Paragraph 47 · 47% changed
Every version of it
Screener
/
SEC EDGAR
/CIK 0001704292
/10-K filed Feb 26, 2026, compared with Feb 27, 2025
/Numbers from the XBRL of the 10-Ks
Nasdaq
Health care · Pharmaceuticals
Zai Lab Ltd ZLAB
The 10-K against last year's
101 changes: 16 added, 12 removed, 71 reworded, 2 quiet changes
10-K Feb 26, 2026 vs Feb 27, 2025
Risk Factors
10.1%
of the text changed · 34,984 words now · 10 new paragraphs, 8 gone
MD&A
17.2%
of the text changed · 4,184 words now · 6 new paragraphs, 4 gone
Legal Proceedings
7.2%
of the text changed · 246 words now
Accounting Policies
5.8%
of the text changed · 4,510 words now
10-K 0001704292-26-000015 (Feb 26, 2026) vs 10-K 0001628280-25-008409 (Feb 27, 2025)
Every paragraph, and how much of it changed
One bar per paragraph, in the order of the 10-K. Height and colour show the share of its words not in the closest paragraph a year earlier; the tallest bars are new paragraphs.
Risk Factors
439 paragraphs · 10 new · 81 reworded · 8 gone · 10-K Feb 26, 2026 against Feb 27, 2025
New paragraph
Reworded (5% of its words or more)
Same or nearly
Paragraph 151 · 44% changed
Every version of it
We are a commercial-stage biopharmaceutical company with a relatively limited operating history. Consequently, any predictions about our future success, performance, or prospects are subject to significant uncertainty, particularly in light of the dynamic and evolving industry in which we operate. We will encounter risks and difficulties frequently experienced by companies in our industry as we continue to expand or enhance our commercial activities. In addition, as a commercial-stage business, we may be more likely to encounter unforeseen expenses, difficulties, complications, and delays. If we do not address these risks and difficulties successfully, our business will suffer.
Paragraph 81 · 41% changed
Every version of it
Although there are some protections with respect to enforcement in mainland China of judgments rendered by Hong Kong courts as a result of reciprocal recognition and enforcement of judgment arrangements, mainland China does not have treaties or agreements providing for the reciprocal recognition and enforcement of judgments awarded by courts of the United States, the United Kingdom, most other western countries, or Japan. In addition, according to PRC Civil Procedures Law, mainland China courts will not enforce a foreign judgment against us or our directors and officers if they decide that the judgment violates the basic principles of Chinese laws or national sovereignty, security, or public interest. Hence, the recognition and enforcement in mainland China of judgments of a court in any of these jurisdictions in relation to any matter not subject to a binding arbitration provision may be difficult or even impossible.
Paragraph 173 · 39% changed
Every version of it
Paragraph 409 · 38% changed
Every version of it
Paragraph 101 · 38% changed
Every version of it
Paragraph 380 · 37% changed
Every version of it
The value of the RMB or HK dollar against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in political and economic conditions. With the development of the foreign exchange market and progress towards interest rate liberalization and RMB internationalization, the Chinese government has announced, and may again in the future announce, changes to the exchange rate system. There is no guarantee that the RMB will not appreciate or depreciate significantly in value against the U.S. dollar. It is difficult to predict how market forces or Chinese or U.S. government policy may impact the exchange rate between the RMB and the U.S. dollar in the future.
Paragraph 356 · 37% changed
Every version of it
Over the lifetime of any patent rights we hold, certain government fees will be paid to a patent office in the respective jurisdiction for any patent application(s) and on any patent(s) resulting therefrom. In some of our licensed matters, we rely on our licensors to pay these fees. In addition to the payment of fees, during the patent application process, the patent office of any given jurisdiction requires compliance with procedural and documentary provisions. In some of our licensed matters, we rely on our licensors to comply with these requirements. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules of a jurisdiction. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction, which may have a material adverse effect on our business, financial condition, results of operations, and prospects.
Paragraph 47 · 47% changed
Every version of it
10-K Feb 27, 2025Furthermore, we have been, and may in the future be, involved in inquiries or investigations by Chinese authorities as part of these enforcement efforts or otherwise. Although we have not experienced a material adverse impact to the Company from such an inquiry or investigation to date, there can be no such assurance that such inquiries or investigations will not have a material adverse effect on our business, reputation, or operations in the future. For example, there have been public reports of recent investigations by Chinese authorities in relation to alleged medical insurance fraud and potential violations of China’s data privacy and other laws by a number of persons affiliated with AstraZeneca. Certain of our former and current employees were formerly employed with AstraZeneca. Some of our current and former employees in our ZEJULA sales team are under criminal investigations by Chinese authorities in their personal capacity and have been detained for questioning or otherwise under police compulsory measures in connection with alleged medical insurance fraud, a crime under Chinese law that can be prosecuted only against individuals and not against companies. Such investigations, allegations, and the reporting thereof, and any potential enforcement actions, formal convictions, or administrative penalties or fines in connection therewith, may materially adversely affect our business and reputation. In addition, such investigations may lead to additional allegations or findings or may implicate or expand to additional employees. While we are not currently aware of any allegations or investigations into actions which may result in the criminal liability of the Company, there can be no assurance that such allegations or investigations will not result in a material adverse effect on our business.
10-K Feb 26, 2026
investigations, allegations, and the reporting thereof, and any potential enforcement actions, formal convictions, or administrative penalties or fines in connection therewith, may materially adversely affect our business and reputation. In addition, such investigations may lead to additional allegations or findings or may implicate or expand to additional employees. There can be no assurance that such allegations or investigations will not result in a material adverse effect on our business.
Paragraph 151 · 44% changed
Every version of it
10-K Feb 27, 2025
We are a commercial-stage biopharmaceutical company with a relatively limited operating history. Consequently, any predictions about our future success, performance, or prospects are subject to significant uncertainty, particularly in light of the dynamic and evolving industry in which we operate. We will encounter risks and difficulties frequently experienced by companies in our industry as we continue to expand or enhance our commercial activities. In addition, as a commercial-stage business, we may be more likely to encounter unforeseen expenses, difficulties, complications, and delays. If we do not address these risks and difficulties successfully, our business will suffer.
10-K Feb 26, 2026
We are a commercial-stage biopharmaceutical company with a relatively limited operating history. Consequently, any predictions about our future success, performance, or prospects are subject to significant uncertainty, particularly in
Paragraph 81 · 41% changed
Every version of it
10-K Feb 27, 2025
Although there are some protections with respect to enforcement in mainland China of judgments rendered by Hong Kong courts as a result of reciprocal recognition and enforcement of judgment arrangements, mainland China does not have treaties or agreements providing for the reciprocal recognition and enforcement of judgments awarded by courts of the United States, the United Kingdom, most other western countries, or Japan. In addition, according to PRC Civil Procedures Law, mainland China courts will not enforce a foreign judgment against us or our directors and officers if they decide that the judgment violates the basic principles of Chinese laws or national sovereignty, security, or public interest. Hence, the recognition and enforcement in mainland China of judgments of a court in any of these jurisdictions in relation to any matter not subject to a binding arbitration provision may be difficult or even impossible.
10-K Feb 26, 2026
Although there are some protections with respect to enforcement in mainland China of judgments rendered by Hong Kong courts as a result of reciprocal recognition and enforcement of judgment arrangements, mainland China does not have treaties or agreements providing for the reciprocal recognition and enforcement of judgments awarded by courts of
Paragraph 173 · 39% changed
Every version of it
10-K Feb 27, 2025Before commencing clinical trials, we must finalize the trial design based on ongoing discussions with the NMPA for trials in mainland China, the FDA for trials in the United States, and any other applicable regulatory authorities. The regulatory authorities may subsequently change their position on the acceptability of trial designs or clinical endpoints, which could require us to complete additional clinical trials or impose unexpected additional approval conditions. Successful completion of our clinical trials is a prerequisite to submitting an NDA (or equivalent filing) to the NMPA, FDA, or other applicable regulatory authorities and to the ultimate approval and commercial launch of our products or product candidates. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. There are inherent uncertainties associated with the development of our products and product candidates. We do not know whether the clinical trials for our product candidates will begin or be completed on schedule or at all or whether the clinical trial results will be favorable.
10-K Feb 26, 2026
setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. There are inherent uncertainties associated with the development of our products and product candidates. We do not know whether the clinical trials for our product candidates will begin or be completed on schedule or at all or whether the clinical trial results will be favorable.
Paragraph 409 · 38% changed
Every version of it
10-K Feb 27, 2025Our directors, executive officers, and other principal shareholders could exert substantial influence over matters such as electing directors and approving material mergers, acquisitions, or other business combination transactions. This may discourage, delay, or prevent a change in control of the Company, which could deprive our shareholders of an opportunity to receive a premium for their shares as part of a sale of the Company and reduce the price of our securities. Such actions may be taken even if they are opposed by certain of our other shareholders. In addition, our directors, executive officers, and other principal shareholders could divert business opportunities away from us to themselves or others.
10-K Feb 26, 2026
may be taken even if they are opposed by certain of our other shareholders. In addition, our directors, executive officers, and other principal shareholders could divert business opportunities away from us to themselves or others.
Paragraph 101 · 38% changed
Every version of it
10-K Feb 27, 2025We may enter into debt arrangements with certain financial institutions to support our business and working capital needs. To date, we have entered into certain debt arrangements with Chinese financial institutions that allow certain of our wholly-owned subsidiaries to borrow up to approximately $240.2 million (or RMB1,721.7 million) to support our working capital needs in mainland China, and Zai Lab Limited has agreed to guarantee approximately $217.7 million (or RMB1,561.7 million) of this debt. Such debt requires us or our subsidiaries to dedicate a portion of our or their cash flow to service interest and principal payments and, if interest rates rise, this amount may increase. As a result, our existing debt may limit our ability to use our cash flow to fund capital expenditures, to engage in transactions, or to meet other capital needs. Additionally, our subsidiaries’ debt service obligations may limit their ability to make future distributions to us. Our debt could also limit our flexibility to plan for and react to changes in our business or industry and may increase our vulnerability to general adverse economic and industry conditions, including a downturn in our business or the economy. This debt is denominated in RMB, and some bears interest at variable rates. As a result, increases in market interest rates and changes in foreign exchange rates could require a greater portion of our cash flow to be used to pay interest, which could further hinder our operations. We may also have difficulty refinancing our existing debt or incurring new debt on terms that we would consider commercially reasonable or at all. To the extent that we incur additional indebtedness, the foregoing risks could increase.
10-K Feb 26, 2026
This debt is denominated in RMB, and some bears interest at variable rates. As a result, increases in market interest rates and changes in foreign exchange rates could require a greater portion of our cash flow to be used to pay interest, which could further hinder our operations. We may also have difficulty refinancing our existing debt or incurring new debt on terms that we would consider commercially reasonable or at all. To the extent that we incur additional indebtedness, the foregoing risks could increase.
Paragraph 380 · 37% changed
Every version of it
10-K Feb 27, 2025
The value of the RMB or HK dollar against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in political and economic conditions. With the development of the foreign exchange market and progress towards interest rate liberalization and RMB internationalization, the Chinese government has announced, and may again in the future announce, changes to the exchange rate system. There is no guarantee that the RMB will not appreciate or depreciate significantly in value against the U.S. dollar. It is difficult to predict how market forces or Chinese or U.S. government policy may impact the exchange rate between the RMB and the U.S. dollar in the future.
10-K Feb 26, 2026
The value of the RMB or HK dollar against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in political and economic conditions. With the development of the foreign exchange market
Paragraph 356 · 37% changed
Every version of it
10-K Feb 27, 2025
Over the lifetime of any patent rights we hold, certain government fees will be paid to a patent office in the respective jurisdiction for any patent application(s) and on any patent(s) resulting therefrom. In some of our licensed matters, we rely on our licensors to pay these fees. In addition to the payment of fees, during the patent application process, the patent office of any given jurisdiction requires compliance with procedural and documentary provisions. In some of our licensed matters, we rely on our licensors to comply with these requirements. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules of a jurisdiction. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction, which may have a material adverse effect on our business, financial condition, results of operations, and prospects.
10-K Feb 26, 2026
Over the lifetime of any patent rights we hold, certain government fees will be paid to a patent office in the respective jurisdiction for any patent application(s) and on any patent(s) resulting therefrom. In some of our licensed matters, we rely on our licensors to pay these fees. In addition to the payment of fees, during the patent application process,
MD&A
66 paragraphs · 6 new · 26 reworded · 4 gone · 10-K Feb 26, 2026 against Feb 27, 2025
New paragraph
Reworded (5% of its words or more)
Same or nearly
Paragraph 25 · 49% changed
Our net product revenue increased by $130.9 $59.6 million in 2024, 2025, primarily due to XACDURO, driven by increased sales for VYVGART since its launch in September 2023 strong patient demand and NRDL listing in January 2024 for expanding hospital adoption but partially constrained by supply limitations during the treatment of gMG. Other key drivers of net product revenue growth include increased sales volumes for year, and NUZYRA, supported by increasing market coverage and penetration. ZEJULA and NUZYRA in 2024. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China. The growth in NUZYRA sales was supported by the inclusion in In 2025, VYVGART revenue included a $5.6 million rebate related to its NRDL renewal and VYVGART Hytrulo included a $2.4 million rebate following a voluntary price adjustment ahead of the NRDL for its IV formulation for the treatment of CABP and/or ABSSSI in the first quarter of 2023 and for its oral formulation for these indications in the first quarter of 2024. negotiation.
Paragraph 41 · 49% changed
Paragraph 6 · 48% changed
In 2024, 2025, we continued to demonstrate strong financial performance, with a 50% 15% increase in total revenue to $399.0 $460.2 million and a 23% 32% decrease in net loss to $257.1 $175.5 million compared to the prior year. Our revenue increase was primarily driven by VYVGART, which has steadily increased sales since its XACDURO, driven by strong commercial launch in September 2023 patient demand and initial NRDL listing in January 2024, ZEJULA, which expanding hospital adoption but partially constrained by supply limitations during the year, and NUZYRA, supported by increasing market coverage and penetration. ZEJULA continued to lead be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in the hospital setting, mainland China. In 2025, VYVGART revenue included a $5.6 million rebate related to its NRDL renewal and NUZYRA, which was supported by the inclusion in VYVGART Hytrulo included a $2.4 million rebate following a voluntary price adjustment ahead of the NRDL negotiation. In the fourth quarter of its IV formulation 2025, the NMPA approved AUGTYRO for the treatment of CABP and/or ABSSSI in January 2023 adult patients with NTRK+ solid tumors and its oral formulation KarXT for these indications in January 2024. Since the fourth quarter treatment of 2024, we are excited to have expanded our commercial portfolio adult patients with the launch in mainland China of VYVGART Hytrulo, the subcutaneous formulation of VYVGART, for gMG and CIDP, XACDURO for HABP and VABP caused by ABC, and AUGTYRO for ROS1+ NSCLC. AUGTYRO was included in the NRDL for this indication in January 2025. schizophrenia. In 2025, 2026, we expect our revenues to continue to increase for our existing and more recently launched commercial products.
Paragraph 40 · 38% changed
Other income, net decreased by $1.7 $1.8 million in 2024 2025 primarily due to the shift from a gain decrease of $2.8 million in 2023 to a loss of $6.1 million in 2024 for our investment in MacroGenics as a result of changes in its stock price, partially offset by an increase of $5.7 $2.3 million in government grants.
Paragraph 36 · 38% changed
Paragraph 57 · 34% changed
Paragraph 8 · 34% changed
We also continued to make progress across our product pipeline. For our global assets, we had promising results from the global Phase I 1 study of ZL-1310, zoci, a potential first-in-class and best-in-class DLL3-targeted DLL3-targeting ADC for the treatment of extensive stage SCLC, and promising pre-clinical data for ZL-1503, our internally developed IL-13/IL-31R IL-13/IL-31Rα bispecific antibody for atopic dermatitis. For our late-stage regional pipeline, we had positive data readouts during the year, including for KarXT povetacicept in schizophrenia, IgA nephropathy and we completed enrollment for the second Phase III study of bemarituzumab for the treatment of gastric cancer. primary membranous nephropathy. We have also expanded and strengthened our global and regional pipelines pipeline through synergistic business development activities, including obtaining exclusive worldwide rights to develop and commercialize ZL-1311, a strategic collaboration and worldwide license agreement with MediLink to use MediLink’s TMALIN ADC platform for the development of ZL-6201, a novel potential first-in-class LRRC15 ADC consisting of an antibody discovered by Zai Lab, next generation TCE targeting MUC17 for the treatment of certain solid tumors gastric and a strategic collaboration with Vertex for the license of povetacicept, a potential best-in-class treatment for IgAN and other B-cell mediated diseases, in mainland China, Hong Kong, Macau, Taiwan, and Singapore. GEJ cancers, which is expected to enter global clinical development this year. For more information on our commercial products and product pipeline, including status and developments in 2024, 2025, see Business – Our Commercial Products and Operations and Business – Our Pipeline of Product Candidates and R&D Activities.
Paragraph 38 · 27% changed
Interest expense increased by $2.3 $3.0 million in 2024, 2025, primarily due to interest expense on increased short-term debt we entered into in 2024. We had no such interest expense in 2023. debts.
Paragraph 25 · 49% changed
10-K Feb 27, 2025
Our net product revenue increased by $130.9 million in 2024, primarily driven by increased sales for VYVGART since its launch in September 2023 and NRDL listing in January 2024 for the treatment of gMG. Other key drivers of net product revenue growth include increased sales volumes for ZEJULA and NUZYRA in 2024. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China. The growth in NUZYRA sales was supported by the inclusion in the NRDL for its IV formulation for the treatment of CABP and/or ABSSSI in the first quarter of 2023 and for its oral formulation for these indications in the first quarter of 2024.
10-K Feb 26, 2026
Our net product revenue increased by $59.6 million in 2025, primarily due to XACDURO, driven by strong patient demand and expanding hospital adoption but partially constrained by supply limitations during the year, and NUZYRA, supported by increasing market coverage and penetration. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China. In 2025, VYVGART revenue included a $5.6 million rebate related to its NRDL renewal and VYVGART Hytrulo included a $2.4 million rebate following a voluntary price adjustment ahead of the NRDL negotiation.
Paragraph 41 · 49% changed
10-K Feb 27, 2025Interest expense increased by $2.3 million in 2024, primarily due to interest expense on short-term debt we entered into in 2024. We had no such interest expense in 2023.
10-K Feb 26, 2026
Income tax benefit was $2.9 million in 2025 primarily due to the deferred tax assets recognized as of December 31, 2025. We had no income tax benefit or expense in 2024.
Paragraph 6 · 48% changed
10-K Feb 27, 2025
In 2024, we continued to demonstrate strong financial performance, with a 50% increase in total revenue to $399.0 million and a 23% decrease in net loss to $257.1 million compared to the prior year. Our revenue increase was primarily driven by VYVGART, which has steadily increased sales since its strong commercial launch in September 2023 and initial NRDL listing in January 2024, ZEJULA, which continued to lead PARP inhibitor sales for ovarian cancer in the hospital setting, and NUZYRA, which was supported by the inclusion in the NRDL of its IV formulation for the treatment of CABP and/or ABSSSI in January 2023 and its oral formulation for these indications in January 2024. Since the fourth quarter of 2024, we are excited to have expanded our commercial portfolio with the launch in mainland China of VYVGART Hytrulo, the subcutaneous formulation of VYVGART, for gMG and CIDP, XACDURO for HABP and VABP caused by ABC, and AUGTYRO for ROS1+ NSCLC. AUGTYRO was included in the NRDL for this indication in January 2025. In 2025, we expect our revenues to continue to increase for our existing and more recently launched commercial products.
10-K Feb 26, 2026
In 2025, we continued to demonstrate strong financial performance, with a 15% increase in total revenue to $460.2 million and a 32% decrease in net loss to $175.5 million compared to the prior year. Our revenue increase was primarily driven by XACDURO, driven by strong patient demand and expanding hospital adoption but partially constrained by supply limitations during the year, and NUZYRA, supported by increasing market coverage and penetration. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China. In 2025, VYVGART revenue included a $5.6 million rebate related to its NRDL renewal and VYVGART Hytrulo included a $2.4 million rebate following a voluntary price adjustment ahead of the NRDL negotiation. In the fourth quarter of 2025, the NMPA approved AUGTYRO for the treatment of adult patients with NTRK+ solid tumors and KarXT for the treatment of adult patients with schizophrenia. In 2026, we expect our revenues to
Paragraph 40 · 38% changed
10-K Feb 27, 2025
Other income, net decreased by $1.7 million in 2024 primarily due to the shift from a gain of $2.8 million in 2023 to a loss of $6.1 million in 2024 for our investment in MacroGenics as a result of changes in its stock price, partially offset by an increase of $5.7 million in government grants.
10-K Feb 26, 2026
Other income, net decreased by $1.8 million in 2025 primarily due to a decrease of $2.3 million in government grants.
Paragraph 36 · 38% changed
10-K Feb 27, 2025Research and development expenses decreased by $31.4 million in 2024 primarily due to:
10-K Feb 26, 2026
Selling, general, and administrative expenses decreased by $21.1 million in 2025 primarily due to our resource prioritization and efficiency efforts.
Paragraph 57 · 34% changed
10-K Feb 27, 2025Although we believe that we have sufficient capital to fund our operations for at least the next twelve months, we may, from time to time, identify opportunities to access capital through debt arrangements on favorable commercial terms. In 2024, we entered into four such debt arrangements with Chinese financial institutions that allow certain of our subsidiaries to borrow up to approximately $198.9 million (or RMB1,421.7 million) to support our working capital needs in mainland China. As of December 31, 2024, we had short-term debt of approximately $131.7 million (or RMB946.8 million) pursuant to these debt arrangements. In January 2025, we entered into a working capital loan contract with another Chinese financial institution with respect to a revolving credit facility of up to RMB300.0 million (approximately $41.1
10-K Feb 26, 2026
We have also identified opportunities to access capital through debt arrangements on favorable commercial terms. As of December 31, 2025, we had such debt arrangements with Chinese financial institutions that allow certain of our subsidiaries to borrow up to approximately $317.4 million (or RMB2,271.7 million) to support our working capital needs in mainland China. As of December 31, 2025, we had short-term debt outstanding of $204.5 million (or RMB1,437.6 million) pursuant to these debt arrangements. These debt arrangements provide us with additional capital capacity that will give us enhanced flexibility to execute on our corporate strategic goals. For more information, see Note 11.
Paragraph 8 · 34% changed
10-K Feb 27, 2025
We also continued to make progress across our product pipeline. For our global assets, we had promising results from the global Phase I study of ZL-1310, a potential first-in-class and best-in-class DLL3-targeted ADC for the treatment of extensive stage SCLC, and promising pre-clinical data for ZL-1503, our internally developed IL-13/IL-31R bispecific antibody for atopic dermatitis. For our late-stage regional pipeline, we had positive data readouts during the year, including for KarXT in schizophrenia, and we completed enrollment for the second Phase III study of bemarituzumab for the treatment of gastric cancer. We have also expanded and strengthened our global and regional pipelines through synergistic business development activities, including a strategic collaboration and worldwide license agreement with MediLink to use MediLink’s TMALIN ADC platform for the development of ZL-6201, a novel potential first-in-class LRRC15 ADC consisting of an antibody discovered by Zai Lab, for the treatment of certain solid tumors and a strategic collaboration with Vertex for the license of povetacicept, a potential best-in-class treatment for IgAN and other B-cell mediated diseases, in mainland China, Hong Kong, Macau, Taiwan, and Singapore. For more information on our commercial products and product pipeline, including status and developments in 2024, see Business – Our Commercial Products and Operations and Business – Our Pipeline of Product Candidates and R&D Activities.
10-K Feb 26, 2026
We also continued to make progress across our product pipeline. For our global assets, we had promising results from the global Phase 1 study of zoci, a potential first-in-class and best-in-class DLL3-targeting ADC for the treatment of extensive stage SCLC, and promising pre-clinical data for ZL-1503, our internally developed IL-13/IL-31Rα bispecific antibody for atopic dermatitis. For our late-stage regional pipeline, we had positive data readouts during the year, including for povetacicept in IgA nephropathy and primary membranous nephropathy. We have also expanded and strengthened our pipeline through synergistic business development activities, including obtaining exclusive worldwide rights to develop and commercialize ZL-1311, a next generation TCE targeting MUC17 for the treatment of gastric and GEJ cancers, which is expected to enter global clinical development this year. For more information on our commercial products and product pipeline, including status and developments in 2025, see Business – Our Commercial Products and Operations and Business – Our Pipeline of Product Candidates and R&D Activities.
Paragraph 38 · 27% changed
10-K Feb 27, 2025
Interest expense increased by $2.3 million in 2024, primarily due to interest expense on short-term debt we entered into in 2024. We had no such interest expense in 2023.
10-K Feb 26, 2026
Interest expense increased by $3.0 million in 2025, primarily due to increased short-term debts.
A paragraph is matched with the one last year that shares the most of its words; under half in common makes it new. The paragraphs shown are the 8 reworded the most in each section.
The paragraph that changed most in each section
The redline
Marked against last year's 10-K: cut words struck through, new words highlighted.
MD&A206 words changed in this paragraph; it is 42% similar to last year's version.
In 2024, 2025, we continued to demonstrate strong financial performance, with a 50% 15% increase in total revenue to $399.0 $460.2 million and a 23% 32% decrease in net loss to $257.1 $175.5 million compared to the prior year. Our revenue increase was primarily driven by VYVGART, which has steadily increased sales since its XACDURO, driven by strong commercial launch in September 2023 patient demand and initial NRDL listing in January 2024, ZEJULA, which expanding hospital adoption but partially constrained by supply limitations during the year, and NUZYRA, supported by increasing market coverage and penetration. ZEJULA continued to lead be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in the hospital setting, mainland China. In 2025, VYVGART revenue included a $5.6 million rebate related to its NRDL renewal and NUZYRA, which was supported by the inclusion in VYVGART Hytrulo included a $2.4 million rebate following a voluntary price adjustment ahead of the NRDL negotiation. In the fourth quarter of its IV formulation 2025, the NMPA approved AUGTYRO for the treatment of CABP and/or ABSSSI in January 2023 adult patients with NTRK+ solid tumors and its oral formulation KarXT for these indications in January 2024. Since the fourth quarter treatment of 2024, we are excited to have expanded our commercial portfolio adult patients with the launch in mainland China of VYVGART Hytrulo, the subcutaneous formulation of VYVGART, for gMG and CIDP, XACDURO for HABP and VABP caused by ABC, and AUGTYRO for ROS1+ NSCLC. AUGTYRO was included in the NRDL for this indication in January 2025. schizophrenia. In 2025, 2026, we expect our revenues to continue to increase for our existing and more recently launched commercial products.
Source: Item 7, 10-K 0001704292-26-000015 vs Item 7, 10-K 0001628280-25-008409
Risk Factors200 words changed in this paragraph; it is 35% similar to last year's version.
Such reliance on third-party manufacturers entails risks to which we would not be subject to if we manufactured products or product candidates ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing or supply agreement by the third party because of factors beyond our control (including a failure to synthesize and manufacture our products or product candidates in accordance with our specifications), and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us. In addition, the NMPA and other regulatory authorities require that our product candidates and any products that we may eventually commercialize be manufactured according to cGMP standards. Any failure by our third-party manufacturers to comply with cGMP standards or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of our product candidates. In addition, such failure could be the basis for the NMPA to issue a warning or untitled letter, withdraw approvals for product candidates previously granted to us, or take other regulatory or legal action, including recall or seizure, total or partial suspension of production, suspension of ongoing clinical trials, refusal to approve pending applications or supplemental applications, detention or product, refusal to permit the import or export of products, injunction, or imposing civil and criminal penalties.
Source: Item 1A, 10-K 0001704292-26-000015 vs Item 1A, 10-K 0001628280-25-008409
Accounting Policies52 words changed in this paragraph; it is 80% similar to last year's version.
In Hong Kong, the Company sells the products to customers, which are typically healthcare providers such as oncology centers. The Company utilizes a third party for warehousing services. Based on the nature of the arrangements, the Company has determined that it is a principal in the transaction since the Company is primarily responsible for fulfilling the promise to provide the products to the customers, maintains inventory risk until delivery to the customers, and has latitude in establishing the price. Revenue is recognized upon delivery to customers at mutually agreed upon prices. Consideration paid to the third party is recognized in operating expenses. With respect to XACDURO, the Company sells the product to Pfizer under a strategic collaboration arrangement, and Pfizer is responsible for sales of XACDURO to distributors in mainland China. Under this arrangement, Pfizer is the Company’s customer and revenue is recognized upon delivery of XACDURO to Pfizer at the contractually agreed prices.
Source: 10-K text, Note 2 – Summary of Significant Accounting Policies, 10-K 0001704292-26-000015 vs 10-K text, Note 2 – Summary of Significant Accounting Policies, 10-K 0001628280-25-008409
Legal Proceedings34 words changed in this paragraph; it is 68% similar to last year's version.
As of December 31, 2024, 2025, the Company’s commitments were $ 1.7 million and related to commercial manufacturing development activities and facilities construction and improvement activities capital expenditures that are contracted but not yet reflected in the consolidated financial statements were statements. Of this amount, $ 6.8 1.5 million and $ 0.2 million were expected to be incurred within one year. year and one to two years from December 31, 2025, respectively.
Source: Item 3, via Note 20 – Commitments and Contingencies, 10-K 0001704292-26-000015 vs Item 3, via Note 20 – Commitments and Contingencies, 10-K 0001628280-25-008409
Sentences and paragraphs added, removed or reworded
Every change, by type
Sentences and paragraphs of ZLAB's Risk Factors and MD&A, 10-K Feb 26, 2026 against 10-K Feb 27, 2025. Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier (may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would
AddedRisk Factors
mainland China, as a result of our requirements in China, it could materially and adversely affect our business and operating results.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
mainland China. In the future, cash proceeds raised from our overseas financing activities may be transferred by us to our Chinese subsidiaries via capital contributions, shareholder loans or intercompany loans, as the case may be.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
evidence collection activities in mainland China, which may further increase difficulties shareholders may face in protecting their interests.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
Since inception, we have incurred significant costs for our commercialization efforts with respect to our approved products, our research and development efforts related to our product candidates and related clinical or pre-clinical trials, our business development activities and related upfront or milestone fees or royalty payments in our license and
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
We may experience operational, regulatory, and competitive risks due to our use of artificial intelligence.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
Artificial intelligence is increasingly being used in the biopharmaceutical industry, and we are exploring and implementing its use in our business operations, including potential use in clinical, discovery, and commercialization activities. The effective development, management, and use of AI require substantial resources, including the implementation of appropriate governance, safeguards, and employee training, and involve risks to our business and operations that may arise from potentially flawed algorithms, insufficient, poor quality or biased data sets, and inappropriate or controversial data practices by data scientists or end-users. If AI applications assist in producing analyses that are deficient or inaccurate, we could be subject to competitive harm, potential legal liability, and reputational harm. We may develop certain AI systems internally and rely on vendors or other third-party providers for integration of specialized capabilities, whose use or development of AI may not meet applicable regulatory standards, which could present additional risks to our business. Use of AI-based software may also lead to the inadvertent release of confidential information. Additionally, the legal and regulatory framework governing AI is rapidly evolving, and existing and future laws, regulations, and regulatory guidance may impose significant compliance obligations, increase costs, or limit how we use AI. Furthermore, some of our competitors may successfully adopt or use AI to enhance their clinical or business operations before we are able to do so, which could leave us at a competitive disadvantage or with higher costs relative to our peers.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
Such reliance on third-party manufacturers entails risks to which we would not be subject to if we manufactured products or product candidates ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing or supply agreement by the third party because of factors beyond
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
agree to less favorable terms in order to maintain the ongoing cooperative relationships with our major customers. If we are unable to reduce our production costs accordingly, our profitability, results of operations, and financial condition may be materially and adversely affected.
Read it in 10-K Feb 26, 2026 at sec.gov
Show the other 46
AddedRisk Factors
period of time to complete, and divert management’s attention from other business concerns. These changes may not, however, be effective in maintaining the adequacy of our internal control.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedRisk Factors
deposit agreement or if you wish us or the depositary to participate in legal proceedings. As a result, you may not be able to exercise your right to vote and you may lack recourse if your ADSs are not voted as you request. In addition, in your capacity as an ADS holder, you will not be able to call a shareholders’ meeting.
Read it in 10-K Feb 26, 2026 at sec.gov
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RemovedRisk Factors
RewordedRisk Factors
RewordedRisk Factors
RewordedRisk Factors
Such authorities may impose a suspension or termination due to a number of factors, including: a failure to conduct the clinical trial in accordance with regulatory requirements or the applicable clinical protocols; a failure to obtain the regulatory approval and/or complete record filings with respect to the collection, preservation, use, and export of mainland China’s human genetic resources; inspection of the clinical trial operations or trial site by the NMPA, FDA, or other regulatory authorities that results in the imposition of a clinical hold, unforeseen safety issues, or adverse side effects; failure to demonstrate a benefit from using a product candidate; changes in government regulations or administrative actions; or lack of adequate funding to continue the clinical trial.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
If our operations were found to be in violation of applicable legal and regulatory requirements, we could be subject to significant civil, criminal, and administrative penalties, including, without limitation, damages, fines, imprisonment, and exclusion from participation in government healthcare programs or contracting with government authorities and the curtailment or restructuring of our operations, which could significantly harm our business.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
The NHSA, together with other government authorities, review the inclusion or removal of drugs from the NRDL, and the tier category of the NRDL under which a drug will be classified, both of which affect the amounts reimbursable to program participants reimbursement ratio and purchase limits for their purchases of those drugs. patients participating in NRDL-related medical insurance coverage.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
Changes in patent laws and regulations in various jurisdictions, changes in the governmental bodies that enforce them, or changes in how the relevant governmental authority enforces them may weaken our ability to obtain new patents or patent rights through our licensors or to enforce any patents in the future.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
RewordedRisk Factors
Until new finalized operational guidelines are issued, such provisions of the China Patent Law providing the proposed framework for data exclusivity can cannot be implemented, implemented and a lower-cost generic or biosimilar drug can emerge onto the market more quickly. quickly in mainland China.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
We are also exposed to risks related to changes in interest rates on our cash and cash equivalents, restricted cash, and short-term investments, as a decrease in interest rate may impact our investment income and related cash flows.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
If we are not able to transfer data outside of mainland China to comply with our contractual requirements or requirements of judicial or law enforcement authorities outside of mainland China, as a result of our requirements in China, it could materially and adversely affect our business and operating results.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedRisk Factors
Zai Biopharmaceutical (Suzhou) Lab (Zhejiang) Co., Ltd., an operating subsidiary of ours that is domiciled in mainland China, received $15.0 $10.0 million in capital contributions via four separate contributions contribution from Zai Lab (Hong Kong) Limited, its sole shareholder, domiciled outside of mainland China, from 2017 to 2018 in 2025 to fund its business operations in mainland China.
Read it in 10-K Feb 26, 2026 at sec.gov
Quiet changesRisk Factors
The Chinese government has significant oversight and discretion over the conduct of our business and may intervene or influence our operations at any time as the government deems appropriate to further regulatory, political, and societal goals.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedMD&A
continue to increase primarily driven by our existing commercial products and recently approved products or indications that are expected to be launched this year.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedMD&A
We also continued to strengthen our business through key new additions to our global leadership team. For example, we appointed Dr. Shan He as Senior Vice President, Chief Business Officer in September 2025. Dr. He is a respected leader with deep expertise in healthcare strategy, capital markets, and entrepreneurship. She will be responsible for leading and directing strategy for business development and strategic partnerships. We also announced the creation of our Oncology Scientific Advisory Board (“SAB”) in August 2025. This newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement of our robust oncology products and pipeline, including multiple internally developed investigational therapies.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedMD&A
(i)Other includes product candidates sold in patient programs prior to commercialization.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedMD&A
Cost of product revenue increased by $43.4 million in 2025 primarily due to increasing sales volumes and higher inventory provision for VYVGART Hytrulo.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedMD&A
Collaboration revenue and cost of collaboration revenue related to promotional activities in mainland China increased by $1.6 million and $0.2 million, respectively, in 2025.
Read it in 10-K Feb 26, 2026 at sec.gov
AddedMD&A
Although we believe that we have sufficient capital to fund our operations for at least the next twelve months, we may, from time to time, utilize debt arrangements on favorable commercial terms or consider additional funding sources to
Read it in 10-K Feb 26, 2026 at sec.gov
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RewordedMD&A
RewordedMD&A
RewordedMD&A
Net cash used in operating activities increased decreased by $16.7 $64.1 million in 2024, 2025, primarily due to a decrease of $77.5 $81.6 million in net loss and an increase of $13.8 $13.7 million in net changes in operating assets and liabilities, partially offset by a decrease of $31.2 million in adjustments to reconcile net loss to net cash used in operating activities, partially offset by a decrease of $108.0 million in net changes in operating assets and liabilities. activities.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedMD&A
Year Ended December 31, Change 2025 2024 2023 $ Net cash used in operating activities (150,789) (214,869) (198,178) (16,691) Net cash used in investing activities (375,193) (10,776) (364,417) 64,080 Net cash provided by (used in) investing activities 307,866 (375,193) 683,059 Net cash provided by financing activities 72,353 349,889 (6,433) 356,322 (277,536) Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash 478 (310) (2,622) 2,312 788 Net decrease increase (decrease) in cash, cash equivalents and restricted cash 229,908 (240,483) (218,009) (22,474) 470,391
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedMD&A
Foreign currency losses increased by $0.3 gains were $19.6 million in 2024, 2025 primarily driven by increased remeasurement gain due to appreciation of the RMB against the U.S. dollar, compared to foreign currency losses of $15.1 million in 2024 primarily driven by remeasurement loss due to depreciation of the RMB against the U.S. dollar.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedMD&A
Research and development expenses attributable to pre-clinical programs increased decreased by $14.6 $7.6 million in 2024, 2025, primarily driven by a decrease of $9.4 million in licensing fees, partially offset by an increase of $9.0 million in licensing fees and an increase of $5.6 $1.8 million in CROs/CMOs/Investigators expenses and other costs related to newly initiated studies.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedMD&A
RewordedMD&A
RewordedMD&A
For our late-stage regional pipeline, we had positive data readouts during the year, including for KarXT povetacicept in schizophrenia, IgA nephropathy and we completed enrollment for the second Phase III study of bemarituzumab for the treatment of gastric cancer. primary membranous nephropathy.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedMD&A
In addition, as of December 31, 2024, 2025, we had commitments for capital expenditures of $6.8 $1.7 million mainly for the purpose of related to commercial manufacturing development activities and facilities construction and improvement activities. capital expenditures.
Read it in 10-K Feb 26, 2026 at sec.gov
RewordedMD&A
RewordedMD&A
In 2025, 2026, we seek to continue advancing our mission of becoming a leading global biopharmaceutical company, driving innovation in treatment options for patients in China and beyond, by focusing on the following corporate strategic goals: accelerate medicines to patients through our R&D activities; expand and strengthen our global and regional pipelines through our internal discovery efforts and synergistic collaborations and corporate development activities; and continue our commercial excellence and execution, including by delivering strong financial performance as we prepare to launch additional products or new indications for existing products and seek as we advance along our path to achieve profitability by the end of 2025. profitability.
Read it in 10-K Feb 26, 2026 at sec.gov
Quiet changesMD&A
Our product revenue is primarily derived from the sales of our commercial products, products primarily in mainland China, net of sales returns and rebates to distributors with respect to the sales of these products.
Read it in 10-K Feb 26, 2026 at sec.gov
Sources
The two latest 10-Ks on EDGAR, section by section. Each change links to the text at sec.gov.
Also
New risk factors: paragraphs with nothing like them last year, quoted in full.
Work with it
Excel workbook · CSV. Google Sheet that stays up to date: paste =IMPORTDATA("https://tickdelta.com/company/ZLAB/export.csv") into a cell.