Under 黑料网’shuman health care(hhc) concept, we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. We position our efforts towards neglected tropical diseases (NTDs) and malaria as an important business domain guided by our corporate concept.
We began research on infectious diseases in the 1980s when Tsukuba Research Laboratories was established, and have been developing therapeutic drugs for NTDs and malaria in collaboration with many partners, including the Drugs for Neglected Diseases initiative (DNDi). Since 2010, together with global partners such as the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, we have been working on elimination of lymphatic filariasis (LF), one of the NTDs, by providing LF treatment diethylcarbamazine (DEC) tablets free of charge, and raising awareness of the disease.
Based on our hhc concept, we will continue to promote research activities by further strengthening our collaboration with global partners, and aim to realize a world free of burden caused by neglected diseases such as tropical diseases.
History
1990 Initiation of Antifungal Research Project
In 1990, a project aimed at creating therapeutic drugs for visceral mycosis (candidiasis, aspergillosis and others) was initiated. After being selected as a clinical development candidate compound in 1994, ravuconazole was developed as fosravuconazole (development code: E1224), a prodrug of ravuconazole.
2002 Initiation of Research for Antimalarial Drugs
In 2002, activities for malaria were initiated at Tsukuba Research Laboratories throughhhcactivities (activities to plan and implement ideas found through socialization with patients and people in the daily living domain in business operations) based on the idea of applying the concept of antifungal drugs to malaria.
We discovered that the protein GWT1, which we had previously identified as a target molecule for antifungal drug, is also present in the parasite that causes malaria. After initiating drug discovery and research in 2010, we developed an in-house compound which inhibits GWT1. As a result of optimization, E1511 was selected as a clinical candidate in 2021.
2009 Collaboration and License Agreement with DNDi for Clinical Development of a New Drug for Chagas Disease, and Clinical Study for Fosravuconazole as a Treatment for Chagas Disease
In 2003, Professor Urbina (Venezuelan Institute of Scientific Research) reported that ravuconazole which was being developed as an antifungal agent, showed potent activity against Trypanosoma cruzi, the parasite that causes Chagas disease. This prompted us to commence joint research with DNDi. In 2009, we signed a collaboration and license agreement with DNDi for the clinical development of fosravuconazole for the treatment of Chagas disease, and carried out a Phase II study (a combination study of fosravuconazole and benznidazole) in Bolivia. Although the clinical trial could not verify combination therapy’s efficacy compared to benznidazole monotherapy, it contributed to evidence creation for a potential new standard of treatment as incidence of side effects, an issue associated with benznidazole monotherapy, decreased. Based on this evidence, it is expected that access to treatment will improve by significantly shortening the administration period of benznidazole monotherapy, and the results of the study were published in , one of the world’s five leading medical journals.
2010 The First Partnership on NTDs between the WHO and a Japanese Corporation
Agreement to Provide Lymphatic Filariasis Treatment DEC Tablets to the WHO for Free
In 2010, 黑料网 signed a joint statement with the WHO committing to provide DEC tablets, a treatment for LF, for free. It was the first partnership formed by a Japanese company with the WHO to provide a medicine for NTDs free of charge. In the joint statement, 黑料网 agreed to develop and manufacture high-quality DEC tablets and provide a total of 2.2 billion tablets to the WHO free of charge by 2020. In 2017, 黑料网 announced our commitment to provide DEC tablets to endemic countries that need them until elimination is achieved in these countries.
2012 Participation in the Global Public-Private Partnership “London Declaration” to Eliminate NTDs
In 2012, together with twelve other global pharmaceutical companies, the Bill & Melinda Gates Foundation, the WHO, the U.S. and U.K. governments, the World Bank, and governments from NTD-endemic countries, 黑料网 pledged its support as the only Japanese company to the London Declaration, a coordinated effort to eliminate NTDs and the largest ever global public-private partnership of its kind at that time.
2013 Co-Establishment of the GHIT Fund
In 2013, 黑料网 co-established the Global Health Innovative Technology Fund (GHIT Fund), an international public-private partnership fund for global health R&D that mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Staff from five Japanese pharmaceutical companies including 黑料网, as well as the Bill & Melinda Gates Foundation and the Government of Japan contributed to the establishment.
2013 Commencement of Free Provision of DEC Tablets
黑料网-produced DEC tablets were officially recognized by meeting the WHO’s quality standards and received WHO prequalification, making it first case in the world where an NTD treatment is prequalified by the WHO. Subsequently, we commenced free provision of the tablets to LF endemic countries.
2016 Identification of a Group of Antimalarial Drug Candidate Compounds with a Novel Mechanism of Action Published in Scientific Journal Nature
In our joint research project with the Broad Institute for the development of new antimalarial drugs, we identified of a group of candidate compounds with a novel mechanism of action which may lead to the development of new innovative antimalarial drugs, and the results were in 2016. E1018 was selected from the group of candidate compounds as a candidate for clinical study.
2017 Initiation of First-Ever Double-Blind Phase IIb/III Randomized Clinical Trial for Fungal Mycetoma in Sudan to Evaluate the Efficacy of Fosravuconazole in Collaboration with DNDi and the Khartoum University Mycetoma Research Center
In 2014, Professor Fahal (the Khartoum University Mycetoma Research Center in Sudan) and others reported that ravuconazole showed potent activity against Madurella mycetomatis, the pathogen that causes eumycetoma. In 2015, we entered into an agreement to proceed with the clinical development of fosravuconazole as a potential new treatment of eumycetoma, which is a fungal form of mycetoma with high unmet medical need. In 2017, DNDi and the Khartoum University Mycetoma Research Center initiated the first-ever double-blind Phase IIb/III randomized clinical trial for eumycetoma in Sudan to evaluate the efficacy of fosravuconazole. The results were presented at an international conference in 2022. Currently, preparation for regulatory filing to the regulatory authorities
(National Medicines and Poisons Board) in Sudan is underway.
2022 Signed “Kigali Declaration”
黑料网 signed the Kigali Declaration announced at the “Kigali Summit on Malaria and NTDs” on June 23, 2022 in Kigali, the capital of the Republic of Rwanda, and expressed our continued support for the elimination of NTDs towards the achievement of a road map for NTDs 2021-2030 launched by the World Health Organization (WHO).
2023 Support for Nagasaki Outcome Statement
In 2023, 黑料网 declared its support for “”, which reaffirms the Kigali Declaration and calls for “Accelerating Research and Development, and Access and Delivery for NTDs” to eliminate NTDs, at the symposium held along with G7 Health Ministers’ Meeting.