. Yuhan has confirmed complete responses in patients who had failed previous cancer treatments at the highest dose stage of the ongoing Phase 1 trial. "YH42946 will be a good option for second- and third-line treatment, but our goal is to establish it as a first-line standard treatment through combination therapy with immuno-oncology agents," Kim said. "Following the Lazcluze-Rybrevant combination therapy, which has become the first-line standard treatment for lung cancer, we want to fill first-line standard treatments with Yuhan products."
Yuhan plans to pursue a package deal approach as its technology transfer strategy, licensing out multiple assets at once. Kim cited a package deal of Nesprotamic and YH42946 as an example. Yuhan estimates that licensing Nesprotamic and YH42946 together could be worth 3.8 trillion to 6 trillion won at the Phase 2 stage and 9 trillion to 16.5 trillion won at the Phase 3 stage. If co-developed with a partner and then transferred, the upfront payment is expected to be around 200 billion won, with the acquisition value after successful Phase 3 trials reaching 9 trillion to 16.5 trillion won.
Yuhan also sees the possibility of a package deal involving Nesprotamic and YH44529. The company estimates that a technology transfer following proof-of-concept (PoC) in Phase 2 could be worth 4.5 trillion to 5.5 trillion won, while a transfer at Phase 3 could reach 10.5 trillion to 16.5 trillion won. The deal size could grow further if indications are expanded to lung cancer, pancreatic cancer, and colorectal cancer.
"When we discuss with global companies looking for new cancer drugs, they bluntly tell us, 'We are looking for antibody-drug conjugates (ADCs), but we can only consider a contract if you show us data demonstrating excellent therapeutic effects through combination administration with our immuno-oncology agents,'" Kim said. "There are countless ADCs in the Chinese market, but simply taking them does not guarantee future value. Global companies are thinking one or two steps ahead, and we intend to provide the answer first."
