Hansoh Pharmaceutical's Strategic Expansion with Xinyue's Second Indication Approval for IgG4-RD

In the evolving landscape of China’s biopharmaceutical sector, companies that combine clinical innovation with regulatory agility are poised to capture significant value. Hansoh Pharmaceutical’s recent regulatory and clinical milestones with Xinyue (inebilizumab) for IgG4-related disease (IgG4-RD) exemplify this dynamic. The drug’s second Biologics License Application (BLA) for IgG4-RD was accepted by the National Medical Products Administration (NMPA) in March 2025 and included in the Priority Review and Approval Procedure in February 2025 [1]. This follows the MITIGATE trial’s groundbreaking results, which demonstrated an 87% reduction in flare risk compared to placebo, with 57.4% of patients achieving flare-free remission [2]. These outcomes not only validate Xinyue’s therapeutic potential but also underscore Hansoh’s ability to address unmet medical needs in rare autoimmune diseases.

A High-Barrier Moat in a Niche Market

Hansoh’s competitive advantage is anchored in its exclusive licensing rights to inebilizumab in China, Hong Kong, and Macau, secured through a 2019 agreement with Viela Bio (now part of Amgen) [3]. This exclusivity, combined with a six-year regulatory data exclusivity period for inebilizumab in China, creates a formidable barrier to entry. The absence of direct competitors in the IgG4-RD space—coupled with the high cost and complexity of biologic manufacturing—further solidifies Hansoh’s market position. Additionally, Xinyue’s inclusion in the National Reimbursement Drug List (NRDL) since 2023 ensures broad patient access, a critical factor in a market where affordability often limits adoption of novel therapies [4].

Financial Strength and R&D Prowess

Hansoh’s financial health reinforces its long-term investment appeal. In 2024, the company reported a profit margin of 36.25% and a debt-to-equity ratio of 0.41%, reflecting disciplined capital management and strong profitability [5]. Its R&D investment of RMB2.7 billion (22% of revenue) in 2024 underscores a commitment to innovation, with over 60 clinical trials across 40 drug candidates in development [6]. This pipeline diversification, spanning anti-tumor, CNS, and metabolic diseases, mitigates reliance on any single product and positions Hansoh to capitalize on multiple growth vectors.

Market Dynamics and Growth Potential

The IgG4-RD treatment market in China is part of a broader rare disease sector projected to grow at a compound annual growth rate (CAGR) of 15.1% from 2025 to 2030, reaching USD 10.78 billion by 2030 [7]. While specific IgG4-RD market data is sparse, the global market for this condition is expected to expand from USD 3.77 billion in 2024 to USD 5.12 billion by 2032, driven by advancements in diagnostics and targeted therapies [8]. Hansoh’s leadership in this niche, supported by Xinyue’s clinical differentiation and regulatory momentum, positions it to capture a disproportionate share of this growth.

Strategic Expansion and Future Prospects

Hansoh’s strategy extends beyond IgG4-RD. A third BLA for inebilizumab in generalized myasthenia gravis (gMG) was accepted by the NMPA in May 2025, illustrating the company’s ability to leverage its core asset across multiple indications [9]. This approach not only maximizes the value of its licensing agreement but also aligns with China’s policy-driven focus on rare diseases, where innovation is incentivized through expedited approvals and reimbursement support.

Conclusion

Hansoh Pharmaceutical’s strategic expansion with Xinyue represents a compelling case study in China’s innovation-driven biopharma sector. By combining clinical excellence, regulatory agility, and financial discipline, the company has established a high-barrier moat in a high-growth niche. As the rare disease market matures and healthcare access improves, Hansoh’s portfolio of differentiated therapies—anchored by Xinyue’s leadership in IgG4-RD—positions it as a long-term winner in a sector poised for transformation.

Source:
[1] Jiangsu Hansoh Pharmaceutical Group Co., Ltd. [https://www.hspharm.com/news/news-detail-513288.htm]
[2] The New England Journal of Medicine (November 2024) [https://www.hspharm.com/news/news-detail-513254.htm]
[3] Hansoh Pharmaceutical: Pioneering Breakthroughs in Rare Autoimmune Diseases [https://www.ainvest.com/news/hansoh-pharmaceutical-pioneering-breakthroughs-rare-autoimmune-diseases-market-dominance-china-2505/]
[4] Jiangsu Hansoh Pharmaceutical Group Co., Ltd. [https://www.hspharm.com/news/news-detail-513319.htm]
[5] Hansoh Pharmaceutical Group Company Limited (3692.HK) [https://finance.yahoo.com/quote/3692.HK/key-statistics/]
[6] Hansoh Pharma | Continuous innovation for better life [https://www.hansoh.cn/en/]
[7] China Rare Diseases Treatment Market Size & Outlook, 2030 [https://www.grandviewresearch.com/horizon/outlook/rare-diseases-treatment-market/china]
[8] Global IgG4-Related Disease Market Size, Share, and ... [https://www.databridgemarketresearch.com/reports/global-igg4-related-disease-market?srsltid=AfmBOorBdamjjtpJsGxaZa9-ko-aHbLOc-B_4iaAtVZuQ-eragfddbGj]
[9] Hansoh Pharmaceutical: Pioneering Breakthroughs in ... [https://www.ainvest.com/news/hansoh-pharmaceutical-pioneering-breakthroughs-rare-autoimmune-diseases-market-dominance-china-2505/]