December 20, 2018
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Shipments of the 25mg Presentation of Anti-cancer Drug TREAKISYM®
Intravenous Infusion Paused and Shipment of SubstituteTOKYO, Japan, December 20, 2018 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") announced today that the import and sale of the 25mg presentation of TREAKISYM®
Intravenous Infusion ("25mg"), a standard low-dosage form of the anti-cancer drug TREAKISYM®
(non-proprietary name: bendamustine hydrochloride) was temporarily stopped. In September 2016,
SymBio obtained marketing approval for 25mg in Japan in addition to the then already approved
TREAKISYM® Intravenous Infusion 100mg ("100mg"). Both 25mg and 100mg are sold through Eisai
Co., Ltd. (Headquarters: Tokyo, Japan).
A batch of 25mg product recently imported from Astellas Deutschland GmbH (“Astellas Deutschland”),
a consolidated subsidiary of Astellas Pharma Inc. (Headquarters: Tokyo, Japan) was determined to bevisually defective. SymBio has asked Astellas Deutschland to identify the root cause of the issue assoon as possible. As the cause has not been identified at this point, considering the health interests ofpatients, SymBio has decided to temporarily stop the import of 25mg presentation and has requested
that Astellas Deutschland provide the appropriate quality assurances. SymBio is taking steps tonormalize the supply as soon as possible and will issue another press release once it is determinedwhen the import of 25mg will resume. As a temporary measure, SymBio will ensure the stability ofTREAKISYM® supply by replacing 25mg with 100mg presentation. Further steps are being considered
in coordination with Astellas Deutschland.
The impact on financial performance is being assessed. SymBio’s financial forecasts for 2018 areunchanged.

[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125

1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
B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December 2016.

SymBio currently has a Phase 3 clinical trial underway for r/r diffuse large B-cell lymphoma(DLBCL), which has the largest number of malignant lymphoma patients.

SymBio initiated a clinical trial to confirm the safety of TREAKISYM® liquid formulation(RI : Rapid Infusion Injection Formulation) in November 2018.

SymBio is aiming to achieve 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 with maintherapeutic focus in oncology, hematology and pain management.

2