Keymed Biosciences Inc. (HKG: 2162) announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Kangyueda (stapokibart) for the treatment of moderate‑to‑severe atopic dermatitis (AD) in adolescents aged 12 years and older – the product’s fourth approved indication in China – while disclosing that Kangyueda revenue reached approximately RMB 660 million in the first three quarters of 2026, up ~227% year‑on‑year.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Approval Type | New indication (fourth in China) |
| Product | Kangyueda – stapokibart injection |
| New Indication | Moderate‑to‑severe atopic dermatitis in adolescents ≥12 years |
| Existing Indications | Moderate‑to‑severe AD in adults; chronic rhinosinusitis with nasal polyps (CRSwNP); seasonal allergic rhinitis (SAR) |
| Approval Date | 16 Oct 2026 |
| Revenue Disclosure | ~RMB 660 million (9M 2026), ~+227% YoY |
Drug Profile & Mechanism of Action
- Molecule: Stapokibart – a humanized, highly potent monoclonal antibody targeting the interleukin‑4 receptor α‑subunit (IL‑4Rα).
- Mechanism: By blocking IL‑4Rα, stapokibart inhibits signaling of both IL‑4 and IL‑13, the central type‑2 (Th2) inflammatory cytokines driving atopic dermatitis and related allergic/airway diseases.
- Platform Breadth: Now approved across four indications – adult AD, adolescent AD, CRSwNP, and SAR – establishing stapokibart as a multi‑disease type‑2 inflammation franchise for Keymed Biosciences.
- Competitive Class: Competes in the IL‑4Rα class alongside dupilumab, offering physicians an additional biologic option across the AD care continuum.
Clinical Evidence – Phase III Adolescent AD Trial
| Endpoint (Week 18) | Stapokibart | Placebo | Statistical Significance |
|---|---|---|---|
| EASI‑75 Response | Up to 73.9% | 43.3% | P < 0.0001 |
| IGA 0/1 with ≥2‑point Improvement | Up to 57.1% | 25.0% | P < 0.0001 |
| Safety (18‑week double‑blind period) | Predominantly mild‑to‑moderate AEs, comparable to placebo | – | – |
The approval is based on a Phase III clinical study of stapokibart in adolescents with moderate‑to‑severe atopic dermatitis. At Week 18, up to 73.9% of stapokibart‑treated patients achieved EASI‑75 (a ≥75% improvement in the Eczema Area and Severity Index) versus 43.3% on placebo, and up to 57.1% achieved clear or almost clear skin (IGA 0/1) with a ≥2‑point improvement from baseline versus 25.0% on placebo. Adverse events during the 18‑week double‑blind period were predominantly mild to moderate and comparable to placebo.
Market Impact & Outlook
- Commercial Traction: Kangyueda generated approximately RMB 660 million in the first nine months of 2026, a ~227% year‑on‑year increase, signaling rapid uptake ahead of the adolescent label expansion.
- Adolescent AD Opportunity: The new label extends Kangyueda to patients ≥12 years, capturing a high‑burden pediatric‑onset population where disease frequently persists from childhood and treatment options are more limited.
- Full‑Spectrum Positioning: With adult and adolescent AD, CRSwNP, and SAR all approved, Keymed can pursue cross‑indication prescribing and formulary strategy around a single biologic franchise.
- Competitive Landscape: Stapokibart joins an expanding IL‑4Rα class in China; differentiation will hinge on efficacy durability, dosing convenience, pricing, and NRDL reimbursement access. Reimbursement terms for the adolescent indication were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory developments, commercial performance, and market expectations for Kangyueda (stapokibart). Actual results may differ due to risks including reimbursement outcomes, competitive dynamics, pricing pressure, and patient adoption. This summary is for informational purposes only and does not constitute investment advice.-Fineline Info & Tech
