February 28, 2022
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio receives approval of TREAKISYM® Liquid Formulation
Rapid Infusion (RI) administration
TOKYO, Japan, February 28, 2022 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that it received approval of a partial change 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.
The Company received approval of RI administration based on the results of its clinical study toinvestigate the safety and pharmacokinetics of the TREAKISYM® liquid formulation administered by10-minute intravenous drip infusion. Similar to Eagle's BENDEKA®, which is currently marketed inthe United States, TREAKISYM® RI administration can significantly reduce the burden on patientsand healthcare professionals by reducing the infusion time from 60 minutes to 10 minutes.
Statement from Fuminori Yoshida, President and CEO of SymBio: “The TREAKISYM® liquid
formulation RI administration was launched as BENDEKA® in the United States in 2016 and has
been marketed for more than 5 years. With a dilution volume of approximately 50 ml, which is onefifth of the current product, the infusion time is reduced to 10 minutes, and because it has and very
low salt content, RI administration is suitable for patients with malignant lymphoma, many of whoare elderly.”
SymBio 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® 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 orrefractory 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 PharmaUSA, Inc. (Headquarters: Durham, North Carolina, President: 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 address underserved medical needs.

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