May 19, 2021
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Chugai receives NHI price listing for polatuzumab vedotin
for treatment of relapsed or refractory diffuse large B-cell lymphoma

TOKYO, Japan, May 19, 2021 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio")
today announced that Chugai Pharmaceutical Co., Ltd. (Headquarters: Tokyo, "Chugai") receives
National Health Insurance (NHI) price listing for polatuzumab vedotin (genetical recombination) for
the treatment of relapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”).
Chugai obtained approval for the use of polatuzumab vedotin in combination with bendamustine andrituximab (“Pola-BR therapy”) in r/r DLBCL on March 23, 2021. As a result, TREAKISYM® becomes
available for use in combination with BR therapy and polatuzumab vedotin* today.
Achieving profitability in fiscal year 2021 is the first milestone in the Company’s secondinauguration. The start of use of Pola-BR therapy for r/r DLBCL is a major step toward achieving thisgoal.
The Company will evaluate any financial impact of the information presented herein for the fiscal
year ending December 2021 and make any required corresponding timely disclosures.

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

1

*(NOTE)[Indications]
Relapsed or refractory diffuse large B-cell lymphoma[Dosage and administration]
When rituximab (genetical recombination) and polatuzumab vedotin (genetical recombination) areused in combination. The usual adult dosage for intravenous drip infusion is 90 mg/m2 (body surfacearea) of bendamustine hydrochloride over an hour period once daily. Administration is performed
daily for 2 days, and the drug is withdrawn for 19 days. This is followed by a single cycle with amaximum of 6 cycles. The dose may be adjusted according to the patient’s condition.
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 manufacturing andmarketing for the indication of relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma andmantle cell lymphoma in Japan.
 TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia in Japanin 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 achieved the primary endpoint (overall response rate) in Phase 3 study of TREAKISYM® incombination with rituximab as treatment for r/r DLBCL and obtained approval of a partial change
application with respect to its marketing approval in March 2021.
 TREAKISYM® ready-to-dilute (“RTD”) liquid formulation was approved in Japan in September
2020.
 SymBio aims 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 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 leading
global specialty biopharmaceutical company dedicated to addressing underserved medical needs.

2