January 7, 2013
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer

SymBio Receives Clinical Trial Notification Acceptance for Phase 2TREAKISYM® (Bendamustine) Trial in CLL

TOKYO, Japan, January 7, 2013 – SymBio Pharmaceuticals Limited (JASDAQ: 4582) today
announced that clinical trial notification (CTN) has been accepted for its phase 2 clinical trial in
Japan using bendamustine hydrochloride (TREAKISYM®, SyB L-0501) for the treatment of patientswith chronic lymphocytic leukemia (CLL).This CTN now allows SymBio to proceed with the clinical
trial, which the Company expects to initiate shortly.
CLL is a cancer of the blood characterized by the progressive accumulation of functionallyincompetent lymphocytes, a type of white blood cell produced by the bone marrow and organs of thelymphatic system. The prevalence of CLL in Japan is estimated to be approximately 2,000 patients.
Bendamustine has been approved for the treatment of CLL in the U.S. and EU, where the diseaseaccounts for an estimated 30% of all leukemia cases. Due to the lack of effective therapies in Japan,
CLL patients are severely underserved, representing a highly unmet medical need. In Japan, aMinistry of Health, Labour and Welfare (MHLW) Working Group has designated TREAKISYM® as aprioritized unapproved drug having high potential to address unmet medical needs in CLL.
In October, 2010, SymBio, along with its partner Eisai Co., Ltd., received marketing approval forTREAKISYM® for the treatment of Japanese patients with relapsed/refractory (r/r) low-grade nonHodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL).
A phase 2 study for TREAKISYM® in r/r Aggressive NHL has been completed, with two phase 2
studies in frontline low-grade NHL and MCL, and relapsed/refractory multiple myeloma patientscurrently ongoing.
[Please see the following for further information on TREAKISYM® and SymBio][Contact]
Hiroki Maekawa
Board Director, Corporate Officer, Chief Financial Officer
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’by Jenapharm, and is currently marketed in Germany under the brand name “Ribomustin®” as atreatment for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia.
Mundipharma has received market authorization in a number of EU countries for bendamustine
under the brand name “Levact®”. In the United States, the drug is marketed as TREANDA® for thetreatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma.
SymBio Pharmaceuticals originally acquired the exclusive right to develop and commercialize
bendamustine in Japan (December, 2005) from Astellas Deutschland GmbH (Headquarters: Munich,Germany, formerly Astellas Pharma GmbH) followed by a second license agreement for theexclusive right to China, Hong Kong, Taiwan, South Korea and Singapore (March, 2007).

About TREAKISYM®
Product Name:
TREAKISYM® for Injection, for intravenous infusion 100 mg
Generic Name:bendamustine hydrochloride
Indications 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 repeated 21-day cycles. The dose may be reduced as deemed
appropriate according to the patient’s condition.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Ltd. 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 companyin Asia Pacific dedicated to addressing underserved medical needs with a focus in oncology,
hematology and autoimmune disease.