STELLA PHARMA CORPORATION [4888.T]
TOKYO, Jun 16 (Pulse News Wire) – Stella Pharma Corporation (4888.T) reported progress on the technology transfer and manufacturing facility changes for its product Stebolonin®. As previously disclosed on April 28, 2026, the company completed pilot plant trials by December 31, 2025, followed by commercial plant production trials in April 2026.
Evaluations confirmed the quality suitability for commercial production. Currently, the company is initiating process validation through real machine manufacturing to ensure stable and reproducible production processes. It plans to apply for partial approval changes related to manufacturing facilities around August 2026, expecting approval by January 2027. Domestic supply and shipments to China's Hainan Island are anticipated to commence shortly thereafter, with inventory secured based on current demand forecasts.
The company stated that ongoing discussions with the Ministry of Health, Labour and Welfare and PMDA will continue to ensure stable product supply. Costs associated with these efforts are included in the fiscal year ending March 2027 earnings forecast, as detailed in the May 13, 2026 interim report. Stella Pharma remains committed to rebuilding a robust supply chain, prioritizing uninterrupted product availability moving forward. Any further developments will be promptly communicated.
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