Company Overview & History
Company Overview
- Name
- Kringle Pharma , Inc.
- Established
- December 21, 2001
- Representative
- President & CEO Kiichi Adachi
- Head Office
- 207 Saito Bio Incubator 7-7-15 Saitoasagi, Ibaraki, OSAKA 567-0085, JAPAN
- Business
- R&D, manufacturing, and marketing of HGF-based pharmaceuticals
- Capital
- 97 million yen (as of September 30, 2023)
- Number of Officers
- 7 Board Members, 3 Auditors
- Number of Employees
- 13 (as of September 30, 2023)
- Stock Exchange Listing
- Tokyo Stock Exchange Growth Market
(Securities code: 4884) - Fiscal Year End
- September
Origin of the Company Name
Kringle Pharma, Inc.
“Kringle domain” is the name of the characteristic protein structure found in HGF, which is believed to play a role in binding mediators (e.g., membranes, other proteins or phospholipids), and in the regulation of proteolytic activity. Our company name, Kringle Pharma, is derived from this “Kringle domain” and “Pharmaceutical company.”
Access
- Street address
- 207 Saito Bio Incubator 7-7-15 Saitoasagi, Ibaraki, OSAKA 567-0085, JAPAN
- Telephone
- TEL: +81-72-641-8739 (10:00 - 12:00, 13:00 - 17:00)
FAX: +81-72-641-8730 (0:00 - 24:00) - Access
-
Osaka Monorail Saito Line (International Culture Park City Monorail Line)
Get off at Saito-Nishi Station and walk approx. 8 minutes
The time required to Saito-Nishi Station: About 17 minutes from Senri-Chuo Station
* The time required does not include the transfer time at the Expo Memorial Park station.
* During morning and evening rush hours, the direct line is available between Senri-Chuo and Saito-Nishi.
History
- 2001
-
- December
- Established Kringle Pharma, Inc. in Kita-ku, Osaka
- 2005
-
- May
- Obtained a license to develop and commercialize HGF protein from Toshikazu Nakamura, Professor Emeritus of Osaka University, and began pharmaceutical development (development code: KP-100)
- 2007
-
- June
- Established a manufacturing method for mass production of pharmaceutical-grade HGF protein as an active pharmaceutical ingredient
- 2012
-
- April
- Completed Phase Ib study of HGF protein for renal failure patients in the US
- 2015
-
- March
- Completed Phase I study of HGF protein for ALS patients in Japan
- 2016
-
- November
- Completed investigator-initiated Phase I/II study of HGF protein in patients with vocal fold scar in Japan
- 2018
-
- October
- Completed Phase I/II study of HGF protein in patients with acute phase spinal cord injury in Japan
- 2019
-
- September
- The Ministry of Health, Labour and Welfare designated HGF protein as an orphan drug for the treatment of acute phase spinal cord injury
- 2020
-
- March
- Capital and business alliance with TOHO HOLDINGS CO., LTD. for distribution of HGF-based drugs in Japan in acute phase spinal cord injury
- April
- Signed a license and supply agreement with Claris Biotherapeutics, Inc. (US)
- July
- Initiated Phase III study of KP-100IT in patients with acute phase spinal cord injury in Japan
- August
- Capital and business alliance with Maruishi Pharmaceutical Co., Ltd. to establish a marketing network for KP-100IT for treating acute phase spinal cord injury
- December
- Listed on the Mothers Market (currently Growth Market) of the Tokyo Stock Exchange
- 2021
-
- February
- Signed a joint research agreement with Keio University School of Medicine, aiming to develop an advanced therapy using HGF and other technologies for the treatment of spinal cord injury
- August
- Claris Biotherapeutics, Inc. began Phase I/II study for the treatment of neurotrophic keratitis in the US
- September
- “Oremepermin Alfa” was registered as the International Nonproprietary Name (INN) for recombinant human HGF (Development code: KP-100)
- December
- Patent entitled “HGF preparation suitable for treatment of nervous diseases” granted in Europe
- 2022
-
- March
- Jointly filed a patent application with Keio University School of Medicine for the treatment of chronic spinal cord injury
- September
- Jointly filed a patent application with Keio University School of Medicine for the combination therapy using HGF and iPS cells in spinal cord injury
- November
- Initiated Phase III study of HGF protein in patients with vocal fold scar in Japan
- 2023
-
- April
- Last patient enrolled in Phase III study of KP-100IT in patients with acute spinal cord injury in Japan
- September
- Started collaboration with Claris Biotherapeutics, Inc. to increase efficiency and scale up production of recombinant human HGF to meet growing global market demand
- October
- Completion of the last observation day of a phase III study in acute phase spinal cord injury
- October
- Published article by Keio University on joint research results on severe spinal cord injury
In a rat model, administration of HGF in the acute phase followed by transplantation of iPS cell-derived neural stem/progenitor cells in the subacute phase successfully restored function to a greater extent than cell transplantation alone treatment - November
- Patent-priority application for a new manufacturing process for HGF
- November
- Receipt of pre-IND meetings from the U.S. FDA for developing acute phase spinal cord injury
- 2024
-
- January
- Funding and future plans released from our partner, Claris Biotherapeutics
- February
- Announced topline data from phase III study of KP-100IT in acute spinal cord injury
- March
- Published article by Keio University on the gene-expression profiles when HGF was administered for acute spinal cord injury