February 7, 2018
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582, JASDAQ Growth)

SymBio’s Mid-Range Plan: FY 2018 to FY 2021 (Four Years)

I. Mid-Range Plan for the Next Four Years(1) Overview of FY 2017 Business Results as of the Date of the Mid-Range Plan
Progress in the Company’s business for FY 2017 (from January 1, 2017 to December 31, 2017) is asfollows:
1. Domestic[Anticancer agent: SyB L-0501 (lyophilized powder formulation), SyB L-1701 (ready-to-dilute (“RTD”)
formulation), SyB L-1702 (rapid infusion (“RI”) formulation) and SyB C-0501 (oral formulation)(generic name: bendamustine hydrochloride, trade name: TREAKISYM®)]
The Company markets TREAKISYM® in Japan through its business partner, Eisai Co., Ltd. (“Eisai”).
The Company obtained marketing approval for first-line treatment of low-grade non-Hodgkin’s
lymphoma and mantle cell lymphoma in December 2016, and for chronic lymphocytic leukemia in
August 2016. These are in addition to the approvals for the indications of recurrent/refractory lowgrade non-Hodgkin’s lymphoma and mantle cell lymphoma which were obtained in October 2010.
This indication expansion has resulted in a significant in-market sales increase of 60.9% year-on-year(NHI price basis). Net sales to Eisai also grew considerably, by 62.7% year-on-year.
In addition to the three already approved indications, the Company continues to work on obtaining
approval for recurrent/refractory intermediate/high-grade non-Hodgkin’s lymphoma (diffuse large Bcell lymphoma) to benefit patients in need of new therapies and to further maximize product value.
For these indications, the Company has completed a Phase II clinical trial and in August 2017 begana Phase III clinical trial (designed in accordance with consultations with the Pharmaceuticals andMedical Devices Agency (“PMDA”)) and completed the first patient enrollment in January 2018.
In addition to the ongoing label expansion initiatives, the Company concluded an exclusive license
agreement with Eagle Pharmaceuticals, Inc. (head office: New Jersey, U.S.) (“Eagle”) in September
2017, under which Eagle licensed to the Company rights under Eagle’s intellectual property todevelop, market, and sell Eagle’s RTD and RI liquid formulations (“TREAKISYM® liquid
formulation”) (Note 1) in Japan. This will further enable the Company to extend the product life until

12031 through patent protection and maximize the value of TREAKISYM®, while bringing significant
benefits to patients and medical professionals. (See press release dated September 21, 2017 titled“Eagle Pharmaceuticals Licenses Japanese Rights for Bendamustine Hydrochloride Ready-to-diluteand Rapid Infusion Injection Products to SymBio Pharmaceuticals Limited.”)In addition to the development and expansion of the intravenous formulation product, the Company
is exploring the development of an oral formulation of TREAKISYM® with a focus on the treatment ofsolid tumors and autoimmune diseases and intends to further expand the business, with an aim tosolidify its business through a platform of TREAKISYM® products. Amid such initiatives, theCompany commenced a Phase I clinical trial for progressive solid tumors in January 2018, with theaim of examining the recommended dosage and schedule as well as tolerability and safety of the oral
formulation of TREAKISYM®, and narrowing down the types of potential target tumors.
(Note 1) RTD and RI are pre-dissolved liquid formulations that differ from currently available freeze-dried (“FD”)
powder injection. RTD (ready-to-dilute) will significantly reduce the preparation time and labor cost for healthcare
providers, and RI (rapid infusion) will reduce infusion duration to 10 minutes from the current 60 minutes, providing
significant benefit and value to both patients and healthcare providers.

[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), genericname: rigosertib]
U.S. Licensor Onconova Therapeutics, Inc. (head office: Pennsylvania, U.S.) (“Onconova”) is
conducting a global Phase III clinical trial (with trial sites in more than 20 countries) of theintravenous formulation of rigosertib sodium for higher-risk myelodysplastic syndromes (HR-MDS)
which do not respond to the current standard treatment with hypomethylating agents (“primary HMA
failure”) or which relapse after treatment under the current standard of care. The Company is
responsible for clinical development in Japan and in December 2015 started a domestic trial for which
30 patients are already enrolled. The Company completed the first patient enrollment in Japan in
July 2016 and patient enrollment is proceeding favorably. Based on the results of the interim analysis
completed in January 2018, the Company will continue the trial with an increase in patient
enrollment in accordance with pre-determined statistical criteria.
Regarding the oral formulation of rigosertib, the domestic Phase I clinical trial for combination
therapy with azacitidine (Note 2) for the target indication of HR-MDS began in December 2015.
Although delays with the investigational drug by Onconova had delayed patient enrollment,
Onconova has recently resumed provision of the investigational drug and the Company commenced a
new domestic Phase I clinical trial in June 2017 to confirm the safety of high-dose oral rigosertib,
which was added to the Phase II clinical trial being conducted by Onconova in the U.S. for first-line
treatment and recurrent/refractory treatment of patients with HR-MDS. First patient enrollment wascompleted in October 2017. After safety is confirmed through this trial, the Company plans to conduct
a domestic clinical trial for combination therapy with azacitidine, and to take part in Onconova’splanned global Phase III clinical trial for combination therapy with azacitidine for the first-line
treatment of patients with HR-MDS.

2

(Note 2) About azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.): This drug (for injection) wasapproved in 2011 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. MDS is a preleukemic state, and decrease in tumor suppressor gene due toexcessive methylation of DNA is thought to be related to the disease. Hypomethylating agents such as azacitidine arethought to suppress progress to leukemia by restoring tumor suppressor gene with a deterrent effect against
methylation of DNA.

[Patient-controlled iontophoretic transdermal system for the short-term management of acute postoperative pain: SyB P-1501]
In October 2015, the Company entered into an agreement with Incline Therapeutics, Inc., a whollyowned subsidiary of US-based The Medicines Company (Head Office: New Jersey, U.S.) for an
exclusive license to develop and commercialize SyB P-1501 in Japan. The Company commenced adomestic Phase III clinical trial for SyB P-1501 in June 2016 and completed the first patient
enrollment in November 2016, with enrollments accumulating. The Company, acting in the bestinterest of patients, determined on April 21, 2017 to temporarily suspend new patient enrollment due
to its recently arising concern as to the continuity of The Medicines Company’s business regarding the
product. The license agreement with Incline Therapeutics, Inc. terminated effective November 30,
2017.
The Company initiated an arbitration against The Medicines Company on October 11, 2017, under
the rules of the International Chamber of Commerce, seeking damages of 82 million U.S. dollar(approximately 9.0 billion yen) arising from The Medicines Company’s repudiation of the license
agreement. (See press releases “Initiation of an Arbitration against The Medicines Company,” dated
November 13, 2017, and “Termination of License Agreement between SymBio Pharmaceuticals
Limited and The Medicines Company,” dated November 30, 2017.)
In conjunction with the termination of the license agreement, the Company will terminate thedevelopment of SyB P-1501, a process that the Company expects to complete by March 31, 2018.
[New drug candidates]
The Company continues to actively seek new drug candidates and in-licensing opportunities globally,
aiming to expand both profitability and growth potential over the medium-to-long-term, anddiscussions with multiple potential licensors are ongoing.
In May 2016, the Company established a wholly-owned subsidiary, SymBio Pharma USA, Inc. (Menlo
Park, California, U.S., “SymBio Pharma USA”), as the Company’s planned strategic base for overseas
business development. Acquiring rights to new drug candidates through SymBio Pharma USA as thebase of global business will be part of the Company’s continued transformation into a global specialty
biopharmaceutical company with capability to develop and commercialize new drugs in the U.S.,
Japan, Europe, and other major global markets.

32. Markets outside Japan
SyB L-0501 is also marketed in South Korea, Taiwan, and Singapore, and product sales of SyB L0501 in these countries progressed favorably at a pace exceeding the Company’s forecasts.
3. Business results
As a result of the above, net sales totaled 3,444,206 thousand yen for the fiscal year ended December
31, 2017, primarily reflecting product sales of TREAKISYM® in Japan. Product sales showed a yearon-year increase of 61.1%. Accordingly, overall net sales rose 45.4% year-on-year.
Selling, general and administrative expenses totaled 4,978,327 thousand yen (a year-on-year increaseof 64.2%), including research and development (“R&D”) expenses of 3,017,812 thousand yen (a yearon-year increase of 81.0%) primarily due to the upfront payment relating to the license agreementwith Eagle Pharmaceuticals for TREAKISYM® liquid formulation (RTD and RI formulations) and
expenses associated with the clinical trial for TREAKISYM®, the intravenous and oral formulations ofrigosertib as well as SyB P-1501, and other selling, general and administrative expenses of 1,960,514
thousand yen (a year-on-year increase of 43.7%).
As a result, an operating loss of 3,947,061 thousand yen was recognized for the fiscal year ended
December 31, 2017 (an operating loss of 2,127,049 thousand yen for the previous fiscal year). In
addition, the Company recorded non-operating expenses totaling 34,229 thousand yen primarily
comprising stock issuance costs of 14,477 thousand yen, foreign exchange losses of 10,421 thousand
yen, and commission fees of 9,090 thousand yen, and non-operating income totaling 4,506 thousand
yen primarily due to interest income of 3,092 thousand yen and dividend income of 1,339 thousand
yen. This resulted in an ordinary loss of 3,976,784 thousand yen (an ordinary loss of 2,316,806
thousand yen for the previous fiscal year) and net loss of 3,977,862 thousand yen (a net loss of
2,313,233 thousand yen for the previous fiscal year).

4(2) SymBio’s Mid-Range Plan – Summary and Background
SymBio is the first Japanese “specialty pharma” specializing in the areas of oncology, hematology, andpain 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 inoncology, hematology and pain management remain untapped as large pharmaceutical companies
avoid development due to concerns about operational efficiency and 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 (drugs with sales surpassing 100 billion yen). Capturing
revenue opportunities through the development and sale of drugs in these therapeutic areas is at thecore of the Company’s business.
One significant aspect of the Company’s business model is to in-license drug candidates with clinicallyconfirmed efficacy and safety from pharmaceutical and bio venture companies in the U.S. and Europe
after rigorous evaluation. This enables the Company to avoid having its own in-house research andmanufacturing function and the associated large capital investments as it aims to conduct effective
business operations with low fixed costs. Also, by focusing on later stage drug candidates that havebeen tested for efficacy and safety (mainly through clinical trials), the development period isshortened, thus lowering the overall development cost and risk.
The Company is building a strong pipeline portfolio and aiming to achieve profitability through thecontinuation of these efforts.
SymBio’s Mid-Range Plan (FY 2018 to FY 2021) sets out to achieve profitability in FY 2021 as the
top-priority management goal. Under this plan, which covers a four year period, the Company has
formulated sales structure plans, including development of the Company’s own salesforce, and apipeline development plan. An outline of the plan is as follows.
Maximize the commercial value of TREAKISYM® and to ensure sustainable profitability andgrowth potential, through:

Increasing sales from already approved indications: increasing market share by further
promoting penetration of first-line treatment of low-grade non-Hodgkin’s lymphoma.

Expansion through additional indications: complete the Phase III study for theindication of relapsed/refractory diffuse large B-cell lymphoma as planned, with the aimof filing a new drug application by the first half of 2020.



Product lifecycle management: launch RTD formulation in the first half of 2021 (and the
RI formulation at a subsequent date), and proceed to switch from the current lyophilized
powder formulation to a liquid formulation as soon as practicable.



Development of oral TREAKISYM®: advance the Phase I study of an oral formulation forprogressive solid tumors and engage in commercialization of an oral formulation toprovide a new treatment option in the future.

Proceed with clinical trials to obtain approval for intravenous and oral formulations ofrigosertib, as new drug candidates following TREAKISYM®, thereby enhancing the5Company’s growth potential and expanding revenue opportunities.
Establish the Company’s own salesforce to maximize profit, giving appropriate consideration
to the expiration of the business partnership agreement with Eisai in December 2020 and thetiming of marketing approval for rigosertib intravenous formulation.



Search for and evaluate new drug candidates for development and continue to explore inlicensing opportunities, giving due consideration to the impact on achieving profitability in
FY 2021.

(3) Business Status, Outlook and Other Assumptions○

SyB L-0501 (lyophilized powder formulation), SyB L-1701 (RTD formulation), SyB L-1702 (RI
formulation) and SyB C-0501 (oral formulation) (generic name: bendamustine hydrochloride;
trade name: TREAKISYM®)


Domestic sales of TREAKISYM® began with the drug’s launch in December 2010 for
relapsed/refractory low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma.
TREAKISYM® is marketed through our marketing partner, Eisai Co., Ltd., (“Eisai”). Sales
have increased steadily and the market share among patients with relapsed/refractory lowgrade non-Hodgkin’s lymphoma and mantle cell lymphoma reached a new high point in 2017.



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. As a result of steady progress in market
penetration including for first-line treatment of low-grade non-Hodgkin’s lymphoma, net sales
for FY 2017 totaled 7.6 billion yen, an increase of 60.9% year-on-year (NHI price basis).



Going forward, in order to further increase sales of TREAKISYM®, the Company incollaboration with Eisai will reinforce marketing to promote and encourage the full andproper use of TREAKISYM®, especially as first-line treatment for low-grade non-Hodgkin’s
lymphoma, establishing TREAKISYM® as the initial drug of choice in 2018, with the aim ofachieving a 60% market share.

Regarding the additional indication of relapsed/refractory diffuse large B-cell lymphoma(DLBCL), after completing the Phase II study for bendamustine-rituximab (BR) therapy andachieving promising clinical trial results, the Company commenced a Phase III study inAugust 2017 with a view toward confirming the efficacy and safety of the Phase II study. The
Company will complete this trial as planned, aiming to file a new drug application in the firsthalf of 2020.

The Company concluded an exclusive license agreement with Eagle Pharmaceuticals, Inc.
(“Eagle”) on September 20, 2017, under which Eagle licensed to the Company rights underEagle’s intellectual property to develop, market and sell Eagle’s liquid formulation injection
products in Japan (to be marketed as TREAKISYM® RTD and TREAKISYM® RI). Taking
countermeasures against the probable launch of generics in Japan was a key consideration as
the marketing exclusivity period for the current FD formulation in Japan will expire in late
2020. Patent protected through 2031, the RTD and RI liquid formulations will significantly
extend the product life of TREAKISYM®. The Company will aim to obtain approval for RTD
in the first half of 2021 (and for RI at a subsequent date). The Company will aim to achieve a6complete transition from the current lyophilized powder formulation to the liquid formulation
as soon as possible after the launch of RTD.
○ SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name:rigosertib sodium)

Rigosertib intravenous: the interim analysis for the global Phase III study (INSPIRE trial) for
higher-risk myelodysplastic syndromes (HR-MDS) patients who do not respond to treatment
with hypomethylating agents (HMAs) or who relapse after the treatment under the current
standard of care (“Primary HMA Failure”) was completed in January 2018. The independent
Data Monitoring Committee (DMC) (Note 3) recommended that the INSPIRE trial continue withenrollment increased from then current 225 patients to 360 patients. Onconova announced it
would follow the DMC’s recommendation. The enrollment criteria for the expanded study willbe identical to that of the original study. Patients with HR-MDS who are refractory to HMAs
have limited treatment options and there is extremely high unmet medical need with existing
therapies. Based on the DMC’s recommendation, the Company will continue in collaboration
with Onconova to move forward with the trial with an increase in the total enrollment ofpatients in Japan up to 40 patients. The Company aims to file a new drug application for
manufacturing and marketing approval for indications of relapsed/refractory HR-MDS in
2021.

(Note 3)

Data Monitoring Committee (DMC): The DMC is a committee of clinical research experts with expertise to

conduct an independent review of the results of the interim analysis and to provide a recommendation to the sponsor
on the appropriateness of continuing the trial and on any needed changes to the trial.

Rigosertib oral formulation: the Company started the Phase I study as a single agent in HRMDS in June 2017, and completed the first patient enrollment in October 2017. The Company
will promptly conduct an oral rigosertib/azacitidine combination trial in Japan after
demonstrating the safety of oral rigosertib, and intends to participate in the global Phase III
study in untreated HR-MDS patients that Onconova is now planning.

Additionally, regarding the indication of transfusion-dependent lower-risk MDS, the Company
will continue to consider its clinical development plans in view of the status of thedevelopment by Onconova.

○ SyB P-1501 patient-controlled pain management drugIn conjunction with the termination (effective November 30, 2017) of the license agreement
entered into between the Company and The Medicines Company (Head Office: New Jersey,U.S.) on October 5, 2015 for the exclusive rights to develop and commercialize the patientcontrolled pain management drug SyB P-1501 in Japan, the Company has terminated thedevelopment of SyB P-1501 and will complete the process of terminating development by
March 31, 2018.

7

○ Establishment of the Company’s own salesforce

Although TREAKISYM® is currently marketed in Japan through Eisai, the Company
considers shifting sales to the Company’s own salesforce to raise profitability to be a toppriority. The Company considers it beneficial to establish its own salesforce so that theCompany can respond to market needs more quickly and accurately to further benefit both
healthcare professionals and patients. This will also lead to further enhancement of productvalue and the ability to provide more specialized information to healthcare professionals,
furthering the Company’s contribution to society.



Under this Mid-Range Plan, the Company expects to engage in the sale of TREAKISYM® on
its own from 2021 following the expiration of the business partnership agreement with Eisai
in December 2020, aiming to achieve profitability in FY 2021 as the top-priority ofmanagement. However, the Company regards it essential to carefully consider the timing of
the establishment of the salesforce and its optimal structure, since it could require additionalcosts to establish the salesforce and to maintain continuous employment of medical
representatives and other required new staff. Consequently, the Company intends to closely
monitor the progress of the development of SyB L-1101 (rigosertib intravenous formulation)and the timing of their manufacturing and marketing approval, as well as the timing of
introducing new drug candidates for development, and thereby make a prudent decision
regarding the establishment of its salesforce in 2018 in a timely manner.

○ New drug candidates and global business expansion


The Company is continually evaluating new drug candidates for development. The Company
will continue to consider in-licensing drug candidates that will increase corporate value,
giving appropriate consideration to the impact on profits for FY 2021. When searching for,evaluating, and negotiating new drug candidates for in-licensing and development, theCompany may do so with a view to commercializing on a global basis.

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

FY 2018(forecast)

FY 2019(target)FY 2020(target)FY 2021(target)Net Sales

4,201

4,238

4,413

11,624 ~ 10,325

Operating Income(loss)(2,981)(3,786)(3,709)1,777 ~ 878

Ordinary Income(loss)(3,044)(3,849)(3,772)

1,724 ~ 825

Net Income(loss)(3,056)(3,853)(3,776)

1,467 ~ 702[Trends of Net Sales and Net Income]Net Sales

Millions of Yen

Net Income

15,00010,0005,000

0-5,000

2018

2019

2020

* The median values of the maximum and minimum values are used for 2021.

9

2021

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. As for 2021, the sales amounts are accounted for based on sales of
TREAKISYM® made through the Company’s own sales force.
Net sales of TREAKISYM® are expected to further expand from 2021 due to the additional
indication of relapsed/refractory diffuse large B-cell lymphoma (DLBCL), for which approval isplanned to be obtained in the first half of 2021. Net sales are calculated and target figures arepresented based on the expected market share range for this indication.
○ Cost of sales is estimated based on the provisions of the licensing and supply agreements with
Astellas Deutschland GmbH, a German subsidiary of Astellas Pharma Inc., and Eagle
Pharmaceuticals, Inc.
○ Selling and general administrative expenses mainly consist of research and development 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.” Newly planned
matters under this Mid-Range Plan are as follows.


Expenses related to a Phase III study for relapsed/refractory diffuse large B-cell
lymphoma (due to commence in August 2017).

Expenses related to the filing of a new drug application for approval and development of
TREAKISYM® liquid formulations (RTD and RI) (in-licensed from Eagle
Pharmaceuticals, Inc. in September 2017).

Expenses related to a Phase I study of oral TREAKISYM® for progressive solid tumors(due to commence in January 2018).

With regard to SyB L-1101 (rigosertib intravenous formulation), milestone payments to thelicensors triggered at the time approval is obtained have not been included in the forecasts,
given that the Company will continue to move forward with the trial with an increase in the
total enrollment of patients in Japan, based on the results of the interim analysis conductedin January 2018.



With regard to new drug candidates for development, in-licensing and development costs are
not accounted for, although the Company continues to evaluate candidates for potential inlicensing.



Other selling and general administrative expenses mainly consist of expenses incurred from
TREAKISYM® marketing, production & distribution, business development andadministrative operations. Expenses related to the establishment and operation of theCompany’s own salesforce are accounted for from 2019, due to expected sales of
TREAKISYM® by the Company itself from 2021 following the expiration of the business
partnership agreement with Eisai in December 2020.

10

○ In terms of personnel planning, there were 78 employees as of December 31, 2017, and theCompany plans to maintain the minimum number of staff required to develop TREAKISYM® (thecurrent lyophilized powder formulation, as well as RTD and RI formulations), oral TREAKISYM®,
rigosertib intravenous formulation and rigosertib oral formulation. A certain increase in staff,
especially medical representatives, will be required from 2019 when the Company establishes its
own salesforce. Personnel costs for the establishment of such salesforce have been accounted for in
the projections.
○ With regard to the Company’s financial plan, the Company makes it a basic policy to maintain 18
months’ worth of funding to ensure business continuity. Anticipated funding requirements include
funding for the development of in-licensed drugs, for investments for new in-licensing andpotential M&A to ensure long-term growth opportunities, and for the establishment of theCompany’s own salesforce. The Company will consider various means of flexible fundprocurement, including raising funds from the financial and capital markets, as well as business
partnerships, in line with future business development needs.

11III. Other Reference Information
Status of the Development Portfolio and Performance Targets
Development
product/
Therapeutic
categories

TREAKISYM®
FD

Anticancer Drug

Indications

Phase I

Phase 2Phase 3Filing of
NDA forapproval

Approval

Relapsed/refractory lowgrade B-cell non-Hodgkin's
lymphoma and mantle cell
lymphoma

Approved in October, 2010

First-line treatment of
low-grade B-cell nonHodgkin’s lymphoma andmantle cell lymphoma

Approved in December, 2016

Chronic lymphocytic
leukemia

Approved in August, 2016

Relapsed/refractory diffuse
large B-cell lymphoma

TREAKISYM®
RTD

All approved indications

TREAKISYM®
RI

All approved indications

TREAKISYM®
Oral

Progressive solid tumors

Anticancer Drug

Anticancer Drug

Anticancer Drug

Rigosertib
Intravenous

Anticancer Drug

Rigosertib
Oral

Anticancer Drug

Note

Details are under review

Relapsed/refractory
higher-risk MDS(myelodysplastic
syndromes)
Higher-risk MDS in
combination (monotherapy)

Plan to begin a Phase 1 study in combination with azacitidine after
completing this phase 1 study.

1st line higher-risk MDS
in combination withazacitidine

Plan to participate in the global Phase 3 study
that is being planned by Onconova after
completing this Phase 1 study.

The above table shows the development plan.
Completed as of December 31, 2017
FY 2018 target
FY 2019 target
FY 2020 target
FY 2021 target

12

The portfolio summary and issues regarding accomplishment of plans are set out below○ SyB L-0501 (lyophilized powder formulation), SyB L-1701 (RTD liquid formulation), SyB L-1702(RI liquid formulation) and SyB C-0501 (oral formulation) (generic name: bendamustinehydrochloride; 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 andmarketing from 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 and Singapore, 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 set forth below. Since its launchin Japan, TREAKISYM® has been administered to approximately 24,000 patientscumulatively (estimated by the Company) as of the end of FY 2017:October 2010:

Obtained approval for manufacturing and marketing of
TREAKISYM® for the indications of relapsed/refractory low-grade Bcell 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 maximize the product value of TREAKISYM® through the following
initiatives, in order to meet underserved medical needs. It will also take the initiative toensure both sustainable profitability and growth potential.



Increasing sales from already approved indications
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 understoodso that it is prescribed more often. To that end, the Company considers it essential to work
closely with Eisai and plan strategies vis-à-vis competing therapies, and tactically execute13

strategic marketing activities such as academic conferences and study groups. Going forward,
the Company 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, by
ever-strengthening its collaboration with Eisai to further increase sales. The Company will
establish its position as the initial drug of choice in 2018, with the aim of achieving a 60%
market share, and pursues further market penetration.


Expansion through additional indications
Diffuse large B-cell lymphoma (DLBCL) accounts for about one-third of malignant lymphoma,
with patient numbers following an upward trend. However, a standard chemotherapy fortreatment of relapsed/refractory DLBCL is currently not available. Instead, multiple drug
therapies are administered which tend to have strong adverse effects placing a burden on
patients. Accordingly, r/r DLBCL is a disease with high unmet medical need. The need fordevelopment of bendamustine-rituximab (BR) therapy has been expressed by both patientand academic associations.
SymBio’s earlier completed Phase 2 study for BR therapy showed very positive results for thetreatment of patients with r/r DLBCL. The NCCN Guidelines, which are the standard forclinical policy in oncology in the U.S. and have recommended BR therapy since 2012, cite theresults of this clinical study. Having started a Phase III study in August 2017 for theindication of relapsed/refractory DLBCL, the Company aims to file a new drug application in
the first half of 2020.



Product lifecycle management
The Company concluded an exclusive license agreement with Eagle Pharmaceuticals, Inc.
(Head Office: New Jersey, U.S.) (“Eagle”) on September 20, 2017, under which Eagle licensed
to the Company rights under Eagle’s intellectual property to develop, market and sell Eagle’s
bendamustine hydrochloride ready-to-dilute (“RTD”) and rapid infusion (“RI”) injection
products in Japan.
Switching from the existing lyophilized powder formulation to the ready-to-dilute (RTD)
liquid formulation will significantly reduce the preparation time. The rapid infusion (RI)
injection product will also shorten the infusion time from the current 60 minutes to 10
minutes, substantially reducing the burden on patients compared to the lyophilized powder
formulation and providing significant benefits to both patients and healthcare providers.
Taking countermeasures against the probable launch of generics in Japan was a key
consideration as the marketing exclusivity period for the current FD formulation in Japan
will expire in late 2020. The Company aims to obtain approval for the RTD formulation in thefirst half of 2021 (and the RI formulation at a subsequent date). These liquid formulations,patent protected through 2031, will significantly extend the product life of TREAKISYM®.
The Company will aim to achieve a complete transition from the current lyophilized powder
formulation to liquid formulation as soon as possible after the launch of RTD.
[About RTD and RI injection products]
The ready-to-dilute (RTD) injection product eliminates the cumbersome manual dissolution process,14

significantly reducing the workload of healthcare providers. In addition, the rapid infusion (RI) injection
product shortens the infusion time from 60 minutes to 10 minutes, substantially reducing the burden on
patients.
<Comparison with current formulation>
Dissolve
Current
Formulation

FD

Inject sterile
water

DiluteIV Infusion

Solution(freeze dried)...
Manually mix withoutcausing bubbles

New
Formulation

RTD

250ml Saline

Not
Required
250ml Saline

RI

60 min.

Not
Required
50ml SalineIV duration 60 min.

IV duration 10 min.

Development of oral TREAKISYM®
Since obtaining approval for manufacturing and marketing of TREAKISYM® for theindications of relapsed/refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell
lymphoma in October 2010, the Company has pursued the expansion of indications formalignant lymphoma. To further enhance the value of TREAKISYM®, the Company plans toproceed with the development of an oral formulation for progressive solid tumors. In January
2018, the Company started the Phase I study of oral TREAKISYM® for progressive solid
tumors. Based on the results of this trial, the Company plans to evaluate the recommended
dose, dosage regimen, the tolerability and the safety of oral TREAKISYM®, identify types ofsolid tumors that show promise for treatment, and determine the subsequent clinical trial
plan.

○ SyB L-1101 (intravenous formulation) / SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)Summary:Rigosertib is a small molecule inhibitor that has a new mechanism of action: it inhibits theactivation of 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 andproliferation, thus killing cancer cells. Since obtaining exclusive rights to develop andcommercialize 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 formulation, the Company is in charge of the clinicaldevelopment in Japan, as part of the global Phase III study (INSPIRE trial) conducted by15

Onconova, the licensor, and started the domestic trial in December 2015. This global Phase
III study is conducted with clinical trial sites in more than 20 countries worldwide, for HRMDS patients who do not respond to treatment with HMAs or who relapse after treatment
under the current standard of care (“Primary HMA Failure”). The interim analysis was
conducted in January 2018, and the independent DMC has recommended that the INSPIRE
trial continue with enrollment increased from the current 225 patients to reach a total
enrollment of 360 patients. Onconova decided to follow the recommendation. The expanded
study enrollment criteria will be identical to the original study.
With regard to rigosertib oral formulation, Onconova is currently in the process ofdetermining the plans for the global Phase III study for the first-line treatment of HR-MDS
patients using the oral formulation of rigosertib in combination with azacitidine. Meanwhile,
the Company started its domestic Phase I study as a single agent in HR-MDS in June 2017,and completed the first patient enrollment in October 2017.

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 and oral as a new drug candidate in addition to the already marketed
TREAKISYM®.

With regard to rigosertib intravenous formulation, patients with HR-MDS who are refractory
to HMAs have limited treatment options and there is extremely high unmet medical need forpatients who respond inadequately to existing therapies. Based on the DMC’s
recommendation, the Company will continue in collaboration with Onconova to move forwardwith the trial with an increase in the total enrollment of patients in Japan up to 40, and aims
to file a new drug application for manufacturing and marketing approval for the indicationsof relapsed/refractory HR-MDS in 2021.

With regard to rigosertib oral formulation, the Company will promptly conduct an oral
rigosertib/azacitidine combination trial in Japan after demonstrating the safety of oral
rigosertib in the Phase I study as a single agent, which is currently underway, and intends toparticipate in the global Phase III study in untreated HR-MDS patients that Onconova is
now planning.

Additionally, regarding the indication of transfusion-dependent lower-risk MDS, theCompany will continue to consider clinical development plans in view of the status of thedevelopment by Onconova.

16This disclosure document is for the purpose of providing information on the Company’s future business strategies
to investors, 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
based on their own judgment.
The Company does not guarantee, in any sense, the possibility of realizing and achieving any performance target
or other 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)contained in this document have been prepared by the Company at its discretion based on the information
available as of the date of this document. Therefore, in the event there are future changes to conditions thatcomprise the assumptions of its business strategy, such as economic conditions, there may be an impact on its
actual business condition and performance such that the results will be different from statements in thisdisclosure document.

17