September 23, 2020
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio Receives Approval of TREAKISYM®
Ready-To-Dilute (RTD) Formulation

TOKYO, Japan, September 23, 2020 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that TREAKISYM® ready-to-dilute (“RTD”) liquid formulation has been
approved in Japan by the Pharmaceuticals and Medical Devices Agency (“PMDA”).
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 2031.1 Compared to the current lyophilized
formulation of TREAKISYM®, the RTD and RI liquid formulations will bring significant benefits topatients and healthcare providers in Japan by eliminating the need for manual reconstitution andsignificantly reducing preparation time. SymBio plans to launch the RTD product in January 2021.
SymBio is also currently conducting a clinical trial with respect to safety of RI, the rapid infusion
presentation of bendamustine HCl injection and has completed the observation period for all patients(LPLV) 2. SymBio will apply for approval after completion of the study, aiming to receive approval in
the second half of 2022. In the United States, the rapid infusion presentation of bendamustinehydrochloride injection was approved by the FDA in 2016 and is marketed in the U.S. by Teva
Pharmaceutical Industries, Ltd. (Headquarters: Israel, “Teva”) as Bendeka (bendamustine HCl)
Injection.
Statement of Fuminori Yoshida, President and Chief Executive Officer of SymBio: “RTD and RI,
which are the next-generation formulations of TREAKISYM®, will bring significant benefits to bothpatients and healthcare providers compared to the existing product. In addition, these new liquid
formulations will enable SymBio to significantly extend the product life of TREAKISYM®. The
approval of RTD is one of the key factors that will enable SymBio to meet its goal of achieving
profitability in 2021. Together with the approval for the additional indication of r/r DLBCL which iscurrently under review by the PMDA, the pieces will be in place to enable SymBio to achieve thisgoal.”

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.
[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125
1 See SymBio’s press release dated September 21, 2017: “Eagle Pharmaceuticals Licenses Japanese

Rights for Bendamustine Hydrochloride Ready-to-dilute and Rapid Infusion Injection Products toSymBio Pharmaceuticals Limited”.
2 See SymBio’s press release dated September 21, 2020: “Last Patient Last Visit (“LPLV”) Achieved inClinical Study for TREAKISYM® Rapid Infusion Liquid Formulation”.

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 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® ready-todilute liquid formulation in September 2019.
SymBio aims to achieve annual sales of JPY 10 billion on a NHI drug price basis at the earliest possiblestage.
SymBio is aiming 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. SymBio’s underlying corporate mission is to “deliver hope to patients in need” as it aspires tobe a leading global specialty biopharmaceutical company dedicated to addressing underserved
medical needs. 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).

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