This section highlights FDA-related milestones and regulatory updates for drugs developed by Zai Lab (ZLAB).
Over the past two years, Zai Lab has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Efgartigimod, KarXT, Repotrectinib, ZL-1102, ZL-1218, ZL-1310, and ZL-1503. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Efgartigimod Alfa Injection - FDA Regulatory Timeline and Events
Efgartigimod Alfa Injection is a drug developed by Zai Lab for the following indication: For the treatment of adult patients with generalized myasthenia gravis (gMG).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Efgartigimod Alfa Injection
- Announced Date:
- July 16, 2024
- Indication:
- For the treatment of adult patients with generalized myasthenia gravis (gMG).
Announcement
Zai Lab Limited and argenx announced that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
AI Summary
Zai Lab Limited and argenx have announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection), also known as efgartigimod SC. This approval marks the first NMPA-approved subcutaneous injectable FcRn blocker in China for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
The treatment is available in a 1,000mg (5.6ml) vial and is designed as an add-on to standard therapy. Data from the Phase 3 ADAPT-SC study showed that efgartigimod SC provides consistent clinical benefits and a safety profile similar to that of the intravenous formulation. Its user-friendly, 30-to-90 second subcutaneous injection offers a more flexible and convenient option for patients managing gMG.
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KarXT (xanomeline-trospium) - FDA Regulatory Timeline and Events
KarXT (xanomeline-trospium) is a drug developed by Zai Lab for the following indication: Healthy Elderly Volunteers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- January 17, 2025
- Indication:
- Healthy Elderly Volunteers
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
AI Summary
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted their New Drug Application for KarXT, which is being developed to treat schizophrenia in adults. This important step could bring a new treatment option to over 8 million Chinese patients who currently face challenges with available therapies. Clinical trials have shown that KarXT significantly reduces symptoms of schizophrenia while offering a safety profile that is manageable. The acceptance of the application indicates that regulators see potential in this novel treatment approach, which could help patients experience fewer side effects compared to current medications. If approved, KarXT may pave the way for a fresh and innovative method to manage schizophrenia, potentially improving the quality of life for many patients in China and possibly influencing treatment practices globally.
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Repotrectinib - FDA Regulatory Timeline and Events
Repotrectinib is a drug developed by Zai Lab for the following indication: NTRK Fusion-Positive Advanced Solid Tumors.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Repotrectinib
- Announced Date:
- April 21, 2025
- Indication:
- NTRK Fusion-Positive Advanced Solid Tumors
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
AI Summary
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for repotrectinib. This application is specifically for treating adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The treatment target includes patients with locally advanced or metastatic disease, where surgery might cause severe complications, and those who have not responded to previous therapies or lack other effective treatment options.
According to Zai Lab, patients with NTRK fusion-positive tumors face significant challenges, especially when they develop resistance to current tyrosine kinase inhibitors. With no approved therapies for both TKI-naïve and TKI-pretreated patients in China, repotrectinib is seen as a promising next-generation option that may improve treatment outcomes and provide a much-needed advancement in addressing these aggressive cancers.
Read Announcement- Drug:
- Repotrectinib
- Announced Date:
- November 15, 2024
- Indication:
- NTRK Fusion-Positive Advanced Solid Tumors
Announcement
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
AI Summary
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended repotrectinib for approval. This next-generation tyrosine kinase inhibitor (TKI) is designed to treat adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and patients aged 12 and older with advanced solid tumors that express an NTRK gene fusion. The recommendation covers patients who have already received a prior NTRK inhibitor, as well as those who have not received one when alternative treatment options provide limited clinical benefit or have been exhausted.
The positive opinion was based on data from the TRIDENT-1 and CARE trials, which demonstrated strong, durable responses in these patient groups. The European Commission (EC) will now review the CHMP recommendation, with a final decision expected in January 2025.
Read Announcement- Drug:
- Repotrectinib
- Announced Date:
- June 13, 2024
- Indication:
- NTRK Fusion-Positive Advanced Solid Tumors
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
AI Summary
Bristol Myers Squibb announced that the FDA has granted accelerated approval for Augtyro™ (repotrectinib). This approval is for treating adult and pediatric patients 12 years of age and older who have solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. These patients include those with locally advanced or metastatic tumors or cases where surgery could lead to severe complications, and whose cancers have progressed following prior treatments or have no other satisfactory options.
The decision was based on encouraging overall response rates and duration of response seen in the Phase 1/2 TRIDENT-1 trial. This trial evaluated Augtyro in patients whether or not they had been previously treated with tyrosine kinase inhibitors (TKIs), thereby expanding the targeted treatment options available for patients with NTRK-positive tumors.
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ZL-1102 - FDA Regulatory Timeline and Events
ZL-1102 is a drug developed by Zai Lab for the following indication: Mild-to-moderate chronic plaque psoriasis (CPP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZL-1102
- Announced Date:
- May 22, 2024
- Indication:
- Mild-to-moderate chronic plaque psoriasis (CPP)
Announcement
Zai Lab Limited announced that the first patient has been dosed in a global Phase 2 clinical trial (NCT06380907) evaluating the efficacy and safety of the company's internally developed anti-IL-17 investigational therapy, ZL-1102, for the treatment of chronic plaque psoriasis (CPP).
AI Summary
Zai Lab Limited announced that the first patient has been dosed in a global Phase 2 clinical trial (NCT06380907) to evaluate ZL-1102, its novel anti-IL-17 investigational therapy for treating chronic plaque psoriasis (CPP). ZL-1102 is an innovative human VH antibody fragment designed for topical use, marking a shift from the traditional systemic treatments for the disease. Unlike other IL-17 therapies that are injected or infused to treat moderate-to-severe cases, ZL-1102 is developed for patients with mild-to-moderate CPP. Its topical application directly to psoriatic skin lesions may bypass unnecessary exposure to the rest of the body and help reduce the risk of systemic side effects.
The trial will assess the safety and effectiveness of different doses over a 16‐week period, focusing on the degree of improvement in skin condition. This study is a significant step for Zai Lab, underscoring its commitment to advancing innovative treatments for patients worldwide.
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ZL-1218 - FDA Regulatory Timeline and Events
ZL-1218 is a drug developed by Zai Lab for the following indication: For the Treatment of Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZL-1218
- Announced Date:
- August 27, 2024
- Indication:
- For the Treatment of Advanced Solid Tumors
Announcement
Zai Lab Limited announced that data from a Phase 1 study of ZL-1218, the company's anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain.
AI Summary
Zai Lab Limited announced that preliminary data from its Phase 1 study of ZL-1218, an anti-CCR8 antibody, will be featured in a poster session at the European Society for Medical Oncology (ESMO) Congress 2024. The event is scheduled for September 13-17, 2024, in Barcelona, Spain, with the specific poster presentation set for September 14 at Fira Barcelona Gran Via, presented by Oriol Mirallas from the Vall d'Hebron Institute of Oncology.
The poster will share early results that demonstrate the potential of ZL-1218 to reduce regulatory T cells and alter T-cell functions in the tumor microenvironment. This approach may lead to a stronger anticancer immune response in patients with advanced solid tumors, offering hope for a new treatment option in oncology.
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ZL-1310 - FDA Regulatory Timeline and Events
ZL-1310 is a drug developed by Zai Lab for the following indication: For DLL3+ Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZL-1310
- Announced Date:
- June 2, 2025
- Indication:
- For DLL3+ Solid Tumors
Announcement
Zai Lab Limited announced that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating zocilurtatug pelitecan, or ZL-1310, the Company's potential first-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for patients with extensive-stage small cell lung cancer (ES-SCLC), will be presented today during a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Zai Lab Limited announced updated data from its ongoing global Phase 1a/1b clinical trial (NCT06179069) for zocilurtatug pelitecan (ZL-1310), a potential first-in-class DLL3-targeted antibody-drug conjugate for patients with extensive-stage small cell lung cancer (ES-SCLC). The new findings, which include results from both dose escalation and expansion cohorts, will be presented today during a poster session at the 2025 ASCO Annual Meeting. Early analyses indicate promising anti-tumor activity and a well-tolerated safety profile at doses below 2.0 mg/kg, with particularly strong responses observed in the second-line treatment setting. Many patients continue to benefit from the therapy, and the results support further development of ZL-1310. Zai Lab also plans to initiate a pivotal trial later this year to further evaluate the treatment’s efficacy in patients with relapsed ES-SCLC.
Read Announcement- Drug:
- ZL-1310
- Announced Date:
- May 19, 2025
- Indication:
- For DLL3+ Solid Tumors
Announcement
Zai Lab Limited announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company's potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). ZL-1310, which is being evaluated in an ongoing global Phase 1a/1b clinical trial (NCT06179069), previously received an Orphan Drug designation for SCLC from the FDA.
AI Summary
Zai Lab Limited announced that the U.S. FDA has granted Fast Track designation to its investigational drug ZL-1310, a potential first-in-class Delta-like ligand (DLL3) antibody‐drug conjugate aimed at treating extensive-stage small cell lung cancer (ES-SCLC). This designation is intended to speed up the drug’s review and development process, allowing for more frequent consultations with the FDA as the clinical program progresses. ZL-1310 is currently being evaluated in an ongoing global Phase 1a/1b clinical trial, and this milestone illustrates the importance of delivering new treatment options where there is an urgent need for effective therapies.
According to Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab, the Fast Track status not only reinforces recent clinical progress but also supports the company’s plans to further advance ZL-1310, including initiating a pivotal study in small cell lung cancer later this year.
Read Announcement- Drug:
- ZL-1310
- Announced Date:
- January 22, 2025
- Indication:
- For DLL3+ Solid Tumors
Announcement
Zai Lab Limited announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC).
AI Summary
Zai Lab Limited announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its experimental product, ZL-1310. This novel drug is a first-in-class DLL3 antibody-drug conjugate (ADC) aimed at treating small cell lung cancer (SCLC), a particularly aggressive and hard-to-treat form of cancer. The designation recognizes the potential of ZL-1310 to offer breakthrough benefits for patients in need of better, safer, and more effective treatment options.
Early clinical trials have shown promising response rates and a favorable safety profile, which has generated hope for improved outcomes in SCLC treatment. With this achievement, Zai Lab may receive several development incentives, such as fee waivers and tax credits, as well as seven years of U.S. market exclusivity upon approval, which can help speed up future development and availability of the therapy.
Read Announcement- Drug:
- ZL-1310
- Announced Date:
- October 9, 2024
- Indication:
- For DLL3+ Solid Tumors
Announcement
Zai Lab Limited announced that data from a Phase 1 study of ZL-1310, the Company's investigational antibody-drug conjugate (ADC), will be presented during a plenary session at the EORTC-NCI-AACR Symposium (ENA) 2024 taking place October 23-25, in Barcelona, Spain.
AI Summary
Zai Lab Limited announced that data from a Phase 1 study of ZL-1310, its investigational antibody-drug conjugate (ADC), will be presented at the prestigious EORTC-NCI-AACR Symposium (ENA) 2024 in Barcelona, Spain. The study, which is open-label and multicenter, focuses on ZL-1310's potential as a novel treatment for small cell lung cancer (SCLC), targeting Delta-like ligand 3 (DLL3), a therapeutic target commonly overexpressed in neuroendocrine tumors.
The presentation, scheduled as an oral session in the meeting’s plenary segment, will detail preliminary results that evaluate the safety, tolerability, and pharmacokinetics of ZL-1310. Designed with the innovative TMALIN® linker-payload platform, ZL-1310 aims to reduce off-target toxicity while increasing anti-tumor effectiveness, potentially offering a new treatment option for patients with SCLC and other neuroendocrine tumors.
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ZL-1503 - FDA Regulatory Timeline and Events
ZL-1503 is a drug developed by Zai Lab for the following indication: For the Treatment of Atopic Dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZL-1503
- Announced Date:
- June 13, 2025
- Indication:
- For the Treatment of Atopic Dermatitis
Announcement
Zai Lab Limited announced new data from its preclinical study of ZL-1503, the Company's promising IL-13/IL-31R bispecific antibody, demonstrating its ability to simultaneously suppress the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis (AD).
AI Summary
Zai Lab Limited announced promising preclinical results for ZL-1503, its novel bispecific antibody that targets both IL-13 and IL-31 receptors. The study, conducted in non-human primates, showed that a single dose of ZL-1503 effectively blocked the inflammatory responses caused by IL-13 and the itch response caused by IL-31 for at least 76 days. In some subjects, the suppression of these effects lasted even longer, with inflammatory inhibition sustained beyond 118 days and itch reduction for over 133 days. The data highlighted a favorable safety profile and a long half-life for the antibody. These results support the advancement of ZL-1503 into IND-enabling studies, emphasizing its potential as an innovative treatment for moderate-to-severe atopic dermatitis and other diseases driven by IL-13 and IL-31 pathways.
Read Announcement- Drug:
- ZL-1503
- Announced Date:
- September 17, 2024
- Indication:
- For the Treatment of Atopic Dermatitis
Announcement
Zai Lab Limited announced that data from a preclinical study of ZL-1503, the company's internally discovered IL-13/IL-31 bispecific antibody for the treatment of atopic dermatitis (AD), will be presented in a late-breaking oral presentation at the European Academy of Dermatology and Venerology Congress (EADV) 2024 taking place September 25-28 in Amsterdam, Netherlands.
AI Summary
Zai Lab Limited announced new preclinical data for ZL-1503, its internally developed IL-13/IL-31 bispecific antibody aimed at treating atopic dermatitis (AD) and other related diseases. The data will be shared in a late-breaking oral presentation at the European Academy of Dermatology and Venerology Congress (EADV) 2024 in Amsterdam, Netherlands, from September 25 to 28.
ZL-1503 is designed to target both the inflammatory and itch-causing pathways by inhibiting IL-13 and IL-31 signals, which may lead to quicker and more effective relief for patients with moderate-to-severe AD compared to current treatments. This new approach could offer improved options for those who do not fully benefit from existing therapies. The detailed results from the preclinical study are expected to provide further insights into the potential benefits of this dual-targeting antibody.
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ZL-6201 - FDA Regulatory Timeline and Events
ZL-6201 is a drug developed by Zai Lab for the following indication: For the treatment of sarcoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZL-6201
- Announced Date:
- March 26, 2025
- Indication:
- For the treatment of sarcoma
Announcement
Zai Lab Limited announced that data from preclinical studies of the Company's internally discovered and developed next-generation, investigational oncology therapies, ZL-6201, an LRRC15 antibody-drug conjugate (ADC) for the treatment of sarcoma, and ZL-1222, a PD-1 targeted IL-12 immunocytokine for cancer immunotherapy, will be presented during poster sessions at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30, 2025 in Chicago, Illinois.
AI Summary
Zai Lab Limited announced that it will present preclinical data on two innovative oncology therapies at the AACR Annual Meeting 2025. The data will be included in poster sessions scheduled to take place from April 25-30, 2025, at the McCormick Place Convention Center in Chicago, Illinois.
The first therapy, ZL-6201, is an LRRC15 antibody-drug conjugate (ADC) designed for treating sarcoma and other LRRC15-positive solid tumors. Its development targets tumors that are difficult to treat with current therapies.
The second investigational product, ZL-1222, is a PD-1 targeted IL-12 immunocytokine aimed at cancer immunotherapy. The therapy intends to combine strong antitumor activity with improved systemic safety. These studies represent promising steps forward in Zai Lab’s objective to address unmet needs in cancer treatment.
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