• Agreement Grants Maruishi Rights for the Development and Commercialization of Cebranopadol for Pain in Japan and South Korea, Marking Adneuris' Second Ex-U.S. Licensing Transaction 

• Under the Terms of the Agreement, Adneuris Will Receive an Upfront Payment of $35 Million (USD), Including a U.S. Royalty Investment, Along with Substantial Development and Commercial Milestone Payments and Tiered Royalties on Net Sales Starting in the Double Digits

• Adneuris Anticipates Submitting a New Drug Application (NDA) for Cebranopadol to the U.S. Food and Drug Administration (FDA) Later This Year for the Treatment of Acute Pain

Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma advancing a new kind of pain medicine, announced that it has entered into an exclusive license agreement with Maruishi Pharmaceutical Co., Ltd. ("Maruishi"), a privately held, perioperative and pain-focused pharmaceutical company based in Osaka, Japan. This agreement grants Maruishi the rights to develop and commercialize cebranopadol, Adneuris' lead investigational therapy, for the treatment of pain in Japan and South Korea.

The agreement marks Adneuris' second ex-U.S. licensing transaction, following its agreement for Greater China, and underscores the company's vision for advancing a new era in pain medicine to treat severe pain. Central to that strategy is cebranopadol, a first-in-class dual-NMR (nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors) agonist that has completed Phase 3 clinical development for moderate-to-severe acute pain and Phase 2 for multiple chronic pain indications. Adneuris plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year.

Under the terms of the agreement, Maruishi will pay Adneuris an upfront payment of $35 million (USD), including a $10 million U.S. royalty investment. Adneuris is also eligible to receive substantial development and commercial milestone payments, plus tiered royalties on net sales in Japan and South Korea starting in the double digits. Maruishi will hold exclusive rights to develop and commercialize cebranopadol for pain in the licensed territory.

“Maruishi's deep expertise in perioperative and pain management, combined with its established commercial infrastructure across Japan, make them an ideal partner to help bring cebranopadol to patients in these important markets across the globe,” said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma, the parent company of Adneuris Therapeutics. “This partnership builds on the momentum of our most recent ex-U.S. agreement and reflects the growing recognition of cebranopadol's potential to offer a new first-in-class option for patients living with pain.”

"We are pleased to expand our long-standing focus on pain management through this collaboration with Adneuris," said Katsuhito Inoue, President and Representative Director, Maruishi Pharmaceutical Co., Ltd. "Cebranopadol's differentiated mechanism and clinical profile suggest the potential to become an important new option for patients living with pain, and we look forward to working with Adneuris to advance its development in Japan and South Korea."

Cebranopadol was evaluated in two pivotal Phase 3 trials — ALLEVIATE-1 (following abdominoplasty) and ALLEVIATE-2 (following bunionectomy) — and overall enrolling more than 2,400 participants across its broader clinical programs. In both ALLEVIATE studies, cebranopadol demonstrated a significant reduction in pain compared with placebo over 48 hours, reduced use of opioid rescue medication, and sustained pain control, supporting its potential to deliver efficacy comparable to standard-of-care therapies, with a differentiated safety profile designed to reduce the risk of side effects associated with conventional opioid treatments, such as dependence and misuse.

Aurora Partners served as an advisor to Adneuris in connection with the transaction.