January 12, 2021
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Market Launch of TREAKISYM® Ready-To-Dilute (RTD) Formulation
TOKYO, Japan, January 12, 2021 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that TREAKISYM® ready-to-dilute liquid formulation (“RTD”) launches
in Japan today.
Under the license agreement entered into between SymBio and Eagle Pharmaceuticals, Inc.
(Headquarters: New Jersey, USA) in September 2017, SymBio obtained the exclusive rights todevelop and commercialize the patent-protected ready-to-dilute (“RTD”) and rapid infusion (“RI”)
liquid formulations of bendamustine hydrochloride (bendamustine HCl) in Japan, enabling SymBio toextend the product life of TREAKISYM® through 2031.
Compared to the current lyophilized formulation of TREAKISYM®, the RTD liquid formulations willbring significant benefits to healthcare providers in Japan by eliminating the need for manual
reconstitution and significantly reducing preparation time.
SymBio is also currently conducting a clinical trial with respect to safety of RI, the rapid infusion
presentation of bendamustine HCl injection. SymBio will apply for approval after completion of thestudy this year. In the United States, the rapid infusion presentation of bendamustine hydrochloride
injection was approved by the FDA in 2016 and is marketed in the U.S. by Teva PharmaceuticalIndustries, Ltd. (Headquarters: Israel, “Teva”) as Bendeka (bendamustine HCl) Injection. With aninfusion time of 10 minutes, RI will significantly lessen the burden on patients and healthcare
professionals.
Statement of Fuminori Yoshida, President and Chief Executive Officer of SymBio: “The launch ofRTD, the next-generation formulation of TREAKISYM®, will significantly extend the product life ofTREAKISYM® and substantially benefit the business due to the improved profit margin compared toour current lyophilized product, and we will swiftly convert to the RTD formulation. In addition, by
obtaining approval for the additional indication of relapsed or refractory diffuse large B-celllymphoma (“r/r DLBCL”), which is currently under regulatory review, we are confident that we will beable to achieve profitability at an early stage."1

SymBio does not expect the information presented herein to have any material impact on its financial
outlook for the fiscal year ending December 2020. Performance forecasts for the fiscal year ending
December 31, 2021 will be disclosed in the announcement of financial results summary for the fiscal
year ending December 2020.
[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125
About ready-to-dilute (RTD) and rapid infusion (RI) formulations
Unlike the current lyophilized formulation, RTD does not require complex manual reconstitution. The
rapid infusion liquid formulation, RI, has the further advantage of reducing the administration timefrom 60 minutes (the administration time for the current lyophilized product) to 10 minutes,
significantly benefitting both patients and healthcare professionals.

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 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 achieved the primary endpoint (overall response rate) in Phase III study of TREAKISYM®
in combination with rituximab as treatment for r/r DLBCL and submitted a partial change
application with respect to its marketing approval in May 2020.
 TREAKISYM® ready-to-dilute (“RTD”) liquid formulation was approved in Japan in September
2020.
 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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