January 18, 2018
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Onconova Announces Plans for the Global Randomized Phase 3 Trial of IV Rigosertib
after Promising Interim Analysis
TOKYO, Japan, January 18, 2017 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo,"SymBio,") announced today that its U.S. partner, Onconova Therapeutics, Inc. (Headquarters:Newtown, PA, “Onconova”) announced on January 17, 2018 (EST) that it is moving forward with theGlobal Randomized Phase 3 trial for the RAS pathway targeted anti-cancer drug IV rigosertib inpatients with higher-risk myelodysplastic syndromes (MDS) who had progressed on, failed, or relapsed
after prior hypomethylating agent (HMA) therapy (the “INSPIRE” trial) with a one-time increase inenrollment following the interim analysis.
Based on the interim analysis, the independent Data Monitoring Committee (DMC) has recommended
that the INSPIRE trial continue with enrollment increased from the current 225 patients to reach a
total enrollment of 360 patients. The expanded study enrollment criteria will be identical to theoriginal study. For Onconova’s full press release, please visit Onconova’s website
at: http://investor.onconova.com/press-releases
Patients with high-risk MDS who are refractory to HMAs have limited treatment options and there is
extremely high unmet medical need for patients who respond inadequately to existing therapies.
Based on the DMC’s recommendation, SymBio will continue in collaboration with Onconova to move
forward with the trial with an increase in the total enrollment of patients in Japan.
The financial impact of this event will be reflected in the Company’s current financial forecast to bereleased on Febraury 7th, 2018.
About the Data Monitoring Committee (DMC)
The DMC is a committee of clinical research experts with expertise to conduct an independent reviewof the results of the interim analysis and to provide a recommendation to the sponsor on theappropriateness of continuing the trial and on any needed changes to the trail.

1About myelodysplastic syndromes (MDS)MDS patients often require frequent blood transfusions due to the development of severe anemia(decrease in the number of red blood cells), with a high rate of progression to acute myelogenous
leukemia (AML). The number of MDS cases are expected to increase as the population ages. MDS andAML are widely recognized as two blood disorders that are difficult to manage given the limited
therapeutic options available for patients, 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-risk and higher-risk MDS. The number of drug-treated MDS patients is estimatedto be about 7,700 in Japan (CancerMPact 2016).
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 rights to develop and commercialize rigosertib in Japan and Korea from
Onconova in July 2011.
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on discovering anddeveloping 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 specificcellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In
addition to rigosertib, Onconova's most advanced drug candidate under development, two other drugcandidates are in clinical trials and several other compounds are in the pre-clinical stage ofdevelopment. 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 with main therapeutic focus in oncology, hematology and pain management.

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