English translation

February 10, 2015
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and CEO(Securities code: 4582)

Tetsuya Maruyama
Director
Finance & Accounting(TEL. 03-5472-1125)

SymBio’s Long Range Plan: FY2015 to FY2017
I.

Long Range Plan for the next three years(1) Overview of FY 2014 business results as of the date of the Long Range Plan
Progress in the Company’s business for FY 2014 (from January 1, 2014 to December 31,2014) is as follows.

1. Domestic[SyB L-0501, generic name: bendamustine hydrochloride; trade name:TREAKISYM®]
The Company markets the anti-cancer agent TREAKISYM® in Japan through its
business partner, Eisai Co., Ltd. (“Eisai”), for the indications of refractory/relapsed
low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma. Net sales (NHI pricebasis) increased as expected, with an increase of 102% year-on-year.
Aiming to maximize the product value of TREAKISYM®, the Company continues topursue three additional indications.
Firstly, as for the indications of frontline low-grade non-Hodgkin’s lymphoma and mantle
cell lymphoma, the Company completed the Phase II clinical trial in February, 2014 andis currently preparing the application for approval. In the EU, Astellas Pharma Europe
Ltd. has already completed the application process for regulatory approval. Considering
this approval progress in Europe, the Company plans to file for approval in Japan;
Secondly, as for the indication of chronic lymphocytic leukemia, the patient enrollment
for Phase II clinical trial was completed in October, 2014. TREAKISYM® has been
designated as an orphan drug (pharmaceutical for treatment of rare diseases) for the1

indication of chronic lymphocytic leukemia in June, 2012.
Lastly, as for the additional indication of refractory/relapsed intermediate/high-grade
non-Hodgkin’s lymphoma, the Company’s development approach is being considered.

[SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), genericname: rigosertib]
The domestic phase I clinical trial of anticancer agent SyB L-1101 (intravenous
formulation) for the indication of refractory/relapsed higher risk myelodysplastic
syndrome (MDS), which is a hematological malignancy, is underway.
In February, 2014, Onconova Therapeutics, Inc. (“Onconova”), the U.S. Licensor,
announced results from its Phase 3 ONTIME trial of IV rigosertib conducted at clinical
trial sites in Europe and the U.S. Although treatment with IV rigosertib plus best
supportive care (BSC) did not demonstrate a statistically significant improvement inmedian overall survival when compared to BSC only, post-hoc analysis demonstrated astatistically significant increase in median overall survival in the subset of patients who
had progressed on or failed previous treatment with hypomethylating agents (HMAs)(i.e., had not responded to HMAs), thus demonstrating potential activity of rigosertib inthese MDS patients
Onconova continues discussions with the U.S. and European regulatory agencies
regarding the possibility of approval based on top-line results of the Phase III ONTIME
trial. These discussions have consequently led Onconova to focus its development
efforts on the unmet medical need of patients who do not respond to treatment with thecurrent standard of care, hypomethylating agents (“Primary HMA Failure”). Onconova
announced its future development plan for Primary HMA Failures.
The Company will continue with its development of IV rigosertib in Japan based on
Onconova’s development plan in the US and Europe.
Patient enrollment for the Phase I clinical trial of SyB C-1101 (oral formulation, or “Oralrigosertib”) in lower risk MDS was completed in August, 2014.

2. Overseas
In June, 2014, SyB L-0501 was approved by the Ministry of Food and Drug Safety(MFDS) in South Korea for the indication of refractory/relapsed low-grade non-Hodgkin’s
lymphoma. In addition to the earlier approval of chronic lymphocytic leukemia andmultiple myeloma, Eisai Korea Inc. (Eisai Korea), a Korean subsidiary of Eisai, promotes
the product for these three indications. The Company’s overseas sales continue to growsteadily as planned and have increased by 2.2 times compared to budget, in particular
because the Company received a purchase order from Eisai Korea in connection with2

their change of packaging facility in FY 2014, and recognized the related sales revenue
which had been originally expected in FY 2015.

3. Fundraising
The Company passed a resolution on November 14, 2014, to issue a 2nd unsecured
bond with convertible bond-type stock acquisition rights (total issue price: 500 million
yen) with Oak Capital Corporation as the allottee, and the 34th warrant (total issue price:
10,363 thousand yen, total issue price of stock when issued through the exercise ofstock acquisition rights: 1,000 million yen). Accordingly, Oak Capital Corporation
completed payment of 510,363 thousand yen to the Company on December 1, 2014.
With regard to the 2nd unsecured bond with convertible bond-type stock acquisitionrights, all stock acquisition rights have been exercised and all bonds converted to theCompany’s common stock in December, 2014.

4. Business results
As a result of the above, net sales totaled 1,955,027 thousand yen for the fiscal year
ended December 31, 2014, primarily reflecting product sales of SyB L-0501 in Japanand overseas markets. Net domestic sales of TREAKISYM® showed a year-on-yearincrease of 12.9%. While net overseas sales increased by 3.6 times compared to theprevious fiscal year mainly due to the recognition of sales from the fulfillment of earlypurchase orders in South Korea, milestone revenue showed a year-on-year decrease of
85.0%. In total, net sales increased by 27.6% compared to the previous fiscal year.
Selling, general and administrative expenses totaled 1,829,918 thousand yen (ayear-on-year decrease of 8.4%), including research and development (“R&D”) expensesof 774,103 thousand yen (a year-on-year decrease of 26.5%) primarily due to expenses
associated with clinical trials for SyB L-0501, SyB L-1101 and SyB C-1101, and otherselling, general and administrative expenses of 1,055,815 thousand yen (a year-on-yearincrease of 11.6 %).
As a result, operating loss of 1,303,279 thousand yen was recognized for the fiscal year
ended December 31, 2014 (operating loss of 1,680,528 thousand yen for the previous
fiscal year). In addition, the Company recorded non-operating expenses totaling 22,288
thousand yen primarily comprising commission fees and stock issuance costs, andnon-operating income totaling 215,251 thousand yen primarily due to foreign exchange
gains. This resulted in an ordinary loss of 1,110,316 thousand yen (ordinary loss of
1,601,424 thousand yen for the previous fiscal year) and net loss of 1,115,877 thousandyen (net loss of 1,605,224 thousand yen for the previous fiscal year).
3(2) SymBio’s Long Range Plan – Summary and Background
SymBio is the first “specialty pharma” in Japan to specialize in the following three areas:
oncology, hematology and autoimmune disease. Although strong demand exists in these
therapeutic areas, development remains challenging due to the need for a high degree of
specialization. Because major pharmaceutical companies are reluctant to develop drugs
for smaller indications and patient numbers in these areas due to questionable returns
versus the amount of investment required, oncology, hematology and autoimmune
disease are regarded as the “undeserved therapeutic areas” in terms of development inJapan and Asia.
The Company sees business opportunities in these “undeserved therapeutic areas”
despite the relatively small market potential, focusing on new drug candidates having highunmet medical needs instead of pursuing new “blockbuster” drugs (where sales often
surpass 100 billion yen). Capturing high revenues through the development and sale ofdrugs in these therapeutic areas is at the core of business development in the Company.
One significant aspect of the Company’s business model is the lack of its own research
and manufacturing facilities, outsourcing and overseeing the clinical development ofquality that drug candidates that it has in-licensed from pharmaceutical companies in the
US and/or Europe. This enables the Company to avoid a large capital investment and to
conduct effective business operations with low fixed costs. Also, by focusing on laterstage drug candidates that have been tested for efficacy and safety in clinical trials, thedevelopment period is shortened, thus lowering the overall development cost and risk.
The Company is building a strong pipeline portfolio and aiming for an early return toprofitability through these efforts.
SymBio’s Long Range Plan is as follows:Maximize the value of our main product, TREAKISYM®, for which manufacturing andmarketing approval has been granted in refractory/relapsed low-grade non-Hodgkin’s
lymphoma and mantle cell lymphoma, and aggressively pursue the expansion ofindications (life cycle management).



Develop the anticancer agent SyB L-1101 (intravenous formulation) /C-1101 (oralformulation) (generic name; rigosertib) as therapy for MDS. Development decisions
regarding the development of rigosertib for solid tumors will be made after considering
the status and data of development overseas.

Proactively negotiate with the aim of in-licensing new drug candidates during FY2015
while continuously searching for and evaluating other new drug candidates.

Increase selling, general and administrative expenses, mainly research anddevelopment costs, in order to in-license and begin the development of new drug
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candidates, and undertake clinical trials with the aim of launching SyB L-1101/C-1101.


Proactively develop and commercialize drugs for Asian markets that are expected toexperience rapid growth (China, Hong Kong, Taiwan, South Korea and Singapore).

(3) Business Status, Outlook and Other Assumptions○


SyB L-0501 (generic name: bendamustine hydrochloride; trade name: TREAKISYM®)
Domestic sales of TREAKISYM® began through Eisai, our business partner, with the
drug’s launch in December, 2010, for refractory/relapsed low-grade non-Hodgkin’s
lymphoma and mantle cell lymphoma. Sales have been increasing steadily andmarket share has reached a high point.

Going forward, in order to further increase sales, the Company aims to strengthen its
marketing arrangement for TREAKISYM® with Eisai, achieve product differentiationfrom targeted competing drugs, and will endeavor to obtain early approval for
additional indications.

Regarding clinical trials for additional indications, the Phase II clinical trial for frontline
low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma has been completed.
Taking into account the possibility of approval of this indication in Europe, theCompany will continue to prepare for the filing of marketing approval in Japan. The
Company has completed patient enrollment in its Phase II clinical trial for chronic
lymphocytic leukemia, and will prepare for filing of marketing approval in Japan uponcompletion of the trial.

Regarding the additional indication of refractory/relapsed intermediate/high-grade
non-Hodgkin’s lymphoma, the Phase II clinical trial generated positive data and theCompany will continue to pursue approval of this indication.

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○

SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation); genericname: rigosertibWith regard to SyB L-1101 (intravenous formulation), patient enrollment of the Phase
I clinical trial for the target indication of refractory/relapsed higher risk MDS wascompleted in January, 2015. The Company will reassess its domestic development
plan, taking into account Onconova’s development plan in the U.S. and Europe.

Regarding SyB C-1101 (oral formulation), the Company will continue to advance thedevelopment of rigosertib for higher risk MDS (in combination with azacitidine) andtransfusion-dependent lower risk MDS. As for development relating to solid tumor,
determination will be made after consideration of overseas development status and
data.

○

Expansion to other Asian markets



SyB L-0501 has been approved and is being marketed in Singapore, Hong Kong,
South Korea and Taiwan, with sales growing at a steady rate. Sales in these markets
are being generated through local partners. In order to maximize sales in Asianmarkets, the Company will work toward further strengthening its business alliances.

With regard to SyB L-1101/C-1101, the Company owns the exclusive right to develop
and market the drug in South Korea as well as Japan, and will continue to pursue
approval in this market.

○ New drug candidates


The Company will continue current negotiations with several companies with the aimof in-licensing during FY2015.

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II.

Earnings Forecast and Performance Target(Unit: millions of yen)
Fiscal year

Net sales

Operating

Ordinary

Net income

income (loss)

income (loss)(loss)FY 2014 (Actual)

1,955(1,303)(1,110)(1,115)FY 2015 (Forecast)

1,870(2,452)(2,481)(2,485)2,919(2,390)(2,419)(2,422)

to 2,148

to (3,005)

to (3,034)

to (3,038)

3,754(2,525)(2,554)(2,557)

to 2,160

to (3,492)

to (3,521)

to (3,524)

FY 2016 (Target)

FY 2017 (Target)

Assumptions and Numerical Basis for Projections and Performance Targets○ With regard to sales, TREAKISYM® makes up the majority of product sales. The
performance target for drug sales assumes that new drugs (additional indications) areapproved as assumed in the business plan, and figures are derived after detailed analysis
and discussions on market size projections, competitive positioning vis-à-vis existing
therapies, market dominance, and sales performance after the commencement of sales.
Furthermore, milestone revenue is estimated based on the Company’s development plan.
○ Cost of sales is estimated based on the provisions of existing license agreements.
○ Selling and general administrative expenses mainly consist of research and development(“R&D”) expenses or other selling expenses and general administrative expenses.


Research and development expenses are estimated based on “III. Other reference
information – Status of Development Portfolio and Performance Targets”. With regard
to TREAKISYM®, since the business alliance agreement with Eisai provides that R&D
expenses shall be split equally between the two parties, half of the estimated expenses
are assumed. Milestone payments are estimated in accordance with provisions in theexisting contract. In-licensing and development costs for one or two new drugcandidates are estimated based on the current status of negotiations.



Other selling and general administrative expenses mainly consist of expenses incurredfrom TREAKISYM® marketing, new business development, production & distribution
and administrative operations. With regard to TREAKISYM®, since the businessalliance agreement with Eisai provides that marketing expenses shall be split equally
between the two parties, half of the estimated expenses are assumed, similar to the
R&D expenses.

○ With respect to the additional indication of refractory/relapsed intermediate/high-grade
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non-Hodgkin’s lymphoma, no related sales and expenses are assumed.
○ As stated in “I. (3) Business Status, Outlook and Other Assumptions,” application for
approval for the indication fist-line low-grade non-Hodgkin's lymphoma is dependent upon
the outcome of approval in Europe. Therefore, numerical assumptions were made basedon two scenarios (approval obtained in Europe / approval not obtained in Europe) andpresented as the maximum and minimum figures.

8III. Other Reference Information
Status of Development Portfolio and Performance Targets
Development
code
Therapeutic
category

Indication

Preclinicalstudy

Refractory/relapsed
low-grade
non-Hodgkin’s lymphoma;
mantle cell lymphoma

SyB L-0501
Anticancer drug

Phase I
clinical trial

Phase II
clinical trial

File forMarketingApproval

MarketingApproval

Marketing Approval (October, 2010)

Frontline low-grade
non-Hodgkin’s lymphoma;
mantle cell lymphoma
Chronic lymphocytic
leukemia
Refractory/relapsedintermediate/high-grade
non-Hodgkin’s lymphoma

Phase II completed

SyB L-1101
Refractory/relapsed
Anticancer drug
higher risk MDS(Intravenous(myelodysplastic syndrome)
formulation)

To be determined based on Onconova’s
development plan

Higher risk MDS

Participation in global clinical trials to beconsidered(in combination with

SyB C-1101
azacitidine)
Anticancer drug
(Oralformulation)
Transfusion-dependent
lower risk MDS

Note 1.

Participation in global clinical trials to beconsidered: The development plan
: Completed as of December 31, 2014 (FY 2014): FY 2015 target: FY 2016 target: FY 2017 target

2. With regard to SyB C-1101, upon completion of the Phase I clinical trial for thetarget indication of higher risk MDS currently underway in Japan, the Company
plans to carry out development for the indications of higher risk MDS (incombination with azacitidine) and transfusion-dependent lower risk MDS. The
Company will consider its participation in global clinical trials for such development.

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Portfolio summary and issues for achieving plans are set out below.
○ SyB L-0501 (generic name: bendamustine hydrochloride; trade name: TREAKISYM®)
Summary:

Bendamustine hydrochloride was used in Germany for many years as an anticancer
drug for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic
leukemia (trade name: Ribomustin).



From 2000, the efficacy and safety of this drug has been re-evaluated and it is now
approved and sold in 69 countries around the world. In December,2005, theCompany obtained the exclusive rights of development and marketing from thelicensor, 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 exceptionof China. Going forward, the Company will continue to collaborate closely with local
business partners to maximize sales.



In Japan, manufacturing and marketing approval was obtained in October, 2010, forrefractory/relapsed low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma,
and sales initiated through Eisai, a business alliance, in December, 2010. Since its
launch in Japan, his TREAKISYM® has been administered to over 9,500 patients(estimated by the Company) by the end of FY 2014.



In order to expand the value of TREAKISYM®, the Company is working on
development for other indications such as frontline low-grade non-Hodgkin's
lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia. The Company’s
future development plan for the additional indication of refractory/relapsedintermediate/high-grade non-Hodgkin’s lymphoma is under consideration.

Issues and Specific Measures:Promotion of Indication Expansion
As for fist-line low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, patient
enrollment for the Phase II clinical trial has been completed. Since application for
approval in Japan is closely linked to approval of the indication in Europe, as soon as
such European approval is confirmed, the Company will proceed with the domestic
application process.
As for chronic lymphocytic leukemia, patient enrollment has also been completed andthe Company will complete the clinical trial as soon as possible followed by
preparations to file for marketing approval in Japan.
Regarding the additional indication of refractory/relapsed intermediate/high-grade10non-Hodgkin’s lymphoma, the Phase II clinical trial has shown positive results and theCompany will continue to make its best efforts in obtaining approval.
Sales and expenses related to this indication are not reflected in this Long Range
Plan.


Maximizing Sales
In Japan, our most significant market, sales of TREAKISYM® are generated throughEisai, our business partner. In order to further promote market penetration, theefficacy and safety of the drug supported by positive data in clinical trials needs to be
more widely understood so that it is more often prescribed. To that end, the Company
will work closely with Eisai and plan strategies vis-à-vis competing therapies, andaggressively develop marketing strategies such as future collaborations with Eisai on
academic conferences and study groups.

○ SyB L-1101 (intravenous formulation) /C-1101 (oral formulation) (the generic name:rigosertib)
Summary:

SyB L-1101/C-1101 is an anticancer drug which functions as a unique multi-kinase
inhibitor. Since obtaining exclusive rights to develop and commercialize the in Japanand South Korea from Onconova in July, 2011, the Company has been actively
developing this drug. The Company has obtained rights for both the intravenous andoral formulations.

With regard to development of this drug, currently, Onconova is pursuingdevelopment in the U.S. and Europe for the indications of myelodysplastic syndromes(“MDS”), head and neck cancer, ovarian cancer, etc. With regard to the intravenous
formulation for refractory/relapsed higher risk MDS, Onconova announced its future
development plan for Primary HMA Failure based on the results of its Phase III
ONTIME trial. With regard to the oral formulation, the Phase II clinical trial for theindication of transfusion-dependent lower risk MDS is underway, and the Phase I/II
clinical trial for the target indication of higher risk MDS (in combination withazacitidine) is also underway.



Onconova is proceeding with its Phase II clinical trial for the indication of head andneck cancer, and the Company will wait for data generated from the clinical trial todetermine whether or not to proceed with domestic development.



Currently, the Company is conducting a Phase I clinical trials using the intravenous
formulation for the target indication of refractory/relapsed higher risk MDS, and theoral formulation higher risk MDS.
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Issues and Specific Measures:Promotion of Indication Expansion
With regard to the intravenous formulation, the Company will determine its domestic
development plan based on the results of the Phase III clinical trial inrefractory/relapsed higher risk MDS which was carried out by Onconova in the U.S.
and Europe. Patient enrollment in Phase I clinical trial was completed in January,
2015, with the final process for completion of the trial now underway.
With regard to the oral formulation, domestic clinical trials will be conducted after
taking into consideration two trials: frontline higher risk MDS in combination withazacitidine), and transfusion-dependent lower risk MDS which are currently underway
in Europe and the U.S. With regard to solid tumors (head and neck cancer, etc.), theoverseas development status/data will be evaluated.



Use of Overseas Data
In order to reduce costs and shorten development timelines, the future developmentof drug candidates in the Company’s pipeline will include the participation in global
clinical trials whenever possible. The Company will thoroughly review clinical data
generated from overseas clinical trials to ensure the quality of domestic marketing
approval applications.

This disclosure document is for the purpose of providing information on the Company’s future businessstrategies to investors, and is not for the purpose of soliciting investments.
The evaluation on 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 performancetarget 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 are judgmentally prepared by the Company based on the information available as ofthe date of this document. Therefore, in the event there are future changes to conditions that make up theassumptions of the business strategy, such as economic conditions, there may be impact on the actual businesscondition and performance such that the results will be different from statements in this disclosure document.

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