November 5, 2019
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio Announces Achievement of Primary Endpoint (Overall Response Rate) in Phase
3 Clinical Trial of TREAKISYM® in relapsed/refractory diffuse large B-cell lymphoma

TOKYO, Japan, November 5, 2019 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced favorable results from its Phase 3 study of the anti-cancer drug
TREAKISYM® (non-proprietary name: bendamustine hydrochloride) in combination therapy withRituximab (“BR Therapy”) in relapsed/refractory diffuse large B-cell lymphoma (“r/r DLBCL”), withthe overall response rate, which was the primary endpoint of the trial, exceeding expectations.
DLBCL accounts for the largest number of patients with malignant lymphoma in Japan, and r/r
DLBCL specifically has a large number of elderly patients with no treatment options other thanconventional combination therapy. Accordingly, there is a longstanding need for a superior therapy
for r/r DLBCL, and patient advocacy groups have urged the Ministry of Health, Labour and Welfare
to make BR therapy available as soon as possible.
SymBio plans to submit a New Drug Application (NDA) in the first half of 2020, after the completingthe final analysis of the Phase 3 study. Together with the NDA submission for TREAKISYM® readyto-dilute (“RTD”) liquid formulation, announced in September 2019, and the continued efforts inestablishing its own sales organization, SymBio is putting conditions in place to achieve profitability
in 2021, which is a key management goal under the mid-range plan.

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

1About diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma (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.
Based on the favorable clinical results of the Phase 2 study of BR therapy in relapsed/refractory
diffuse large B-cell lymphoma (“r/r DLBCL”) conducted by SymBio*, BR therapy has been
recommended in the National Comprehensive Cancer Network (NCCN) Guidelines in the UnitedStates since 2012.
(Note on results of the Phase 2 study (59 patients): Overall response rate (ORR) 62.7%; Completeresponse (CR) 37.3%.)
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® was approved for the additional indications of first-line treatment of low-grade Bcell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December 2016.

SymBio completed registration of the first patient in the Phase 3 clinical trial in Japan in April
2019. The primary objective of the trial is to confirm the safety of TREAKISYM® rapid infusion(“RI”).



SymBio submitted a New Drug Application (“NDA”) for marketing authorization ofTREAKISYM® ready-to-dilute (“RTD”) liquid formulation in September 2019.

SymBio aims to achieve annual sales of JPY 10 billion on a NHI drug price basis at the earliest
possible stage.

2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., 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 leadingglobal specialty biopharmaceutical company dedicated to addressing underserved medical needs.

3