Exhibit

No.

Description

99.1

Press release issued March 7, 2019.

ZAI LAB LIMITED

By: 

/s/ Billy Cho

Name: 

Billy Cho

Title: 

Chief Financial Officer

Date: March 7, 2019

•

In January 2019, Zai Lab announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for niraparib for the maintenance treatment of adult patients with recurrent epithelial, ovarian, fallopian tube or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy. NMPA acceptance of the NDA was over one year ahead of expectations.  Niraparib was also designated as a “National Science and Technology Major Project” by the Chinese government as part of a key initiative to strengthen local innovation.

•

In January 2019, Zai Lab announced that it completed patient enrollment of its Phase 3 clinical trial of niraparib, which is in development for second-line maintenance therapy in patients with recurrent platinum-sensitive ovarian cancer.

•

In October 2018, Zai Lab announced the marketing approval of ZEJULA^® (niraparib) in Hong Kong for the maintenance treatment of adult patients with recurrent platinum-sensitive high-grade serous epithelial ovarian cancer. The product was launched in Hong Kong in November 2018.

•

In September 2018, Zai Lab presented results of its clinical trial that evaluated the Pharmacokinetic (PK) profile of niraparib made in China for Chinese ovarian cancer patients. The study demonstrated a comparable PK profile to that generated in the global study conducted by Tesaro (now part of GSK).

•

In August 2018, Zai Lab dosed its first patient in a Phase 3 registrational trial in China for SCLC (Small-Cell Lung Cancer).  Current enrollment is on schedule.

•

In June 2018, Zai Lab dosed its first patient in a Phase 3 clinical trial in China for first-line maintenance therapy of patients with platinum-responsive ovarian cancer.  Current enrollment is on schedule.

•

In December 2018, Zai Lab launched Optune in Hong Kong and treated its first patient with newly diagnosed glioblastoma multiforme.

•

In September 2018, Zai Lab announced a global strategic development collaboration with Novocure. Zai Lab obtained an exclusive license to develop and commercialize TTFields in greater China and will also support enrollment of Chinese patients to accelerate clinical trial enrollment for additional indications.

•

In February 2019, MacroGenics announced positive top-line results from its SOPHIA Phase 3 clinical trial. Margetuximab demonstrated improved progression-free survival compared to HERCEPTIN® (trastuzumab) when used in combination with chemotherapy in patients with HER2-positive metastatic breast cancer. We plan to discuss the approval pathway for HER2-positive breast cancer in China with the NMPA.  

•

In November 2018, Zai Lab and MacroGenics entered in to an exclusive collaboration and licensing agreement to develop and commercialize three assets for greater China including: (i) margetuximab, an immune-optimized anti-HER2 antibody; (ii) MGD013, a first-in-class bispecific DART antibody designed to coordinate PD-1 and LAG-3 blockade for the treatment of solid and hematological tumors; and (iii) an undisclosed tri-specific TRIDENT molecule.

•

In September 2018, Zai Lab presented interim results of a Phase 2 clinical trial of brivanib in Chinese patients with previously-treated liver cancer at the Chinese Society of Clinical Oncology. The study demonstrated evidence of anti-tumor activity with a manageable safety profile.  Zai Lab plans to conduct a combination study with a PD-1 antibody for HCC patients in China.

•

In October 2018, Zai Lab and Five Prime Therapeutics dosed the first patient in a Phase 3 global registrational trial of bemarituzumab in combination with chemotherapy in patients with previously-untreated advanced gastric cancer. The first global patient was dosed at a participating site in China, which was an industry first.  

•

In December 2018, Zai Lab initiated the abbreviated bridging program previously agreed to with the NMPA, which is expected to allow us to significantly accelerate NDA preparation and submission timeline by up to two years

•

In October 2018, the U.S. FDA approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections.  The European Medicines Agency also announced acceptance of European Marketing Authorization Application for both oral and intravenous formulations.

•

ETX2514 is expected to initiate global Phase 3 registrational clinical trials for patients with MDR Acinetobacter pneumonia and bloodstream infections in 2019.  In collaboration with Entasis, Zai Lab has been preparing to submit a clinical trial application to initiate patient dosing in the Asia-Pacific portion of the global registrational trial.

•

Throughout 2018, Zai Lab continued to demonstrate its positioning as the “gateway to China for innovative assets” by completing four strategic partnerships and adding six assets into its pipeline.  Zai Lab intends to continue to evaluate opportunities that it believes has products or capabilities that are a strategic or commercial fit with Zai Lab’s current drug candidates and business.

•

In February 2019, Immuno-Oncology Pioneer, Lieping Chen, M.D., Ph.D., joined Zai Lab’s Scientific Advisory Board (SAB).  Dr. Chen will advise Zai Lab as it continues to progress its internally-developed oncology pipeline. In addition to Dr. Chen, other members of Zai Lab’s SAB include Neal Rosen, M.D., Ph.D., Gwen Fyfe, M.D., and Richard Flavell, Ph.D., FRS.

•

In October 2018, William Lis was appointed to Zai Lab’s Board of Directors.  Mr. Lis has over 25 years of biopharmaceutical experience. He served as CEO and a Director of Portola Pharmaceuticals, Inc. from 2010 until 2018. Under his leadership, Portola successfully grew from a discovery stage company to a fully integrated R&D and commercial organization.  Prior to Portola, Mr. Lis held executive positions at Scios, Inc. (a Johnson & Johnson company) and Millennium Pharmaceuticals.

•

In September 2018, Zai Lab appointed industry leader, Tao Fu, as President and Chief Operating Officer and opened an office in San Francisco to serve as its U.S. Headquarters and further strengthen its business development and discovery capabilities. Mr. Fu has been, and continues to be, a member of Zai’s Board of Directors since 2017.

•

In September 2018, Zai Lab raised gross proceeds of $150 million in a public offering of American Depositary Shares.

•

In August 2018, Yongjiang Hei, MD, Ph.D., joined Zai Lab as Chief Medical Officer of Oncology, and brings with him over 20 years of global oncology clinical development

experience.  Dr. Hei was the Global Development Leader for numerous oncology drugs at Amgen and also served as the Medical Head for Amgen China.  Dr. Hei also served as the US Medical Director for Roche, and Senior Global Brand Medical Director and Executive Director in Oncology for Novartis.

•

In August 2018, Kai-Xian Chen, Ph.D., was appointed to Zai Lab’s Board of Directors.  Professor Chen is a globally preeminent scientist widely regarded as a pioneer in the field of interdisciplinary healthcare research and also served as a member of the National Committee of Chinese People’s Political Consultative Conference (CPPCC) from 2007 to 2017.

•

In June 2018, Dr. William Liang was appointed Chief Commercial Officer.  Dr. Liang has over 20 years of experience in the biopharma industry, heading China and regional commercial operations of global companies.  Dr. Liang was instrumental in establishing market-leading oncology and other franchises in China for AstraZeneca and Roche, overseeing commercial success of top selling drugs such as Tagrisso®, Iressa®, Tarceva®, MabThera®, Herceptin®, Avastin® and Pegasys®.

•

Zai Lab continues to expand its platform, particularly in R&D and commercial teams.  As of March 1, 2019, Zai Lab employed 448 full-time employees, including nearly 60 employees with M.D. or Ph.D. degrees.  Currently, approximately 40% and 43% of the Company’s employees are engaged in R&D and commercial activities, respectively.

•

PK study presentation at AACR (American Association for Cancer Research)

•

Potential China NDA approval and launch

•

Tesaro (now GSK) to announce top-line PRIMA data in first-line maintenance treatment of ovarian cancer for all comers

•

Initiate trials in other key indications in China

•

Complete enrollment of first-line ovarian cancer Phase 3 clinical trial

•

Potential China GBM NDA approval and launch

•

Initiate exploratory trial in China for gastric cancer

•

Submission of a biologics license application to the U.S. FDA for HER2-positive metastatic breast cancer by our partner MacroGenics

•

Initiate global phase 3 registrational trial in combination with a PD-1 antibody for patients with gastric cancer

•

Initiate Phase 1/2 study in combination with a PD-1 antibody in HCC patients in mainland China and Hong Kong

•

Initiate global Phase 3 registrational study with Entasis

•

NDA preparation and potential submission

•

As of December 31, 2018, cash and cash equivalents and short-term investments totaled $263.3 million which includes the net proceeds from the follow-on offering in September 2018.

•

R&D expenses were $120.3 million for the year ended December 31, 2018 compared to $39.3 million for the same period in 2017. The increase in R&D expenses was primarily attributable to an increase in upfront licensing fees of $46.8 million from four new strategic partnerships in 2018 (including MacroGenics upfront fees of $25.0 million that were expensed in 2018 and paid in January 2019), ongoing and newly initiated late-stage clinical trials, payroll and payroll-related expenses, and expansion of research efforts to support internal programs.  

•

SG&A expenses were $21.6 million for the year ended December 31, 2018 compared to $12.0 million for the same period in 2017. The increase was primarily due to the increase in payroll and payroll-related expenses due to increased commercial and administrative headcount as Zai Lab expanded its operations.

•

For the year ended December 31, 2018, Zai Lab reported a net loss of $139.1 million, or net loss per share attributable to common stockholders of $2.64, compared to a net loss of $50.4 million, or net loss per share attributable to common stockholders of $2.32, for the year ended December 31, 2017.  

As of December 31,

2017

2018

$

$

Assets

Current assets:

Cash and cash equivalents

229,660,148

62,951,607

Short-term investments

—

200,350,000

Accounts receivable

—

89,708

Inventories

—

3,822

Prepayments and other current assets

954,506

5,749,260

Total current assets

230,614,654

269,144,397

Investments in equity investees

1,650,348

3,149,855

Prepayments for equipment

126,411

275,853

Property and equipment

11,853,764

20,494,482

Intangible assets

20,089

321,566

Long term deposits

306,825

556,738

Value added tax recoverable

5,062,137

8,044,258

Total assets

249,634,228

301,987,149

Liabilities and shareholders' equity

Current liabilities:

Short-term borrowings

—

3,642,616

Accounts payable

8,967,685

37,432,035

Other payables

3,101,459

7,766,843

Total current liabilities

12,069,144

48,841,494

Deferred income

2,394,124

2,063,942

Total liabilities

14,463,268

50,905,436

Shareholders' equity

Ordinary shares

2,995

3,481

Subscription receivable

(18

)

—

Additional paid-in capital

345,269,688

498,043,011

Accumulated deficit

(110,551,613

)

(249,626,508

)

Accumulated other comprehensive income

449,908

2,661,729

Total shareholders' equity

235,170,960

251,081,713

Total liabilities and shareholders' equity

249,634,228

301,987,149

Year ended December 31,

2017

2018

$

$

Revenue

—

129,452

Cost of sales

—

(43,590

)

Gross profit

—

85,862

Operating expenses:

Research and development

(39,341,518

)

(120,278,023

)

Selling, general and administrative

(12,049,518

)

(21,575,921

)

Loss from operations

(51,391,036

)

(141,768,082

)

Interest income

527,351

3,260,634

Interest expense

—

(39,672

)

Changes in fair value of warrants

200,000

—

Other income

933,158

1,968,325

Other expense

(403,997

)

(1,909,549

)

Loss before income tax and share of loss from

   equity method investment

(50,134,524

)

(138,488,344

)

Income tax expense

—

—

Share of loss from equity method investment

(249,652

)

(586,551

)

Net loss

(50,384,176

)

(139,074,895

)

Net loss attributable to ordinary shareholders

(50,384,176

)

(139,074,895

)

Loss per share - basic and diluted

(2.32

)

(2.64

)

Weighted-average shares used in calculating net

   loss per ordinary share - basic and diluted

21,752,757

52,609,810

Year ended December 31,

2017

2018

$

$

Net loss

(50,384,176

)

(139,074,895

)

Other comprehensive income, net of tax of nil:

Foreign currency translation adjustments

1,148,440

2,211,821

Comprehensive loss

(49,235,736

)

(136,863,074

)