October 27, 2010
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative DirectorPresident and Chief Executive Officer

SymBio Announces Japan NDA Approval of TREAKISYM® (Bendamustine Hydrochloride)
TOKYO, Japan, October 27, 2010 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,President & CEO: Fuminori Yoshida, “SymBio”) announced today that the Ministry of Health,Labor and Welfare (MHLW) has approved the Company’s New Drug Application (NDA) for
TREAKISYM® (SyB L-0501, bendamustine hydrochloride) for the treatment of refractory/relapsed
low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma. With this approval,
TREAKISYM® presents a new treatment option for Japanese patients with difficult-to-treat
cancers, thereby extending and improving quality of life.
TREAKISYM® is the first oncology drug in-licensed by SymBio (December, 2005), and developed
for Japan and other Asia Pacific markets. Bendanustine hydrochloride has been used extensively
in Germany for the treatment of non-Hodgkin's lymphoma, multiple myeloma and chronic
lymphocytic leukemia, with the granting of market authorizations in a number of EU countriesthis year. In the US, Cephalon has been marketing the drug after receiving FDA approval for thetreatment of patients with chronic lymphocytic leukemia, and indolent B-cell non-Hodgkin's
lymphoma in 2008.
Flawless execution and nimbleness has enabled SymBio to shorten time to market for
TREAKISYM®, only requiring 5.5 years from the Company’s inception to market approval despite
the average two year lag in oncology launches in Japan versus the EU and US. SymBio concluded
a license agreement with Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito,“Eisai”) in August, 2008 for the co-development and commercialization of bendamustinehydrochloride in Japan, and wishes to express its appreciation to everyone involved in thedevelopment and launch of TREAKISYM®.
As part of ongoing label expansion plans and in accordance with the License Agreement signedwith Eisai, SymBio initiated two additional phase 2 studies for TREAKISYM® this year, with thestart of an international collaborative phase 2 trial of bendamustine HCI in combination withrituximab for the treatment of refractory and relapsed aggressive NHL in Korea and Japan(March), and phase 2 trial in first-line untreated multiple myeloma (July).
In Asia Pacific, bendamustine has been approved in Japan, Singapore, and Hong Kong as theCompany aspires to be a leading Oncology Specialty Phrama in the region.

SymBio will continue to expand the use of TREAKISYM® in the hematology space as rapidly as
possible in order to address the unmet medical needs of patients as its business presence in theAsia Pacific region continues to gain momentum, and key pieces of the Company’s strategic
development and commercialization plans in these markets fall into place with the achievement ofimportant milestones.

Note to Editors
1. About Bendamustine Hydrochloride
Bendamustine was first synthesized in the former ‘East Germany’ by Jenapharm, and iscurrently marketed in Germany under the brand name of Ribomustin® as a treatment for
non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. In the UnitedStates, the product has been approved by the U.S. Food and Drug Administration and is currently
prescribed under the brand name TREANDA® for the treatment of chronic lymphocytic leukemia
and relapsed indolent B-cell non-Hodgkin's lymphoma
SymBio Pharmaceuticals Limited originally acquired the exclusive right to develop andmarket bendamustine hydrochloride in Japan (December, 2005), followed by China, South Korea,
Taiwan and Singapore (March, 2007) from Astellas Deutschland GmbH (Headquarters: Munich,Germany, formerlly Astellas Pharma GmbH).
2. About TREAKISYM®
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:
・ Low-grade B-cell non-Hodgkin’s lymphoma
・ Mantle cell lymphoma
Dosage and Administration:
・ The usual adult dose of bendamustine hydrochloride is120 mg/m2 infused
intravenously over 60 minutes on Days 1 and 2 of repeated 21-day cycles.
The dose may be reduced appropriately according to the patient’s condition.
3. About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Ltd. was established in March, 2005 by Fuminori Yoshida, whopreviously served concurrently as Corporate VP of Amgen Ltd. and 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 pharmaceuticalcompany in Asia Pacific dedicated to addressing underserved medical needs in the areas of
oncology, hematology and autoimmune disease.

[Contact]
SymBio Pharmaceuticals Limited.
Hiroki Maekawa,
Board Director, Corporate Officer, Chief Financial Officer
Tel: +081(0)3 5472 1125
URL: http://www.symbiopharma.com/