By Fineline Cube 
China‑based Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced today that the China National Medical Products Administration (NMPA) has granted approval for the company’s SQ‑129 intravitreal sustained‑release injection to commence clinical trials. The investigational product is aimed at adult patients suffering from diabetic macular edema (DME), as well as those with macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Product Overview
- Drug Class – Category 2.2 chemical – a long‑acting intravitreal formulation designed to maintain therapeutic drug levels within the vitreous cavity.
- Mechanism – While detailed pharmacodynamics remain proprietary, pre‑clinical studies indicate that SQ‑129 reduces vascular permeability and inflammation, thereby mitigating retinal edema.
- Safety Profile – Pharmacological and pharmacotoxicological data demonstrate a favorable safety margin, with no dose‑limiting toxicities observed in animal models.
Regulatory Milestone
- NMPA Clearance – Approval to conduct Phase 1/2 clinical trials represents a critical step toward potential market entry, as the NMPA’s Category 2.2 designation allows accelerated development pathways for ocular therapeutics.
- Trial Design – The forthcoming studies will evaluate safety, tolerability, and preliminary efficacy in patients with DME, BRVO‑ and CRVO‑associated macular edema, using a randomized, double‑blind, placebo‑controlled framework.
Market Significance
- Unmet Need – Currently, no approved sustained‑release intravitreal therapy exists for DME or retinal vein occlusion‑related macular edema in either China or globally, positioning SQ‑129 as a potentially first‑in‑class candidate.
- Competitive Edge – By combining a robust safety profile with a sustained‑release platform, Xingqi Pharma aims to reduce injection frequency, improve patient adherence, and lower overall treatment costs.
Outlook
- Next Steps – Xingqi will initiate the first‑in‑human study in the second half of 2025, with a projected timeline of 18–24 months to complete Phase 2 and submit a New Drug Application (NDA) to the NMPA.
- Strategic Impact – Successful development could establish Xingqi as a leading player in ocular therapeutics and open opportunities for licensing or partnership in international markets.-Fineline Info & Tech