Company Overview & History

Company Overview

Name
Kringle Pharma , Inc.
Established
December 21, 2001
Representative
President & CEO　Kiichi Adachi
Head Office
Saito Bio Incubator 7-7-15 Saitoasagi, Ibaraki, Osaka 567-0085, JAPAN
Office Nakanoshima Qross
10F, Nakanoshima Qross Research & Development Center,
4-3-51 Nakanoshima, Kita-ku, Osaka 530-0005, JAPAN
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.”

Access

Office Nakanoshima Qross
10F, Nakanoshima Qross Research & Development Center,
4-3-51 Nakanoshima, Kita-ku, Osaka 530-0005, JAPAN
https://www.nakanoshima-qross.jp/en/access/

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