September 26, 2019
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio Submits New Drug Application for TREAKISYM®
Ready-To-Dilute (RTD) Formulation

TOKYO, Japan, September 26, 2019 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") today announced that it has submitted a New Drug Application (“NDA”) for marketing
authorization of TREAKISYM® ready-to-dilute (“RTD”) liquid formulation. The NDA covers allindications for which TREAKISYM® is approved. In addition, a Phase 3 clinical trial for the additional
indication of relapsed/refractory diffuse large B-cell lymphoma (“r/r DLBCL”) is ongoing, and the NDA
will cover the approval of RTD for r/r DLBCL once the indication is approved.
Under the license agreement entered into between SymBio and Eagle Pharmaceuticals, Inc.
(Headquarters: New Jersey, USA) in September 2017, SymBio obtained the exclusive rights to develop
and commercialize the patent-protected ready-to-dilute (“RTD”) and rapid infusion (“RI”) liquid
formulations of bendamustine hydrochloride in Japan, enabling SymBio to extend the product life ofTREAKISYM® through 2031.* Compared to the current lyophilized formulation of TREAKISYM®, theRTD and RI liquid formulations will bring significant benefits to patients and healthcare providers inJapan by eliminating the need for manual reconstitution and significantly reducing preparation time.
SymBio will launch the RTD product in the first quarter of 2021, after obtaining marketing
authorization.
Symbio is currently conducting a clinical trial on the safety of RI, a low-volume liquid formulation ofbendamustine hydrochloride with a 10-minute infusion time (compared to the current 60 minutes).
SymBio will apply for approval early after the study is complete, with the aim of launching the drug inthe first half of 2022. In the United States, RI or the rapid infusion presentation of bendamustinehydrochloride injection was approved by the FDA in 2016 and is currently marketed in the U.S. byTeva Pharmaceutical Industries, Ltd. (Headquarters: Israel, “Teva”) as Bendeka (bendamustine HCl)
Injection.
Fuminori Yoshida, President and Chief Executive Officer of SymBio, stated: “The RTD producttogether with RI, which are the next-generation formulations of TREAKISYM®, have significant
benefits which will dramatically reduce the burden on patients and healthcare providers, compared tothe existing product. In addition, these new liquid formulations will enable SymBio to significantly

1extend the product life TREAKISYM®, which will have an extremely positive impact on SymBio’scorporate value. This NDA submission is the first step in a major leap forward toward SymBio’s secondinauguration. Together with another NDA for the additional indication of r/r DLBCL which we plan tosubmit in the first half of 2020, the probability that SymBio will become profitable in 2021 has
increased.”[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125
* See SymBio’s press release dated September 21, 2017: “Eagle Pharmaceuticals Licenses Japanese

Rights for Bendamustine Hydrochloride Ready-to-dilute and Rapid Infusion Injection Products toSymBio Pharmaceuticals Limited.”
About ready-to-dilute (RTD) and rapid infusion (RI) formulations
Unlike the current lyophilized formulation, RTD does not require complex manual reconstitution. Therapid infusion liquid formulation, RI, has the further advantage of reducing the administration timefrom 60 minutes (the administration time for the current lyophilized product) to 10 minutes,
significantly benefitting both patients and healthcare professionals.

2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 cell
lymphoma, and chronic lymphocytic leukemia.
TREAKISYM® Intravenous Infusion 100 mg was approved in Japan in October 2010 for theindications of relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and mantle celllymphoma.

TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia inJapan in August 2016.

TREAKISYM® Intravenous Infusion 25 mg was approved in Japan in September 2016.

TREAKISYM® was approved for the additional indications of first-line treatment of low-grade
B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December 2016.

SymBio began a Phase 3 clinical trial in August 2017 for r/r diffuse large B-cell lymphoma(DLBCL), which has the largest number of malignant lymphoma patients. SymBio completed theobservation period of all patients (Last Patient/Last Visit, or “LPLV”) in the trial in September
2019.

SymBio will publish top-line results on efficacy in the fourth quarter of 2019, and aim to submit aNew Drug Application (NDA) in the second quarter of 2020.

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 Amgen Japan. 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. 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).

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