October 25, 2019
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Onconova Provides Update on the Global Phase 3 INSPIRE Trialof Rigosertib in Myelodysplastic Syndromes and on Future Clinical Trial Plans
TOKYO, Japan, October 25, 2019 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio") announced today that on October 24, 2019 (EST), its U.S. licensor for Rigosertib, Onconova
Therapeutics, Inc. (Headquarters: Newtown, PA, “Onconova”), provided an update on the global
Phase 3 INSPIRE study of IV rigosertib and on Onconova’s future clinical trial plans.
For Onconova's full press release, please visit Onconova's website at: investor.onconova.com/pressreleases
According to Onconova’s announcement, Onconova is approaching enrollment of 90 percent of therequired 360 randomized patients for the global Phase 3 INSPIRE Trial and Onconova continues toanticipate reporting top-line data in the first half of 2020. The INSPIRE Trial is a global, multicenter, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk
myelodysplastic syndromes (“HR-MDS”) patients who had progressed on, failed to respond to, orrelapsed after previous treatment with a hypomethylating agent ( “HMA-refractory”).
Regarding the development of oral rigosertib, as a result of Onconova’s consultations with the FDA on
SPA (Special Protocol Assessment), Onconova plans to conduct a randomized Phase 2 trial with acontrol arm of single agent azacitidine for the continued development of oral rigosertib plus
azacitidine in first-line HR-MDS patients.
In collaboration with Onconova and as part of the global Phase 3 INSPIRE Trial, SymBio isconducting the trial in Japan and proceeding with planned enrollment. Treatment options are limited
for HR-MDS patients who are HMA-refractory and there is an extremely high medical need.
About myelodysplastic syndromes (MDS)MDS are conditions that can occur the blood-forming cells in the bone marrow become dysfunctional
and thus produce an inadequate number of circulating blood cells. MDS patients often require
frequent blood transfusions due to the development of severe anemia (decrease in the number of red1

blood cells), with a high rate of progression to acute myelogenous leukemia (AML). The number ofMDS cases are expected to increase as the population ages. MDS and AML are widely recognized as
two blood disorders that are difficult to manage given the limited therapeutic options available forpatients, particularly for patients who have a drug-resistant form of the disease. A high unmet
medical need clearly exists for the establishment of new effective therapies to treat both lower-riskand higher-risk MDS. The number of drug-treated MDS patients is estimated to be about 11,000 in
Japan at male-female ratio of 2:1 and majority of the patients are elderly people.
About Rigosertib
Rigosertib is a small molecule inhibitor that has a new mechanism of action: it inhibits the activationof Ras as an oncogene-related product, thereby blocking the action of multikinases, including PI3K,and inhibits cellular signaling in cancer cells necessary for their survival and proliferation, thus
killing cancer cells. SymBio obtained the development and commercialization licensing rights for
Rigosertib from Onconova in July, 2011 for Japan and Korea.
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on discoveringand developing novel products to treat cancer. Onconova's clinical and pre-clinical stage drug
development candidates are derived from its extensive chemical library and are designed to work
against specific cellular pathways that are important in cancer cells, while causing minimal damage
to normal cells. In addition to Rigosertib, Onconova's most advanced drug candidate underdevelopment, two other drug candidates are in clinical trials and several other compounds are in thepre-clinical stage of development. For more information, please visit http://www.onconova.com.
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 the Company incorporated its wholly-owned subsidiary in the U.S., SymBio
Pharma USA, Inc. (Headquarters: Menlo Park, California, President: Mr. Fuminori Yoshida).
The Company’s underlying corporate mission is to “deliver hope to patients in need” as it aspires to bea leading global specialty biopharmaceutical company dedicated to addressing underserved medical
needs.

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