Hengrui Pharma Files NDA for SHR-1819, a Novel IL-4Rα Monoclonal Antibody for Atopic Dermatitis

Shanghai, September 2, 2026 — China's Center for Drug Evaluation (CDE) has accepted a new drug application from Jiangsu Hengrui Pharmaceuticals Co., Ltd. for SHR-1819 (zutuoqibai dan kang), a novel monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), for the treatment of atopic dermatitis. The filing marks a significant milestone in China's rapidly intensifying race to develop best-in-class therapies in the autoimmune and allergy space.

SHR-1819 is a self-developed monoclonal antibody that simultaneously blocks IL-4 and IL-13 signaling pathways, suppressing Type 2 inflammation at its source. The drug is currently being studied across multiple indications including seasonal allergic rhinitis, atopic dermatitis, nodular prurigo, and chronic spontaneous urticaria. Its most advanced programs — allergic rhinitis and atopic dermatitis — have both reached Phase III clinical trials.

A Crowded and Competitive Landscape

Hengrui's entry into the NDA stage comes as China's IL-4Rα monoclonal antibody market is becoming one of the most competitive therapeutic battlegrounds in the country's biopharmaceutical sector. At least ten major domestic programs are now in late-stage development, with several already reaching the market or awaiting regulatory approval.

The global benchmark remains Sanofi and Regeneron's dupilumab (brand name Dupixent), the world's first approved IL-4Rα antibody. Originally cleared by the U.S. FDA in 2017 for moderate-to-severe atopic dermatitis, dupilumab has since expanded into asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease. It generated €15.714 billion (EUR) in global sales in 2025, making it one of the best-selling autoimmune drugs worldwide.

In China, Keymed Biosciences (Kang Nuoya Biomedical Technology) was the first domestic player to secure approval with its drug siprubartide (sipuqibai dankang), which became the world's first IL-4Rα monoclonal antibody approved for allergic rhinitis and entered China's National Reimbursement Drug List in 2026.

Three additional candidates — manduqimab from Akeso, SSGJ-611 from Shanghai Cp Guojian Pharmaceutical Co., Ltd., and teliquartide from Genor Biopharma — all filed NDAs in February 2026 for moderate-to-severe atopic dermatitis. By April 2026, ledequartide from Corvus Pharmaceuticals and Simcere Pharmaceutical followed suit, reporting a 52-week EASI-75 response rate of 96.6%, with nearly 90% of patients achieving near-complete skin clearance. Kemeiquartide from Maiji Bio and China Grand Pharma also filed, pursuing a differentiated strategy targeting China's grassroots healthcare market.

Two more programs — TQH2722 from Chia Tianqing and otoquartide from Quanxin Bio and Simcere — remain in Phase III trials, pursuing Type 2 inflammation-related diseases and multiple indications respectively.

The "Golden Target" of Autoimmunity

IL-4Rα — the alpha subunit of the interleukin-4 receptor — sits at the apex of the Type 2 inflammation cascade. By binding to this receptor, IL-4Rα monoclonal antibodies block both IL-4 and IL-13 signaling simultaneously, a "dual-pathway inhibition" strategy that suppresses Th2-driven inflammation at its root. This mechanism gives the drug class broad therapeutic reach across atopic dermatitis, asthma, CRSwNP, and allergic rhinitis, earning IL-4Rα the industry moniker of "golden target" in autoimmune and allergic disease.

Compared with single cytokine inhibitors, IL-4Rα antibodies offer broader coverage across multiple Type 2 inflammatory conditions and tend to produce faster onset of action. Patient compliance is also favorable, with some candidates undergoing long-acting formulation upgrades to extend dosing intervals.

Breaking the Original Monopoly

Dupilumab remains the clinical gold standard with extensive global multi-center trial data and the widest approved indications. However, its relatively high cost and the need for biweekly dosing have created opportunities for domestic competitors. Chinese pharmaceutical companies have pursued optimization through molecular engineering — including half-life extension for less frequent dosing — as well as differentiated indication expansion into areas like allergic rhinitis and chronic spontaneous urticaria.

The wave of NDAs filed in 2026 signals that China's IL-4Rα market is on the cusp of a dramatic transformation. With Hengrui — widely regarded as one of China's top pharmaceutical companies — now entering the race with SHR-1819, the competitive dynamics are set to intensify further. The company's deep clinical pipeline across multiple indications and its established commercial infrastructure position it as a formidable contender in what is shaping up to be one of China's most important autoimmune drug markets.

The question now is not whether China will have a homegrown IL-4Rα antibody market — it is which companies will capture the lion's share of a therapeutic category that could generate billions in annual sales.