Photocure and Asieris clash over USD 11m China milestone for Cevira approval

Norway-based Photocure ASA (OSE: PHO) faces a widened legal dispute with China-based Asieris Pharmaceuticals (SSE: 688176) over a USD 11 million milestone payment tied to the China approval of APL-1702 (Cevira), a photodynamic drug-device combination for cervical precancerous lesions — with Asieris now seeking the return of the USD 6.6 million it has already paid.

Photocure invoiced the USD 11 million milestone after Asieris received a Drug Registration Certificate from China's National Medical Products Administration (NMPA) in March 2026, enabling commercial launch of Cevira in China. That was described by the company as the world's first approved non-surgical pharmacological therapy for cervical high-grade squamous intraepithelial lesions (HSIL). Asieris made a partial payment of USD 6.6 million in April 2026, arguing the approved label was insufficient to trigger the full amount. Photocure commenced arbitration on July 23, 2026. On August 3, 2026, Asieris filed its formal response denying Photocure's claim in full and lodging a counterclaim seeking recovery of the USD 6.6 million already remitted. Photocure said it maintains the milestone was fully achieved and intends to pursue full payment.

The dispute centers on milestone trigger language in the 2019 worldwide license agreement under which Photocure out-licensed Cevira to Asieris for up to USD 250 million in total potential payments, comprising a USD 5 million signing fee, up to USD 54 million in development and regulatory milestones across China, the US, and EU, and the balance in sales-based commercial milestones, plus tiered royalties of 10% to 20% of net sales. The USD 11 million China regulatory milestone sits within a tranche of up to USD 18 million tied to Chinese clinical and regulatory events. As previously announced, Asieris's position has consistently been that the label scope obtained from the NMPA does not satisfy the contractual trigger for the full payment.

Of note, the EMA accepted a marketing authorization application for Cevira in February 2026 while a US FDA Phase III trial design has been agreed, with additional milestone payments of up to USD 36 million contingent on US and EU approvals. The outcome of the current arbitration may influence how those future milestone triggers are interpreted.

Asieris holds the only global development and commercialization rights to Cevira, with Photocure retaining API manufacturing and IP ownership. Positive Phase III data were reported in March 2024. The parties have no alternative partner arrangement for the asset, concentrating all of Photocure's Cevira-related upside through a single licensee now in active arbitration with it.

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