September 9, 2020
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Last Patient Last Visit (“LPLV”) Achieved in Clinical Study for
TREAKISYM® Rapid Infusion Liquid Formulation

TOKYO, Japan, September 9, 2020 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that it has completed the observation period for all patients (LPLV) in its
clinical study in Japan with the primary objective to confirm the safety of TREAKISYM® rapidinfusion (“RI”), a bendamustine liquid injection product with 10-minute administration time.
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 RTD (ready-to-dilute) and RI liquid formulations ofbendamustine hydrochloride in Japan, enabling SymBio to extend the product life of TREAKISYM®
through 2031.* Similar to the RTD product, for which the new drug application (“NDA”) is currently
under review for approval, RI is a liquid formulation product that does not require dissolution. Inaddition, RI will reduce the infusion time from 60 minutes (the infusion time for the current
lyophilized product) to 10 minutes, significantly benefitting both patients and healthcare providers.
With respect to RTD, SymBio anticipates and is currently preparing for launch in the first quarter of2021. RI approval is planned for the second half of 2022, after completion of the above-mentioned
clinical study.
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

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* 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.”

About ready-to-dilute (RTD) and rapid infusion (RI) formulations
Unlike the current lyophilized formulation, RTD does not require complex manual reconstitution. Therapid 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
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 AmgenJapan. 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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