SBI Pharma | News Release | Bladder Cancer Treatment

News

2017.12.18

Launch of the Photodynamic Diagnostic Agent “ALAGLIO® Divided Granules 1.5g” -Contributing to the Initial Treatment of Non-Muscle Invasive Bladder Cancer through the Visualization of Tumor Lesions –

Chugai Pharmaceutical Co., Ltd. SBI Pharmaceuticals Co., Ltd. TOKYO, December 18, 2017 — Chugai Pharmaceutical Co., Ltd. (Head office: Tokyo; Chairman & CEO: Osamu Nagayama; “Chugai”) announced that it will launch the photodynamic diagnostic agent, “ALAGLIO® Divided Granules 1.5g” (“this Agent”) on December 19th. This Agent was developed by SBI Pharmaceuticals Co., Ltd., (Head office: […]

News

2017.09.27

“ALAGLIO® Divided Granules 1.5g,” a Photodynamic Diagnostic Agent Obtained Manufacture and Marketing Approval

SBI Pharmaceuticals Co., Ltd., (Head office: Minato-ku, Tokyo; Representative Director & President: Yoshitaka Kitao; “SBI Pharma”), a subsidiary of SBI Holdings, Inc., engaged in the research and development of medicines using 5-ALA (5-Aminolevulinic acid) (*1) and Chugai Pharmaceutical Co., Ltd. (Head office: Chuo-ku, Tokyo; Chairman & CEO: Osamu Nagayama; “Chugai”) hereby announce that the manufacture and marketing approval of a photodynamic diagnostic agent, “ALAGLIO® Divided Granules 1.5g” (Generic name: Aminolevulinic acid hydrochloride; “this Agent”) has been obtained from the Ministry of Health, Labour and Welfare for the indication of diagnostic agent to visualize non-muscle invasive bladder cancer at the operation of its transurethral resection.

Information

2017.04.24

Positive Data of Phase III Clinical Trial in Patients of Non-Muscle Invasive Bladder Cancer were Presented at the 105th Annual Meeting of the Japanese Urological Association

SBI Pharmaceuticals Co., Ltd. SBI Pharmaceuticals Co., Ltd., (Head office: Minato-ku, Tokyo; Representative Director & President: Yoshitaka Kitao; “SBI Pharmaceuticals”), a subsidiary of SBI Holdings, Inc., engaged in research and development of pharmaceuticals, health foods and cosmetics using 5-aminolevulinic acid (“5-ALA”)(*1), hereby announces that the resection of bladder cancer by using aminolevulinic acid hydrochloride (SPP-005) […]

News

2017.03.13

SBI Pharma and Chugai Enter an Agreement of Exclusive Marketing Rights for “ALAGLIO® Granule 1.5g” in Japan

SBI Pharmaceuticals Co., Ltd. Chugai Pharmaceutical Co., Ltd. TOKYO, March 13, 2017 — SBI Pharmaceuticals Co., Ltd. (Head Office: Minato-ku, Tokyo; Representative Director and President: Yoshitaka Kitao; “SBI Pharma”), a subsidiary of SBI Holdings, Inc., engaged in the research and development of medicines using 5-ALA* (5-Aminolevulinic acid), has entered a licensing agreement with Chugai Pharmaceutical […]

News

2017.01.27

Notice on the Start of Phase II Clinical Trial using 5-ALA by University of Oxford and SBI Pharmaceuticals

SBI Holdings, Inc. SBI Pharmaceuticals Co., Ltd. University of Oxford SBI Pharmaceuticals Co., Ltd., (Head office: Minato-ku, Tokyo; Representative Director & President: Yoshitaka Kitao; “SBI Pharmaceuticals”), a subsidiary of SBI Holdings, Inc., engaged in research and development of pharmaceuticals, health foods and cosmetics using 5-aminolevulinic acid (“5-ALA”)*1 and the University of Oxford in the United […]

News

SBI Pharma and Scivita Medical entered into exclusive distribution agreement of single use endoscopes in urology field in Japan

Publication of a Research Paper -5-ALA+SFC might improve symptoms of Electron Transfer Complex I deficiency in Drosophila-

Announces Publication of Research Paper on 5-ALA phosphate for Sarcopenia

Notice regarding US FDA Medical Device Registration of “Aladuck 405/II”

NutraIngredients-Awards granted for clinical study project with the food supplement 5-ALA + SFC as an immune system enhancer for COVID-19 vaccines(SBI Holdings, photonamic)

Photonamic and Lumeda Enter into Collaboration for a Clinical Study with Photodynamic Therapy (“PDT”) in the Field of Non-Small Cell Lung Cancer (NSCLC)(SBI Holdings, photonamic)

Notice regarding Succession of Supplement Business to SBI ALApromo

Publication of a Research Paper on 5-ALA from Tokyo Metropolitan University in FEBS Open Bio -5-ALA/SFC extend healthspan in Drosophila-

Results of A First-in-Human Study for New Application of Photodynamic Therapy with 5-Aminolevulinic Acid for Extracorporeal Photopheresis Published in “Pharmaceutics”(SBI Holdings, photonamic)

Start of Phase II Clinical Trial using 5-ALA by the University of Oxford and SBI Pharmaceuticals

New Release of “Aladuck 405”, Bicolor LED Medical Light Source

SBI Pharmaceuticals and TAGCyx ANNOUNCES THE RESEARCH AND DEVELOPMENT COLLABORATION OF INOVATIVE CANCER THERAPY

A Collaboration Research Related to Development of Mitochondrial Disease Treatment by 5-Aminolevulinic Acid and Sodium Ferrous Citrate was Published

The collaboration study with Cancer Chemotherapy Center of JFCR was published in Scientific Reports, an online journal of Nature

Comprehensive Commercialization Rights Granted to Neopharma on the Pharmaceuticals Containing 5-ALA

Presentation of Research Paper on 5-ALA by Yamagata University, Faculty of Medicine to PLOS ONE, a U.S. Scientific Journal ~ 5-ALA Deficiency Attenuates Mitochondrial Function and Impairs Glucose Tolerance~

Launch of the Photodynamic Diagnostic Agent “ALAGLIO® Divided Granules 1.5g” -Contributing to the Initial Treatment of Non-Muscle Invasive Bladder Cancer through the Visualization of Tumor Lesions –

“ALAGLIO® Divided Granules 1.5g,” a Photodynamic Diagnostic Agent Obtained Manufacture and Marketing Approval

Positive Data of Phase III Clinical Trial in Patients of Non-Muscle Invasive Bladder Cancer were Presented at the 105th Annual Meeting of the Japanese Urological Association

SBI Pharma and Chugai Enter an Agreement of Exclusive Marketing Rights for “ALAGLIO® Granule 1.5g” in Japan

Notice on the Start of Phase II Clinical Trial using 5-ALA by University of Oxford and SBI Pharmaceuticals

Exclusive License Agreement Concluded with Neopharma on the Therapeutic Drug s for Diabetes and Malaria Infection

Research Paper on the Safety and Usefulness of 5-ALA in the Patients with Type 2 Diabetes in Bahrain in the Food Intervention Test Published in the “Journal of Diabetes Research”

Registration of a U. S. Patent for Treatment of Influenza Virus Infection through Joint Application with Tokushima University

Registration of a U. S. Patent on the External Preparation for Skin Containing 5-ALA

Registration of a Patent for Enhancer of Survival of Transplanted Organ through Joint Application with National Center for Child Health and Development

Registration of a Patent for Treatment and Prevention of Radiation Damage through Joint Application with The University of Tokyo

Registration of a Patent for Treatment and Prevention of Influenza Virus Infection through Joint Application with Tokushima University

Registration of a Patent on a Device to Identify Cancer Metastasis in Sentinel Lymph Node

Registration of a Patent for Photodynamic Therapy Using a Photosensitizer or 5-Aminolevulinic Acids

Registration of a Patent for Treatment and Prevention of Cancer Anemia

Registration of a Patent for Treatment and Prevention of Chronic Kidney Disease

Registration of a Patent for Photodynamic Diagnosis and Photobleaching-Prevention Agent through Joint Application with Tokyo Institute of Technology

Curative and Protective Effects of the Combined Treatment of 5-aminolevulinic Acid and Iron against Malaria Infection was Confirmed in Animal Model.

Registration of a U. S. Patent on a Method for Treating Diabetes Containing 5-ALA as an Active Ingredient

Product Registration of Food Supplement in Jordan

ReproCELL and SBI Pharmaceuticals Develop Selective Removal Technology of Residual iPS Cells from iPS Derived-differentiated Cells for Regenerative Medicine Through Technological Application of SBI Pharmaceuticals’ 5-ALA

Acquisition of a Patent through Joint Application with National Hospital Organization for Therapeutic Agent for Allergic Rhinitis Containing 5-ALA as an Active Ingredient

Release of Medical Light Source “Violet LD Light Source Alcedo LS-VSD”

Acquisition of a Patent through Joint Application with Tokyo Institute of Technology

Conclusion of a Patent Licensing Agreement with Cosmo Oil

Acquisition of a Patent for Prophylactic/Ameliorating Agent for Adult Diseases Containing 5-ALA as an Active Ingredient

Presentation of Research Paper on 5-ALA by Osaka City University to PLOS ONE, a U.S. Scientific Journal — Findings of ALA-PDT in killing MRSA, one of the major bacterial species causing in-hospital infections —

Conclusion of Agreement on Joint Research between the University of Oxford in the United Kingdom and SBI Pharmaceuticals — Planning to start a phase II clinical trial to assess the effectiveness of 5-ALA in preventing a reduction in cardiac output after heart bypass surgery —

Proposal on Development of Green Light Source is Selected for NEDO’s “FY2013 Innovation Commercialization Venture Support Project”

SBI Pharmaceuticals Officers to Serve as Visiting Professors at Fudan University in China

Release of Medical Light Source “Bicolor LED Light Source Aladuck LS-DLED”

Notice Regarding Start of Clinical Studies on Type 2 Diabetes by Using 5-ALA at the Bahrain Defense Force Royal Medical Service Hospital

ReproCELL and SBI Pharmaceuticals Agree on a Joint Research Regarding ES/iPS Cell Technology Using 5-ALA

Announcement of Communication to Grant a Patent in Europe for Therapeutic Agent for Male Sterility through Administration of 5-Aminolevulinic Acid

Announcement of Decision to Grant a Patent in Japan for Method of Detecting Bladder Cancer through Oral Administration of 5-Aminolevulinic Acid

Announcement of the First Successful Surgical Removal of Bladder Cancer in the Middle East Using 5-Aminolevulinic Acid as an Intraoperative Diagnostic Drug at a Medical Center of Arabian Gulf University in Bahrain

Presentation of Research Paper on 5-ALA by Kochi University to PLoS ONE, a U.S. Scientific Journal — Findings of 5-Aminolevulinic Acid (5-ALA) in Protecting against Cisplatin-Induced Acute Kidney Injury (AKI) —

Findings of Mechanism of 5-aminolevulinic Acid (5-ALA) and Iron in Synergistically Inhibiting Growth of Plasmodium Falciparum Malaria Parasites

New Launch of “ALAGLIO® Internal Medicine 1.5g,” an Orally-administered in vivo Diagnostic Agent for Malignant Glioma

SBI Pharmaceuticals Obtains a Business License for Selling and Renting Highly Controlled Medical Devices

SBI Pharmaceuticals Submits a Phase-2 Clinical Trial CTA to MHRA for a Drug to Treat Cancer Chemotherapy-induced Anemia

Announcement—the new drug “ALAGLIO® Internal Medicine 1.5g”, an Orally-administered in vivo Diagnostic for Malignant Glioma, is Listed on the NHI Drug Price List

Notice Regarding Conclusion of Basic Agreement with King Hamad University Hospital in Bahrain on Clinical Study of 5 a minolevulinic a cid

SBI Pharmaceuticals Obtains Manufacture and Marketing Approval for Orally-administered in vivo Diagnostic Agent “ALAGLIO®” for Malignant Glioma — Japan’s First Orally-administered Fluorescence Diagnostic Agent for Use in the Surgical Resection of Brain Tumor

Joint Clinical Research on Diabetes with Arabian Gulf University in Bahrain

Basic Agreement Reached with the Bahrain Development Bank for Promoting 5-ALA Business in Bahrain

Notice on the Establishment of Joint Venture Company with Dawani Group Holding, a Major Corporate Group in Bahrain

Memorandum of Understanding between Mumtalakat, the Sovereign Wealth Fund of Bahrain, and SBI Pharmaceuticals Co., Ltd. to Cooperate in the 5-ALA Business in Bahrain Focusing on the Pharmaceuticals Industry

Agreement to Collaborate Reached with the Royal College of Surgeons in Ireland – Medical University of Bahrain for Starting Clinical Studies

Notice on the Establishment of Joint Venture Company with Dawani Group Holding, Bahrain’s Major Corporate Group for Sales of 5-ALA Products

SBI Pharmaceuticals Announces Conclusion of Basic Agreement to Start Clinical Research on Diabetes with Arabian Gulf University in Bahrain

Notice on the Press Release Published by the Bahrain Economic Development Board

SBI Pharmaceuticals Submits a Phase-1 Clinical Trial IND to U.S. FDA for a Drug to Treat Cancer Chemotherapy-induced Anemia

SBI Pharmaceuticals Submits a Phase-1 Clinical Trial CTA to MHRA for a Drug to Treat Cancer Chemotherapy-induced Anemia

SBI Pharmaceuticals Obtains the Product License of Healthy Supplement from the Dubai Authority

SBI Pharmaceuticals Opens a Representative Office in Bahrain

Notice on the Appointment of a New Executive Officer

Notice on the Appointment of a New Director

Notice on application for marketing approval of in vivo diagnostic agent for malignant glioma in Japan

Notice on Publication by Univ. of Hawaii of Paper on 5-ALA in Electronic Edition of U.S. Science Journal Clinical and Translational Science Publication of the results of clinical studies on the relationship between 5-ALA and glucose levels

SBI Pharmaceuticals Announces Obtainment of Marketing Authorization of Products Containing 5-ALA from The Kingdom of Bahrain Ministry of Health

Notice on Agreement with Bahrain Government for the Promotion of the 5-ALA Business

Notice on SBI ALApromo’s Obtainment of First-class Marketing Authorization and Restructuring of ALA-related Business

NutraIngredients-Awards granted for clinical study project with the food supplement 5-ALA + SFC as an immune system enhancer for COVID-19 vaccines
(SBI Holdings, photonamic)

Photonamic and Lumeda Enter into Collaboration for a Clinical Study with Photodynamic Therapy (“PDT”) in the Field of Non-Small Cell Lung Cancer (NSCLC)
(SBI Holdings, photonamic)

Results of A First-in-Human Study for New Application of Photodynamic Therapy with 5-Aminolevulinic Acid for Extracorporeal Photopheresis Published in “Pharmaceutics”
(SBI Holdings, photonamic)

ALA Study Results Presented at the 49th Annual Meeting of Japan Society of Clinical Oncology (1)
– Success in diagnosis of peritoneal dissemination using ALA –

ALA Study Results Presented at the 49th Annual Meeting of Japan Society of Clinical Oncology (2)
– Success in diagnosis of peritoneal dissemination and lymph node metastasis using ALA –

ALA Study Results Presented at Japanese Cancer Association, 70th Annual Meeting (2)
– Finding of ALA’s effect of enhancing hyperthermia therapy –

ALA Study Results Presented at 39th Annual Meeting of Japanese Association for Acute Medicine
– Discovery of ALA’s inhibitory effect on inflammatory cytokine production –

The study Results of ALA Presented Japanese Cancer Association, 70th Annual Meeting (1)
– Finding of ALA’s life-prolonging effect in mice with cancer –

ALA Study Results Presented at Japanese Cancer Association, 70th Annual Meeting (3)
– Identification of sensitivity determinant in photodynamic therapy using ALA –

ALA Study Results Presented at Japanese Society of Parasitology, 71st Meeting.
– Findings of ALA’s growth inhibiting effect against P. falciparum malaria parasite growth –