- Business
- Kringle Pharma, Inc. (TSE: 4884) is a late clinical-stage biopharmaceutical company primarily engaged in the research, development, manufacturing, and marketing of hepatocyte growth factor (HGF)-based regenerative pharmaceuticals for intractable diseases. The company develops recombinant human HGF protein drugs including KP-100IT (oremepermin alfa) for acute spinal cord injury in Phase III with topline data announced in February 2024 and marketing authorization application submitted in November 2024; HGF for vocal fold scar in ongoing Phase III; HGF for amyotrophic lateral sclerosis following Phase II completion; HGF for acute kidney injury post Phase I; and partner Claris Biotherapeutics' program for neurotrophic keratitis in Phase I/II, with additional basic research and joint academic programs targeting idiopathic osteonecrosis of the femoral head, idiopathic pulmonary fibrosis, peripheral neuropathy, chronic spinal cord injury, and combination therapies with iPS cells. Founded on December 21, 2001, and headquartered in Saito Bio Incubator, Ibaraki, Osaka, Japan, with an additional office in Nakanoshima, Osaka, Kringle Pharma operates mainly in Japan while pursuing global partnerships including capital and business alliances with TOHO HOLDINGS CO., LTD. and Maruishi Pharmaceutical Co., Ltd. for Japanese distribution of acute spinal cord injury drugs; a license and supply agreement with Claris Biotherapeutics, Inc. (US) renewed for production scale-up in September 2023; joint research agreements with Keio University School of Medicine since 2021 for spinal cord injury therapies, Kobe University in June 2025 for Peyronie's disease, Gifu University in April 2024 for femoral head necrosis, Kanazawa University in June 2024 for pulmonary fibrosis, and Keio University in November 2024 for spinal cord injury biomarkers; US orphan drug designation and FDA pre-IND meetings in 2023; and patent grants and applications including for nervous disease treatments in Europe and new manufacturing processes.