Shanghai Fosun Pharmaceutical has signed an exclusive global option agreement for the development, registration, manufacturing and commercialisation of AR1001, an innovative drug candidate for the treatment of Alzheimer's Disease (AD).

The transaction adopts an "option fee plus license payment" structure. Fosun Pharma will pay AriBio a USD 60 million option fee and retains the right to decide whether to exercise the option within the agreed exercise period. Upon exercise of the option, Fosun Pharma will pay up to USD 180 million in upfront and regulatory milestone payments. Sales milestone payments will be triggered when annual net sales of the licensed product reach at least USD 2.5 billion.

AR1001 is a best-in-class, once-daily oral phosphodiesterase-5 inhibitor with disease-modifying potential being developed for the treatment of AD. It is currently being evaluated in POLARIS-AD (NCT05531526), a global phase 3 clinical trial for early AD. The trial has enrolled more than 1,500 patients across the US, Europe, China, South Korea, and other countries and regions. Enrollment was completed in 2025, and top-line results are anticipated in 2026. AR1001 has demonstrated therapeutic effects through multiple mechanisms, including neuroprotection, inhibition of tau phosphorylation, suppression of inflammatory responses, and improvement of cerebral blood flow. Preclinical and clinical data to date indicate a favorable safety profile, blood-brain barrier penetration, and potential therapeutic benefit in patients with early AD, ranging from mild cognitive impairment to mild dementia.

This agreement further deepens and expands the successful prior collaboration, under which Fosun Pharma secured rights to develop, register, manufacture and commercialise AR1001 in Chinese mainland, Hong Kong and Macao as well as in 10 designated ASEAN countries.

Jai Jun Choung, PhD, Chairman and Co-Chief Executive Officer, AriBio, said, "This global partnership with Fosun Pharma represents a transformational milestone in our mission to bring innovative treatments to Alzheimer's Disease patients and families worldwide, one of the most pressing unmet medical needs of our time. For more than a decade, AriBio has remained deeply committed to the global effort to develop effective and accessible treatments for AD with our belief to address multiple underlying disease mechanisms. Fosun Pharma's proven global capabilities and shared commitment to tackling AD make them an ideal partner to advance AR1001. We look forward to working closely together to accelerate toward commercial launch and furthering our broader strategic collaboration."

With the agreement, the partnership is extended to global markets, including major regions such as the US, Europe and Japan. Going forward, both parties will leverage Fosun Pharma's established capabilities in R&D, manufacturing, regulatory affairs and commercialisation to accelerate the global launch of AR1001.

Chen Yuqing, Chairman, Fosun Pharma, said, "As one of the core challenges in the field of neurodegenerative diseases, Alzheimer's Disease research and drug development urgently require new breakthroughs. Fosun Pharma's deeper global collaboration with AriBio represents a strong alliance in both R&D and commercialisation, which will help accelerate the global clinical development and market launch of AR1001, an innovative oral therapy for AD. If the results of the phase 3 clinical trial further validate its efficacy and safety, AR1001 has the potential to become a groundbreaking treatment for AD, offering patients a new therapeutic option.”