August 31, 2017
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Initiation in Japan of the Phase 3 Clinical Trialof the Anti-cancer Drug TREAKISYM®
for the Indication of relapsed/refractory diffuse large B-cell lymphoma
TOKYO, Japan, August 31, 2017 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio,") announced today that SymBio initiated a Phase 3 study (“the Study”) in Japan of the anticancer drug TREAKISYM® (non-proprietary name: bendamustine hydrochloride; "the Product") forthe indication of relapsed/refractory diffuse large B-cell lymphoma or r/r DLBCL.
Although DLBCL accounts for about one-third of malignant lymphoma in terms of patient numbers, astandard chemotherapy for treatment of DLBCL is currently not available, thus multiple drug
therapies*1 are administered. Multiple drug therapies, however, tend to have strong adverse effects,
placing a burden on patients, and accordingly a new therapy is much-awaited.
Having completed a Phase 2 study for bendamustine-rituximab (BR) therapy, SymBio achievedremarkable clinical trial results*2 for the treatment of patients with r/r DLBCL. Based on theachievements of this clinical study, BR therapy has been recommended in the NCCN Guidelines inthe U.S., the standard for clinical policy in oncology, since 2012.
After consultation with The Pharmaceuticals and Medical Devices Agency (PMDA), SymBio has now
initiated a Phase 3 study. The objective of the Study is to confirm the efficacy and safety of BR
therapy.
r/r DLBCL falls under a therapeutic area with high unmet medical needs, where a new drug therapy
is much-awaited, as the strong need for development of BR therapy has been voiced by a patientgroup and relevant academic societies.
Swiftly enrolling patients in the Study, SymBio aims to file an NDA for r/r DLBCL in the 2nd half of2019.
This event will not impact SymBio’s current financial forecast.

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Investor Relations
Tel: +81 (0)3 5472 1125

*1. Multiple drug therapies are administered by way of a combination of multiple anti-cancer drugs
with different modes of action. It is necessary to carefully select patients in light of safety, sincemultiple anti-cancer drugs with strong cytotoxic action such as myelosuppression are used in thistherapy.
*2. An analysis of 59 cases in the Phase 2 study showed an ORR of 62.7% and CR of 37.3%.

About diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma or DLBCL is a disease where large, malignant B-cell lymphocytes growand develop into malignancy in lymph nodes and various organs. DLBCL is the most prevalent formof malignant lymphoma in Japan (30~40%), with patients in their 60s and 70s at peak onset age. Asthe majority of patients are elderly, patient numbers are expected to increase as Japan’s aging
population continues to grow. Since the efficacy of current chemotherapy treatment is limited,patients with DLBCL who are resistant to chemotherapy or who relapse or are refractory totreatment, have an extremely poor prognosis, thus new safe and effective drugs are long-awaited.
References:
The Japanese Society for Lymphoreticular Tissue Research, Request for unapproved or off-labeldrugs, http://www.mhlw.go.jp/file/06-Seisakujouhou-11120000-Iyakushokuhinkyoku/gakkai3-2-5-1.pdf

Michinori Ogura, Treatment of elderly patients with malignant lymphoma (Koreisha Akusei Rinpashu no Chiryou),
Nippon Ronen Igakkai Zasshi 47: 271-275

Friedberg, JW. relapsed/ refractory diffuse large cell B-cell lymphoma. ASH Education Book 2011 (1): 498-505

About TREAKISYM®
From first use in Germany in the 1970s, TREAKISYM®, a cytocide anti-cancer drug, is now widelyused in more than 50 countries with indications for low-grade non-Hodgkin’s lymphoma, mantle celllymphoma, and chronic lymphocytic leukemia.
The Product, under the brand name of TREAKISYM® Intravenous Infusion 100 mg, wasapproved in October, 2010 for manufacturing and marketing for the indication of
relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma inJapan.

2The Product was approved for the additional indication of chronic lymphocytic leukemia in Japanin August, 2016.

TREAKISYM® Intravenous Infusion 25 mg, a standard low-dose product, was approved for
manufacturing 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.

TREAKISYM® has been marketed through Eisai Co., Ltd. since December, 2010.

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 SymBio incorporated its wholly-owned subsidiary in the U.S., called 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 aleading global specialty biopharmaceutical company dedicated to addressing underserved medical
needs with main therapeutic focus in oncology, hematology and pain management.

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