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Company Presentation August 2019 Update

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Page 1: Company Presentation - Zai Lab Limited

Company Presentation

August 2019 Update

Page 2: Company Presentation - Zai Lab Limited

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 filings with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the fiscal year ended December 31, 2018. 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.

This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities of Zai Lab Limited.

Page 3: Company Presentation - Zai Lab Limited

Agenda

3

Zai vision, team and infrastructure overview

Pipeline and progress

Financial and catalysts

Page 4: Company Presentation - Zai Lab Limited

Biotech Leader in Bringing Innovative Therapies to China and Worldwide

4

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

9 Late stage programs; 4 US FDA approved

products across 6indications; 2 Launches

in HK1; 1 China NDA submission

Gateway to China for

innovative assets

6 in-licensing deals since

last year, 5 involving global

co-development

Discovery via internal

research 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; 25+ ongoing and planned

trials

Note: (1) Also in Macau.

Page 5: Company Presentation - Zai Lab Limited

Strong, Execution-oriented Leadership Team

5

James YanPh.D., M.D., DABT

EVP, Head of Pre-clinical

Development and Program

& Portfolio Management

Harald Reinhart M.D.

Chief Medical Officer

- Autoimmune and

Infectious Diseases

Billy ChoMBA, MA

Chief Financial Officer

Jonathan WangMBA

SVP, Head of BD

Tao FuMBA, MS, CFA

President and COO

Yong-Jiang HeiM.D., Ph.D.

Chief Medical Officer

- Oncology

Valeria FantinPh.D.

Chief Scientific Officer

Mandy LiMBA

Executive Director,

HR

William LiangM.D., MBA

Chief Commercial Officer

Ning XuM.D., MBA

EVP, Head of Clinical

and Regulatory

Samantha DuPh.D.

Founder, Chairman, and CEO

Page 6: Company Presentation - Zai Lab Limited

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

• ~550 employees

• Broad and validated late-stage pipeline focused on

oncology

• Large, in-house R&D and clinical team (~250 FTEs)

• Experienced innovative oncology sales team (~250 FTEs

and expanding)

Page 7: Company Presentation - Zai Lab Limited

Ready-Built Commercial Organization

7

Commercial Organization

Sales

Marketing

BU

InfectiousMarket Access

Reimburse-

ment

Distributor

management

Pricing/

Hospital

listing

Medical

Affairs

MSL

Medical studies

BU

Oncology

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 many of the top innovative oncology products in China today

Page 8: Company Presentation - Zai Lab Limited

Agenda

8

Zai vision, team and infrastructure overview

Pipeline and progress

Financial and catalysts

Page 9: Company Presentation - Zai Lab Limited

Broad and Validated Late-stage Innovative Pipeline with Potential

First-in-Class and/or Best-in-Class Profile on a Global Basis

Note: (1) Also approved in Macau, (2) Advanced systemic mastocytosis,

(3) Combo therapy, (4) Combo and mono therapy, (5) Triple-negative

breast cancer.

Niraparib Greater China

Program Indication Preclinical Phase 1 Phase 2Phase 3/ Pivotal

Commercial Territories

Partner

Oncology FDA approved HK Commercial

LaunchInfectious

China

NDA

TTFields Greater China

Margetuximab Greater China

MGD013

Bemarituzumab

Brivanib

Greater China

Greater China

Omadacycline Greater China

A.Baumanii Bacterial Infections Sulbactam-Durlobactam Asia Pacific

Ovarian Cancer (2nd line maintenance) / PK Study1

IO Combo in Gastric, Ovarian, Non Small Cell Lung Cancer (NSCLC)

Ovarian Cancer (1st line maintenance)

Small Cell Lung Cancer

Glioblastoma (GBM) - Optune

Mesothelioma

NSCLC

Brain Metastases

Pancreatic Cancer

Ovarian Cancer

Gastric Cancer

HER2+ Breast Cancer

HER2+ Gastric Cancer3

Gastric Cancer, Gastroesophageal Junction (GEJ)

Hepatocellular Carcinoma (HCC)3

Community-Acquired Bacterial Pneumonia (CABP)

Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

9

Ripretinib

Gastrointestinal Stromal Tumors (GIST) (4th line)

Others, i.e. ASM2, gliomas

Greater China

INCMGA0012

(PD-1)

Merkel cell, Anal, MSI-high Endometrial

NSCLC and other solid tumors Greater China

Gastric4

Other, i.e. TNBC5, NSCLC, HCC, Melanoma, etc.3Greater China

GIST (2nd line)

Page 10: Company Presentation - Zai Lab Limited

Continuously Enhancing Discovery Efforts with 1-2 INDs per Year Starting in 2020

10

ZL-1102 Autoimmune

ZL-1201 Oncology

ZL-1211 Oncology

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 11: Company Presentation - Zai Lab Limited

Zai’s Oncology Pipeline Focuses on Four Common Tumor Types with Synergistic Late Stage Assets

11

Margetuximab

Bemarituzumab

MGD013

Brivanib

Gastro

Intestinal

Women’s

Cancer

Brain

Cancer

Lung

Cancer

Margetuximab

* Mesothelioma

approved

Ripretinib

INCMGA0012 (Anti-PD-1 Monoclonal Antibody)

Page 12: Company Presentation - Zai Lab Limited

Three FDA Approved Products with Significant China Market Potential

12

• 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 waiver 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.

52K

>1.0m

OC Cur. Add. Market

45K

>1.0m

GBM Cur. Add. Market

2.7m

16.5m

ABSSI CABP

Page 13: Company Presentation - Zai Lab Limited

Niraparib: ~44K Eligible Patients Annually in 2L Ovarian Cancer Maintenance

Source: Ovarian Cancer National Alliance & Medical Studies.

Annual

Patients #Addressable

market is

over $1Bn

52,000

34,00028,900

74,800

43,70045,900

2L platinum sensitive

New OC diagnosed

2L recurrent >=3L platinum sensitive

Total platinum sensitive

PARPi eligible

13

Page 14: Company Presentation - Zai Lab Limited

TTFields: “Pipeline in a Product” Opportunity

14Source: China Cancer Statistics 2015.

48,000

new cases

150,000

new cases

Gastric

Cancer

680,000

new cases

90,000

new cases

50,000

new cases

Brain-met

NSCLC

Pancreatic

cancer

Ovarian

cancer

GBM/

MesotheliomaTotal

~1 million

new patients

Approved Indications

Page 15: Company Presentation - Zai Lab Limited

15

Ripretinib: Zai Lab - Deciphera Collaboration Overview

Asset –

Ripretinib

Deal

structure

China

development

• Best-in-class and broad-spectrum inhibitor of KIT & PDGFRa

• Indications: GIST, Systemic Mastocytosis; other potential indications

include Gliomas, NSCLC, sarcomas, etc.

• Near term - 4L GIST NDA submission expected 1Q 2020 and 2L GIST

pivotal trial ongoing

• Plan to join 2L global GIST pivotal trial (INTRIGUE) – potential to be first-

in-class for 2L GIST in China

• China standalone registration strategy for 4L GIST – to explore

accelerated pathway

• Exclusive Greater China rights

• Upfront: $20M

• Development milestone up to $50M; Sales milestones up to $135M

• Royalties: low to high teens

Page 16: Company Presentation - Zai Lab Limited

16

Global Pivotal Phase 3 INVICTUS Trial Achieved Primary Endpoint of Progression Free Survival

Source: Deciphera corporate presentation, August 2019

Note: (1) One patient was randomized to placebo but did not receive study drug; (2) m PFS = medium progression free survival; (3) ORR = objective response rate; (4) mOS = median overall

survival; (5) According to the pre-specified hierarchical testing procedure of the endpoints, the hypothesis testing of mOS cannot be formally conducted unless the test of ORR is statistically

significant. Because statistical significance was not achieved for ORR, the hypothesis testing of OS was not formally tested.

Page 17: Company Presentation - Zai Lab Limited

17

Promising Efficacy in Early Clinical Studies: Updated Phase 1 Results across All Lines of Treatment

N=178, ≥100mg/d

Source: Deciphera corporate presentation, August 2019

Note: (1) Overall number of patients (n=178) remains the same as prior data presented at ESMO 2018; based on additional data cleaning, one patient from each of 2nd line and 4th/≥4th line

were reclassified as 3rd line patients; (2) RECIST data per investigator assessment; (3) Median treatment durations were: 2nd line = 44 weeks, 3rd line = 48 weeks, 4th line = 46 weeks and ≥4th

line = 29 weeks; (4) Includes 60 patients who elected for intra-patient dose escalation from 150 mg QD to 150 mg BID; (4) Number of patients in ≥4th line includes 60 patients from 4th line.

• Updated adverse events were consistent with previously presented phase 1 data

• Most common treatment-emerging grade 3/4 adverse events ≥5% patients were

lipase increase, anemia, hypertension and abdominal pain

Page 18: Company Presentation - Zai Lab Limited

18

Substantial GIST Patient Pool in China with ~110K Treated Patients per Year

Significantly larger market potential in

China

New incidence per year Treated

prevalent pts.

in China

China (2018) 2018

~30,000

~110,000

5,000 6,400

US EUKIT PDGFRa Wild type

80~85%

10~15%

Total

10% 100%

Similar to the US, over 90%

GIST patients with KIT and

PDGFRa mutations

Source: Global epidemiology of gastrointestinal stromal tumors (GIST): A systematic review of population-based cohort studies, Feb 1 2016.; China GIST treatment guideline, Company

intelligence.

Page 19: Company Presentation - Zai Lab Limited

19

China’s Development will Largely Leverage Global Studies and Data

GIST 4th line INVICTUS

INTRIGUEGIST 2nd line

Phase I expansion

Leverage

INVICTUS for

China registration

China to join global

study, potentially

first-in-class in China

Systemic Mastocytosis/

Maligant Gliomas

NSCLC, Germ cell & Penile,

Melanomas, Soft Tissue Sarcomas,

Renal impairment

Other tumors

Pending finalization

of global

development plan

GIST 2nd/3rd/4th

line

Top-line data

August 2019

Update in

August 2019

Readout in

2019

Phase I

expansion

Phase I

expansion

Indication Preclinical Phase I/II Phase IIIGlobal

timeline

China study

plan

Initiated in

2018

Page 20: Company Presentation - Zai Lab Limited

Margetuximab: Positive Phase 3 Data (SOPHIA) in Heavily Pretreated HER2+ Metastatic Breast Cancer

PFS Results

Arm 1 vs. Arm 2

(all-comers)

5.8 vs. 4.9 mos

HR=0.76

p=0.033

Arm 1 vs. Arm 2

CD16A 158F

allele (86%)

6.9 vs. 5.1 mos

HR=0.68

p=0.005

20

Discussions ongoing with the Chinese regulators on the regulatory path forward

OS Results

Arm 1 vs. Arm 2

(all-comers)

18.9 vs. 17.2 mos

Arm 1 vs. Arm 2

CD16A 158F allele

(86%)

23.6 vs. 16.9 mos

Page 21: Company Presentation - Zai Lab Limited

Harmonize Gastric Development of Margetuximab – Zai Owns All Relevant Assets in China

21

Pivotal Global MAHOGANY Study to initiate in 3Q19

Designed arm including INCMGA0012

Source: MacroGenics ASCO 2019 Conference Call, P44.

Page 22: Company Presentation - Zai Lab Limited

Significant Unmet Need for HER2+ Cancers in China

22Note: (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

234

272

US China

+16%

Gastric CancerBreast cancer

Regional

comparison

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

Patient population82~88K HER2+ gastric

cancer patients

54~68K HER2+ breast

cancer patients

Current treatment

Herceptin 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 23: Company Presentation - Zai Lab Limited

23

Incyte PD-1: Zai Lab - Incyte Collaboration Overview

• Development and exclusive

commercial rights to

INCMGA0012 in Greater China

• Opportunity to join Incyte global

clinical trials and leverage

Incyte’s global data

• Upfront: $17.5M

• Development & Sales milestones:

up to $60M

• Tiered royalties from the low to

mid-twenties

• Option to co-promote with Zai

Lab in Greater China

• Incyte has retained certain rights

to develop INCMGA0012 in

Greater China

Page 24: Company Presentation - Zai Lab Limited

24

Deal Rationale

• Control a competitive PD-1 in China to complement Zai Lab oncology

portfolio

• Leverage Incyte’s extensive global clinical programs and data for

INCMGA0012

• Generate significant combo opportunities with Zai Lab’s innovative

pipeline

• Harmonize margetuximab global gastric cancer study

• Win in the large and nascent PD-1 market in China as a foundational

therapy for combinations

1

2

3

4

5

Page 25: Company Presentation - Zai Lab Limited

25

PD-1 Extensive Ongoing and Planned Global Trial Programs

Source: ClinicalTrials.gov. Accessed August 15, 2018; Incyte Corporation - Investor and Analyst Presentation, June 2018.

Multiple ongoing trials including label-enabling studies

Multiple

additional

global phase

3 trials

planned

Zai Lab to join some studies to leverage global data for fast China registration

Page 26: Company Presentation - Zai Lab Limited

26

Significant PD-1 Combination Potential and Synergies with Zai Lab’s Innovative Pipeline

Freedom to develop combinations Strong development synergies

Brivanib

Others

Cervical Cancer

Hepatocellular Carcinoma

Zai Lab current and future

assets

KOL network and medical

activities

Study sites

Clinical operations team &

resources

Marge-

tuximabGastric cancer

Page 27: Company Presentation - Zai Lab Limited

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

27

2018: Accelerated Hong Kong launch

Zejula Oct’18; Optune Dec’182019: 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 28: Company Presentation - Zai Lab Limited

Agenda

28

Zai vision, team and infrastructure overview

Pipeline and progress

Financial and catalysts

Page 29: Company Presentation - Zai Lab Limited

Financial Overview

29

Zai Lab currently has a strong balance sheet and remains committed to

capital efficiency and creation of significant shareholder value

Total net proceeds raised since inception $678.2 million

Cash, cash equivalents and short-term investments $431.3 millionAs of Mar 31, 2019

Net loss in 2018 $139.1 million

Net cash used in operating activities in 2018 $97.5 million

Shares outstanding (basic) 67.0 millionAs of Mar 31, 2019

Page 30: Company Presentation - Zai Lab Limited

Continued Momentum: Major Near-term Milestones & Catalysts

30

Event

Niraparib

• Potential China NDA approval for 2L ovarian cancer

• Global Phase 3 1L ovarian cancer (PRIMA) readout in 2019

• US FDA approval for late line OC treatment (Oct 2019)

• Completion of enrollment of China 1L ovarian cancer (PRIME)

• Continued enrollment of the China Phase 3 SCLC trial

• Initiate trials in other key indications in China

Optune

• Submit application for innovative medical device designation

• Submit regulatory dossier for approval in GBM with request for trial waiver

• Potential launch in China for GBM

• Initiate trials in other key indications in China

Ripretinib• Global Phase 3 trial in 4L GIST readout

• Initiate 2L GIST trial in China

Margetuximab

• US BLA filing in 4Q 2019 by MacroGenics

• Initiate China breast cancer study

• Initiate pivotal trials in gastric cancer

Omadacycline• Complete registrational trial and prepare for NDA submission for two major

indications

Sulbactam-

Durlobactam

• Obtain CTA approval

• Initiate pivotal trial

Additional

Pipeline

• Continue pursuing transformational BD opportunities

• Advance and announce internal candidate(s)

Page 31: Company Presentation - Zai Lab Limited

4560 Jinke Road, Jingchuang Plaza, Building 1

Shanghai, China

+86 21 6163 2581

+86 21 6163 2570