Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 105

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 105
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. The current median survival of patients with metastatic pancreatic cancer is four to six months, and the five-year survival rate of pancreatic cancer is 7.2%. We expect to file for regulatory approval in China in the second half of 2025.

Additional Indication for AUGTYRO (Repotrectinib)

As discussed in Our Commercial Products and Operations, we have an exclusive license from Turning Point (now a wholly owned subsidiary of BMS) to develop and commercialize repotrectinib in Greater China, and we have launched AUGTYRO in mainland China for ROS1+ NSCLC.  

We are evaluating repotrectinib for the treatment of NTRK+ solid tumors and are participating in the Greater China portion of the global Phase I/II TRIDENT-I study for the treatment of TKI-naïve and TKI-pretreated patients with NTRK-positive advanced solid tumors. In August 2023, the NMPA granted BTD for repotrectinib for the treatment of patients with advanced solid tumors that have a NTRK gene fusion who have progressed following treatment with TRK TKIs. NTRK+ is estimated to be an oncogenic driver in approximately 0.5% of patients with a variety of advanced solid tumors. 

In June 2024, BMS announced that, based on the results of the TRIDENT-1 trial, the FDA granted accelerated approval of AUGTYRO for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic, or where surgical resection is likely to result in severe 

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morbidity. This indication was approved under accelerated approval based on overall response rate and duration of response, and continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. We plan to submit an sNDA to the NMPA for NTRK+ solid tumors in the first half of 2025.

Our Immunology, Neuroscience, and Infectious Disease Pipeline

Additional Opportunities for Efgartigimod

As discussed in Our Commercial Products and Operations, we have an exclusive license from argenx to develop and commercialize efgartigimod in Greater China, and in mainland China, we have launched VYVGART for the treatment of adult patients with gMG and VYVGART Hytrulo for gMG and CIDP. We are evaluating significant