September 18, 2019
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Progress (LPLV) of Phase 3 Clinical Trialof the Anti-cancer Drug TREAKISYM®
in relapsed/refractory diffuse large B-cell lymphoma

TOKYO, Japan, September 18, 2019 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that after completion of the target enrollment it has completed theobservation period for all patients (LPLV: Last Patient Last Visit) in its Phase 3 study of the anticancer drug TREAKISYM® (non-proprietary name: bendamustine hydrochloride) in
relapsed/refractory diffuse large B-cell lymphoma (“r/r DLBCL”).
SymBio plans to announce top-line results on efficacy of the drug during the fourth quarter of 2019.
Based on the announced results of the Phase 3 study, SymBio continues preparation of a New Drug
Application (NDA) for r/r DLBCL as an additional indication for TREAKISYM®, targeting submission
during the second quarter of 2020.
DLBCL accounts for the largest number of patients with malignant lymphoma in Japan, and r/rDLBCL specifically has a large number of elderly patients with no treatment options other thanconventional combination therapy. Accordingly, with respect to r/r DLBCL, there is significant unmet
medical need and patient advocacy groups have urged the Ministry of Health, Labor and Welfare(MHLW) to make the use of BR therapy (combination treatment of bendamustine and rituximab)
available as soon as possible.
Achieving profitability in 2021 is one of the key management goals under SymBio’s mid-range plan,and to reach this goal SymBio will continue its company-wide efforts toward NDA submission toobtain market approval of r/r DLBCL as the fourth additional indication for TREAKISYM®.
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1About diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma or DLBCL is a disease where large, malignant B-cell lymphocytes
develop in the lymph nodes or in organs or other areas outside the lymph nodes. DLBCL is the mostprevalent form of malignant lymphoma in Japan, accounting for between 30% and 40% of patients. As
the majority of patients are elderly, with most patients in their 60s and 70s at the time of diagnosis,
patient numbers are expected to increase as Japan’s population continues to age. As the efficacy of
current chemotherapy treatments is limited, and patients with DLBCL who are resistant tochemotherapy or who relapse or are refractory to treatment have an extremely poor prognosis, there
is a high level of need for new safe and effective drugs.
References:
The Japanese Society for Lymphoreticular Tissue Research, Request for unapproved or off-label drugs,
http://www.mhlw.go.jp/file/06-Seisakujouhou-11120000-Iyakushokuhinkyoku/gakkai3-2-5-1.pdf

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

About TREAKISYM®
TREAKISYM® (non-proprietary name: bendamustine hydrochloride), a cytocide anti-cancer drug firstused in Germany in the 1970s, is now widely used in more than 50 countries with indications for lowgrade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.
TREAKISYM® Intravenous Infusion 100 mg was approved in October, 2010 for manufacturingand marketing for the indication of relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma
and mantle cell lymphoma in Japan.

TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia inJapan in 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.

SymBio currently has a Phase 3 clinical trial underway for r/r diffuse large B-cell lymphoma (r/rDLBCL), which has the largest number of malignant lymphoma patients, since August 2017.

SymBio is aiming to achieve annual sales of JPY 10 billion on a NHI drug price basis at the earliest
possible stage.
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 AmgenJapan. In May, 2016 SymBio incorporated its wholly-owned subsidiary in the U.S., 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 a leading
global specialty biopharmaceutical company dedicated to addressing underserved medical needs.

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