In the pharmaceutical industry, a drug once hailed as a beacon of hope for domestic innovation—yet mired in scientific controversy—awaits redemption. On December 15, Fosun Pharma announced its acquisition of Green Valley Pharma, including its core product, Sodium Oligomannate Capsules, which will be integrated into Fosun’s innovative drug pipeline. This move has sent ripples through the medical community. With its robust global R&D capabilities and growing portfolio in the central nervous system (CNS) field, Fosun Pharma aims to revive this beleaguered drug and address the unmet needs in Alzheimer’s disease (AD) treatment.
**Sodium Oligomannate Capsules: From Glory to Suspension** Green Valley’s Sodium Oligomannate Capsules were once a star in China’s pharmaceutical landscape. Approved conditionally in November 2019, it marked the first new AD drug globally in 17 years—an event likened to a "nuclear explosion" in the industry. However, skepticism persisted, notably from prominent scientist Rao Yi, who questioned its 36-week Phase III trial design and reliance on a single efficacy metric (ADAS-Cog score). Compounding the challenges, the drug’s registration expired in November 2024 without full approval, leading Green Valley to halt production in 2025.
The deeper issue lay in Green Valley’s limited experience and resources for large-scale neurodegenerative disease trials. Its international multicenter trial paused in 2022, and post-marketing studies failed to meet regulatory requirements, exposing the gap between groundbreaking theory and rigorous clinical execution—a gap Fosun Pharma may now bridge.
**Clinical Demand and Acquisition Rationale** AD, a leading neurodegenerative disorder, affects over 17 million patients in China (2021 data), with current treatments like cholinesterase inhibitors offering only symptomatic relief. While two amyloid-beta (Aβ) monoclonal antibodies (Lecanemab and Donanemab) recently gained approval, their modest efficacy (below minimal clinically important difference) and safety risks (e.g., ARIA) limit accessibility. Sodium Oligomannate’s "gut-brain axis" mechanism—targeting gut microbiota to modulate neuroinflammation and Aβ/tau pathology—offers a differentiated approach. Supported by emerging research (e.g., a 2025 *Molecular Psychiatry* study), its potential for disease modification and safety profile could position it as a viable alternative if validated through robust trials.
**Fosun Pharma’s CNS Strategy** This acquisition aligns with Fosun’s long-term CNS focus. Its portfolio now includes Opicapone Capsules (a COMT inhibitor for Parkinson’s) and FXS4983 (an oral AD drug in Phase III). By integrating Green Valley’s assets, Fosun strengthens its neurodegenerative disease pipeline, combining drugs and devices (e.g., magnetic resonance-guided focused ultrasound).
**Challenges and Broader Implications** AD drug development remains fraught with failure, as seen in setbacks for Novo Nordisk’s Semaglutide and other Big Pharma candidates. Fosun must navigate Sodium Oligomannate’s post-marketing trials and re-registration hurdles. Yet, experts like Dr. Howard Fillit (ADDF) emphasize the need for multi-target therapies beyond Aβ, underscoring the drug’s potential niche.
Fosun’s bold move reflects Chinese pharma’s ambition to tackle global health challenges. Whether the gut-brain axis proves transformative or not, this acquisition underscores the value of scientific diversity in conquering AD’s complexities.
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