By Fineline Cube Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Conbercept Ophthalmic Injection in the treatment of retinopathy of prematurity (ROP), specifically covering Zone I (stage 1+, 2+, 3, or 3+), Zone II (stage 3+) ROP, and aggressive posterior ROP (AP-ROP). The clearance marks the fifth approved indication for Kanghong’s flagship Category 1 biologic drug, extending its reach from adult retinal diseases into pediatric ophthalmology.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Approval Type | New indication approval |
| Product | Conbercept Ophthalmic Injection |
| New Indication | Retinopathy of prematurity (ROP): Zone I (stage 1+, 2+, 3, or 3+), Zone II (stage 3+), and aggressive posterior ROP (AP-ROP) |
| Date | 03 Sept 2026 |
| Next Steps | Commercialization of the ROP indication in China |
Drug Profile & Approved Indications
- Molecule: Conbercept Ophthalmic Injection, a Category 1 biologic drug independently developed by Kanghong Biologics
- Indication Count: This approval marks the drug’s fifth indication
- Previously Approved Indications:
- Neovascular (wet) age-related macular degeneration (nAMD)
- Visual impairment due to choroidal neovascularization secondary to pathologic myopia (pmCNV)
- Visual impairment caused by diabetic macular edema (DME)
- Visual impairment caused by macular edema secondary to retinal vein occlusion (RVO) — including branch (BRVO) and central (CRVO) forms
- New Addition: ROP, the first pediatric retinal indication in the product’s portfolio
Clinical & Development Outlook
- The new indication targets the most treatment-relevant forms of ROP, including aggressive posterior disease (AP-ROP) that carries high risk of rapid progression
- With ROP coverage, Conbercept now spans both adult and pediatric retinal vascular disease, broadening its clinical footprint in ophthalmology
- The expansion reinforces the durability of a single molecule platform supporting serial indication growth over time
Market Impact & Outlook
- Underserved niche: ROP remains a leading cause of preventable childhood blindness, with limited approved anti-VEGF options in China — giving Conbercept differentiated positioning in pediatric ophthalmology
- Lifecycle value: A fifth indication deepens the product’s commercial longevity and strengthens its competitive moat against other anti-VEGF agents in the retinal space
- Portfolio breadth: Coverage across nAMD, DME, RVO, pmCNV and now ROP makes Conbercept one of the broadest-labeled domestic anti-VEGF drugs in China
- Strategic signal: The approval underscores Kanghong Pharmaceutical’s (SHE: 002773) commitment to expanding its flagship biologic across the full spectrum of retinal disease
Forward‑Looking Statements: This brief is for informational purposes only and does not constitute investment advice or an offer to buy or sell any security. Statements regarding drug commercialization, indication expansion and market potential are forward-looking and subject to risks and uncertainties, including competitive developments, reimbursement outcomes and clinical adoption. Actual results may differ materially. Readers should conduct their own due diligence before making investment decisions.-Fineline Info & Tech