Yuhan ends J&J cancer project, signs HIV drug API deal with Gilead

Yuhan, a South Korean pharmaceutical company, and Johnson & Johnson Innovative Medicine (JJIM) have decided to cease the development of a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for treating non-small cell lung cancer (NSCLC). This decision comes on the heels of a recent FDA approval for their existing drug Lazcluze. The drug, when used in combination with J&J’s Rybrevant, has been approved as a first-line treatment for patients with EGFR-mutated NSCLC.

The conclusion of this research project was confirmed by a J&J spokesperson to Endpoints News. The pivotal Phase 3 trial that led to the approval demonstrated that Lazcluze, in combination with Rybrevant, resulted in a lower occurrence of secondary EGFR resistance mutations among patients. This achievement reduces the necessity for further development of fourth-generation EGFR tyrosine kinase inhibitors in this specific area.

The partnership between J&J and Yuhan began back in 2018, specifically to develop Lazcluze. Despite the termination of the current research project, this original licensing agreement remains intact and unaffected. Yuhan continues to engage in the development of various prescription medications, including antibiotics and antivirals, and also produces active pharmaceutical ingredients (APIs).

In addition to their collaboration with J&J, Yuhan has recently entered into a new contract worth $80 million (107.6 billion won) to supply Gilead Sciences with APIs for HIV drugs. This contract, which extends until September of the following year, was disclosed in a regulatory filing in Korea. Following this announcement, Yuhan’s stock experienced a rise of approximately 15% on Friday morning.

Gilead Sciences has a longstanding commitment to HIV research and development. The company was pivotal in bringing to market the first once-daily oral medication for pre-exposure prophylaxis against HIV. Gilead currently has 11 approved HIV medications and is conducting 11 ongoing clinical trials. Notably, Gilead’s HIV injection, lenacapavir, has demonstrated a significant reduction in the risk of HIV infections by at least 96% in two pivotal Phase 3 clinical trials.

The relationship between Yuhan and Gilead dates back to 2019 when they struck an initial deal. Yuhan received $15 million upfront and could potentially earn milestone payments totaling up to $770 million. This agreement granted Gilead the rights to develop and commercialize two of Yuhan’s small molecules aimed at treating advanced fibrosis associated with nonalcoholic steatohepatitis (NASH).

Thus, while Yuhan and JJIM have ended one specific research project, Yuhan continues to advance its pharmaceutical endeavors through strategic partnerships and new agreements, underscoring its ongoing influence and presence in the global pharmaceutical industry.