Fosun Pharma is spending 1.4 billion Chinese yuan ($200 million) to take on a 53% stake in Green Valley Pharmaceuticals and dust off the company’s shelved Alzheimer’s disease drug.
The move is expected to help address the unmet treatment needs of Alzheimer’s patients in China and bolster Fosun’s innovative product pipeline for central nervous system disorders, the company explained in a filing (PDF) with the Shanghai Stock Exchange.
Fosun may have its work cut out reviving Green Valley’s Alzheimer’s disease med sodium oligomannate, or GV-971. In August, Chinese regulators opted not to renew the drug’s conditional approval following months of reports that Green Valley had already halted sales after failing to renew its license on time. The final rug pull came after years of scrutiny on the seaweed-derived drug, which was hailed as a major breakthrough when it first hit the scene in 2019.
Citing increasing Alzheimer’s prevalence in China and low treatment rates that point to “significant market growth potential,” Fosun is picking up where Green Valley left off with GV-971. That will involve advancing post-marketing confirmatory trials and international studies of the drug in a “timely manner,” the Shanghai-based pharma said in its filing.
GV-971, which is extracted from brown algae, was first discovered by Ocean University of China and subsequently co-developed by SIMM and Green Valley. The drug's original approval in its home country preceded the growing field of Alzheimer’s treatments now populated by innovations from Eli Lilly and Biogen.
The drug broke through a decade-long treatment drought to nab a conditional nod in China back in 2019, with regulators swayed by a phase 3 study of 818 patients that showed sodium oligomannate outperformed placebo on a clinical scale measuring patients’ cognitive function, known as ADAS-Cog.
The data soon attracted scrutiny, however, due to the study’s sole positive showing in ADAS-Cog. At the same time, secondary efficacy markers in the trial didn’t track an improvement over placebo.
Green Valley was put on the hook to conduct further post-marketing studies to confirm the drug’s long-term efficacy. The company had five years to renew its marketing license, as is standard for all drugs approved in China.
As Green Valley sought to bring its Alzheimer’s offering worldwide, the drugmaker had initiated a global phase 3 trial in 2020, but pulled the plug in 2022 due to “unfavorable factors,” including insufficient funding and COVID-related setbacks.
Despite some turbulence in its past, sodium oligomannate had been included under China’s national reimbursement since 2022 and reportedly sold 2.13 million boxes in 2024, reaching sales of about $88 million. Chinese regulators signed off on Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla last year, welcoming two new Alzheimer’s drugs into the country. The two anti-amyloid antibodies were also included in China's inaugural drug list recommended for commercial health insurance coverage.