G e n o v a t e 1

Genovate Biotechnology Co., Ltd.

健亞生物科技股份有限公司

24 August 2017

G e n o v a t e 2

Company Overview

Genovate is a fully integrated specialty pharmaceutical company focusing on new drug development and equipped with PIC/S GMP manufacturing, marketing and distribution capabilities.

Major Investors: National Development Fund, Executive Yuan (26.54%) Chinachem Group (HK) (13.89%)

Established: 1993

Number of Employees: 165

Paid-in Capital: $35M

Revenue: $14M (2016)

Major Partners: Medeor – Cellular immunotherapy; Jointly develop MDR-101 in Asia SyneuRx – CNS disorders; Responsible for CMC of NaBen® (2 BTDs) NaviFUS – BBB opening; Jointly develop CNS treatments

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Major Milestones (1995-2005)

1995 Established as the first government invested new drug development company.

1997 Acquires Bristol Myers Squibb Taiwan’s GMP manufacturing plant and establishes CRO operation and provides GCP clinical services.

2000 Completes PrestaraTM phase 3 studies as part of the NDA and receives an “approvable letter” from the US FDA.

2001 Allies with Roche to develop and manufacture Ribavirin.

2003 Receives marketing approval of Genetaxyl Crem Less® (paclitaxel) & UrotrolTM (propiverine).

2004 Allies with Tanabe Seiyaku (Japan) and Yuhan (Korea) to co-develop PrestaraTM in Asia.

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Major Milestones (2006-2017)

2008 Allies with NHRI to develop DPP4 inhibitor DBPR108 and licenses the China rights to CSPC in 2012.

2008 Spins off CRO business unit and establishes Qualitix.

2009 Concludes toll manufacturing agreements with Daiichi-Sankyo Taiwan.

2010 Introduces strategic investor QPS for Qualitix for regional market expansion.

2012 Obtains approval for OTC listing in Taiwan (TPEx:4130).

2013 Invests in SyneuRx (TPEx:6575) who receives two “Breakthrough Therapy Designations“ from the US FDA in 2014 (SND13) and 2015 (SND12).

2013 Invests in Reber (TPEx:6479), TheVax (TPEx:6567) with lead program of HPV therpapeutic vaccine, and PuraPharm (HKEx:1498) majored in concentrated Chinese medicine granules and invented Nong’s® clinic providing a total solution in Chinese medicine dispensary system.

2014 Initiates PhIII study of PMR and allies with Otsuka to codevelop it in Asia.

2014 Invests in UniPharma (TPEx:6621) specialized in diagnostics and devices.

2015 Invests in Medeor Therapeutics specialized in cellular immunotherapy.

2016 Invests in NaviFUS dedicated in providing solutions to crossing BBB.

2017 Invests in Capnia (NASDAQ:CAPN) with lead program addressing PWS.

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GMP Manufacturing (1/2)

Site Area: 125,391 Sq. ft (3,530 pin) Plant Size: 71,235 Sq. ft (2,005 pin)

Capabilities Capacity (per day)

Tablet

Film Coating, Sugar Coating

1,310,000 Tabs

Capsule 200,000 Caps

Topical

Jar

Tube

200 Kg

800 Jars

7,000 Tubes

Injection Liquid

Less than 10 cc Dosage

Less than 10 cc Dosage

Bigger Size to 100cc Dosage

~ 20,000 Vials

~ 20,000 Ampoules

~ 360L

Blister PKG/Al-Al PKG Line 1,200,000 Tabs/Caps

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GMP Manufacturing (2/2)

Accreditation

2007 AFM by Japanese MHLW for non-sterile and sterile products

2008 GMP accredited by Korean MFDS

2010 PIC/S GMP accredited by TFDA and sterile ophthalmic solutions line added in 2014.

Development and manufacture of proprietary products

New drugs, such as GenetaxylTM (patented new formulation of Paclitaxel), RobatrolTM (Ribavirin capsule marketed by Roche), LinicorTM (Niacin ER/Lovastatin marketed by TSH), MycostatinTM (Nystatin powder for oral solution).

Niche generic drugs, injectable preparation such as Atracurium, Rocuronium, and Cisatracurium as adjunct to general anaesthesia and ophthalmic solutions such as Bimatoprost、Latanoprost、Dorzolamide for glaucoma treatment.

Professional contract manufacturing services

Major clients including DSTW, TSH, etc.

Professional contract development and manufacturing services

Major clients including SyneuRx (NaBen®), UIC Group (BowkleanTM - Sodium Picosulfate/Magnesium Oxide/Anhydrous Citric Acid), etc.

Drug export to Korea and southeast Asia since 2003.

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Niche Formulation (1/2)

Mycostatin for Oral Suspension

Indication: candidiasis in the oral cavity

Active ingredient: Nystatin

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Genetaxyl Crem Less Injection Indication: advanced carcinoma of the

ovary, breast cancer, non-small cell lung cancer, AIDS-related Kaposi's sarcoma.

Active ingredient: Paclitaxel

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Niche Formulation (2/2)

Bowklean for Colonoscopy

A patent free (against Ferring’s Prepopik) bowel cleansing agent Bowklean was launched in March 2016.

A prospective randomized controlled clinical trial of the efficacy and safety of Bowklean versus Klean-Prep with Dulcolax for the bowel preparation prior to colonoscopy was successfully completed in 630 subjects.

The primary efficacy result, the success rate of Aronchick scale, showed superiority of Bowklean group to Klean-Prep with Dulcolax group. The adverse events, including abdominal pain/cramping, nausea, vomiting, chest pain and dizziness, were less frequently reported for Bowklean group than Klean-Prep with Ducolax group (25% vs 44.6%, p<0.0001).

The split-dose dosing was selected and subjects were instructed to take the first pouch the day before and the second pouch in the morning prior to colonoscopy.

Lemon-flavored good taste and small volume preparation greatly increases patient acceptance.

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New Indication New Drug MycocepTM

New indication of Mycocep (Mycophenolate Mofetil, MMF) in the maintenance therapy of Lupus Nephritis (LN).

There are approximately 30,000 SLE patients in Taiwan. The prevalence of renal disease requiring medical evaluation and treatment is about 49% in Chinese patients with SLE after 5 years of initial diagnosis.

MMF is recommended by the ACR guidelines (2012) for the treatment and management of LN. Based on its better treatment outcome in terms of time to treatment failure and its less severe adverse events compared to azathioprine (AZA) treatment, MMF has emerged as the first-line standard-of-care therapy for both inducing and maintaining improvement of LN in recent year.

The drugs approved by Taiwan FDA for treating SLE are limited to corticosteroids, hydroxychloroquine, AZA, belimumab plus Myfortic (Mycophenolate Sodium) in mid-2016 for induction therapy of LN. The unmet medical needs for maintenance therapy of LN remain huge.

Taiwan pivotal study comparing MMF versus AZA for maintenance therapy of LN has been completed.

Taiwan NDA targeted for 2H/2017.

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New Formulation New Drug PMR

Patented “once-a-day” modified-release of Cilostazol for the treatment of Intermittent Claudication (IC).

The global market of IC treatments is over US$500M and about US$18B for antiplatelet treatments. The global sales of Cilostazol is about US$250M.

Taiwan PhI pharmacokinetic study showed that in comparison to Ciloslazol bid, PMR had

Lower Cmax Lower Cmax/Cmin ratio Lower area under the plasma concentration time curve (AUC)

Taiwan PhII study nicely demonstrated the trend of better efficacy and safety profile (including less headache, diarrhea and palpitation, the leading causes of treatment discontinuation) comparing to Cilostazol bid.

Successful completion of pre-IND meeting with the US with development plans confirmed.

US IND targeted for 2H/2017 and NDA by Q4/2018.

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DPP4 Inhibitor DBPR108

A novel and patented DPP4 inhibitor with better efficacy and safety profiles against Januvia in preclinical evaluation.

China market rights licensed to China Shijiazhuang Pharma Company (CSPC) listed in Hong Kong and a top three pharma in China.

PhIa and PhIb studies completed under US IND;

PhI completed and PhII currently conducted in China by CSPC.

As a late-comer into DPP4 inhibitors market, DBPR108 is positioned as a “friendly” anti-diabetic drug for Chinese patients.

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New Formulation New Drug Granpatch®

Patentable “twice-weekly” patch formulation of granisetron for CINV Treatment.

Sancuso once-weekly granisetron patch causes skin irritaton and is not cost effective.

Varubi (rolapitant) by Tesaro with mean terminal t1/2 of 7 days and approved by US FDA on 2-Sep-2015 was anticipated to address the US CINV market opportunity of exceeding $1 billion.

Taiwan pharmacokinetics study of Granpatch demonstrated bioequivalence on AUC but lower Cmax as compared to Sancuso.

US development feasibility under evaluation.

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SyneuRx International（心悅）

Mission: To develop novel therapeutics with best efficacy and least side effects for patients and families with CNS disorders.

SND13 in Add-on Therapy for Schizophrenia

PhII/III, adaptive Design

≤ 800(240) subjects

BTD in 2014

SND12 in Combination Therapy for Refractory Schizophrenia

PhII/III, adaptive Design

≤ 632(287) subjects

BTD in 2015

SND5 in Dementia

TCM in China and NCE in US/EU (PhII~)

LOI signed with Wufeng Chicheng Biotech Co., Ltd. in Aug 2017 for the exclusive supply of raw material

Genovate is responsible for CMC and global manufacturing of NaBen®.

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Soleno Therapeutics

Lead program: DCCR addressing Prader-Willi syndrome (PWS), an orphan disease characterized by severe behavioral complications, obesity, and premature death.

DCCR in PWS

QD tablet formulation

5 Phase I and 3 Phase II studies in obesity, dyslipidemia, and PWS

More than >200 treated subjects

Safety profile well matched against the therapeutic benefits

Protected by multiple issued patents, including composition of matter

Successful Completion of FDA Meeting in Jul 2017 with primary endpoint, dosing paradigm and study duration confirmed

Timing to NDA by 2020

DCCR pipeline: Multiple orphan opportunities, such as PWS, hypothalamic obesity and Smith-Magenis syndrome.

Genovate is investigating feasibility of introducing DCCR to Asia.

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Medeor Therapeutics

Lead program: Medeor-10X series of groundbreaking cellular immunotherapies, to minimize or eliminate the need for chronic anti-rejection drug therapy in organ transplant recipients, are paradigms of personalized and precision medicine.

MDR-10X cellular immunotherapy engineered from organ donor blood cells induces immune tolerance, the “Holy Grail” of organ transplantation minimizes or eliminates the need for chronic anti-rejection drug

therapy

MDR-101

Based on compelling PhI/II data in nearly 30 subjects and with FDA’s agreement in Apr 2017 to a Special Protocol Assessment (SPA) for the design of a pivotal PhIII in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants, this study has been initiated and will lead to BLA once completed.

Genovate is investigating feasibility of introducing MDR-10X to Asia.

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NaviFUS（浩宇）

Lead program: NaviFUS, a revolutionary technology using focused ultrasound technology in conjunction with circulating microbubbles to noninvasively, locally and transiently disrupt BBB at the discrete targets and enhance drug delivery into the brain with real-time neuronavigation tools.

Previous preclinical studies have demonstrated that NaviFUS induced BBB opening is harmless in small and large testing animals.

NaviFUS effectively enhances drug delivery to the target tissues by increasing drug concentration by 2-60 folds of that in the unexposed tissues, and improves treatment outcome of brain tumors.

Potential indications in optimizing the treatment outcomes of therapeutic agents for cancers, neurodegenerative or psychiatric disorders, etc.

NaviFUS in brain tumor(s) Pre-IDE submission made to the US FDA in Jan 2017.

Pre-IDE submission made to Taiwan FDA in Aug 2017.

Genovate is investigating feasibility of taking its CNS drug(s) in combination with NaviFUS.

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PuraPharm

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Highlights

Being one of the fastest growing Chinese medicine companies in HK and the largest supplier of Concentrated Chinese medicine granules (CCMG) in Hong Kong with a leading market share of 70%.

Being one of the only five, and the only non-PRC company licensed by the CFDA to manufacture and sell CCMG products in China.

Being the only Chinese medicine manufacturer and also the first ever, to have CCMG products verified and recognized by the US Pharmacopeia.

Been awarded “Corporate Achievement Award” at the Outstanding Import and Export Enterprise Awards 2016. (ranked “Top Four Companies of Proprietary Chinese Medicine Exports 2012”

Nanning Factory Visit by Mr. Xi Jin Ping, Vice President of the People's Republic of China in 2010.

Acquiring US Chinese herbal formulas company K'An Herb in Mar 2017. Being the first HK-funded medical institution granted approval in Jul 2017 to

operate in Guangxi under the Mainland and Hong Kong Closer Economic Partnership Arrangement (CEPA) and planning to replicate Nong’s Chinese medicine clinics by opening 50 clinics in Guangxi within 5 years.

Acquiring Japanese health products company SODX in Aug 2017.

PuraPharm serves as a gate to enter the Chinese medicine market in China.

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UniPharma（華宇）

Major Radio Frequency Ablation Therapies (RFA) business areas in Taiwan:

Liver and Thyroid

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GenVax Pharmaceuticals（健如）

Mission: To develop innovative drugs for improving drug administration,

safety and quality of life; Focusing on 505(b)(2) new drugs, high entry barrier generics and

orphan drugs.

Project A New active ingredient, an enantiomer isolated from an approved

drug substance Indication: Treatment of autoimmune diseases

Project B New indication and new dosage form of an approved anti-diabetic

drug Indication: Treatment of dementia and cognitive impairement

Project C New dosage form of a selective COX-2 inhibitor Indication: Short-term management of moderate pain

Genovate is jointly developing a few selective projects with GenVax.

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核心優勢與策略佈局

核心優勢

核心技術：劑型改良、配合工廠生產（心悅、健如）

優勢利基：選題靈活、搭配投資、取得合作商機（心悅、華宇、生控）

市場應用：經臨床驗證後，進行區域授權（DBPR108）

國際競爭力：依各計畫屬性，規劃不同的開發策略（PuraPharm、浩宇、Medeor）

策略佈局

PMR：2018美國NDA，成功後尋求國際授權。

心悅：全力配合兩個「BTDs」計畫的時程，完成美國PAI。

華宇：8/18上興櫃，共同開發護肝新藥UPN161與治療酗酒新藥UPN163。

浩宇：合作開發CNS疾病新療法，預計2018展開臨床試驗。

Soleno：評估區域臨床參與，換取快速完成美國NDA，時程約在2020。

健如：共同合作新藥計畫，預計2018年底進入美國IND。

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獲利模式

建立風險均衡的產品組合

上市品牌/特色學名藥並接受委託研發代工。不但可以熟悉市場需求，且積極培養劑型開發人才與生產製造能力/團隊。

設計與開發具市場優勢的505(b)(2)新藥。

經由合作與選題，創造「me-better」或「first-in-class」新藥。

評估並投資與公司專長和產品線互補的機會

依需要適時引進合作或共同開發、擴展公司產品組合與研發能量。

依公司財務需求，處分轉投資公司的股票。

集中資源於在地優勢的重點領域

中樞神經系統治療、免疫癌症療法及醫材。

積極串聯產官學研，打造「聚落型」商業模式，提升國際競爭力。

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營業收入 (2014～20171H)

-

100.0

200.0

300.0

400.0

500.0

2014 2015 2016 2017 1H

學名藥銷售 257.7 246.4 194.8 95.1

ODM/OEM 217.8 231.2 216.4 112.2

475.5 477.6

411.2

207.3

佰萬

資料來源：公開資訊觀測站/合併營收

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稅前淨利 (2014～20171H)

資料來源：公開資訊觀測站/合併綜合損益表

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研發策略之股權投資 (1/2)

持有之公司 營業項目 持股比例 健亞合作項目

昌達生化科技 醫藥研發與技術委辦服務之公司（CRO）

6.326% 臨床委託

瑞寶基因 動物疫苗 0.991% 無

心悅生醫 中樞神經系統 新藥開發

8.401% 劑型開發與生產製造

PuraPharm 中藥研究生產 與銷售

0.915% 多醣體研發

華宇藥品 護肝新藥與高階 醫療器材

12.464% 劑型開發與生產製造

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研發策略之股權投資 (1/2)

持有之公司 營業項目 持股比例 健亞合作項目

生控基因 子宮頸癌與B肝 治療型疫苗

0.559% HPV Vx 中國開發

Medeor Therapeutics 免疫細胞治療 4.450% 亞洲換肝

浩宇生醫 聚焦式超音波腦部藥物釋放系統

13.276% 失智症

Soleno Therapeutics 小胖威利症候群 治療新藥

2.190% 區域市場

健如醫藥 505(b)(2)新藥及利基學名藥之研究及開發

34.880% 自體免疫疾病新藥

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商業模式

Co-Investment Joint Development

CIJD

共同投資 聯合開發

共投聯發

G e n o v a t e

THANKS FOR YOUR ATTENTION!

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