By Fineline Cube Kawin Technology (SHA: 688687) announced it has voluntarily withdrawn its market filing for peginterferon alfacon‑2 in combination with tenofovir alafenamide fumarate (TAF) for adult chronic hepatitis B (HBV), following feedback from China’s National Medical Products Administration (NMPA). The company plans to conduct additional supplementary clinical studies and may resubmit based on future data.
Regulatory Update
| Item | Detail |
|---|---|
| Company | Kawin Technology (688687.SH) |
| Drug | Peginterferon alfacon‑2 (long‑acting interferon) |
| **Original Indication | Chronic hepatitis C (HCV) – approved 2018 |
| **Supplemental Indication | HBV (combined with TAF) – voluntarily withdrawn |
| Filing Submitted | September 2024 |
| Withdrawal Date | 15 Jan 2026 |
| **Reason | NMPA feedback and internal review; need for additional data |
Clinical Study Results & Significance
| Endpoint | Outcome |
|---|---|
| **Study Design | World’s first 48‑week interferon + nucleoside analog registration study |
| **Primary Endpoint | Hepatitis B surface antigen (HBsAg) loss |
| HBsAg <10 IU/mL | >50% of patients with low baseline HBsAg and interferon‑responsive profiles |
| HBsAg Clearance | >20% of patients |
- Clinical Benefit: Demonstrated significant HBsAg reduction and clearance in advantaged patient populations
- Innovation: First to evaluate long‑acting interferon + TAF regimen with HBsAg loss as primary endpoint
- Strategic Rationale: Results support potential functional cure pathway, but NMPA requires additional data for broader patient labeling
Market Context & Competitive Landscape
| Parameter | China HBV Market | Global HBV Market |
|---|---|---|
| HBV Patients (2026E) | 87 million | 296 million |
| Functional Cure Rate (Current) | <5% | <5% |
| Interferon‑Based Therapy Share | 12% | 8% |
| Addressable Market (2030E) | ¥18 billion | $12 billion |
| Kawin Peak Revenue (pre‑withdrawal) | ¥420 million | – |
Key Competitors:
- Pegasys (Roche) – Standard interferon for HBV, limited efficacy
- Vemlidy (Gilead) – TAF monotherapy, no functional cure
- Bepirovirsen (GSK) – RNA‑based functional cure candidate, Phase III
- Peginterferon alfacon‑2 – differentiated long‑acting interferon with potential functional cure if resubmitted successfully
Strategic Positioning
- Manufacturing: Kawin’s Wuhan biologics facility (capacity 5 million vials/year) will continue producing peginterferon alfacon‑2 for HCV; no capacity constraints for future HBV trials
- Clinical Next Steps:
- Supplementary studies to broaden patient population beyond “advantaged” subgroup
- Potential resubmission timeline: H2 2027
- Financial Impact: Withdrawal delays revenue by 12‑18 months, but preserves optionality for stronger label
- Pipeline Synergy: HBV program complements Kawin’s NASH and oncology interferon programs
Forward‑Looking Statements
This brief contains forward‑looking statements regarding supplementary clinical studies, potential resubmission timelines, and commercial forecasts for peginterferon alfacon‑2. Actual results may differ due to competitive dynamics, regulatory requirements, and clinical trial outcomes.-Fineline Info & Tech