12 April 2023 | Wednesday | News
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.[1,2]
ANNIKO has been approved in China for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma (advanced r/r cHL) who have undergone at least second-line chemotherapy, as well as first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) in combination with chemotherapy.
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.
Announcing the partnership, ST Chief Executive Officer Carlo Montagner said ANNIKO was the first immuno-oncology drug to be included in the company's therapeutic portfolio and the arrangement was further endorsement of ST's regional capabilities.
"ANNIKO will provide a new opportunity for patients in our regions with nasopharyngeal carcinoma - a very difficult to treat cancer - to be treated with an immune-based therapy," he said.
"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."
Akeso CEO Michelle Xia said the company looked forward to collaborating with ST and providing eligible cancer patients with world-class therapy.
"We trust that ST's expertise in these regions, navigating complex regulatory channels will ensure our therapy reaches as many eligible patients as possible," she said.
"We look forward to a successful and mutually beneficial partnership, working together with a shared goal of improving patient outcomes."
Regulatory activities are currently in progress.