May 10, 2021
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio submits a partial change application for use of TREAKISYM®
Liquid Formulation for Rapid Infusion (RI) administration

TOKYO, Japan, May 10, 2021 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio")
today announced that it has submitted a partial change application with respect to its Marketing
Authorization for TREAKISYM® 100mg/4mL ready-to-dilute (“RTD”) liquid formulation to add rapidinfusion (“RI”) administration.
Under the license agreement entered into between SymBio and Eagle Pharmaceuticals, Inc.
(Headquarters: New Jersey, USA, “Eagle”) in September 2017, SymBio obtained the exclusive rights
to develop and commercialize the patent-protected liquid formulations of bendamustine hydrochloride(bendamustine HCl) in Japan. TREAKISYM® RTD was launched in January 2021 and the Company
is currently actively switching from TREAKISYM® lyophilized (“FD”) formulation to RTD.
TREAKISYM® RI reduces the infusion time from the current 60 minutes (for the FD and RTD
formulations) to 10 minutes, which is same as in the U.S. The partial change application to add RI
administration was based on the results of a clinical study conducted by the Company to investigate
the safety and pharmacokinetics of the RI liquid formulation administered by 10-minute intravenous
drip infusion. The shorter infusion time will significantly benefit patients and healthcare providers.
Statement from Fuminori Yoshida, President and CEO of SymBio: “The liquid formulation (RIadministration) was approved by the FDA in the United States in 2016 and has been marketed formore than 5 years. With a dilution volume of 50 ml, which is one-fifth of the current product, theinfusion time is reduced to 10 minutes, and because it has and very low salt content, it is suitable forpatients with malignant lymphoma, many of who are elderly.”
SymBio expect the information presented herein to have no impact on its financial outlook for thefiscal year ending December 2021.

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[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125
About TREAKISYM® Liquid Formulation in the U.S. Market
In the United States, RI or the rapid infusion presentation of bendamustine hydrochloride injection
was approved by the FDA in 2016 and is currently marketed in the U.S. by Teva PharmaceuticalIndustries, Ltd. (Headquarters: Israel, “Teva”) as BENDEKA® (bendamustine HCl) Injection. Sales infiscal 2018 amounted to approximately 65 billion yen.

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 manufacturing andmarketing for the indication of relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma andmantle cell lymphoma in Japan.
 TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia in Japanin 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 obtained approval for the marketing of TREAKISYM® Intravenous Drip Infusion
100mg/4mL (RTD, ready-to-dilute, liquid formulation) for all the above indications in September
2020.
 TREAKISYM® FD and RTD formulations were approved for the additional indication of relapsed or
refractory diffuse large B-cell lymphoma (r/r DLBCL) in March 2021 and April 2021, respectively.
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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