January 31, 2022
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Initiation of a phase 2 clinical trial of bendamustine and rituximab combination therapy
followed by autologous hematopoietic stem cell transplantation in patients withrelapsed or refractory diffuse large B-cell lymphoma
TOKYO, Japan, January 31 2022 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio" or the “Company”) today announced that an investigator-led phase 2 clinical study to assess
the efficacy and safety of bendamustine (TREAKISYM®) in combination with rituximab (“BRtherapy”) followed by autologous hematopoietic stem cell transplantation in patients with relapsed orrefractory diffuse large B-cell lymphoma (DLBCL) (the "Study") commenced on January 26, 2022,
pursuant to a joint clinical research agreement between SymBio and Saitama Medical University.
The Study is led by Dr. Yasuhito Terui, professor of Hematology Department at the Saitama Medical
University Hospital.
TREAKISYM® was approved for marketing in BR therapy and with rituximab and polatuzumabvedotin (“P-BR therapy”) in March 2021 for relapsed or refractory DLBCL. With this Study, we willfurther explore the clinical application of BR therapy in patients with relapsed or refractory DLBCL
who are candidates for autologous hematopoietic stem-cell transplantation.
This Study was reviewed and approved by the nationally certified Clinical Research Review Board ofSaga University, the administrators of Saitama Medical University, Saga University, and otherparticipating institutions.
This Study was submitted to the Ministry of Health, Labour and Welfare and registered with theJapan Registry of Clinical Trials (jRCT), a database developed by the Ministry of Health, Labour andWelfare, and the information is published in jRCT.
https://jrct.niph.go.jp/latest-detail/jRCTs071210121
The Company does not expect the information presented herein to have any material impact on its
financial outlook for the fiscal year ending December 2022.

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[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125
About TREAKISYM®
TREAKISYM® (non-proprietary name: bendamustine hydrochloride), a cytocide anti-cancer drug firstused in Germany in the 1970s, is now widely used in more than 50 countries with indications for lowgrade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.
TREAKISYM® Intravenous Infusion, freeze-dried (FD) formulation, was approved in October 2010
for manufacturing and marketing for the indication of relapsed/refractory low-grade B-cell nonHodgkin's lymphoma and mantle cell lymphoma in Japan.

TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia inJapan in August 2016.

TREAKISYM® was approved for the additional indications of first-line treatment of low-grade Bcell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December 2016.

TREAKISYM® ready-to-dilute (RTD) liquid formulation was approved in Japan in September
2020 for all the above indications.

TREAKISYM® FD and RTD were approved for the additional indication of relapsed or refractory
DLBCL in March 2021 and April 2021, respectively.

About autologous hematopoietic stem cell transplantation and relapsed or refractory diffuse large Bcell lymphoma
Diffuse large B-cell lymphoma (DLBCL) is a disease where large, malignant B-cell lymphocytes develop
in the lymph nodes or in organs or other areas outside the lymph nodes. DLBCL is the most prevalent
form of malignant lymphoma in Japan, accounting for between 30% and 40% of patients. As themajority of patients are elderly, with most patients in their 60s and 70s at the time of diagnosis, patientnumbers are expected to increase as Japan’s population continues to age. The long-term prognosis ofpatients with relapsed or relapsed DLBCL treated with conventional salvage chemotherapy alone isunsatisfactory. Following salvage chemotherapy, high-dose chemotherapy combined with autologous
hematopoietic stem-cell transplantation (HDC/AHSCT) has been reported to improve the long-termprognosis. The Japanese Society of Hematology’s Clinical Practice Guidelines of Hematopoietic
Oncology recommend HDC/AHSCT for patients with relapsed or relapsed DLBCL aged 65 years or
younger who respond to salvage chemotherapy (complete response + partial response).

2About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Limited was established in March 2005 by Fuminori Yoshida who
previously served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen
Japan. In May 2016, SymBio incorporated its wholly-owned subsidiary in the U.S., SymBio Pharma
USA, Inc. (Headquarters: Durham, North Carolina, President: Mr. Fuminori Yoshida). SymBio’s
underlying corporate mission is to “deliver hope to patients in need” as it aspires to be a leading
global specialty biopharmaceutical company dedicated to addressing underserved medical needs.

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