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°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into a licensing agreement granting exclusive rights concerning the research, development, manufacture and marketing of Eisai's in-house discovered potential anticancer agent E7046, which is an investigational prostaglandin E₂ (PGE₂) type EP₄ receptor antagonist, to Adlai Nortye Biopharma Co., Ltd. (Headquarters: Hangzhou, China, “Adlai Nortye”) in all regions outside of Japan and part of Asia (excluding China).

E7046 is an orally administered, selective EP₄ receptor antagonist discovered by Eisai's U.S. Andover research facility. It is suggested that PGE₂ signals through EP₄ receptors may suppress the antitumor activity of immune cells. By inhibiting EP₄, E7046 is expected to act on the tumor microenvironment via a different mechanism to immune checkpoint inhibitors to potentially demonstrate antitumor effects. Currently, E7046 is being investigated as a monotherapy in a Phase I clinical study as well as a Phase Ib clinical study in combination with radiotherapy/chemoradiotherapy.

Under this agreement, Eisai will receive from Adlai Nortye a one-time payment, milestone payments in accordance with the progress of development, as well as certain royalties according to sales revenue after launch.

Adlai Nortye is a science-led clinical stage biopharmaceutical company dedicated to discovering, developing and commercializing new and effective immunotherapy for patients with cancer. Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. By licensing E7046 to Adlai Nortye, which is developing several tumor immunotherapies that have synergies with E7046, Eisai aims to maximize the value of the agent in order to hopefully contribute to the treatment of patients in the future who need tumor immunotherapies as soon as possible.

Discovered in-house by Eisai, E7046 is an investigational, orally-administered EP₄ antagonist that is believed to selectively bind to EP₄ receptors, which are a subtype of prostaglandin E₂ (PGE₂) receptors. It is known that activating EP₄ receptors causes monocytes, a type of white blood cell, to differentiate into M2 macrophages which have immuno-suppressive effects. As demonstrated in preclinical studies, inhibiting EP₄ receptors reduces M2 macrophages, and by increasing M1 macrophages which activate immune response, antitumor effects can be expected. Currently E7046 is being investigated in a Phase I clinical study, and a Phase Ib clinical study of E7046 in combination with radiotherapy/chemoradiotherapy is also underway.

Adlai Nortye is a science-led biopharmaceutical company dedicated to discovering, developing and commercializing new drugs. Adlai Nortye focuses on discovering and developing important new treatments for cancer and metabolic diseases. Adlai Nortye's mission is to improve patient lives by identifying and acquiring differentiated innovative medicines that help people live better, live longer.

Adlai Nortye has 19 patents granted and 7 PCT published. With extensive experience in peptide and protein drugs, Adlai Nortye has expanded its expertise into small molecules and therapeutic antibodies. Through close collaborations with global partners, Adlai Nortye has successfully positioned itself in the fields of immuno-oncology and metabolic diseases and has several programs ongoing from early pre-clinical to Phase 3 ready.