Exhibit

No.

Description

99.1

Press release issued March 19, 2020.

ZAI LAB LIMITED

By: 

/s/ Billy Cho

Name:

Billy Cho

Title:

Chief Financial Officer

Date: March 19, 2020

•

In March 2020, Zai Lab announced that the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA for first-line maintenance treatment of patients with ovarian cancer.

•

Based on IQVIA data, ZEJULA was the leading PARP inhibitor with market share in Hong Kong of 71% by value for 2019. ZEJULA was also ranked amongst the top 5 oncology drugs launches in Hong Kong after 2014 behind Keytruda®, Opdivo®, Tecentriq® and Tagrisso® based on first full-year revenue.

•

In February 2020, Zai Lab dosed the first patient in the Phase 1b study of niraparib with MGD013, a first-in-class PD1/LAG-3 bispecific antibody, in advanced or metastatic gastric cancer.

•

In February 2020, Zai Lab terminated the Phase 3 study of niraparib as first-line maintenance treatment of patients with small-cell lung cancer due to changes in the treatment landscape in China.

•

In January 2020, Zai Lab launched ZEJULA in China.

•

In December 2019, Zai Lab announced that the China NMPA approved the NDA for ZEJULA as maintenance treatment of patients with recurrent ovarian cancer. This approval represents the fastest approval time by the NMPA in 2019 for a locally manufactured, category 1 oncology drug.

•

In November 2019, Zai Lab completed enrollment of the China Phase 3 PRIME study of ZEJULA in patients with first-line ovarian cancer.

•

Initiate registrational bridging trial for late-line ovarian cancer treatment in second half of 2020

•

Expect final clinical data from the NORA study, the pivotal trial for maintenance therapy of Chinese patients with recurrent ovarian cancer in first half of 2020

•

Continue to collaborate with our Partner GSK on additional indications and opportunities

•

In January 2020, Zai Lab announced that the first patient has been enrolled in a Phase 2 pilot clinical trial evaluating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as first-line treatment in patients with gastric adenocarcinoma.

•

In September 2019, the NMPA accepted the Marketing Authorization Application (MAA) of Optune, a Tumor Treating Fields delivery system for the treatment of glioblastoma (GBM).

•

Potential China GBM MAA approval with trial waiver in first half of 2020

•

Complete enrollment of the Phase 2 pilot clinical trial in first-line gastric adenocarcinoma in 2020

•

File MAA for malignant pleural mesothelioma in China

•

Partner Milestone: Novocure to announce interim results from Phase 3 pivotal LUNAR trial in patients with non-small cell lung cancer in second half of 2020

•

In November 2019, Zai Lab received the Clinical Trial Authorization (CTA) approval for the registrational bridging study of ripretinib in patients with advanced GIST. The previously announced positive top-line data from the pivotal Phase 3 INVICTUS clinical study of ripretinib in patients with advanced GIST will support the NDA package of ripretinib in China.

•

Submit NDA to the China NMPA for advanced GIST in 2020

•

Initiate bridging trial for second-line GIST in second half of 2020

•

In February 2020, Zai Lab announced that the first patient has been dosed in the registrational bridging study of margetuximab, in combination with chemotherapy, for the treatment of patients with metastatic HER2-positive breast cancer.

•

In February 2020, Zai Lab received CTA approval for the Phase 2/3 MAHOGANY study, a clinical trial of margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as first-line treatment for patients with advanced HER2-positive gastric cancer and gastroesophageal junction (GEJ) cancer.

•

Enroll first Chinese patient in second half of 2020 in the global Phase 2/3 MAHOGANY initiated by MacroGenics

•

Partner Milestone: MacroGenics expects final overall survival (OS) data from the Phase 3 SOPHIA study in HER2+ metastatic breast cancer by year end of 2020. MacroGenics also anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020

•

In March 2020, Zai Lab entered into a contract sales agreement with Hanhui, a leading local pharmaceutical company with a strong commercial presence in antibiotics. The agreement allows us to leverage Hanhui’s existing infrastructure to optimize an anticipated future commercial launch of omadacycline in China given that omadacycline is a broad spectrum antibiotic in both the hospital and community setting.

•

In February 2020, Zai Lab announced that the NMPA has accepted its NDA with Category 1 new drug designation for NUZYRA for the treatment of CABP and ABSSSI.

•

In February 2020, Zai Lab submitted a request for Priority Review to the NMPA for patients developing CABP in the context of coronavirus infection.

•

In March 2020, Zai Lab’s partner Entasis Therapeutics announced it expects top-line results of the global Phase 3 ATTACK (Acinetobacter Treatment Trial Against Colistin) registrational trial in early 2021.

•

Enroll first Chinese patient into the global Phase 3 ATTACK trial in first half of 2020

•

Enroll first Chinese patient to the global Phase 1 basket trial in second half of 2020

•

Initiate pivotal study in second-line MSI-high endometrial cancer in China in second half of 2020

•

Enroll first Chinese patient into the Incyte-sponsored global Phase 3 study of INCMGA0012 with platinum-based chemotherapy in first-line metastatic squamous and non-squamous non–small cell lung cancer in China in second half of 2020

•

Zai Lab’s partner Five Prime Therapeutics expects futility results from the Phase 3 FIGHT trial in gastric and GEJ cancer in mid-2020

•

Submit two global Investigational New Drug (IND) applications in 2020

•

Research facilities located in Menlo Park, California scheduled to open in mid-2020

•

Continue to pursue bolt-on and transformational business development opportunities

•

In January 2020, Zai Lab announced the closing of an underwritten public offering of 5,500,000 American depositary shares (“ADSs”) at a price of $47.50 per ADS. In addition, the underwriters fully exercised their option to purchase an additional 500,000 ADSs at the public offering price. Total proceeds, net of underwriting fees and other offering expenses, were $281.3 million.

•

In January 2020, Zai Lab announced the appointment of Lonnie Moulder, formerly chief executive officer of TESARO, to its Board of Directors.

•

In December 2019, Zai Lab announced the appointment of Timothy Yap, M.D., Ph.D., to its Scientific Advisory Board.

•

Zai Lab continues to expand its U.S. presence to enhance internal drug discovery and business development, with the securing of a lease for a larger facility in San Francisco and the opening of a Boston office.

•

Zai Lab continues to expand and hire talented professionals. As of February 2020, Zai Lab employed 733 full-time employees, with 293 and 340 employees engaged in R&D and commercial activities, respectively.  

•

Revenues for the full year of 2019 were $13.0 million, compared to $0.1 million in 2018. Revenues for the period were comprised of $6.6 million in sales of ZEJULA in Hong Kong and Macau, and $6.4 million of in sales of Optune in Hong Kong.

•

R&D expenses were $142.2 million for 2019, compared to $120.3 million for 2018. The increase in R&D expenses was primarily attributable to ongoing and newly initiated late-stage clinical trials, payroll and payroll-related expenses from increased R&D headcount and expansion of research efforts to support internal development programs.  

•

Selling, General & Administrative expenses were $70.2 million for 2019, compared to $21.6 million for 2018. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and related costs as Zai Lab expanded its commercial operations in China.

•

For the full year of 2019, Zai Lab reported a net loss of $195.1 million, or net loss per share attributable to common stockholders of $3.03, compared to a net loss of $139.1 million, or net loss per share attributable to common stockholders of $2.64, for the full year of 2018.

•

As of December 31, 2019, cash and cash equivalents, short-term investment and restricted cash totaled $276.4 million. In addition, in January 2020, Zai Lab announced the closing of an underwritten public offering with total proceeds, net of underwriting fees and other offering expenses, of approximately $281.3 million.

As of December 31,

2018

2019

$

$

Assets

Current assets:

Cash and cash equivalents

62,951,607

75,932,037

Short-term investments

200,350,000

200,000,000

Accounts receivable

89,708

3,791,407

Inventories

3,822

6,004,932

Prepayments and other current assets

5,749,260

6,735,917

Total current assets

269,144,397

292,464,293

Restricted cash, non-current

—

510,218

Investments in equity investees

3,149,855

2,397,655

Prepayments for equipment

275,853

439,604

Property and equipment, net

20,494,482

21,353,437

Operating lease right-of-use assets

—

15,071,292

Land use rights

—

7,655,115

Intangible assets, net

321,566

1,147,797

Long term deposits

556,738

377,128

Value added tax recoverable

8,044,258

13,736,949

Total assets

301,987,149

355,153,488

Liabilities and shareholders' equity

Current liabilities:

Short-term borrowings

3,642,616

6,450,503

Accounts payable

37,432,035

22,659,600

Current operating lease liabilities

—

4,350,765

Other current liabilities

7,766,843

13,174,389

Total current liabilities

48,841,494

46,635,257

Deferred income

2,063,942

2,881,351

Non-current operating lease liabilities

—

10,976,846

Total liabilities

50,905,436

60,493,454

Shareholders' equity

Ordinary shares (par value of US$0.00006 per share;

   83,333,333 shares authorized, 58,006,967 and

   68,237,247 shares issued and outstanding as of

   December 31,2018 and 2019, respectively)

3,481

4,094

Additional paid-in capital

498,043,011

734,733,914

Accumulated deficit

(249,626,508

)

(444,697,632

)

Accumulated other comprehensive income

2,661,729

4,619,658

Total shareholders' equity

251,081,713

294,660,034

Total liabilities and shareholders' equity

301,987,149

355,153,488

For the year ended

December 31,

2018

2019

$

$

Revenue

129,452

12,984,751

Cost of sales

(43,590

)

(3,748,806

)

Gross profit

85,862

9,235,945

Operating expenses:

Research and development

(120,278,023

)

(142,221,056

)

Selling, general and administrative

(21,575,921

)

(70,210,828

)

Loss from operations

(141,768,082

)

(203,195,939

)

Interest income, net

3,220,962

7,939,230

Other income, net

58,776

937,785

Loss before income tax and share of loss from equity

   method investment

(138,488,344

)

(194,318,924

)

Income tax expense

—

—

Share of loss from equity method investment

(586,551

)

(752,200

)

Net loss

(139,074,895

)

(195,071,124

)

Net loss attributable to ordinary shareholders

(139,074,895

)

(195,071,124

)

Loss per share - basic and diluted

(2.64

)

(3.03

)

Weighted-average shares used in calculating net loss per

   ordinary share - basic and diluted

52,609,810

64,369,490

For the year ended

December 31,

2018

2019

$

$

Net loss

(139,074,895

)

(195,071,124

)

Other comprehensive income, net of tax of nil:

Foreign currency translation adjustments

2,211,821

1,957,929

Comprehensive loss

(136,863,074

)

(193,113,195

)