August 26, 2016
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Approval of the Anti-cancer Drug TREAKISYM® for the Additional Indication ofChronic Lymphocytic Leukemia
TOKYO, Japan, August 26, 2016 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") announced today that the anti-cancer drug TREAKISYM® (non-proprietary name:bendamustine hydrochloride; "the Product") is now approved for the additional indication of chronic
lymphocytic leukemia.
SymBio has developed and applied for this indication upon request of the Ministry of Health, Labourand Welfare as one of the "unapproved or off-label drugs with high medical needs." SymBio has alreadyreceived marketing and manufacturing approval for the indication of recurrent/refractory low-grademalignant non-Hodgkin's lymphoma and mantle cell lymphoma in October, 2010.
SymBio has marketed the Product through Eisai Co., Ltd. since December, 2010 and its current
market share is about 60% for the indication of recurrent/refractory low-grade malignant
non-Hodgkin's lymphoma and mantle cell lymphoma, as estimated by SymBio. The Product is now
expected to offer a new treatment option for many patients with chronic lymphocytic leukemia.
In addition to these indications, in December, 2015, SymBio submitted a J-NDA for the first-line
treatment of low-grade malignant non-Hodgkin's lymphoma and mantle cell lymphoma, which iscurrently being reviewed by the Pharmaceuticals and Medical Devices Agency. Also, a Phase 2 study
in patients with recurrent/refractory advanced aggressive malignant non-Hodgkin's lymphoma has
been completed.
SymBio will pursue expanded indications and the full range of use of the Product in an effort tomaximize its value.
The approval of this chronic lymphocytic leukemia indication will not impact the current financial
forecast.

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About chronic lymphocytic leukemia (CLL)
CLL is a cancer of the blood characterized by the progressive accumulation of functionally incompetent
lymphocytes, a type of white blood cell produced by the bone marrow and organs of the lymphaticsystem. The number of CLL patients in Japan is estimated to be around 2,000. In the U.S. and EU,
bendamustine has been approved for the treatment of CLL where the disease accounts for an
estimated 30% of all leukemia cases. Due to the lack of effective therapies in Japan, CLL patients areseriously underserved and a high unmet medical need exists for the development of an effective
alternative therapy.
Overview of TREAKISYM® (The underlined section is newly approved.)
Product name:TREAKISYM® for injection, for intravenous infusion 100 mg

Generic name:Bendamustine hydrochloride

Indications and usage:

For the treatment of relapsed or refractory forms of the following diseases

1. Low-grade B-cell non-Hodgkin’s lymphoma
Mantle cell lymphoma
2. Chronic lymphocytic leukemia
Dosage and administration:
1. Low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma
The recommended adult dose is bendamustine hydrochloride 120 mg/m2 (body surface area) via 1-hour
intravenous infusion once daily for 2 days on treatment, followed by 19 days off treatment, withrepeated cycles. Dosage may be reduced as appropriate in accordance with the patient's condition.
2. Chronic lymphocytic leukemia
The recommended adult dose is bendamustine hydrochloride 100 mg/m2 (body surface area) via 1-hour
intravenous infusion once daily for 2 days on treatment, followed by 26 days off treatment, withrepeated cycles. Dosage may be reduced as appropriate in accordance with the patient's condition.
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 the Company incorporated its wholly-owned subsidiary in the U.S., called
SymBio Pharma USA, Inc. (Headquarters: Menlo Park, California, President: Mr. Fuminori Yoshida).
The Company’s underlying corporate mission is to “deliver hope to patients in need” as it aspires to bea leading global specialty biopharmaceutical company dedicated to addressing underserved medicalneeds with main therapeutic focus in oncology, hematology and pain management.

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