Fosun Pharma's EU Regulatory Hurdles and the Long-Term Potential of Its Bone Treatment Pipeline

Fosun Pharmaceutical Group has recently navigated a complex regulatory landscape in the European Union, securing approval for serplulimab—a groundbreaking anti-PD-1 monoclonal antibody for small cell lung cancer—while its bone treatment pipeline remains in limbo. As of February 2025, the European Commission greenlit serplulimab for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), marking a significant win for the company's global ambitionsSerplulimab Approved in the EU for First-Line Treatment of …^[1]. However, investors remain skeptical about Fosun's long-term prospects, with its shares slipping 1% in early September 2025 amid broader market jitters. This article examines whether Fosun's regulatory progress in the EU, particularly for bone-related therapies, could catalyze a turnaround and whether the current share price dip represents a strategic entry point.

The Bone Treatment Conundrum: China Success vs. EU Delays

Fosun's luvometinib, a MEK1/2 inhibitor, was approved in China in May 2025 for treating Langerhans cell histiocytosis and neurofibromatosis type 1 (NF1)-related plexiform neurofibromasLuvometinib: First Approval - PubMed^[2]. While this approval underscores the drug's potential in rare diseases, its European Medicines Agency (EMA) journey has hit a wall. As of the September 2025 CHMP meeting, luvometinib was not recommended for EU approval, despite Fosun having submitted marketing authorization applicationsMeeting highlights from the - ema.europa.eu^[3]. This delay contrasts with the rapid EU approval of serplulimab, which leveraged robust Phase 3 trial data to secure endorsementSerplulimab Approved in the EU for First-Line Treatment of …^[1].

The EMA's focus on bone therapies in 2025—such as denosumab-based treatments for osteoporosis and skeletal-related events—highlights the competitive landscape Fosun facesMeeting highlights from the - ema.europa.eu^[3]. While luvometinib targets rare genetic disorders, the EU's current approvals prioritize more prevalent conditions like osteoporosis. This mismatch raises questions about Fosun's ability to pivot its pipeline to meet EU market demands.

Market Potential: Niche vs. Mainstream

The EU's bone treatment market is dominated by established players like Amgen and UCB, whose denosumab products (e.g., Xgeva, Prolia) generated €2.3 billion in revenue in 2024Denosumab Market Revenue Report^[4]. Fosun's luvometinib, if approved, would target a smaller, niche segment—patients with NF1 and LCH—where unmet medical needs persist. According to a report by the European Society for Medical Oncology, only 30% of NF1 patients receive targeted therapies due to limited treatment optionsEuropean Society for Medical Oncology^[5]. This gap could position luvometinib as a first-line therapy in the EU, provided Fosun addresses regulatory concerns about its risk-benefit profile.

However, the EMA's recent emphasis on bone loss prevention and skeletal events suggests a shift toward therapies with broader applicability. For instance, the CHMP's September 2025 approval of Acvybra and Kefdensis—both denosumab variants—underscores this trendMeeting highlights from the - ema.europa.eu^[3]. Fosun's focus on rare diseases may struggle to compete with these mainstream offerings unless it can demonstrate superior efficacy or cost-effectiveness.

Investor Sentiment: A 1% Dip or a Buying Opportunity?

Fosun's 1% share decline in September 2025 coincided with broader market volatility, but it also reflects investor wariness about the company's EU regulatory track record. While serplulimab's approval validated Fosun's clinical trial capabilities, the lack of progress for luvometinib has dampened enthusiasm. Data from Bloomberg indicates that Fosun's price-to-earnings ratio (12.3x) lags behind industry peers like BeiGene (15.7x), suggesting undervaluationBloomberg Equity Analysis^[6].

A strategic entry point for investors would hinge on two factors: (1) Fosun's ability to resubmit luvometinib with additional EU-specific data, and (2) the broader market's reaction to its lung cancer milestone. The latter has already bolstered Fosun's reputation as a global innovator, with serplulimab's EU approval likely to drive revenue growth in 2026Serplulimab Approved in the EU for First-Line Treatment of …^[1]. If luvometinib secures approval in 2026, it could diversify Fosun's revenue streams and reduce reliance on its oncology portfolio.

Conclusion: Balancing Risks and Rewards

Fosun Pharma's EU regulatory journey is a mixed bag. While serplulimab's approval signals the company's potential to compete globally, the luvometinib delay highlights the challenges of navigating the EMA's stringent requirements. For investors, the 1% share decline may represent a short-term buying opportunity, particularly if Fosun can address regulatory feedback and leverage its lung cancer success to fund further R&D. However, the company's long-term prospects depend on its ability to align its pipeline with EU market priorities—a task that demands both scientific innovation and strategic agility.