Singapore-headquartered biopharmaceutical company Specialised Therapeutics Asia (ST) will partner with CTTQ-Akeso (Shanghai) Biomed. Tech. Co. (CTTQ-Akeso) and Chia Tai Tianqing Pharmaceutical Group Co. to commercialise a new immuno-oncology therapy in Australia, Singapore and across Southeast Asia.

The therapy ANNIKO (penpulimab) is an anti-PD1 monoclonal antibody currently under regulatory review by the US FDA for nasopharyngeal carcinoma – a difficult to treat form of head and neck cancer.

This follows the FDA granting ANNIKO orphan drug and fast track designations in 2020, as well as a further "breakthrough therapy" designation in March 2021. In addition, ANNIKO was granted a FDA Real-Time Oncology Review (RTOR) in 2021, to accelerate the drug approval process.

Under the terms of the arrangement, ST will be responsible for all marketing, regulatory and distribution activities in its key regions of Australia, Singapore and across Southeast Asia.

CTTQ-Akeso retains the rights of conducting any development work in relation to ANNIKO and Akeso retains all rights to product manufacture and supply.

"Nasopharyngeal carcinoma is native to Southeast Asia, affecting between 15 and 50 people in every 100,000 and with almost 37,000 new cases diagnosed annually in this region. Making ANNIKO available for this disease is a high priority", said ST Chief Executive Officer Carlo Montagner.