May 8, 2013
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative DirectorPresident and Chief Executive Officer

SymBio Initiates Japanese Phase II Trial for TREAKISYM® (Bendamustine) in CLL

TOKYO, Japan, May 8, 2013 – SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President &CEO: Fuminori Yoshida, “SymBio”, JASDAQ: 4582) announced today that it commenced enrollment
in a Phase 2 clinical trial in Japan for bendamustine hydrochloride (Brand Name: TREAKISYM®) inchronic lymphocytic leukemia (CLL) patients.
In partnership with Eisai Co., Ltd., SymBio received marketing approval for TREAKISYM® (SyB L0501) in October, 2010, to treat Japanese patients with relapsed/refractory (r/r) low-grade nonHodgkin’s lymphoma (LG-NHL) and mantle cell lymphoma (MCL).
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 lymphatic
system. The number of CLL patients in Japan is estimated to be around 2,000. In the US 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. In Japan, the Ministry of Health, Labour and Welfare (MHLW) Working Group has
designated TREAKISYM® as a prioritized unapproved drug having high potential to address the lack ofan effective therapy in CLL. TREAKISYM® was designated by MHLW as an orphan drug for the CLL
indication in June, 2012.
SymBio has initiated several phase 2 trials for SyB L-0501. The Company continues to pursue otherindications for TREAKISYM® in the hematology space as nimbly as possible in order to maximize thepotential of TREAKISYM® and address other high unmet medical needs in patients.
[Please read the following for further information on TREAKISYM® and SymBio][Contact]
Tomoyuki Watanabe
Director, Head of Corporate Planning Division
Tel: +081(0)3 5472 1125

About TREAKISYM® (SyB L-0501)
Bendamustine hydrochloride was first synthesized in the early 1960s in the former East Germany byJenapharm, and is currently marketed in Germany under the brand name Ribomustin® as a treatment
for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. Mundipharma
has received marketing authorization in a number of EU countries for bendamustine under the brandname Levact®. In the United States, the drug has been approved by the U.S. Food and Drug
Administration and is marketed as TREANDA® for the treatment of chronic lymphocytic leukemia andrelapsed indolent B-cell non-Hodgkin's lymphoma. SymBio Pharmaceuticals originally acquired theexclusive right to develop and commercialize bendamustine in Japan (December, 2005) from Astellas
Deutschland GmbH (Headquarters: Munich, Germany, formerly Astellas Pharma GmbH) followed bya second license agreement for the exclusive right to China, Hong Kong, Taiwan, South Korea andSingapore (March, 2007) where, China aside, the drug has been launched.

About TREAKISYM®
Product Name:
TREAKISYM® for Injection, for intravenous infusion 100 mg
Generic Name:bendamustine hydrochlorideIndications and Usage:
For the treatment of relapsed/refractory forms of the following indications:・ Low-grade B-cell non-Hodgkin’s lymphoma
・ Mantle cell lymphoma
Dosage and Administration:
The standard adult dose of bendamustine hydrochloride is 120 mg/m2 infused intravenously over 60
minutes on Days 1 and 2 of a repeated 21-day cycle. The dose may be reduced as deemed
appropriate according to the patient’s condition.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals was established in March, 2005, by Fuminori Yoshida, who previously
served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen Japan(currently Takeda Bio Development Center Limited). The company’s underlying corporate mission is“delivering hope to patients in need” as it aspires to be a leading specialty pharmaceutical company inAsia Pacific dedicated to addressing underserved medical needs with focus in oncology, hematology
and autoimmune disease.