Newly launched Adneuris Therapeutics has entered its first ex-US licensing agreement, granting Zhejiang Conba Pharmaceutical exclusive rights to develop and commercialize its lead pain candidate cebranopadol in mainland China, Hong Kong, Macao and Taiwan, as the company prepares to submit a US FDA New Drug Application (NDA) later this year.
Under the agreement, Conba will pay Adneuris a USD 17.5 million upfront payment, along with development and commercial milestone payments totaling more than USD 100 million and tiered royalties on net sales beginning in the double digits. The Chinese pharmaceutical company will hold exclusive rights to develop and commercialize cebranopadol for acute pain in the licensed territory, with the option to expand into additional indications, including cancer pain and other chronic pain conditions.
The licensing transaction follows days after the launch of Adneuris on July 9 as a wholly owned subsidiary of Tris Pharma, established to advance cebranopadol through regulatory approval and commercialization. The company plans to submit an NDA to the US FDA later this year seeking approval for the treatment of moderate-to-severe acute pain.
Cebranopadol is a first-in-class dual nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptor agonist designed to provide opioid-level analgesia while potentially reducing the dependence, misuse, and overdose risks associated with conventional selective MOP agonists. The investigational therapy has been evaluated in more than 33 clinical trials involving over 2,400 participants.
The NDA will be supported by two pivotal Phase III studies. ALLEVIATE-1, conducted in patients following abdominoplasty, and ALLEVIATE-2, following bunionectomy, both met their primary endpoints, demonstrating statistically significant reductions in pain intensity compared with placebo over 48 hours, reduced opioid rescue medication use, and longer times to first rescue medication.