Company Overview
Shin-Bio Pharmaceutical Co., Ltd. (4582) is a biotech venture founded by Fuminori Yoshida, the current Representative Director, President, and CEO in March 2005. The business strategy is to develop and provide new drugs that fill the blank therapeutic areas left undeveloped due to the small number of patients, focusing on the medical needs of the high-incidence fields of "cancer, blood diseases, and viral infections," particularly by introducing development candidates that have obtained proof-of-concept (PoC) in humans and developing the drugs from the clinical trial stage, aimed at a highly probable and swift drug discovery business model.
The candidate drug initially introduced was "bendamustine hydrochloride," an anticancer agent for malignant lymphoma developed by Astellas Pharma GmbH in Germany (trade name in Japan: Trexan(R)), with an exclusive development and sales contract signed domestically in December 2005. The company began clinical trials targeting relapsed/refractory low-grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma (MCL) as development code "SyB L-0501" (FD formulation) from 2006 and signed a joint development and sales license agreement with Eisai (4523) domestically in 2008, obtained marketing approval in 2010, and began sales in December of the same year. Trexan(R) has continued to expand its indication with its development and, in addition to obtaining approval for chronic lymphocytic leukemia (CLL) and low-grade NHL/MCL in untreated (initial treatment) patients in 2016, also obtained approval for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in March 2021, expanding the indications for the drug. In 2017, the company also signed an exclusive development and sales rights contract in Japan for RTD (ready-to-dilute) formulation/RI administration (development codes "SyB L-1701/SyB L-1702")※ as a liquid-type Trexan(R) with Eagle, obtained marketing approval in September 2020 for the RTD formulation, and has been switching from the FD formulation to the RTD formulation since 2021, obtaining approval for RI administration in February 2022, with 90% of sales being switched to the RI administration by the end of December 2023. The license agreement with Eisai was terminated on December 9, 2020, and the company is currently transitioning to a self-marketing system.
※The FD formulation previously purchased from Astellas Pharma required dissolution work (approximately three hours including adjustment time) at the medical site during use, but the liquid-type RTD formulation does not require the same work, significantly reducing the workload for medical professionals. In addition, RTD formulation and RI administration only differ in the volume of physiological saline diluent, with RTD formulation diluted in 250 ml and RI administration diluted in 50 ml. Therefore, while the infusion time for intravenous administration is the same as with the FD formulation for 60 minutes, administration time for the RI administration is shorter at 10 minutes, providing significant benefits in reducing patient burden.
As a second development candidate, the company signed an exclusive development and sales contract in Japan and South Korea with Onconova Therapeutics, Inc. for the candidate drug "rigosertib" (development codes "SyB L-1101" [injection] / "SyB C-1101" [oral]) for the indication of myelodysplastic syndrome (MDS)※. Further, the company signed an exclusive worldwide development, manufacturing, and sales license agreement with Chimerix, Inc. in September 2019 for BCV targeting all viral diseases except orthopox viruses such as smallpox and monkeypox. BCV has a high antiviral activity against a wide range of DNA viruses and is expected to be an effective drug in multiple diseases. In addition to continued joint research with overseas academia, the company announced in May 2023 that it had established the PoC in humans in a clinical trial targeting AdV infection after hematopoietic stem cell transplantation. The center of future development is expected to be BCV, with a subsidiary operating in the United States to formulate and promote global development strategies, and another subsidiary established in Ireland in January 2024.
※MDS is an intractable disease in which abnormal hematopoietic stem cells in the bone marrow are unable to produce normal blood cells, causing a decrease in normal blood cells and symptoms such as anemia, infections, and bleeding, and has a high possibility of developing into acute myeloid leukemia, making it a refractory disease mainly occurring in the elderly.
(Written by FISCO guest analyst, Jo Sato)