ZLAB on Nasdaq

Zai Lab Limited

Chinese pharmaceutical company based in Shanghai, listed on Nasdaq (ZLAB)1

In its 2026 annual report the company says: “We are a patient-focused, innovative, commercial-stage, global biopharmaceutical company with a substantial presence in both Greater China and the United States. We are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease.”7

Price unavailable

Last updated Oct 21, 2026.

Overview

$457.2MRevenue, fiscal 20254
-$175.5MNet income, fiscal 20254

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  • TickerZLAB on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersShanghai1
  • Websitezailaboratory.com
  • Incorporated inCayman Islands5
  • Business address899 Halei Road, Building B, Pudong, Shanghai5
  • Filer categoryLarge accelerated filer5
  • Legal formcompany limited by shares3
  • LEI549300P2UYQ9U5LY1T583
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressPO Box 311, KY1-1205 George Town, Cayman Islands3

We are a patient-focused, innovative, commercial-stage, global biopharmaceutical company with a substantial presence in both Greater China and the United States. We are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. We intend to leverage our competencies and resources to positively impact human health. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline, including multiple commercial products and multiple programs in late-stage clinical development. We have also built an in-house R&D team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights.7 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-50.2%Operating margin4
-38.4%Net margin4
15.0%Revenue growth, 20254
-24.5%Return on equity4
-$158.9MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Zejula brought in 41% of the revenue Zai Lab Limited broke down this way in fiscal 2025.

  1. Zejula$189.0M441%up 1% from 2024
  2. Vyvgart/Vyvgart Hytrulo$94.2M421%up 1% from 2024
  3. Nuzyra$60.8M413%up 41% from 2024
  4. Optune$48.3M411%up 19% from 2024
  5. Qinlock$35.6M48%up 24% from 2024
  6. Xacduro$22.9M45%up 593% from 2024
  7. Augtyro$5.5M41%up 409% from 2024
  8. Product and Service, Other$717.0K40%
Products and services by year
Products and services202320242025
Zejula$168.8M$187.1M$189.0M
Vyvgart/Vyvgart Hytrulo$10.0M$93.6M$94.2M
Nuzyra$21.7M$43.2M$60.8M
Optune$47.0M$40.5M$48.3M
Qinlock$19.2M$28.8M$35.6M
Xacduro$0$3.3M$22.9M
Augtyro$0$1.1M$5.5M
Product and Service, Other$0$0$717.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue28¢$190.5M
  • Research and development32¢$220.9M
  • Selling, general and admin40¢$277.6M
  • Income tax0¢$2.9M

Out of $457.2M in revenue.4 The company lost money this year.

Financial statements

Revenue891011124$457.2M in 2025+354305% since 2018
0$200.0M$400.0M$600.0M2018: $129.0K$129.0K20182019: $13.0M$13.0M2019+9966%2020: $49.0M$49.0M2020+277%2021: $144.1M$144.1M2021+194%2022: $212.7M$212.7M2022+48%2023: $266.7M$266.7M2023+25%2024: $397.6M$397.6M2024+49%2025: $457.2M$457.2M2025+15%
Operating income891011124-$229.4M in 2025+62% since 2018
-$800.0M-$600.0M-$400.0M-$200.0M02018: -$141.8M-$141.8M20182019: -$203.2M-$203.2M2019+43%2020: -$301.8M-$301.8M2020+49%2021: -$700.1M-$700.1M2021+132%2022: -$404.4M-$404.4M2022−42%2023: -$366.6M-$366.6M2023−9%2024: -$282.1M-$282.1M2024−23%2025: -$229.4M-$229.4M2025−19%
Net income891011124-$175.5M in 2025+26% since 2018
-$800.0M-$600.0M-$400.0M-$200.0M02018: -$139.1M-$139.1M20182019: -$195.1M-$195.1M2019+40%2020: -$268.9M-$268.9M2020+38%2021: -$704.5M-$704.5M2021+162%2022: -$443.3M-$443.3M2022−37%2023: -$334.6M-$334.6M2023−25%2024: -$257.1M-$257.1M2024−23%2025: -$175.5M-$175.5M2025−32%

Every line of the income statement as filed: the last 3 fiscal years, latest first.4

Period ending2025-12-312024-12-312023-12-31
Product revenue, net$457.2M$397.6M$266.7M
Collaboration revenue$3.0M$1.4M$0
Total revenues$460.2M$399.0M$266.7M
Cost of product revenue-$190.5M-$147.1M-$95.8M
Cost of collaboration revenue-$561.0K-$742.0K$0
Research and development-$220.9M-$234.5M-$265.9M
Selling, general, and administrative-$277.6M-$298.7M-$281.6M
Gain on sale of intellectual property$0$0$10.0M
Loss from operations-$229.4M-$282.1M-$366.6M
Interest income$33.0M$37.1M$39.8M
Interest expenses-$5.2M-$2.3M$0
Foreign currency gains (losses)$19.6M-$15.1M-$14.8M
Other income, net$3.5M$5.3M$7.0M
Loss before income tax-$178.5M-$257.1M-$334.6M
Income tax benefit$2.9M$0$0
Net loss-$175.5M-$257.1M-$334.6M
Loss per share basic (in dollars per share)-$0.16-$0.26-$0.35
Loss per share diluted (in dollars per share)-$0.16-$0.26-$0.35
Weighted-average shares used in calculating net loss per ordinary share basic (in shares)1.1B shares989.5M shares966.4M shares
Weighted-average shares used in calculating net loss per ordinary share diluted (in shares)1.1B shares989.5M shares966.4M shares

Compare Zai Lab Limited with another company

Corporate structure

Zai Lab Limited sits at the top of its group. 8 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Zai Lab Limited

  • Zai Lab Limited Shanghai, China
    • Zai Anti Infectives (Hong Kong) Limited Subsidiary · Hong Kong
    • Zai Auto Immune (Hong Kong) Limited Subsidiary · Hong Kong
    • Zai Lab (AUST) Pty. Ltd. Subsidiary · Australia
    • Zai Lab (Hong Kong) Limited Subsidiary · Hong Kong
    • Zai Lab (Taiwan) Limited Subsidiary · Taiwan
    • Zai Lab (US) LLC Subsidiary · Delaware, United States
    • ZL China Holding Two Limited Subsidiary · Hong Kong

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Zai Lab Limited reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$89.6M4 Dec 31, 2025$85.1M4 Dec 31, 2024+5.3%
Accumulated depreciation$42.2M4 Dec 31, 2025$37.1M4 Dec 31, 2024+13.6%
Property and equipment, net$47.4M4 Dec 31, 2025$48.0M4 Dec 31, 2024−1.2%
Operating-lease assets (leased space)$19.2M4 Dec 31, 2025$21.5M4 Dec 31, 2024−10.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$679.6M4 Dec 31, 2025$449.7M4 Dec 31, 2024+51.1%
Marketable securities, current$10.0M4 Dec 31, 2025$330.0M4 Dec 31, 2024−97.0%
Long-term investments$3.1M12 Dec 31, 2024$9.2M12 Dec 31, 2023−66.2%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$76.1M4 Dec 31, 2025$56.0M4 Dec 31, 2024+35.9%
Finite-lived intangibles, gross$87.7M4 Dec 31, 2025$61.5M4 Dec 31, 2024+42.6%
Accumulated amortization$11.5M4 Dec 31, 2025$5.4M4 Dec 31, 2024+111.9%
Finite-lived intangibles, net$76.1M4 Dec 31, 2025$56.0M4 Dec 31, 2024+35.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$74.7M4 Dec 31, 2025$39.9M4 Dec 31, 2024+87.4%
Raw materials$23.1M4 Dec 31, 2025$13.3M4 Dec 31, 2024+74.1%
Work in process$5.8M4 Dec 31, 2025$2.5M4 Dec 31, 2024+127.6%
Finished goods$45.8M4 Dec 31, 2025$24.1M4 Dec 31, 2024+90.5%

Properties, in its own words

We lease our principal executive offices in Shanghai and Cambridge, Massachusetts as well as various administrative offices in Shanghai, Beijing, Guangzhou, Hong Kong, Taiwan, and South San Francisco, California and

research and development facilities in Shanghai and a small site in San Diego, California. We also lease two manufacturing facilities, including a small molecule and a large molecule facility, in Suzhou to support production of certain of our products and product candidates. In addition, we have completed the construction of a new office and research building in Suzhou. We believe these facilities are sufficient to meet our near-term needs.

Item 2 of the 10-K filed Feb 26, 2026.7

Leadership

Who has led Zai Lab Limited, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (14)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • ZL China Holding Two Limited Hong Kong6
  • Zai Anti Infectives (Hong Kong) Limited Hong Kong6
  • Zai Auto Immune (Hong Kong) Limited Hong Kong6
  • Zai Lab (AUST) Pty. Ltd. Australia6
  • Zai Lab (Hong Kong) Limited Hong Kong6
  • Zai Lab (Taiwan) Limited Taiwan6
  • Zai Lab (US) LLC Delaware6

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • Zai Lab LtdMay 30, 2017 to Oct 5, 20265

Timeline

  1. Aug 6, 20268-K Results of operations38
  2. Jun 17, 20268-K Shareholder vote39
  3. May 21, 20268-K Executive or director change40
  4. May 7, 20268-K Results of operations41
  5. Feb 26, 20268-K Results of operations42
  6. Nov 6, 20258-K Results of operations43
  7. Oct 16, 20258-K Entered a material agreement; New debt or obligation44
  8. Aug 7, 20258-K Results of operations45
  9. Jun 18, 20258-K Shareholder vote46
  10. May 8, 20258-K Results of operations47
  11. Feb 27, 20258-K Results of operations48
  12. Jan 3, 20258-K Entered a material agreement; New debt or obligation49
  13. Jan 4, 2021New chief executive Ying Du becomes CEO19

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.33) a share, on Nov 6, 2025.50

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results38
  2. May 7, 2026Reported quarterly or annual results41
  3. Feb 26, 2026Reported quarterly or annual results42
  4. Nov 6, 2025Reported quarterly or annual results43
  5. Aug 7, 2025Reported quarterly or annual results45
  6. May 8, 2025Reported quarterly or annual results47
  7. Feb 27, 2025Reported quarterly or annual results48
  8. Nov 12, 2024Reported quarterly or annual results51

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

519 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 58 major events, 232 insider forms, 40 large holders, 168 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Aug 21, 20264 EDGAR
  3. Aug 20, 2026144 EDGAR
  4. Aug 19, 2026144 EDGAR
  5. Aug 18, 20264 EDGAR
  6. Aug 13, 20264 EDGAR
  7. Aug 13, 20264 EDGAR
  8. Aug 12, 2026144 EDGAR
  9. Aug 11, 2026144 EDGAR
  10. Aug 6, 202610-Q EDGAR
  11. Aug 6, 20268-K EDGAR
  12. Jul 6, 20264 EDGAR
  13. Jul 6, 20264 EDGAR
  14. Jul 1, 20264 EDGAR
  15. Jun 30, 2026144 EDGAR
  16. Jun 29, 20264 EDGAR
  17. Jun 29, 20264 EDGAR
  18. Jun 29, 20264 EDGAR
  19. Jun 26, 2026144 EDGAR
  20. Jun 26, 2026144 EDGAR

The 519 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

129 open-market trades by officers, directors and large owners since October 2021: 9 buys and 120 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 19, 2026Chen YajingChief Financial OfficerSale260$27.00$7.0KForm 4
Aug 12, 2026Lis WilliamDirectorSale8,506$25.00$212.7KForm 4
Aug 11, 2026Chen YajingChief Financial OfficerSale619$25.00$15.5KForm 4
Jul 1, 2026GAYNOR RICHARDDirectorBuy1,736$19.05$33.1KForm 4
Jun 30, 2026Du YingChairperson & CEOSale7,026$18.53$130.2KForm 4
Jun 26, 2026Edmondson Frazor Titus IIIChief Legal OfficerSale4,103$17.46$71.6KForm 4
Jun 26, 2026Du YingChairperson & CEOSale24,543$17.46$428.5KForm 4
Jun 26, 2026Chen YajingChief Financial OfficerSale2,264$17.46$39.5KForm 4
Jun 22, 2026Lis WilliamDirectorSale7,040$18.09$127.4KForm 4
May 18, 2026Du YingChairperson & CEOSale50,000$19.00$950.0KForm 4
May 15, 2026Du YingChairperson & CEOSale50,000$20.74$1.0MForm 4
May 14, 2026Edmondson Frazor Titus IIIChief Legal OfficerSale3,517$20.19$71.0KForm 4
May 14, 2026Du YingChairperson & CEOSale50,000$20.09$1.0MForm 4
May 13, 2026Du YingChairperson & CEOSale50,000$19.97$998.3KForm 4
Apr 6, 2026Smiley Joshua LSee RemarksSale3,017$20.45$61.7KForm 4
Apr 6, 2026Edmondson Frazor Titus IIIChief Legal OfficerSale1,224$20.45$25.0KForm 4
Apr 6, 2026Du YingChairperson & CEOSale2,653$20.45$54.3KForm 4
Apr 6, 2026Chen YajingChief Financial OfficerSale853$20.45$17.4KForm 4
Apr 6, 2026Amado RafaelSee RemarksSale2,739$20.45$56.0KForm 4
Apr 2, 2026Smiley Joshua LSee RemarksSale9,614$20.39$196.0KForm 4

All 129 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Samantha (Ying) Du,61$908.7K$10.7M64
2025Josh Smiley56$672.8K$4.7M64
2025Rafael Amado62$641.7K$4.0M64
2025F. Ty Edmondson60$590.9K$3.3M64
2025Yajing Chen58$520.0K$3.2M64
2024Chief Executive Officer and Chairperson of the Board of Directors$901.0K$9.1M64
2024President and Chief Operating Officer$667.1K$5.5M64
2024PresidentHead of Global Research and Development$636.3K$3.6M64
2024Chief Legal Officer and Corporate Secretary$585.9K$2.8M64
2024Chief Financial Officer$502.5K$2.6M64
2023Chief Executive Officer and Chairperson of the Board of Directors$868.5K$12.0M64
2023President and Chief Operating Officer$637.5K$5.6M64
2023PresidentHead of Global Research and Development$620.0K$4.9M64
2023Chief Financial Officer$424.4K$2.0M64

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 93. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Rtw Investments, LP6,574,032$124.9M1.1%No change
TCG Crossover Management, LLC6,137,627$116.6M2.8%New
Ra Capital Management, L.P.5,743,533$109.1M0.9%+36,271
ADAR1 Capital Management, LLC3,369,034$64.0M3.0%+1,943,667
Fmr LLC2,815,214$53.5M0.0%+1,552,823
Goldman Sachs Group Inc2,315,480$44.0M0.0%+2,204,893
Woodline Partners LP2,207,293$41.9M0.1%New
Frazier Life Sciences Management, L.P.1,902,320$36.1M0.8%No change
Bamco Inc /ny/1,623,694$30.9M0.0%−34,624
Two Sigma Investments, LP1,299,394$24.7M0.0%+989,671
Citadel Advisors LLC1,284,706$24.4M0.0%−403,926
Rock Springs Capital Management LP814,707$15.5M0.8%No change
BlackRock, Inc.664,462$12.6M0.0%−200,684
Jane Street Group, LLC476,541$9.1M0.0%+208,615
B Group, Inc.450,646$8.6M4.9%No change
Nantahala Capital Management, LLC400,000$7.6M0.2%New
Schroder Investment Management Group393,167$7.2M0.0%No change
Nan Fung Trinity (hk) Ltd346,466$6.6M0.6%No change
Aberdeen Group plc311,294$5.9M0.0%+73,555
Citigroup Inc300,775$5.7M0.0%+299,816
Spruce Street Capital LP279,110$5.3M1.0%New
Ameriprise Financial Inc253,171$4.8M0.0%+9,614
BNP PARIBAS ASSET MANAGEMENT Holding S.A.246,982$4.7M0.0%+130,422
Hennion & Walsh Asset Management, Inc.230,418$4.4M0.1%+16,095
Hudson Bay Capital Management LP215,000$4.1M0.0%+185,000

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Zai Lab Limited is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARZai Lab Ltd2
  • CIK0001704292
  • Employer ID (EIN)98-11445957
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company7
  • Incorporated inCayman Islands7
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address899 Halei Road, Building B, Pudong, Shanghai, China2
  • Phone8621616325882
  • Shares outstanding1,106,407,390 Common Stock shares; 307,140,690 Adr shares as of Feb 20, 20267
  • Public float$3.8B as of Jun 30, 20257
  • AuditorKPMG LLP, Short Hills, New Jersey PCAOB ID 185; it also attests to the company’s internal control over financial reporting7
  • On EDGAR sinceMay 30, 20172
  • Filings736 in all: 4 (256), 144 (116), 8-K (71), 6-K (55), SC 13G/A (31), 3 (21), 10-Q (17), CORRESP (16)2
    All 45 form types

    UPLOAD (16), SC 13G (14), SCHEDULE 13G/A (13), 424B5 (8), DEF 14A (7), DEFA14A (7), PRE 14A (7), 10-K (6), 4/A (6), S-8 (6), SCHEDULE 13G (6), F-1/A (5), ARS (4), CT ORDER (4), DRSLTR (4), 20-F (3), 20-F/A (3), 5 (3), DRS/A (3), EFFECT (3), 3/A (2), 424B2 (2), 424B4 (2), 8-K/A (2), DRS (2), F-1 (2), S-3ASR (2), SEC STAFF LETTER (2), 10-K/A (1), 144/A (1), 424B3 (1), 8-A12B (1), F-1MEF (1), F-3ASR (1), F-6 (1), F-6EF (1), POSASR (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per shareZLABThe Nasdaq Global Market
Ordinary Shares, par value $0.000006 per share9688

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Zai Lab Limited names in Item 1A of its 10-K filed Feb 26, 2026: 75 risks under these headings, as written.7

  • Risks Related to Doing Business in China
  • Uncertainties in the Chinese legal system could materially and adversely affect us.
  • Changes in relations between the United States and China, as well as relations between China and other countries, may adversely impact our business, financial condition, and results of operations.
  • The Chinese government may intervene in or influence our business, which could result in a material change in our operations, strategy, research and development activities, commercial activities, business, financial condition, results of operations, prospects, and the value of our securities.
  • Because the majority of our operations are in mainland China, there have been concerns regarding oversight of audits of our financial statements filed with the SEC.
  • We may be subject to additional approval, filing, and compliance obligations with Chinese authorities in connection with our engagement of KPMG LLP, a U.S. auditor that is subject to PCAOB inspection.
  • We are subject to extensive data protection, privacy, and information security laws, regulations, and policies in China. Compliance with such laws, rules, and regulations, and any other future laws and regulations in these areas, may entail significant expenses and could materially affect our business and results of operations, including as a result of government enforcement actions and significant penalties.
  • The economic, political, and social conditions in mainland China, as well as governmental policies, could affect the business environment and financial markets in mainland China and our ability to operate our business, financial condition, results of operations, and prospects.
  • We are required to obtain certain approvals and licenses from Chinese authorities to operate our Chinese subsidiaries.
  • Under Chinese laws and regulations, we may be required by the CSRC or other Chinese regulatory authorities to obtain approval or follow certain procedures to issue our securities to foreign investors, and we cannot predict whether or when we will be able to obtain such approval or complete such procedures.
  • We may be exposed to liabilities under anti-corruption, anti-bribery, and anti-fraud laws in China and the United States, including the FCPA, and any allegation, investigation, or determination that we, or our employees or contracted third parties, have violated such laws could have a material adverse effect on our business or reputation.
  • Restrictions on currency exchange may limit our ability to receive and use financing in foreign currencies effectively.
The other 64 risks
  • We may rely on dividends and other distributions on equity paid by our Chinese subsidiaries to fund any cash and financing requirements we may have, and any limitation on the ability of our Chinese subsidiaries to make payments to us could have a material adverse effect on our business operations.
  • Chinese regulations relating to the establishment of offshore special purpose companies by residents in mainland China may subject our China resident beneficial owners or our wholly foreign-owned subsidiaries in mainland China to liability or penalties, limit our ability to inject capital into these subsidiaries, limit the ability of these subsidiaries to increase their registered capital or distribute profits to us, or otherwise adversely affect us.
  • Chinese regulations establish complex procedures for certain acquisitions of mainland China based companies by foreign investors, which could make it more difficult for us to pursue growth through acquisitions in mainland China.
  • Completing the necessary inspection and approval processes for our Chinese manufacturing facilities, such as by the FDA, NMPA, and EMA, may be time consuming and costly.
  • Our business benefits from certain financial incentives and discretionary policies granted by local governments. Expiration of, or changes to, these incentives or policies would have an adverse effect on our business, financial condition, and results of operations.
  • It may be difficult for shareholders and regulators outside of mainland China to conduct investigations or collect evidence in mainland China.
  • If we are classified as a Chinese resident enterprise for Chinese income tax purposes, such classification could result in unfavorable tax consequences to us and our non-Chinese shareholders or ADS holders.
  • We and our shareholders may face tax consequences and other requirements in mainland China with respect to indirect transfers of equity interests in Chinese resident enterprises.
  • Certain of our investments may be subject to review from the Committee on Foreign Investment in the United States, which may delay or block a transaction from closing.
  • Changes in United States and international trade policies and relations, particularly with regard to China, may adversely impact our business, financial condition, and results of operations.
  • It may be difficult to enforce against us or our management in mainland China any judgments obtained from foreign courts.
  • Failure to renew our current leases or locate desirable alternatives for our leased properties could materially and adversely affect our business.
  • Risks Related to Our Financial Position
  • We have incurred significant losses since our inception and anticipate that we will continue to incur losses for at least the next few quarters. If we are unable to generate sufficient revenue from our commercial products, on the anticipated timeline or at all, at a level that more than offsets our expenses, we will be unable to achieve or maintain profitability.
  • We may seek additional funding, such as for our product development programs and commercialization efforts, which may not be available on acceptable terms or at all. If we are unable to raise capital on acceptable terms when needed, we could be forced to delay, reduce, or terminate certain programs or activities.
  • We and our subsidiaries have entered into debt arrangements with certain financial institutions in China, and we may in the future consider additional debt arrangements, to fund our business or working capital needs. Such debt arrangements may restrict our future operations.
  • We may enter into certain capital raising, business collaboration, or other arrangements that may cause dilution to our shareholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • We may not be able to access the capital and credit markets on terms that are favorable to us.
  • Our results of operations may be adversely affected by sustained periods of increased inflation.
  • Risks Related to Our Business and Industry
  • Our ability to generate revenues is highly dependent on the success of our commercial products and our ability to obtain regulatory approvals for our product candidates.
  • If we are not successful in gaining broad acceptance of our commercial products, our business would be harmed.
  • We may not obtain regulatory approval of our product candidates, on the anticipated timeline or at all, which could delay or limit our ability to realize the full potential of our product pipeline.
  • We have limited experience manufacturing our products and product candidates on a large clinical or commercial scale. We rely on third parties for our supply chain, and if we experience problems with any of these third parties, the manufacture of our products or product candidates could be delayed, which could harm our business and results of operations.
  • If our manufacturing facilities are damaged or destroyed, or production at such facilities is otherwise interrupted, or if any new manufacturing facilities are not approved by regulators, our business and prospects would be negatively affected.
  • We have a limited operating history, which may make it difficult for you to evaluate the success of our business and to assess our future prospects.
  • We may decide to pursue a particular product, product candidate, or indication and fail to pursue other products, product candidates, or indications that may later prove to be more profitable or for which there is a greater likelihood of success.
  • The market opportunities for certain of our products and product candidates may be small, such as when those opportunities are limited to patients who are ineligible for other treatment options or who have not responded to prior treatments, and our estimations with respect to these populations may be inaccurate.
  • The pharmaceutical industry is highly regulated, and such regulations are subject to change, which may affect the approval and commercialization of our products and product candidates, and any failure to comply with such regulations could have adverse legal and financial impact.
  • If safety, efficacy, manufacturing, or supply issues arise with any therapy or treatment that we use in combination with our products and product candidates, such as chemotherapy drugs, we may be unable to market such products or product candidate or may experience significant regulatory delays or supply shortages, and our business could be materially harmed.
  • We face substantial competition, which may result in our competitors discovering, developing, or commercializing drugs before or more successfully than we do, or developing products or therapies that are more advanced or effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our products and product candidates.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome.
  • We may incur additional costs or experience delays in completing pre-clinical or clinical trials or ultimately be unable to complete the development and commercialization of our product candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, the progress of such clinical trials and our receipt of necessary regulatory approvals could be delayed or prevented.
  • Our products and product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any regulatory approval.
  • If we are unable to obtain NMPA approval for our products and product candidates to be eligible for an expedited registration pathway, the time and cost we incur to obtain regulatory approvals may increase. Even if we receive a Category 1 drug designation, it may not lead to a faster development, review, or approval process.
  • We continue to be subject to ongoing obligations and continued regulatory review with respect to our commercial products, which may result in significant additional expense, and if we fail to comply with ongoing regulatory requirements or experience any unanticipated problems with any of our commercial products, we may be subject to penalties.
  • Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.
  • As the Company develops globally, we may increase the size and capabilities of our organization, and we may experience difficulties in managing such growth.
  • We may explore additional regional or global licensing or collaboration arrangements for the development and/or commercialization of product candidates, which may expose us to significant additional costs, such as upfront fees, milestone payments, royalty payments, and the costs of related clinical or pre-clinical trials, may divert management attention or resources away from our other products and product candidates, and may expose us to additional risks of conducting business in additional international markets.
  • We may engage in future partnerships, in-licensing arrangements, joint ventures, or other types of business acquisitions that could disrupt our business, cause dilution to holders of our securities, and harm our financial condition and operating results.
  • We may need to significantly reduce our prices for our approved products in mainland China to be included in the NRDL for reimbursement, which could diminish our sales or adversely affect our profitability.
  • Companies in mainland China that manufacture or sell drugs and medical devices are required to comply with extensive regulations and hold a number of permits and licenses to carry on their business. Our ability to obtain and maintain these regulatory approvals is uncertain, and future government regulation may place additional burdens on our efforts to commercialize our products and product candidates.
  • If we fail to maintain our licenses or other intellectual property-related agreements for our products or product candidates or if we otherwise experience disruptions or disputes relating to our business relationships, we could lose the ability to continue the development and commercialization of our products and product candidates, and such disputes could cause us to use substantial resources.
  • Reputational harm to our products, including product liability claims or lawsuits against us or any of our licensors, could cause us to incur substantial liabilities or loss of revenue or harm our reputation.
  • Potential cybersecurity threats are changing rapidly and advancing in sophistication. We may not be able to protect our systems and networks, or the confidentiality of our confidential or other information (including personal information), from cyberattacks and other unauthorized access, disclosure, and disruption.
  • We may experience operational, regulatory, and competitive risks due to our use of artificial intelligence.
  • We, our employees, and our contracted third parties are subject to laws and government regulations relating to privacy and data protection that have required us to modify certain of our policies and procedures with respect to the collection and processing of personal data, and future laws and regulations may cause us to incur additional expenses or otherwise limit our ability to collect and process personal data.
  • We may face further restrictions (or even prohibitions) on our ability to transfer our scientific data abroad if Chinese regulators impose new restrictions (or change their interpretation of existing restrictions) on life sciences companies like us and the scientific data we obtain, generate, and maintain.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties, including our licensors, CMOs, and other suppliers, to support the commercial and clinical supply of our products and product candidates. Failure of such third parties to supply us with a sufficient quantity of products, in a timely matter or at all, may adversely affect our business.
  • We rely on third parties to conduct our pre-clinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products or product candidates and our business could be substantially harmed.
  • If we lose our relationships with CROs, our product development efforts could be delayed.
  • We depend on other parties to manage certain intellectual property rights that are material to our business. Any failure to effectively protect these rights could adversely affect our business and operations.
  • We rely on third-party distributors to sell our commercial products, and a limited number of customers have generated a substantial portion of our revenue. If we fail to maintain an effective distribution channel for our products, our business and sales of the relevant products could be adversely affected.
  • The illegal distribution and sale by third parties of counterfeit versions of our products or stolen products could have a negative impact on our reputation and business.
  • Our business, results of operations, and financial condition may be adversely affected by deterioration in the credit quality of, or defaults by, our customers, and our deposits and investments may be negatively affected by fluctuations in interest rates.
  • Risks Related to Intellectual Property
  • If we are unable to obtain and maintain protection for our products and product candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties may compete directly against us.
  • Our owned or in-licensed patents could be found invalid or unenforceable if challenged in court or before the U.S. Patent and Trademark Office or other foreign authority.
  • We may not be able to protect our intellectual property.
  • Developments or uncertainties in patent law could have a negative impact on our business.
  • If we are unable to maintain the confidentiality of our trade secrets, our business and competitive position may be harmed.
  • If our products or product candidates infringe, misappropriate, or otherwise violate the intellectual property rights of third parties, we may incur substantial liabilities, and we may be unable to sell or commercialize these products and product candidates.
  • Intellectual property litigation and proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • We may be subject to claims that we or our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or are in breach of confidentiality, non-disclosure, non-use, non-competition, or non-solicitation agreements with such current or former employers, some of whom may be our competitors or potential competitors.
  • We may not be successful in obtaining intellectual property rights for acquired or in-licensed product candidates.
  • If we or our licensors or collaboration partners do not obtain patent term extension and data exclusivity for our products or their products or any product candidates we may develop, our business may be materially harmed.

Legal proceedings

We are, from time to time, subject to various claims, lawsuits, and other legal and administrative proceedings arising in the ordinary course of business. Some of these claims, lawsuits, and other proceedings may involve highly complex issues that are subject to substantial uncertainties and could result in damages, fines, penalties, non-monetary sanctions, or relief. However, we do not consider any such claims, lawsuits, or proceedings that are currently pending, individually or in the aggregate, to be material to our business or likely to result in a material adverse effect on our future operating results, financial condition, or cash flows.

The opening of Item 3, Legal Proceedings.7

Sources

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