By Fineline Cube 
Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced that the National Medical Products Administration (NMPA) has granted approval for a clinical trial of its Class 1 biologic, GR2301, an anti‑IL‑15 monoclonal antibody, in the treatment of vitiligo.
How GR2301 Works
GR2301 is a recombinant, fully human antibody that binds interleukin‑15 (IL‑15), preventing its interaction with IL‑15Rα. The blockade also disrupts the IL‑15/IL‑15Rα complex and the downstream IL‑2Rβ/IL‑2Rγ signaling assembly, ultimately inhibiting the JAK‑STAT pathway that drives the autoimmune response underlying vitiligo.
Clinical & Development Milestones
- NMPA approval paves the way for a Phase I/II trial, expected to enroll 120–150 patients across 12 sites nationwide.
- Preclinical studies demonstrate GR2301’s capacity to normalize IL‑15 levels and restore melanocyte function in murine models of depigmentation.
- The antibody’s fully human composition and clear pharmacodynamic profile align with global trends toward highly specific, low‑immunogenic biologics.
Market Implications
Vitiligo affects roughly 1 % of the global population, yet approved systemic therapies remain limited. By targeting IL‑15—a cytokine increasingly implicated in melanocyte autoimmunity—GR2301 could carve a niche in the rapidly expanding autoimmune dermatology market. Chongqing Genrix’s NMPA clearance also positions the company for future collaborations or licensing deals with international partners.
Next Steps
The company plans to initiate the trial in Q4 2025, with interim safety data slated for release in early 2026. Successful outcomes could accelerate GR2301’s path to a global regulatory submission, potentially offering patients a novel, targeted option for vitiligo management.-Fineline Info & Tech