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Company Presentation March 2019

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Page 1: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Company PresentationMarch 2019

Page 2: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Disclaimer

2

This presentation includes forward-looking statements, beliefs or opinions, including statements with respect to our business, financial condition, results of operations and plans. These forward-looking statements involve known and unknown risks and uncertainties, many of which are beyond our control and all of which are based on our management’s current beliefs and expectations about future events. Forward-looking statements are sometimes identified by the use of forward-looking terminology such as “believe,” “expects,” “may,” “will,” “could,” “should,” “shall,” “risk,” “intends,” “estimates,” “aims,” “plans,” “predicts,” “continues,” “assumes,” “positioned” or “anticipates” or the negative thereof, other variations thereon or comparable terminology or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. Forward-looking statements may and often do differ materially from actual results. No assurance can be given that such future results will be achieved. Factors that may materially affect our results include, among other things, the scope, rate and progress of our clinical and preclinical trials and other research and development activities, anticipating timing of new clinical trials, our plans to commercialize our product candidates, the timing of, and ability to, obtain and maintain necessary regulatory approvals for our product candidates and those risks listed in our prospectus filed with the Securities and Exchange Commission on September 21, 2017 and in our filings with the Securities and Exchange Commission. Such forward-looking statements contained in this presentation speak only as of the date of this presentation. We expressly disclaim any obligation or undertaking to update any forward-looking statement contained in this presentation to reflect any change in our expectations or any change in events, conditions or circumstances on which such statements are based unless required to do so by applicable law.

You may get copies of our final prospectus and other Securities and Exchange Commission filings for free by visiting EDGAR on the Securities and Exchange Commission’s website at http://www.sec.gov.

Page 3: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Agenda

3

Zai vision, team and infrastructure overview

Pipeline and progress

Financial and catalysts

Page 4: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Biotech Leader in Bringing Innovative Therapies to China and Worldwide

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Zai Lab is an innovative, research based, commercial stage biopharma, based in US and China, treating patients with unmet medical needs around the globe.

Growth Pillars

7 Late stage programs; 3 US FDA approved

products; 2 Launches in HK; 1 China NDA

submission

Gateway to China for innovative assets

4 in-licensing deals last year, 3 involving global co-

development

Discovery via internalresearch and pipeline generation platform

1-2 INDs/year in 2020

Strategic Enablers

2 Pureplay innovative commercial platforms

Extensive global and local industry and

regulatory expertise

Best China-based clinical development and

operations team; 20+ ongoing and planned

trials

Page 5: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Strong, Execution-oriented Leadership Team

5

Samantha DuPh.D. Founder, Chairman & CEO

Tao FuMBA, MS, CFAPresident and COO

Harald Reinhart M.D.Chief Medical Officer - Autoimmune and Infectious Diseases

William Liang M.D.Chief CommercialOfficer

Jonathan WangMBASVP Head of BD

Ning Xu M.D.EVP Head of Clinical and Regulatory

James YanPh.D.EVP, Head of Pre-clinical development and Drug Safety

Yong-Jiang HeiM.D., Ph.D.Chief Medical Officer -Oncology

Billy ChoMBA, MAChief Financial Officer

Page 6: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Building a fully-integrated innovative biopharma leader in China

66

Beijing (clinical & regulatory)

Suzhou(manufacturing)

Shanghai (HQ & R&D)

HK(commercial)

Guangzhou(commercial)

San Francisco (US HQ & R&D)

Zai commercial presence / coverage

Zai office/footprint

• >450 employees

• Leading late-stage oncology portfolio

• Best China-based clinical team (~150 FTEs)

• Elite innovative oncology sales team (~200 FTEs and expanding)

Page 7: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

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Clinical development and regulatory team with strong execution capability

Clinical Development & Regulatory Affairs Department

Clinical Project

Directors

Clinical Operations

Regulatory Affairs

Regulatory Director

CQA

Quality managers

CQA specialistRA managers Project

managers

Field monitors

CTAs

Oncology TA Medical

Physicians / Medical

Directors

Data Management BiostatisticsPV

PV physician/specialists

Medical Affairs

MSL

Data management specialists

Biostaticians

Page 8: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Ready-Built Commercial Organization

8

Commercial Organization

Sales

Marketing

BU headInfectious Market access

Reimburse-ment

Distributor management

Pricing/ Hospital listing

MedicalAffairs

MSL

Medical studies

BU headOncology

Sales

Marketing

Key teams

Sales operation

SFE

Training, etc.

Proven track record and heritage from top-selling oncology MNCs and brands in China –Current Zai team launched 8 of the top 10 innovative oncology products in China today

Page 9: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Agenda

9

Zai vision, team and infrastructure overview

Pipeline and progress

Financial and catalysts

Page 10: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Broad and Validated Late-stage Innovative Pipeline with Global First-in-Class and/or Best-in-Class Profile

Note: (1) Combo and mono therapy; (2) Combo therapy.

ZL-2306 (Niraparib) Greater China

Program Indication Preclinical Phase 1 Phase 2 Phase 3/ pivotal

Commercial Territories Partner

Oncology FDA approved HK Commercial Launch

Infectious

China NDA

Optune(TTFields)

Greater China

Margetuximab

Greater ChinaMGD013

FPA144 (Bemarituzumab)

ZL-2301 (Brivanib)

Greater China

Greater China

ZL-2401 (Omadacycline) Greater China

A.Baumanii Bacterial Infections ETX2514 Asia Pacific

Ovarian Cancer (2nd line maintenance) / PK Study

IO Combo in Gastric Cancer2

Ovarian Cancer (1st line maintenance)

Small Cell Lung Cancer

Glioblastoma (GBM)

Mesothelioma

NSCLC

IO Combo in Ovarian Cancer2

IO Combo in NSCLC2

Other1

Brain Metastases

Pancreatic Cancer

Ovarian Cancer

Gastric Cancer

HER2+ breast cancer

HER2+ gastric cancer2

Ovarian2

Gastric Cancer, GEJ

Hepatocellular Carcinoma (HCC)2

Community-Acquired Bacterial Pneumonia (CABP)

Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Gastric1

TNBC

NSCLC

HCC

Other2

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Page 11: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Continuously Enhancing Discovery Efforts with 1-2 INDs per year starting in 2020

11

ZL-1102 Topical Psoriasis

ZL-1201 Hematology & Oncology

ZL-1211 Gastric Cancer

ZL-2103 Autoimmune & Oncology

Multiple undisclosed Oncology

Best-in-class Human IgG Transgenic Mice Platform (US site)

Improved diversity/yield through B cell cloning & encapsulation

Versatile platform adaptable for bi-specifics

Foundation for Future Discovery Pipeline Generation

Zai Lab’s Current Discovery Pipeline

Page 12: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Strong Oncology Franchise in 5 Common Cancers in China with Synergistic Late Stage Assets

12

I-O TTFieldsTarget Therapy

Niraparib

Gastric Cancer

Women’s Cancer

Brain Cancer

Lung Cancer

OvarianBreast

Breast

Breast GBM

SCLC

NSCLC

NSCLC

Margetuximab

Bemarituzimab

MGD013

Optune

Liver Cancer

Brivanib

Breast

Brain Met

Page 13: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Three FDA Approved Products with Significant China Market Potential

13

• New, breakthrough cancer treatment modality for multiple tumor types

• 1st novel GBM treatment in ~15 years

Positioning/Strategy

China Market Opportunity

(Annual Incidence in 2018E)

China Regulatory

Status

• Approved in HK and launched (Q4 2018)

• NDA accepted by NMPA (Dec 2018)

• Priority Review (Jan 2019) • Category 1 drug• Local manufacturing

• Launched in HK (Dec 2018)• Pursue clinical trial waver in

China• Recommended in China Glioma

guidelines based on Level 1 evidence

• Abbreviated clinical trial agreed for China

• Supported by China national key grants

• Category 1 drug• Local manufacturing

• Best-in-class PARP franchise • The only next generation, once-daily broad spectrum antibiotic available in oral and IV formulations

ZL-2306 (Niraparib) ZL-2401 (Omadacycline)Optune

(1)(2)

Source: Cancer Statistics in China, National Bureau of Statistics of China, US Department of Health & Human Services, Respiratory Medicine, Thorac Cancer, and Broker Estimates.Note: (1) Primarily include ovarian, breast (gBRCA, TNBC), SCLC and Gastric; (2) Primarily include NSCLC, Brain Metastases, Pancreatic and Ovarian Cancer.

54K

>1.0m

OC Cur. Add. Market

45K

>1.0m

GBM Cur. Add. Market

2.7m

16.5m

ABSSI CABP

Page 14: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Niraparib has Best-in-class Properties Compared to Olaparib in China

14

Company

Headquarter China England

Drug Category Class I(Local Innovation)

Class 5(Import)

Manufacturing Local Import

Efficacy (PFS: BRCA+ / BRCA- in second line maintenance) 21 mos / 9.3 mos 19.1 mos / 7.4 mos

1st line maintenance trial design All-comers (PRIMA data expected end of the year) gBRCA only

Dosing 200mg QD 300mg BID

PK Properties Low DDI/Brain penetration high DDI/no brain penetration

Commercialization Local, Direct Co-Marketingw/ Merck

Zejula (ZL-2306) / Niraparib Lynparza / Olaparib

Zai Lab’s NDA accepted by NMPA in Dec ‘18 with priority review status (one year ahead of schedule)

Page 15: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Margetuximab Positive Topline Phase 3 (SOPHIA) in Heavily Pretreated Her2+ Metastatic Breast Cancer

All-comers CD16A 158F allele (85%) Margetuximab

+chemo vs.

trastuzumab +chemo

HR=0.76 p=0.033 Margetuximab+chemo

vs. trastuzumab

+chemo

HR=0.68 p=0.005

24% improvement in PFS 32% improvement in PFS

• Initiate discussions with Chinese regulators for mBC based on SOPHIA

• Initiate gastric PD-1 combination study in 2019

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Page 16: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Significant Unmet Need for HER2+ Cancers in China

16(1) Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive Trastuzumab-Refractory Metastatic Breast Cancer(2) HER2 Status in Gastric and Gastroesophageal Junction. Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study; HER2 status in gastric cancers: a retrospective analysis from four Chinese

representative clinical centers and assessment of its prognostic significance

25

679

US China

>27x

234272

US China

+16%

Gastric CancerBreast cancer

Regional comparison

HER2+ % in China 12-13%220~25%1

Patient population 82~88K HER2+ gastric cancer patients

54~68K HER2+ breast cancer patients

Current treatmentHerceptin as first line SoC

No target therapy available as SoC for 2nd line in China

Herceptin the main metastatic treatment available

Perjeta and Kadcyla not approved for metastatic setting

Page 17: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Method of Action Indication Stage

Broad Strategic Collaboration with MacroGenics Across Multiple Assets

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Immune-optimized anti-HER2 monoclonal antibody

First-in-class bispecific blocking PD-1 and LAG-3

Multi-specific TRIDENTTM molecule

HER2-positive BC

HER2-positive GC

Various solid and hematologic malignancies

Undisclosed

Phase III Positive

Phase II

Phase I

Pre- clinical

Margetuximab

MGD013

TRIDENTTM

Zai Lab acquired exclusive development and commercial rights for 3 programs for Greater China

Page 18: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Optune, a Revolutionary Treatment for GBM and Other Major Tumor Types

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References: (1) Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs. maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017; 318(23):2306–2316; (2) Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1–5, 2017; Washington, DC. Oral presentation LBA AACR CT007

NCCN guidelines include and recommend Optune in combo with TMZ in new GBM patients as Category 1 recommendation

Median OSExtended by ~5 months

PFSImproved by 2.7 months

Multiple other solid tumor expansion opportunities e.g. mesothelioma

EF-14 ph3 pivotal trial in newly diagnosed GBM

Page 19: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Large Chinese GBM Patient Pool with Huge Unmet Need

19Source: Global surveillance of trends in cancer survival 2000–14; KOL interviews, RDPAC, China Glioma Treatment Guideline (2015).

45

13

China US

>3X

Thousands Five-year survival rate

~5%

37%

All Cancer Lung

20%

GBM

KOL interviews

Incidence in China: 3.2/100,000 population

“It’s a deadly cancer, 5-yr survival is lower than metastatic lung cancer”

- KOL

“it’s less exciting in GBM… Opdivo fails to demonstrate survival benefits in brain cancer trial”

- KOL

“Temozolomide is currently the only approved therapy for GBM in China – we have very limited choice for one of the most deadly cancers”

Large patient pool Poor prognosis Limited treatment options

Page 20: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Agenda

20

Zai vision, team and infrastructure overview

Pipeline and progress

Financial and catalysts

Page 21: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Financial Overview

21

Zai Lab currently has a strong balance sheet and remains committed to capital efficiency and creation of significant shareholders’ value

Total net proceeds raised since inception $462.6 million

Cash, cash equivalents and short-term investments $263.3 millionAs of Dec 31, 2018

Net cash used in operating activities in 2018 $97.5 million

Net cash used in operating activities in 2017 + 2016 $64.5 million

Shares outstanding (basic) 58.0 millionAs of Dec 31, 2018

Page 22: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Continued Momentum: Major 2019 Milestones & Catalysts

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Event

ZL-2306

• Potential China NDA approval and launch• China Phase 3 data in 2L Ovarian cancer• PRIMA readout• Initiate trials in other key indications in China

Optune• Potential China GBM NDA approval w/ trial waiver and launch• Initiate trials in other key indications in China

Margetuximab• SOPHIA topline data• Initiate China breast cancer study• Initiate pivotal trials in gastric cancer

ZL-2401 • Complete registration trial and prepare for NDA submission

ETX2514 • Initiate dosing in Phase 3 global registrational trial

Additional Pipeline

• Continue pursuing transformational BD opportunities

• Advance and announce internal candidate(s)

Page 23: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Zejula & Optune Commercially Launched in Hong Kong, Paving Way for Mainland China

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2018: Accelerated Hong Kong launchZejula Oct’18; Optune Dec’18

2019: Full readiness for China launch

Hong Kong China

Core marketing, sales management, market access, and government affairs teams in place

Recruiting full team of oncology specialists

Extensive pre-launch programs including Mainland-HK scientific exchanges

Page 24: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

Fulfilling our Mission: Deliver Innovative, Transformative Treatments to Patients in China and the World

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Our first Optune patient…

• Diagnosed in May’18. Original tumor size 3.5cmx4.2cm x2.7cm

• Poor prognosis: IDH-1 wildtype; promoter MGMT methylation.

• Craniotomy for near total excision

• On adjuvant Temozolomide

56 years old, male, GBM patientRecently married chef travels between HK & China

…treated 3 months after deal signing

Doctor placed array on patient

Supported by Zai Specialist

“To have a committed team of doctors and Zai Lab and Novocure staff to provide this treatment makes me feel happier than winning the lottery. I will go back to work after the new year holiday”

- HK patient

Page 25: PowerPoint Presentation - Credit Suisse...This presentation includes forward- looking statements, beliefs or opinions, including statements with respect to our business, financial

4560 Jinke Road, Jingchuang Plaza, Building 1Shanghai, China

+86 21 6163 2581

+86 21 6163 2570