Aribio, the first among domestic corporations to take on a global phase 3 clinical trial for a new Alzheimer's drug, is expected to see the trial's success or failure determined as early as September. The company said it is also reviewing the possibility of pursuing a listing on KOSDAQ or KOSPI through an initial public offering (IPO), spurred by a global licensing deal worth up to 7 trillion won recently signed with Fosun Pharma.
Aribio on the 18th held a press briefing in Yeouido, Seoul, to share the status of the AR1001 global phase 3 trial and details of the Fosun Pharma agreement.
On the 13th, the company signed an exclusive licensing agreement with China's Fosun Pharma for the global development, approval, manufacturing, and commercialization of AR1001. The deal is worth up to $4.7 billion (about 7 trillion won).
◇ "One pill a day for dementia," a 7 trillion won big deal with Fosun
The company said it plans to announce the topline results of the global phase 3 trial of its orally administered Alzheimer's treatment candidate AR1001 in September–October.
AR1001 is a disease-modifying, orally administered Alzheimer's treatment candidate in the PDE-5 inhibitor class under development by Aribio. A global phase 3 study (POLARIS-AD) involving more than 1,500 patients is underway in the United States, Europe, the United Kingdom, China, and Korea.
Kim Sang-yoon, a neurology professor at Bundang Seoul National University Hospital who led the clinical trial, said at the briefing, "Once the last patient dosing wraps up in June, after data cleaning and data lock and then code breaking, the topline results will come out in September–October."
Kim said, "The interim analysis is sufficiently tracking the effects seen in phase 2," adding, "In global trials that require large expense, studies are sometimes halted at interim if effects are lacking, but so far the momentum remains positive."
Under the terms with Fosun Pharma, Aribio will first receive $60 million (about 90 billion won) as an option expense, and after the phase 3 topline announcement it will receive an additional $80 million (about 120 billion won), bringing the total upfront to $140 million (about 210 billion won). If development succeeds, the company will also receive milestone payments by approval and commercialization stage and a royalty of up to 20%.
Aribio said that even after this agreement, it will retain leadership over the global trials and regulatory process. The company stressed that Aribio will continue to hold the technology rights to AR1001, allowing it to pursue label expansions.
Fred Kim, head of Aribio's U.S. branch, said, "Although we signed with Fosun Pharma, we did not hand over all development leadership," adding, "Aribio's U.S. branch will continue to lead through the NDA (new drug application) stage after completion of phase 3." He said, "Fosun Pharma also agreed that Aribio will lead the project until the regulatory filing," and explained, "Fosun Pharma will take on roles starting from the commercialization stage."
If phase 3 succeeds, the company is targeting global approvals and launches in 2027–2029.
Details on the manufacturing rights structure were also shared.
Fred Kim, head of the U.S. branch, said, "Manufacturing rights are currently granted only to Samjin Pharmaceutical in Korea and Fosun Pharma," adding, "Arcera, which signed licensing deals for the Middle East, Central and South America, Africa, and the CIS, does not have manufacturing rights."
◇ "We will keep pushing the Solux merger… considering a standalone listing, too"
The possibility of Aribio pursuing a standalone listing was also mentioned.
Solux, a lighting company that is the largest shareholder, has been pushing a merger by absorption with Aribio, but the financial authorities requested about 10 corrections to the securities registration statement related to the Aribio–Solux merger, repeatedly delaying the plan. Aribio had faced funding pressure due to the expense burden of the global phase 3, but the technology out-licensing to Fosun Pharma has eased the cash crunch.
Co-CEO Sung Su-hyun said, "We are continuing to pursue a merger with Solux," but added, "We are reviewing not only a KOSDAQ listing but also the possibility of a KOSPI listing as another path."
Co-CEO Sung Su-hyun said, "We are not withdrawing the plan to merge with Solux," adding, "Among multiple directions, we are keeping open the possibility of a KOSPI listing as well as KOSDAQ." He also said, "When upfront and milestone funds flow into the company, we believe achieving a unicorn-level corporate valuation is possible."
Regarding the relationship with Solux, Sung said, "Aribio, Aribio Lab, and Solux are structured to grow together," explaining, "Solux will serve in a holdings role." He said, "Solux plans to change its corporate name to Ari and, based on its data center capabilities, is reviewing a direction to grow into a future-oriented platform company that holds Aribio and Aribio Lab."
◇ "We will see it through to the end"… a 16-year push to develop a new dementia drug
Among domestic corporations, Aribio is the only one to directly conduct a global phase 3 trial to develop a new Alzheimer's treatment. It took 16 years from the company's founding to phase 3.
Co-CEO Jung Jae-joon said, "In Korea, it has been treated as standard practice to transfer technology to multinational drugmakers at phase 2," adding, "But only if a Korean company directly conducts a global phase 3 and leads commercialization can it hold true sovereignty over a new drug."
Jung said, "The fact that we have been able to see the global phase 3 through to the end in itself is meaningful for this challenge."
He said, "Our initial goal was to complete phase 3 and then commercialize directly as a Korean new drug, but we needed a realistic choice to finish the global trial," explaining, "With exchange-rate volatility and a high extension-study participation rate increasing the clinical expense burden, Fosun Pharma's proposal meant more than simple financial support."
Jung said, "We will actively share the global phase 3 capabilities and platform we have built with domestic bio corporations," adding, "We hope this leads not to the success of a single company but to a leap for Korea's entire new drug industry."
Aribio adviser Lee Byung-gun said, "Aribio is currently spending more than 10 billion won every month on clinical expense," adding, "This deal was concluded under that funding pressure." Lee said, "Fosun has a passion and drive different from the traditional global big pharma," adding, "This collaboration could be a starting point for bio industry cooperation among Korea, China, and broader Asia."
He said, "In the domestic VC sector, once something is judged negatively, there is a structural tendency not to take another look," adding, "This Fosun Pharma deal is meaningful in that the global market has begun to reappraise Aribio."
Kim Sang-yoon, a neurology professor at Bundang Seoul National University Hospital, said, "Korea's Alzheimer's research is world-class, but the reality has been a lack of funding and infrastructure," adding, "This drug development could serve as an opportunity to showcase K-bio's competitiveness."
Jung said, "We do not intend to stop with completing AR1001 phase 3; we plan to expand indications to Parkinson's disease and vascular dementia and to pursue development of follow-on pipelines such as an amyloid vaccine."