May 22, 2019
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Launch of “Regenerative Medicine” Productsthat can be used with the anti-cancer drug TREAKISYM®
as a pretreatment agent
TOKYO, Japan, May 22, 2019 -- Novartis Pharma K.K. (headquarters: Tokyo) today announced thatthe chimeric antigen receptor T-cell (CAR-T) therapy, KYMRIAH® (non-proprietary name:tisagenlecleucel), has obtained NHI Price Listing for the treatment of CD19 positive relapsed orrefractory B-cell acute lymphoblastic leukemia (ALL) and CD19 positive relapsed or refractory diffuse
large B-cell lymphoma (DLBCL).
Novartis’ press release: www.novartis.co.jp/news/news-archive
SymBio Pharmaceuticals Limited ("SymBio," headquarters: Tokyo) obtained a partial change
approval for its anti-cancer drug TREAKISYM® (non-proprietary name: bendamustine hydrochloride)on March 26, 2019. The approval provides a new treatment option to patients by enabling the use ofTREAKISYM® as a pretreatment agent in Adoptive T-cell therapy (*).
TREAKISYM® was newly included as a standard-of-care option for low-grade B-cell non-Hodgkin'slymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia in the 2018 Guidelines for
Tumors of Hematopoietic and Lymphoid Tissues, issued by JSH (Japan Society of Hematology) onJuly 20, 2018.
In addition to expanding the use of TREAKISYM® by obtaining approval for its use as a pretreatment
agent, SymBio is currently conducting a Phase 3 study of TREAKISYM® in DLBCL. As
TREAKISYM® increasingly establishes its position as standard therapy in the treatment of malignant
lymphoma, SymBio will continue to expand the business to enhance corporate value.
[Contact]
Investor Relations /Tel: +81 (0)3 5472 1125(*) Adoptive T-cell therapy is a type of immunotherapy in which tumor-specific cytoxic T-cells areinfused into cancer patients for the purpose of targeting and destroying tumor cells.

1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 manufacturingand 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.

SymBio is conducting a Phase 3 clinical trial for r/r diffuse large B-cell lymphoma (r/r DLBCL),
which has the largest number of malignant lymphoma patients. The trial began in August 2017.

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 whopreviously 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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