February 9, 2017
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio’s Mid-Range Plan: FY 2017 to FY 2019

I. Mid-Range Plan for the Next Three Years(1) Overview of FY 2016 Business Results as of the Date of the Mid-Range Plan
Progress in the Company’s business for FY 2016 (from January 1, 2016 to December 31, 2016) is asfollows:
1. Domestic[Anticancer agent: SyB L-0501 (generic name: bendamustine hydrochloride, trade name:TREAKISYM®)]
The Company markets TREAKISYM® in Japan through its business partner, Eisai Co., Ltd. (“Eisai”),
for the indications of recurrent/refractory low-grade non-Hodgkin’s lymphoma and mantle cell
lymphoma, the first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma,
and chronic lymphocytic leukemia. Although net sales showed a slight decrease of 99.2% year-on-year(NHI price basis), net sales through Eisai were generally as planned.
By pursuing four indications, the Company has already obtained approvals for three indications, andcontinues to pursue approval for the remaining one additional indication, for patients who need newtherapies and for maximizing the product value of these agents.
The Company filed a supplemental New Drug Application (sNDA) in Japan to the Pharmaceuticals
and Medical Devices Agency (“PMDA”) in December 2015 for the indication of chronic lymphocytic
leukemia, and obtained approval for the additional indication in August 2016. The Company has
developed and applied for this indication upon request of the Ministry of Health, Labour and Welfare
in Japan as one of the “Unapproved or Off-Label Drugs with High Medical Needs.” This is the second
approval after the approval of an sNDA for the indication of recurrent/refractory low-grade
non-Hodgkin’s lymphoma and mantle cell lymphoma which the Company has already received in
October 2010.
Regarding the first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma,
the Company filed an sNDA in Japan in December 2015 and received approval for additional1

indications in December 2016. In Europe, while the Company received a notice from Astellas PharmaGmbH (Head office: Germany) that they withdrew their application in January 2016, the Company,
upon consultation with the PMDA, went ahead with the procedures for obtaining approval for the
additional indications in Japan and was able to obtain such approval.
Lastly, regarding the indication of recurrent/refractory intermediate/high-grade non-Hodgkin’s
lymphoma, the Company continues to discuss the path forward for approval with the PMDA.
[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), genericname: rigosertib]
Regarding these agents, for which a license agreement was entered into in July 2011, the Company
has changed their generic name from “rigosertib” to “rigosertib sodium” in accordance with the noticeof decision on its Japanese Accepted Names for Pharmaceuticals (JAN) received in October 2016. For
the global Phase III trial of the intravenous formulation of rigosertib sodium conducted by Onconova
Therapeutics, Inc. (Head office: Pennsylvania, U.S.; “Onconova”), the U.S. Licensor, the Company is incharge of the clinical development in Japan and started the domestic trial in December 2015. The
global Phase III trial is conducted with clinical trial sites in more than ten countries worldwide, forhigher-risk myelodysplastic syndromes (HR-MDS) which do not respond to the current standard
treatment with hypomethylating agents (HMAs) or which relapse after treatment under the current
standard of care (“primary HMA failure”). The Company completed the first patient enrollment inJapan in July 2016. Enrollments are currently accumulating.
Regarding the oral formulation of rigosertib, the Company started its domestic Phase I clinical trial of
the oral formulation of rigosertib sodium in combination with azacitidine (Note 1) for the target
indication of HR-MDS in December 2015. However, the provision of the investigational drug of thisclinical trial by Onconova has been delayed. At present, patient enrollment has not yet been started.
As soon as this issue on the provision of the investigational drug is resolved, the Company will resume
patient enrollment, complete this clinical trial as planned, and consider its participation in the global
Phase III clinical trial to be conducted by Onconova.
(Note)

About azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.): This drug was approved in2011 upon successful confirmation of extended overall survival for the first time in the Phase III clinical trial
for the indication of MDS, and is currently used as a first-line drug for MDS patients who have difficulties inhematopoietic stem cell transplantation.

[Patient-controlled iontophoretic transdermal system for the short-term management of acutepost-operative pain: SyB P-1501]
In October 2015, the Company entered into an agreement with Incline Therapeutics, Inc., awholly-owned subsidiary of U.S.-based The Medicines Company (Head Office: New Jersey, U.S.) for an
exclusive license to develop and commercialize in Japan SyB P-1501. The Company commenced adomestic Phase III clinical trial for SyB P-1501 in June 2016 and completed the first patient
enrollment in November 2016. The Company intends to complete the Phase III clinical trial at theearliest possible time, with the aim of obtaining approval by the end of 2019.

2

[New drug candidates]
The Company continued with search and evaluation activities to acquire license rights of new drugcandidates in global terms, aiming to grow into a biopharmaceutical company with both profitability
and growth potential, always from a medium-to-long-term perspective. Negotiations for multiple
licensing agreements are currently underway.
Meanwhile, in May 2016, the Company established a wholly-owned subsidiary, SymBio Pharma USA,
Inc. (Head office: Menlo Park, California, U.S., “SymBio Pharma USA”), as the Company’s strategic
base for its overseas business development. By actively acquiring the worldwide rights concerning new
drug candidates with SymBio Pharma USA as the base of global business, the Company will accelerate
its transformation into a global specialty biopharmaceutical company with the aim of developing andcommercializing new drugs in the U.S., Japan, Europe and other major global markets
2. Overseas
SyB L-0501 is also marketed in South Korea, Taiwan and Singapore, and sales in these countries havebeen strong.
3. Business results
As a result of the above, net sales totaled 2,368,112 thousand yen for the fiscal year ended December
31, 2016, primarily reflecting product sales of TREAKISYM® in Japan. Product sales showed ayear-on-year increase of 10.6%, and the Company recorded non-recurring revenue including resulting
from achieving the sales milestone of SyB L-0501 in Taiwan. Accordingly, overall net sales rose 22.5%
year-on-year.
Selling, general and administrative expenses totaled 3,031,242 thousand yen (a year-on-year decreaseof 3.3%), including research and development (“R&D”) expenses of 1,667,098 thousand yen (ayear-on-year decrease of 18.1%) primarily due to expenses associated with the clinical trial for
TREAKISYM®, the intravenous and oral formulations of rigosertib as well as SyB P-1501, and otherselling, general and administrative expenses of 1,364,143 thousand yen (a year-on-year increase of
24.0%).
As a result, operating loss of 2,127,049 thousand yen was recognized for the fiscal year ended
December 31, 2016 (operating loss of 2,551,662 thousand yen for the previous fiscal year). In addition,
the Company recorded non-operating expenses totaling 196,467 thousand yen primarily comprisingforeign exchange loss of 158,514 thousand yen, stock issuance costs of 11,658 thousand yen andcommission fees of 8,975 thousand yen, and non-operating income totaling 6,710 thousand yen
primarily due to interest income of 5,235 thousand yen and dividends income of insurance of 1,221
thousand yen. This resulted in an ordinary loss of 2,316,806 thousand yen (ordinary loss of 2,630,386
thousand yen for the previous fiscal year) and net loss of 2,313,233 thousand yen (net loss of 2,632,095
thousand yen for the previous fiscal year).
Segment information has been omitted as the Company operates within a single segment of thepharmaceutical industry which includes the development and commercialization of drugs,

3manufacturing, marketing and other related activities.
(2) SymBio’s Mid-Range Plan – Summary and Background
SymBio is the first Japanese “specialty pharma” to specialize in the following three areas: oncology,
hematology and pain management. Although strong demand exists in these therapeutic areas,development remains challenging due to the need for a high degree of specialization. “Underserved
therapeutic areas” in oncology, hematology and pain management remain untapped, where large
pharmaceutical companies are cautious in development due to a concern over operational efficiency
and resulting low profitability.
The Company sees business opportunities in these “underserved therapeutic areas” despite therelatively small market potential, introducing new drug candidates to fulfil high unmet medical needs
instead of pursuing new “blockbuster” drugs (where sales often surpass 100 billion yen). Capturing
revenue opportunities through the development and sale of drugs in these therapeutic areas is at thecore of business development in the Company.
One significant aspect of the Company’s business model is to in-license drug candidates with clinicallyconfirmed efficacy and safety from pharmaceutical companies in the U.S. and Europe after strict
evaluation, while not having its own in-house research and manufacturing function. This enables theCompany to avoid a large capital investment for research and manufacturing facilities as it aims to
conduct effective business operations with low fixed costs. Also, by focusing on later stage drugcandidates that have been tested for efficacy and safety in mainly clinical trials, the development
period is shortened, thus lowering the overall development cost and risk.
The Company is building a strong pipeline portfolio and aiming for a steady return to profitability
through the continuation of these efforts.
SymBio’s Mid-Range Plan is as follows:To maximize the value of our main product, TREAKISYM®, which has already achieved a highmarket share as a treatment for relapsed/refractory low-grade non-Hodgkin’s lymphoma andmantle cell lymphoma, and solidify the Company’s earning’s base by also promoting its
penetration as first-line treatment of these diseases as it has obtained the approval of such
additional indications in December 2016, and establish its position as the initial drug of choice
as soon as practicable.



To proceed with clinical trials to obtain approval for rigosertib sodium (intravenous
formulation/oral formulation), which is a therapy for myelodysplastic syndromes (MDS), a
hematological malignancy, and for SyB P-1501, a drug for patient-controlled, short-term
management of acute post-operative pain during hospitalization, as new drug candidates
after TREAKISYM®, thereby enhancing the Company’s growth potential and expanding
revenue opportunities.



To consider establishing the Company’s own salesforce, giving particular attention to thetiming of marketing approval for SyB P-1501, a patient-controlled pain management drug,
and rigosertib (intravenous), as well as to the timing of introducing new drug candidates fordevelopment.

4To expand our pipeline portfolio, in order to ensure long-term growth opportunities. The
Company will proactively search for and evaluate new drug candidates for development, andconsider obtaining global licenses as well as taking a stake in companies possessing new drugcandidates for development.

With these initiatives, the Company aims for further growth, in order to transform from a
specialty pharma in Asia with a focus on Japan, to a truly global specialty pharma withenhanced economic and social value.

(3) Business Status, Outlook and Other Assumptions○ SyB L-0501 (generic name: bendamustine hydrochloride; trade name: TREAKISYM®)


Domestic sales of TREAKISYM® began through Eisai Co., Ltd., (“Eisai”) our business partner,with the drug’s launch in December 2010, for relapsed/refractory low-grade non-Hodgkin’s
lymphoma and mantle cell lymphoma. Sales have been increasing steadily and the market
share among patients with relapsed/refractory low-grade non-Hodgkin’s lymphoma andmantle cell lymphoma has reached a high point.



TREAKISYM® received approval for the additional indications of chronic lymphocytic
leukemia in August 2016, and of first-line treatment of low-grade non-Hodgkin’s lymphoma
and mantle cell lymphoma in December 2016.

Going forward, in order to further increase sales of TREAKISYM®, the Company will makeefforts to maximize the product value of TREAKISYM® by further reinforcing marketingcollaboration with Eisai to achieve maximized market penetration and encourage its full andproper use, especially as first-line treatment of low-grade non-Hodgkin’s lymphoma andmantle cell lymphoma, to establish its position as the initial drug of choice.

Regarding relapsed/refractory intermediate/high-grade non-Hodgkin’s lymphoma, the PhaseII study has been completed, and the Company will continue to consider pursuing additional
indications.

○ SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation); generic name: rigosertib
sodiumWith regard to rigosertib (intravenous), the Company completed the first patient enrollment inJapan in July 2016 for the global Phase III study (INSPIRE trial) for higher-risk
myelodysplastic syndromes (HR-MDS) patients who do not respond to treatment withhypomethylating agents (HMAs) or who relapse after the treatment under the current
standard of care (“Primary HMA Failure”). The Company will continue to conduct the trial
steadily aiming to file a new drug application for manufacturing and marketing approval in
2018.



With regard to rigosertib (oral), the Company will continue to advance the Phase I study inJapan using the oral formulation of rigosertib sodium in combination with azacitidine for
HR-MDS patients, and consider participating in the global Phase III study in 2019 incollaboration with its U.S.-based business partner, Onconova Therapeutics, Inc.
(Pennsylvania) (“Onconova”).

Additionally, the Company will discuss the development plan for the indication oftransfusion-dependent lower-risk MDS, taking Onconova’s development status into account.

5○ SyB P-1501 for a patient-controlled pain management drug
Regarding SyB P-1501, the Company completed the first patient enrollment in November 2016
for the Phase III study, for the indication of short-term acute post-operative pain management
during hospitalization. The Company will continue to make steady progress in the trial,aiming to file a new drug application for manufacturing and marketing approval in 2018.

○ Establishment of the Company’s own salesforce

While marketing TREAKISYM® in Japan through its business partner, Eisai, the Company
regards it as one of the important management issues to shift to the Company’s own salesforce
to raise profitability. The Company considers it beneficial to establish its own salesforce sothat the Company can respond to market needs more quickly and accurately to contribute to
the advancement of medicine as well as to clients and patients. This will also lead tomaximizing product value by providing more specialized information, and realizing a specialty
pharma with enhanced economic and social value.

However, the Company regards it essential to carefully consider the timing of theestablishment of the salesforce and its optimally effective and suitable system, since it could
require additional costs to establish the salesforce and to maintain continuous employment ofMedical Representatives and other required new staff. Consequently, the Company intends toclosely monitor the progress of the development of SyB P-1501, a patient-controlled pain
management drug, and SyB L-1101 (rigosertib intravenous formulation) and the timing of
their manufacturing and marketing approval, as well as the timing of introducing new drugcandidates for development, and thereby make a prudent decision regarding theestablishment of its salesforce in a timely manner.

○ New drug candidates and global business expansion


The Company continues to evaluate several new drug candidates for development. Upon
discovery of candidates that will eventually contribute to the improvement of corporate value,
the Company will enter into negotiations for in-licensing at the appropriate time.

When researching, evaluating and negotiating new drug candidates for development, theCompany will focus on obtaining exclusive rights to commercialize the new drug candidates on
a global basis, and thus aims to become a global specialty pharma, transforming from a
specialty pharma focused on the Asian region.

6II. Earnings Forecast and Performance Targets
Unit: millions of yen

Fiscal YearNet Sales

Operating

Ordinary Income

Net Income

Income (loss)(loss)(loss)FY 2016 (actual)

2,368(2,127)(2,317)(2,313)

FY 2017 (forecast)

2,903(3,239)(3,303)(3,307)3,926(2,309)(2,373)(2,377)～3,401～(2,509)～(2,573)～(2,577)

4,605(1,872)(1,936)(1,940)～3,586～(2,261)～(2,325)～(2,329)

FY 2018 (target)
FY 2019 (target)

Assumptions and Numerical Bases for Projections and Performance Targets○ Net sales are mainly comprised of product sales for TREAKISYM®. The performance targets for
drug sales are derived after detailed analysis and discussions on market size projections,competitive positioning and advantages vis-à-vis existing therapies, and sales performance after
commencement of sales. Furthermore, while the Company is currently in the midst of the Phase III
study for SyB P-1501, a patient-controlled pain management drug, aiming to file a new drug
application for manufacturing and marketing approval in 2018, it will need to monitor the progressof its clinical development going forward. Hence, estimated sales from SyB P-1501 are not included
if approval is obtained and the drug launched during the period of this Mid-Range Plan.
○ Cost of sales is estimated based on the provisions of the licensing and distribution agreements
relating to TREAKISYM®.
○ Selling and general administrative expenses mainly consist of research and development (selling
expenses or other selling expenses and general administrative expenses.


Research and development expenses are estimated based on “III. Other Reference Information– Status of the Development Portfolio and Performance Targets”. With regard to SyB P-1501, apatient-controlled pain management drug, and SyB L-1101 (rigosertib intravenous
formulation), milestone payments to the licensors triggered at the time approval is obtained
are not accounted for, as the Company will need to monitor the progress of the Phase III
studies going forward. Additionally, with regard to new drug candidates for development,
in-licensing and development costs are not accounted for, although the Company is proceedingwith continuous evaluation and negotiation for the candidates.



Other selling and general administrative expenses mainly consist of expenses incurred from
TREAKISYM® marketing, production & distribution, business development andadministrative operations. With regard to TREAKISYM®, since the business alliance7agreement with Eisai provides that marketing expenses shall be divided equally between thetwo parties, half of the estimated expenses are assumed, as the case for R&D expenses.
○ With respect to the additional indication of relapsed/refractory intermediate/high-grade
non-Hodgkin’s lymphoma, no related sales or expenses are assumed.
○ In terms of personnel planning, there were 77 employees as of December 31, 2016, and theCompany plans to assign the minimum number of staff required to develop SyB P-1501, apatient-controlled pain management drug, SyB L-1101 (rigosertib intravenous formulation) and
SyB C-1101 (rigosertib oral formulation). When the Company establishes its own salesforce, acertain increase in the number of staff, especially Medical Representatives, is expected from 2019.
However, as stated in “I. Mid-Range Plan for the Next Three Years, (3) Business Status, Outlook
and Other Assumptions,” the plan requires careful consideration going forward, and hence thepersonnel expenses relating to the establishment of the Company’s own salesforce have not beenaccounted for.
○ During the period of this Mid-Range Plan, the market share of TREAKISYM® for first-line
treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, for which approval
for this additional indication was obtained in December 2016, will have a considerable effect on the
Company’s performance. Consequently, sales assumptions were made for the market share in 2019
based on two scenarios (80% and 50%), and presented as the maximum and minimum target
figures, respectively.
○ With regard to the Company’s financial plan, the Company makes it a basic policy to maintain 18
months’ worth of business funds in order to ensure business continuity. Funding is required fordevelopment of in-licensed drugs; and investments for new in-licensing and M&As to ensure
long-term growth opportunities and other funding requirements for the establishment of theCompany’s own salesforce, are anticipated. The Company will consider various means of flexible
fund procurement, including raising funds from the financial and capital markets, as well as
business partnerships, in line with future business development needs.
○ The total number of the Company’s authorized shares was increased from 56,000,000 shares to167,000,000 shares, following the approval of partial amendment to the Articles of Incorporation at
the Extraordinary Shareholders’ Meeting held on November 11, 2016.

8

III. Other Reference Information
Status of the Development Portfolio and Performance Targets
Development
Product/
Therapeutic

Indication(s)Phase I

Phase II

Phase III

Filing of a
New Drug
Application
for Approval

Approval

Categories

TREAKISYM®
Anticancer Drug

Relapsed/refractory
low-grade B-cell
non-Hodgkin's
lymphoma andmantle cell
lymphomaFirst-line treatmentof low-grade B-cell
non-Hodgkin’s
lymphoma andmantle cell
lymphoma

Approved in October, 2010

Approved in December, 2016

Chronic lymphocytic
leukemia

Approved in August, 2016

Relapsed/refractoryintermediate/high-grade B-cell
non-Hodgkin's
lymphomarigosertib(intravenous)
Anticancer
Drugrigosertib (oral)
Anticancer Drug

SyB P-1501
Patient-controlled
pain management
drug

Phase II completed

Relapsed/refractory
higher-risk MDS(myelodysplastic
syndromes)
Higher-risk MDS in
combination withazacitidine
Transfusiondependent lower-risk
MDS

To be determined based on Onconova’s
development status

Short-term
management of acutepost-operative pain
duringhospitalization

Note
The

Shows the development plan
Completed as of December 31, 2016 (FY 2016)
FY 2017 target
FY 2018 target
FY 2019 target

9The portfolio summary and issues regarding accomplishment of plans are set out below○ SyB L-0501 (generic name: bendamustine hydrochloride; trade name: TREAKISYM®)
Summary:

SyB L-0501 is a cytotoxic, anticancer agent. It has been in use in Germany since the 1970s forthe treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma and chronic
lymphocytic leukemia, and is now approved and sold in 88 countries around the world.

In December 2005, the Company obtained the exclusive rights for development and marketingfrom its licensor, Astellas Deutschland GmbH, a German subsidiary of Astellas Pharma Inc.,
to develop and sell the drug in Japan, China (incl. Hong Kong), South Korea, Taiwan andSingapore, and has obtained approval in all licensed territories with the exception of China.

The history of approvals and sales of SyB L-0501 in Japan is as follows. Since its launch inJapan, TREAKISYM® has been administered to approximately 18,000 patients (estimated by
the Company) as of the end of FY 2016:

October 2010:

Obtained approval for manufacturing and marketing of
TREAKISYM® for the indications of relapsed/refractory low-grade
B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.



December 2010:

Initiated sales through Eisai, a business partner.

August 2016:

Obtained approval for the additional indication of chronic
lymphocytic leukemia.



September 2016:

Obtained approval for marketing of TREAKISYM® intravenous
infusion 25mg.



December 2016:

Obtained approval for the additional indications of first-line
treatment of low-grade B-cell non-Hodgkin’s lymphoma and mantle cell
lymphoma.

January 2017:

Initiated sales of TREAKISYM® intravenous infusion 25mg.

Issues and Specific Measures:

The Company will promote the full and proper use of TREAKISYM® as a new treatment option
in order to meet underserved medical needs. It will also take the initiative in maximizing sales
and further expand its indications in an effort to optimize its product value.

Maximizing Sales
In Japan, our most significant market, sales of TREAKISYM® are generated through Eisai,
our business partner. In order to promote further market penetration, the efficacy and safetyof the drug as supported by positive data in clinical trials need to be more widely understood sothat it is prescribed more often. To that end, the Company considers it essential to work closelywith Eisai and plan strategies vis-à-vis competing therapies, and tactically execute strategic
marketing activities such as academic conferences and study groups. Going forward, theCompany will encourage full and proper use of TREAKISYM® and promote its market
penetration particularly for first-line treatment of low-grade non-Hodgkin’s lymphoma andmantle cell lymphoma, by ever-strengthening its collaboration with Eisai to further increase10

sales. This will lead to establishing its position as the initial drug of choice and maximizing the
product value of TREAKISYM®.


Promotion of Indication Expansion
Regarding the additional indication of relapsed/refractory intermediate/high-grade
non-Hodgkin’s lymphoma, the Phase II study has shown positive results and the Company willcontinue to make best efforts towards obtaining approval. Sales and expenses related to thisindication are not reflected in this Mid-Range Plan.

○ SyB L-1101 (intravenous formulation) / SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)Summary:rigosertib sodium is an anticancer drug which functions as a unique multi-kinase inhibitor(which has the effect of eradicating cancer cells by inhibiting multi-kinase involved in thegrowth, proliferation, and metastasis of the cells). Since obtaining exclusive rights to develop
and commercialize the drug (both intravenous formulation and oral formulation) in Japan andSouth Korea from Onconova in July 2011, the Company has been actively conducting clinicaldevelopment of this drug.

With regard to rigosertib (intravenous), the Company is in charge of the clinical development
in Japan, as part of the global Phase III study (INSPIRE trial) conducted by Onconova, thelicensor, and started the domestic trial in December 2015. This global Phase III study isconducted with clinical trial sites in more than ten countries worldwide, for HR-MDS patients
who do not respond to treatment with HMAs or who relapse after treatment under the current
standard of care (“Primary HMA Failure”). The Company completed the first patient
enrollment in July 2016 and is currently working on procedures to enroll more patients withthe disease.

With regard to rigosertib (oral), Onconova is currently in the process of determining the plans
for the global Phase III study for HR-MDS patients using the oral formulation of rigosertib in
combination with azacitidine. Meanwhile, the Company started its domestic Phase I study forthe target indication of HR-MDS in December 2015. However, provision of the investigational
drug for Onconova’s clinical trial has been delayed, and thus the patient enrollment has beensuspended at present.



The Phase I study in Japan for rigosertib (oral) for the indication of transfusion-dependent
lower-risk MDS has already been completed.

Issues and Specific Measures:

The Company will enhance its growth potential and aim to expand future revenue
opportunities by proceeding with clinical trials to obtain marketing approval for rigosertib(intravenous / oral), as a new drug candidate following TREAKISYM®.



Accelerating Various Clinical Trials for Marketing Approvals
With regard to rigosertib (intravenous), the Company aims to complete the INSPIRE trial
promptly in order to file a new drug application for manufacturing and marketing approval in
2018. As for rigosertib (oral), the Company will resume patient enrollments in the Phase I

11study in Japan, once the matter of drug provision is resumed. After completion of the trial, itplans to participate in the global Phase III study in 2019. Regarding the future clinicaldevelopment plans for the indication of transfusion-dependent lower-risk MDS through theoral formulation, the Company will discuss its plan, taking Onconova’s development status
into account.
○ SyB P-1501 (a patient-controlled pain management drug)
Summary:

SyB P-1501 is a drug for patient-controlled, short-term management of acute post-operative
pain during hospitalization. The Company acquired the exclusive development anddistribution rights for SyB P-1501 in Japan from U.S.-based The Medicines Company (New
Jersey) in October 2015.



SyB P-1501 is a highly convenient, patient-controlled iontophoretic transdermal systemproviding on-demand systemic delivery of analgesia (patient-controlled analgesia, “PCA”). A
patient recovering from surgery in the hospital simply presses the button on the credit
card-sized device attached to the upper arm or chest, and a certain amount of ionized drug isdelivered transdermally to achieve an analgesic effect.

For medical institutions also, SyB P-1501 is a very advantageous and innovative product for
PCA that can be maintained and managed very easily, thus substantially reducing costs andthe labor of healthcare professionals when compared to the current PCA method using anelectrical pump.



SyB P-1501 was approved in the U.S. and Europe (April 2015 and November 2015
respectively) and sales have commenced. In Japan, the Phase I study targeting healthy
volunteers has been completed and the Phase III study for the indication of short-term acutepost-operative pain management during hospitalization started in June 2016, with theCompany completing the first patient enrollment in November 2016.

For the actual sales of SyB P-1501 after approval is obtained, first the Company will mainly
target the replacement market for the IV-PCA (intravenous patient-controlled analgesia)
method, and then penetrate the patient-controlled epidural analgesia market and also theoverall market for post-operative pain management where PCA is not used, in an effort toexpand revenue opportunities in the medium- to long-term.

Issues and Specific Measures:

The Company will enhance its growth potential and aim to expand future revenue
opportunities by proceeding with clinical tests to obtain marketing approval for SyB P-1501,
as a new drug candidate following TREAKISYM®, as well as rigosertib (intravenous
formulation / oral formulation).



Early Application for Marketing Approvals
For SyB P-1501 the Company plans to submit an application for manufacturing andmarketing approval upon completion of the Phase III study in Japan since the Phase I study
has been completed and the Company can utilize the data from clinical trials carried out inthe U.S. and Europe to expeditiously obtain its approval. The Company intends to promptly

12complete the Phase III study in Japan, which is underway, and submit an application for
approval in 2018.

This disclosure document is for the purpose of providing information on the Company’s future business strategies toinvestors, and is not for the purpose of soliciting investment.
Evaluation of the Company’s business strategies and investment decisions shall be made by investors themselves basedon their own judgment.
The Company does not guarantee, in any sense, the possibility of realizing and achieving any performance target orother matter of our business strategies and does not assume any liability for any such information.
All forward-looking statements (including, but not limited to, the performance targets in our business plan) containedin this document have been prepared by the Company at its discretion based on the information available as of the dateof this document. Therefore, in the event there are future changes to conditions that comprise the assumptions of its
business strategy, such as economic conditions, there may be an impact on its actual business condition andperformance such that the results will be different from statements in this disclosure document.

13