ZLAB

EX-99.1

2 zlab-202686x8kex991.htm

EX-99.1

Document

Exhibit 99.1

Zai Lab Announces Second Quarter 2026

Financial Results and Recent Corporate Updates

–The Company advanced multiple global oncology and immunology programs toward key clinical and regulatory milestones, with significant pipeline catalysts expected in the second half of 2026

–Global Phase 1 data for zocilurtatug pelitecan (zoci) in combination with a PD-L1 inhibitor in first-line SCLC to be presented at ESMO 2026; planned initiation of a registrational Phase 3 study later this year

–Registrational Phase 3 DLLEVATE study evaluating zoci in second-line plus SCLC remains on track, with enrollment expected to be completed in the first half of 2027, supporting a potential U.S. accelerated approval submission in 2027

–Global Phase 1/1b study of ZL-1503, a potential first-in-class long-acting IL-13/IL-31Rα bispecific antibody for the treatment of atopic dermatitis, continues to advance, with initial first-in-human data expected in the second half of 2026

–KarXT successfully launched in mainland China; encouraging early launch trends building momentum ahead of potential NRDL inclusion

–Total revenues of $106.3 million in the second quarter of 2026; net product revenue grew 11% versus prior quarter driven by stabilization of ZEJULA and double-digit volume growth for VYVGART; commercial business positioned for a return to meaningful growth in 2027

Conference call and webcast today, August 6, 2026, at 8:00 a.m. ET (8:00 p.m. HKT)

SHANGHAI & CAMBRIDGE, Mass., August 6, 2026 -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the second quarter of 2026, along with recent product highlights and corporate updates.

“Zai Lab is entering an exciting new chapter in our evolution,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “Over the past several years, we have evolved from bringing innovative medicines to patients in China to becoming a global biopharmaceutical company developing our own differentiated medicines for patients around the world. Today, our innovation pipeline is rapidly maturing. We advanced zocilurtatug pelitecan (zoci), our potential best-in-class DLL3 antibody-drug conjugate (ADC), from Investigational New Drug (IND) to global Phase 3 in under two years, and our growing portfolio of internally developed medicines, including ZL-1503, gives us confidence that innovation will increasingly drive Zai Lab's next phase of growth. Meanwhile, we continue to strengthen our commercial business. This quarter, we sharpened our commercial focus, delivered sequential revenue growth, maintained commercial profitability, and laid the foundation for a return to meaningful growth in 2027. Together, these achievements position Zai Lab to create long-term value for patients and shareholders.”

“We are excited about the progress across our growing global pipeline, with three registrational studies expected to be underway by year end and the potential for our first U.S. regulatory submission next year,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Zoci has demonstrated a differentiated profile — strong systemic and intracranial activity with a favorable safety profile — that supports development across multiple treatment settings in small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNECs). In immunology, ZL-1503 has the potential to address both inflammation and itch through dual inhibition of IL-13 and IL-31. Combined with its extended half-life enabled by YTE modifications, we believe its differentiated profile has the potential to address significant unmet needs in one of the largest markets in immunology. We look forward to sharing important clinical updates for both programs in the second half of the year.”

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Second Quarter 2026 Financial Results

•Total revenue was $106.3 million in the second quarter of 2026, compared to $110.0 million for the same period in 2025. Product revenue, net was $105.8 million in the second quarter of 2026, compared to $109.1 million for the same period in 2025. Net product revenue increased 11% versus the prior quarter, driven by stabilization of ZEJULA and continued volume growth for VYVGART. In the second half of the year, we expect to further stabilize product sales while laying the foundation for a return to meaningful growth in 2027.

•Research and Development (R&D) expenses were $61.8 million in the second quarter of 2026, compared to $50.6 million for the same period in 2025. This increase was primarily due to an increase in licensing fees under our license and collaboration agreements, partially offset by decreased clinical and pre-clinical costs.

•Selling, General and Administrative (SG&A) expenses were $72.9 million in the second quarter of 2026, compared to $71.0 million for the same period in 2025. SG&A remained relatively flat year over year, reflecting continued

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 26, 2026

ZAI LAB LIMITED

(Exact name of registrant as specified in its charter)

Cayman Islands001-3820598-1144595 (State or other jurisdiction of incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

899 Halei Road Building B, Pudong Shanghai, China 201203

314 Main Street 4th Floor, Suite 100 Cambridge, MA, USA02142 (Address of principal executive offices)(Zip Code)

+86 21 6163 2588 +1 857 706 2604 (Registrant’s Telephone Number, Including Area Code) Not Applicable (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act: Title of each classTrading Symbol(s) Name of each exchange on which registered

American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per shareZLABThe Nasdaq Global Market Ordinary Shares, par value $0.000006 per share*9688The Stock Exchange of Hong Kong Limited

*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On February 26, 2026, Zai Lab Limited issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The information contained in this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description

99.1Press Release issued by Zai Lab Limited on February 26, 2026

104The cover page of this report is formatted in Inline XBRL

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ZAI LAB LIMITED

By:/s/ Yajing Chen Yajing Chen

Chief Financial Officer

Date: February 26, 2026