CSPC Pharma's Dupilumab Biosimilar and COPD Franchise: A Dual-Engine Growth Strategy in China's Booming Biologics Market

China's biologics market is on a trajectory to grow at a compound annual rate of over 15% through 2030, driven by an aging population, rising chronic disease prevalence, and government incentives for affordable advanced therapies. At the forefront of this transformation is CSPC Pharmaceutical Group Limited, a company leveraging strategic regulatory agility and commercial scalability to dominate two high-prevalence therapeutic niches: atopic dermatitis and chronic obstructive pulmonary disease (COPD). By pairing a Dupilumab biosimilar with an established COPD biologic franchise, CSPC has engineered a dual-engine growth strategy that positions it as a top-tier investment in China's healthcare innovation landscape.

Regulatory Agility: Navigating China's Biosimilar Framework with Precision

CSPC's recent clinical trial approval for its Dupilumab biosimilar in China marks a pivotal milestone. The biosimilar, a recombinant fully human monoclonal antibody targeting IL-4Rα, has demonstrated high similarity to the reference drug, Dupixent, in non-clinical and pharmaceutical studies. This achievement, secured in August 2025, underscores CSPC's ability to align with China's stringent regulatory standards while accelerating development timelines.

The company's regulatory prowess is further highlighted by its 2024 approval of Dupixent for COPD, a first-in-class biologic in China. This rapid regulatory progress—just months after phase 3 trials showed a 30–34% reduction in COPD exacerbations—reflects CSPC's deep understanding of the National Medical Products Administration (NMPA)'s priorities. By prioritizing therapies that address unmet medical needs and align with national healthcare goals, CSPC has minimized bureaucratic hurdles and positioned itself as a trusted partner in China's biosimilar ecosystem.

Commercial Scalability: Targeting High-Prevalence, High-Growth Markets

CSPC's dual-track strategy is anchored in two therapeutic areas with massive untapped potential.
1. Atopic Dermatitis: The Chinese market for atopic dermatitis biologics is projected to grow at a 12.4% CAGR, reaching USD 1.02 billion by 2030. With 10 million adults suffering from moderate-to-severe atopic dermatitis, CSPC's Dupilumab biosimilar offers a cost-effective alternative to Dupixent, which commands a premium price.
2. COPD: China's 65 million COPD patients represent a USD 25.98 billion global market by 2030. CSPC's Dupixent franchise, already generating revenue, provides immediate cash flow while the biosimilar pipeline matures.

CSPC's localized manufacturing and distribution infrastructure further amplifies scalability. The company's facilities meet global quality standards, ensuring supply chain resilience and cost efficiency. Partnerships with global giants like Regeneron and Sanofi also provide access to cutting-edge R&D and commercialization expertise, reducing time-to-market for new therapies.

Strategic Positioning: A Dual-Engine Model for Risk Mitigation and Growth

CSPC's dual-engine approach mitigates risk while maximizing growth. The COPD franchise generates near-term revenue, funding the development and commercialization of the Dupilumab biosimilar. This creates a virtuous cycle: profits from the biologic stabilize the business, while the biosimilar's lower cost expands market access, driving volume growth.

Moreover, CSPC's alignment with China's Healthy China 2030 initiative—focusing on chronic disease management and affordable healthcare—ensures long-term policy tailwinds. The company's AI-driven R&D and digital innovation initiatives further enhance its ability to predict demand and optimize production, a critical advantage in a market where supply chain efficiency determines success.

Investment Thesis: A High-Conviction Play on China's Healthcare Transformation

CSPC's strategic agility, commercial infrastructure, and dual-engine model make it a compelling investment. Key catalysts include:
- Regulatory milestones for the Dupilumab biosimilar, with potential NMPA marketing approval by 2027.
- Revenue growth from the COPD franchise, supported by Dupixent's first-mover advantage.
- Partnership synergies with global biopharma leaders, enhancing R&D and commercialization capabilities.

Analysts have assigned a “Buy” rating to CSPC shares, with a price target of HK$6.80. Given the company's track record of rapid regulatory approvals and its alignment with China's healthcare priorities, this target appears conservative. Investors seeking exposure to China's biologics boom should consider CSPC as a core holding, particularly as the company transitions from clinical-stage biosimilars to revenue-generating products.

In a market where regulatory agility and commercial scalability are rare commodities, CSPC Pharmaceutical Group has positioned itself as a leader. Its dual-engine strategy not only addresses two of China's most pressing unmet medical needs but also creates a durable competitive moat in a sector poised for explosive growth. For investors, the time to act is now.