Huahai Pharmaceutical’s Anti-IL-36R Antibody Huayijing Receives NMPA Priority Review Approval for Generalized Pustular Psoriasis Flares

Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced that its Category 1 therapeutic biologic HB0034 (trade name: Huayijing) has received marketing approval from China’s National Medical Products Administration (NMPA) under priority review designation for the treatment of generalized pustular psoriasis (GPP) flares in adults weighing ≥40 kg. As China’s first domestically developed innovative anti-IL-36R antibody, Huayijing represents a breakthrough therapy for this rare, life-threatening systemic neutrophilic skin disease, demonstrating rapid and significant pustule clearance within one week of single-dose administration.

Regulatory Milestone

Drug Profile & Clinical Efficacy

• Mechanism of Action: Anti-IL-36R monoclonal antibody that inhibits the IL-36 inflammatory pathway, a key driver of neutrophilic inflammation in GPP
• Clinical Trial Results:
• Primary Endpoint Met: Significant clearance of skin pustules by Week 1 compared to placebo
• Dosing Regimen: Single intravenous dose demonstrated rapid onset of action
• Safety Profile: Favorable safety with no new safety signals identified
• Innovation Status: First-in-class domestically developed IL-36 pathway inhibitor in China
• Therapeutic Impact: Addresses critical need for rapid-acting, targeted therapy in acute GPP flares

Disease Context & Market Need

Generalized pustular psoriasis (GPP) is an ultra-rare, life-threatening condition affecting approximately 1-2 per million people globally, with potentially fatal complications including sepsis, multi-organ failure, and cardiovascular events. Prior to Huayijing’s approval, treatment options were limited to off-label systemic immunosuppressants with suboptimal efficacy and significant safety concerns.

The global GPP therapeutics market, while small in patient population, commands premium pricing due to high unmet need and life-threatening nature of the disease. Spesolimab (anti-IL-36R antibody) received FDA approval in 2022, validating the IL-36 pathway as a clinically proven target, but remains unavailable in many markets including China until now.

Key clinical advantages of Huayijing:

• Rapid onset of action (significant improvement within 7 days)
• Targeted mechanism addressing root cause rather than broad immunosuppression
• Favorable safety profile suitable for acute flare management
• Domestic availability ensuring patient access in China’s healthcare system

Strategic Implications

• For Huahai Pharmaceutical: Marks transformation from generic manufacturer to innovative biologics developer, creating new revenue streams beyond traditional business
• Market Leadership: Establishes first-mover advantage in China’s GPP treatment market with potential for international expansion
• Pricing Power: Orphan drug status and life-threatening indication support premium pricing strategy
• Pipeline Validation: Success validates Huahai’s biologics development capabilities and supports advancement of other pipeline candidates
• Healthcare Impact: Addresses critical gap in China’s rare disease treatment landscape, aligning with national healthcare priorities

Commercial Outlook

• Patient Population: Estimated 1,000-2,000 GPP patients in China requiring acute flare treatment annually
• Pricing Strategy: Expected to command annual treatment costs of RMB 300,000-500,000 based on international benchmarks
• Reimbursement: Likely candidate for National Reimbursement Drug List (NRDL) inclusion given orphan status and life-threatening indication
• Manufacturing: Leveraging Huahai’s established biologics manufacturing infrastructure for commercial-scale production
• Global Potential: Potential for regional partnerships in Asia-Pacific markets with similar unmet needs

Next Steps

• Commercial Launch: Immediate market availability through specialized dermatology centers and rare disease networks
• Physician Education: Comprehensive training programs for dermatologists and emergency medicine specialists on GPP recognition and treatment
• Real-World Evidence: Post-marketing surveillance studies to further validate long-term efficacy and safety
• International Filings: Preparation for regulatory submissions in Southeast Asia and emerging markets

Forward‑Looking Statements
This brief contains forward-looking statements regarding commercial launch, market adoption, and international expansion. Actual results may differ due to risks including market acceptance, reimbursement decisions, competitive developments, and regulatory requirements in other jurisdictions.-Fineline Info & Tech