Notice of Regulatory Approval for Silk-Elastin Wound Healing Sheet, a Novel Recombinant Protein
- 2025/05/07 News
KYOTO, JAPAN — [May 7, 2025] —Sanyo Chemical Industries, Ltd. hereby announces that it has obtained regulatory approval for the novel wound recombinant protein “Silk-Elastin Wound Healing Sheet” (hereinafter “the Product”) in Japan. The Product was jointly developed with Professor Naoki Morimoto and his team at the Department of Plastic and Reconstructive Surgery, Kyoto University Hospital, and will be marketed exclusively in Japan by Kaken Pharmaceutical Co., Ltd. This product is the first medical device in Japan to utilize genetic engineering technology.
Following the recent regulatory approval in Japan, Sanyo Chemical is moving forward in earnest with preparations for FDA submission as part of its strategy to enter the U.S. market. In the United States, Sanyo Chemical is seeking marketing and distribution partners to bring this breakthrough treatment to patients as swiftly as possible.
≫Release：Notice of Regulatory Approval for Silk-Elastin Wound Healing Sheet, a Novel Recombinant Protein