Kringle Pharma (Japan)

Kringle Pharma is a late-stage regenerative drug discovery bioventure that provides innovative treatment for patients suffering from intractable diseases using HGF protein. The company conducts clinical trials for multiple intractable diseases, mainly rare diseases, and has established a system to manufacture HGF protein at pharmaceutical grade. It is listed on the Tokyo Stock Exchange Growth Market.

Kringle Pharma was established on December 21, 2001, in Osaka City. In May 2005, it obtained a license from the late Professor Toshikazu Nakamura (Professor Emeritus, Osaka University) to develop HGF protein (development code: KP-100). In June 2007, it established a manufacturing method for mass production of HGF protein drug substance (pharmaceutical grade). In April 2012, it completed a Phase Ib study of HGF protein in patients with renal failure in the United States. In March 2015, it completed a Phase I study in ALS patients in Japan. In November 2016, it completed a Phase I/II study (investigator-initiated) in patients with vocal cord scars in Japan. In October 2018, it completed a Phase I/II study in patients with acute spinal cord injury in Japan. In September 2019, the Ministry of Health, Labour and Welfare designated HGF protein as an orphan drug for acute spinal cord injury. In March 2020, it formed a capital and business alliance with Toho Holdings Co., Ltd. In April 2020, it concluded a license and supply agreement with Claris BioTherapeutics, Inc. (USA). In July 2020, it started a Phase III study of KP-100IT in patients with acute spinal cord injury in Japan. In August 2020, it formed a capital and business alliance with Maruishi Pharmaceutical Co., Ltd. In December 2020, it listed its shares on the Tokyo Stock Exchange Mothers Market (now Growth Market). In February 2021, it concluded a joint research agreement with Keio University School of Medicine. In August 2021, Claris BioTherapeutics, Inc. started a Phase I/II study for neurotrophic keratitis. In September 2021, the international nonproprietary name for recombinant human HGF protein (KP-100) was decided as 'Oremepermin Alfa'. In December 2021, a patent for 'HGF preparation suitable for treatment of neurological diseases' was registered in Europe. In March 2022, it filed a joint patent application with Keio University School of Medicine for treatment of chronic spinal cord injury. In September 2022, it filed a joint patent application with Keio University School of Medicine for combination therapy of HGF and iPS cells for spinal cord injury. In November 2022, it started a Phase III study in patients with vocal cord scars in Japan. In September 2023, it started collaboration with Claris BioTherapeutics, Inc. to improve efficiency and expansion of recombinant human HGF protein manufacturing in the United States. In October 2023, the final observation date of the Phase III clinical trial for acute spinal cord injury ended. In February 2024, it released the top-line results of the Phase III clinical trial for acute spinal cord injury. In May 2024, the Japanese nonproprietary name for HGF was decided as 'Oremepermin Alfa'. In April 2025, it opened the Nakanoshima Qross office.

1. 1クリングルファーマ株式会社kringle-pharma.com
2. 2企業情報｜クリングルファーマ株式会社kringle-pharma.com
3. 3ごあいさつ｜企業情報｜クリングルファーマ株式会社kringle-pharma.com
4. 4会社概要・沿革｜企業情報｜クリングルファーマ株式会社kringle-pharma.com
5. 5Kringle Pharma (Japan)wikidata.org