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

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Business: R&D, manufacturing, and marketing of HGF-based pharmaceuticals
Capital: 11 million yen (as of the end of September 2024)
Number of Officers: 7 Board Members, 3 Auditors
Number of Employees: 15 (as of the end of September 2024)
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.”

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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
April: Started a joint study with Gifu University on HGF's applied study for idiopathic osteonecrosis of the femoral head
May: The generic name for HGF in Japan was decided as "Oremepermin Alpha"
June: Started a collaborative study with Kanazawa University on HGF's applied study for idiopathic pulmonary fibrosis
November: Started joint research with Keio University on the search for new acute biomarkers to predict spontaneous recovery after spinal cord injury
November: Application for marketing authorization for first-class pharmaceuticals