May 15, 2020
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

The 25th Congress of the European Hematology Association (“25th EHA AnnualCongress”) Accepts Abstract for Phase III Clinical Trial of TREAKISYM®
in Relapsed or Refractory Diffuse Large B-Cell Lymphoma for Publication
TOKYO, Japan, May 15, 2020 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio")announced in November 2019 that it had achieved its primary endpoint (response rate) in a Phase III
study of the antineoplastic agent TREAKISYM® (bendamustine hydrochloride) in combination withrituximab ("BR therapy") for the treatment of relapsed or refractory diffuse large B-cell lymphoma("relapsed or refractory DLBCL"), and is pleased to announce that an abstract of the study has been
accepted for publication by the Virtual Edition of the 25th EHA Annual Congress scheduled to be heldin June 2020, as well as the official EHA journal's official library and virtual conference platform,
including HemaSphere.
Abstract Title: EHA-1113 SINGLE ARM TRIAL OF BENDAMUSTINE IN COMBINATION WITH
RITUXIMAB FOR RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA IN
JAPANKey results of the phase III clinical trial (38 patients):
By gene activity pattern.
GCB type:

overall response rate (“ORR”) 83%, complete response (“CR”) 67%

Non-GCB type:

ORR 78%, CR 39%

By age groupLess than 65 years old:

ORR 86%, CR 71%

65 years of age or older but less than 75 years: ORR 75%, CR 45%
75 years or older:

ORR 73%, CR 36%

For more information, please visit the 25th EHA Annual Congress website at:https://ehaweb.org/congress/eha25/key-information-2/1

Relapsed or refractory Diffuse Large B-Cell Lymphoma is one of the most common types of malignant
lymphoma, and particularly for relapsed or refractory DLBCL, from the viewpoint of life prognosis,
the development of new therapeutic agents are eagerly awaited. BR therapy is widely used in Europe
and the United States for patients with relapsed or refractory DLBCL, and in Japan, patientadvocacy and academic groups have submitted a request to Japan’s Ministry of Health, Labour andWelfare to make BR therapy available as soon as possible for the treatment of relapsed or refractory
DLBCL.
On May 14, the company submitted a partial amendment application for BR therapy for thetreatment of relapsed or refractory DLBCL, which was accepted for review.

Contact
Investor Relations
Tel: +81 (0)3 5472 1125

About diffuse large B-cell 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 mostprevalent form of malignant lymphoma in Japan, accounting for between 30% and 40% of patients. As
the majority of patients are elderly, with most patients in their 60s and 70s at the time of diagnosis,
patient numbers are expected to increase as Japan’s population continues to age. As the efficacy of
current chemotherapy treatments is limited, and patients with DLBCL who are resistant tochemotherapy or who relapse or are refractory to treatment have an extremely poor prognosis, there
is a high level of need for new safe and effective drugs.
Based on the favorable clinical results of the Phase II study of BR therapy in relapsed/refractory
diffuse large B-cell lymphoma (“r/r DLBCL”) conducted by SymBio Note, BR therapy has been
recommended in the National Comprehensive Cancer Network (NCCN) Guidelines in the UnitedStates since 2012.
(Note on results of the Phase II study (59 patients): Overall response rate (ORR) 62.7%; Complete
response (CR) 37.3%.)
References:
The Japanese Society for Lymphoreticular Tissue Research, Request for unapproved or off-label drugs,
http://www.mhlw.go.jp/file/06-Seisakujouhou-11120000-Iyakushokuhinkyoku/gakkai3-2-5-1.pdf

Friedberg, JW. Relapsed/ refractory diffuse large B-cell lymphoma. ASH Education Book 2011 (1): 498-505

2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 100 mg was approved in October 2010 for manufacturingand marketing for the indication of relapsed/refractory low-grade B-cell non-Hodgkin'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.

SymBio completed registration of the first patient in the Phase III clinical trial in Japan in April
2019. The primary objective of the trial is to confirm the safety of TREAKISYM® rapid infusion.

SymBio submitted a New Drug Application for marketing authorization of TREAKISYM® readyto-dilute liquid formulation in September 2019.

SymBio aims to achieve annual sales of JPY 10 billion on a NHI drug price basis at the earliest
possible stage.
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: Menlo Park, California, 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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