Adneuris licenses Phase 3 pain therapy cebranopadol to Conba for Greater China

Adneuris Therapeutics has granted Zhejiang Conba Pharmaceutical exclusive rights to develop and commercialise its investigational pain therapy cebranopadol across Greater China in a deal worth more than $117.5 million in upfront and milestone payments, plus tiered royalties.

The agreement covers mainland China, Hong Kong, Macao and Taiwan and marks Adneuris’ first licensing transaction outside the USA as the company prepares to submit a New Drug Application (NDA) to the US Food and Drug Administration later this year.

Under the terms of the agreement, Conba will pay $17.5 million upfront, with the potential for development and commercial milestone payments exceeding $100 million, alongside tiered royalties on future net sales.

The partnership gives Conba exclusive rights to develop and commercialise cebranopadol for acute pain within the licensed territories, with the option to expand development into additional indications including cancer pain and other chronic pain conditions.

Cebranopadol has completed a Phase 3 clinical programme for moderate-to-severe acute pain and is designed to target both nociceptin/orphanin FQ peptide (NOP) and μ-opioid peptide (MOP) receptors. The dual mechanism is intended to provide effective pain relief while reducing some of the limitations associated with conventional opioid medicines.

Acute pain remains one of the most common reasons for opioid prescribing worldwide, prompting continued efforts to develop new therapies that maintain analgesic efficacy while improving safety and reducing the potential for misuse and dependence.

The company plans to submit an NDA for cebranopadol in the USA later this year, representing an important regulatory milestone for the programme.

Ketan Mehta, founder and chief executive officer of Tris Pharma, said: “This agreement is about more than extending cebranopadol’s reach into one of the largest pain management markets in the world; it’s about giving those patients access to a new potential option in pain management.”

Cebranopadol has been evaluated in two Phase 3 studies, Alleviate-1 and Alleviate-2, which investigated the treatment following abdominoplasty and bunionectomy respectively. Across its broader clinical development programme, the therapy has been studied in more than 2,400 participants.

According to Adneuris, both studies demonstrated statistically significant reductions in pain compared with placebo over 48 hours, alongside reduced use of opioid rescue medication and sustained pain control.

Fan Zhou, president of Zhejiang Conba Pharmaceutical, said: “Postoperative pain remains poorly managed for millions of patients here, and existing options often force a tradeoff between efficacy and safety.”

The licensing agreement also supports Conba’s strategy of expanding its pain management portfolio through partnerships with companies developing late-stage innovative therapies. For Adneuris, the transaction provides additional resources as it prepares for potential regulatory review in the USA while extending the future commercial reach of cebranopadol into one of the world’s largest pharmaceutical markets.

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