March 25, 2020
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Completion of Patient Enrollment in Clinical Trialfor TREAKISYM® Rapid Infusion

TOKYO, Japan, March 25, 2020 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that it has completed patient enrollment in a clinical study in Japan withthe primary objective to confirm the safety of TREAKISYM® rapid infusion (“RI”) product.
As a part of strategic life cycle management of TREAKISYM®, under the license agreement between
SymBio and Eagle Pharmaceuticals, Inc. (Headquarters: New Jersey, USA) in September 2017,
SymBio obtained the exclusive rights to develop and commercialize the patent-protected ready-todilute (“RTD”) and RI liquid formulations of bendamustine hydrochloride in Japan. The liquid
formulations extend the product life of TREAKISYM® through 2031*, further increasing the value ofTREAKISYM® and setting the foundation for the Company’s strategic growth. In addition to the RTD
product, for which the new drug application (“NDA”) for marketing authorization was submitted inSeptember 2019, the RI product will reduce the infusion time from 60 minutes to 10 minutes,
significantly benefitting both patients and healthcare providers.
SymBio plans to submit the NDA for RI and obtain approval in the second half of 2022. The
application will include all indications for which TREAKISYM® is currently approved and relapsed/refractory diffuse large B-cell lymphoma (“r/r DLBCL”), for which the Company plans to submit anNDA towards the first half of 2020.
Fuminori Yoshida, President and Chief Executive Officer of SymBio, stated: “As RI, the next
generation of TREAKISYM®, has exceptionally high added value and nearly 100% share in the U.S.
market, we anticipate rapid market penetration in Japan. In addition, considering this formulation
has a dilution volume of 50 ml, which is one-fifth of the current product, and low salt content, it will
be easier for elderly patients to use. Extending the product life of TREAKISYM® through the patent
protection period will further solidify the foundation for the growth of the Company.”[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.”
https://www.symbiopharma.com/news_e/20170921_1e.pdf

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. In addition, the patent projectionof the liquid formulations enable extension of the product life of TREAKISYM® through 2031. The
equivalent product in the United States, Bendeka, was approved by the FDA in 2016 and is currently
marketed in the U.S. by Teva Pharmaceutical Industries, Ltd. (Headquarters: Israel) withapproximately 65 billion yen in sales in 2018.

2About TREAKISYM®
From first use in Germany in the 1970s, TREAKISYM®, a cytocide anti-cancer drug, is now widelyused in more than 50 countries with indications for low-grade non-Hodgkin’s lymphoma, mantle celllymphoma, and chronic lymphocytic leukemia.
TREAKISYM® Intravenous Infusion 100 mg was approved in Japan in October 2010 for theindications of relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and mantle celllymphoma.

TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia inJapan in August 2016.

TREAKISYM® Intravenous Infusion 25 mg, a standard low-dose product, was approved in Japanin September 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 initiated a Phase 3 clinical trial for r/r diffuse large B-cell lymphoma (DLBCL), which has
the largest number of malignant lymphoma patients, in August 2017 and announced theachievement of a favorable response rate that exceeded expected levels, which represents a primary
endpoint, in November 2019.

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. 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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