March 26, 2019
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

TREAKISYM® Approved for use
as a Pretreatment to Adoptive T-Cell Therapy
TOKYO, Japan, March 26, 2019 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio,") announced today that it has obtained a partial change to its marketing authorization for
the anti-cancer drug TREAKISYM® (non-proprietary name: bendamustine hydrochloride), approving
TREAKISYM® for use as a pretreatment to adoptive T-cell therapy.(1)Today, Novartis Pharma K.K. (headquarters: Tokyo) obtained marketing approval for the firstchimeric antigen receptor T-cell (CAR-T) therapy (KymriahTM) for the treatment of CD19 positive
relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and CD19 positive relapsed orrefractory diffuse large B-cell lymphoma (DLBCL).(2) After the launch of KymriahTM, TREAKISYM®
may be used as a pretreatment agent for CAR-T therapy. In the area of adoptive T-cell therapy, anincreasing number of new products are in development in Japan and in other countries, andTREAKISYM® now contributes to the treatment of patients in this expanding field.
As a standard therapy in the treatment of malignant lymphoma, TREAKISYM® is establishing its
position as a backbone therapy, and the addition of new regenerative and gene therapies will further
expand the use of TREAKISYM® in hematology.
(1) Adoptive T-cell therapy is a type of immunotherapy in which tumor-specific cytoxic T-cells areinfused into cancer patients with the goal of recognizing, targeting and destroying tumor cells.
(2) Please refer to the press release issued by Novartis Pharma K.K. on March 26, 2019 at thefollowing link: https://www.novartis.co.jp/news/news-archive[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125

1About TREAKISYM®
From first use in Germany in the 1970s, bendamustine hydrochloride, a cytocide anti-cancer drug, isnow widely used in more than 50 countries with indications for low-grade non-Hodgkin’s lymphoma,
mantle cell lymphoma, and chronic lymphocytic leukemia.
Under the brand name of TREAKISYM®, Intravenous Infusion 100 mg, was approved in October2010 for manufacturing and marketing for the indication of relapsed/refractory low-grade B-cell
non-Hodgkin's lymphoma and mantle cell lymphoma in Japan.

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 formanufacturing and marketing in Japan in September 2016.

TREAKISYM® was approved for the additional indication of first-line treatment of low-grade Bcell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December 2016.

TREAKISYM® has been marketed through Eisai Co., Ltd. since December 2010.
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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