March 8, 2022
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio announces publication the final results of its
phase 3 clinical trial of TREAKISYM® in r/r DLBCLTOKYO, Japan, March 8, 2022 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio")
today announced that the final results of its phase 3 clinical trial of the anticancer drug
TREAKISYM® (bendamustine hydrochloride) in combination with rituximab ("BR therapy"1;
bendamustine hydrochloride 120mg/m2) for the treatment of relapsed or refractory diffuse large B-celllymphoma ("r/r DLBCL") were published.
The final results of SymBio’s phase 3 study and a long-term follow-up study of BR therapy for r/rDLBCL were published in Annals of Hematology. Based on the efficacy of BR therapy shown in thisstudy, the Company obtained regulatory approval of DLBCL as an additional indication for
TREAKISYM® in March 2021.
Key results of the study (38 patients)•Overall response rate (CR+PR): 76.3%•Complete response (CR): 47.4%•Median overall survival (OS): 29.2 months

Given the limited treatment options for r/r DLBCL, the approval of BR therapy, and of polatuzumab
vedotin in combination with BR therapy (Pola-BR therapy2; bendamustine hydrochloride 90mg/m2) by
Chugai Pharmaceutical Co., Ltd. (Headquarters: Tokyo), provides a much-needed treatment option
for patients.
For more information, please visit the Annals of Hematology website at:https://link.springer.com/article/10.1007/s00277-022-04801-2

1

Contact
Investor Relations
Tel: +81 (0)3 5472 1125
Note 1[Dosage and administration]
For concomitant use of rituximab (genetical recombination)
The usual adult dosage for intravenous drip infusion is 120mg/m2 (body surface area) of
bendamustine hydrochloride over an hour period once daily. Administration is performed daily for 2days, and the drug is withdrawn for 19 days. This is followed by a single cycle with a maximum of 6cycles.
Note 2[Dosage and administration]
When rituximab (genetical recombination) and polatuzumab vedotin (genetical recombination) areused in combination. The usual adult dosage for intravenous drip infusion is 90 mg/m2 (body surfacearea) of bendamustine hydrochloride over an hour period once daily. Administration is performed
daily for 2 days, and the drug is withdrawn for 19 days. This is followed by a single cycle with amaximum of 6 cycles. The dose may be adjusted according to the patient’s condition.
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.

TREAKISYM® RTD to be added rapid infusion (“RI”) or 10 minutes administration were approvedin February 2022.
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.

3