Zai Lab Boosts Patient Access to AUGTYRO for Lung Cancer

Zai Lab Introduces AUGTYRO for ROS1+ NSCLC in China

In a significant development for lung cancer treatment, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has announced that AUGTYRO (repotrectinib) has been included in the 2024 National Reimbursement Drug List (NRDL) by China's National Healthcare Security Administration (NHSA). This update is pivotal as it aims to expand treatment options for adult patients suffering from locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Key Additions to the National Reimbursement Drug List

The recent NRDL update does not only encompass AUGTYRO but also includes renewals for other crucial treatments. NUZYRA (omadacycline) will see its intravenous (IV) formulation renewed for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Additionally, QINLOCK (ripretinib) is renewed for treating advanced gastrointestinal stromal tumor (GIST) patients who have previously received treatment with three or more kinase inhibitors.

Impact on Patients and Healthcare

Andrew Zhu, Chief Commercial Officer of Zai Lab, emphasized that the inclusion of AUGTYRO will significantly enhance access for patients with ROS1+ NSCLC in China. He noted, "We look forward to launching AUGTYRO by the end of 2024," highlighting the treatment's promising durability. The renewals of NUZYRA and QINLOCK further support Zai Lab's commitment to improving patient access to essential medications at more affordable prices.

Commitment to Patient Access

Josh Smiley, President and Chief Operating Officer of Zai Lab, reiterated the company's mission to provide innovative medicines where there are significant unmet medical needs. With six products now included in the NRDL, Zai Lab aims to broaden patient access across China, cooperating continuously with the NHSA to improve affordability and accessibility for innovative treatments.

Understanding ROS1+ NSCLC and Its Treatment

Lung cancer remains the most frequently diagnosed type of cancer and the leading cause of cancer-related deaths globally. In recent studies, approximately 1,060,600 new cases and 733,300 deaths were reported in China for 2022 alone. Non-small cell lung cancer (NSCLC) represents about 85% of all lung cancer cases, with approximately 70% being diagnosed as locally advanced or metastatic at initial diagnosis. Notably, ROS1 rearrangements are found in about 2% of advanced NSCLC patients in China.

About AUGTYRO and Its Mechanism

AUGTYRO is a next-generation tyrosine kinase inhibitor (TKI) specifically designed to target ROS1 and NTRK oncogenic drivers. This innovative treatment presents a solution for patients facing resistance mutations linked to existing targeted therapies, which often curtail the effectiveness of these treatments. AUGTYRO aims to offer improved duration of response and combat potential tumor progression, even in cases where metastases occur in the brain.

Regulatory Approvals and Breakthrough Designation

In November 2023, AUGTYRO received approval from the U.S. Food and Drug Administration (FDA) for treating adult patients with locally advanced or metastatic ROS1-positive NSCLC. Following this, in May 2024, it was approved by China's National Medical Products Administration (NMPA) for the same indications. Additionally, in August 2023, AUGTYRO was granted Breakthrough Therapy Designation by the NMPA for advanced solid tumors harboring an NTRK gene fusion.

Overview of Other Treatments: NUZYRA and QINLOCK

NUZYRA is a novel antibacterial agent that works effectively across a broad spectrum of bacterial infections, including both Gram-positive and Gram-negative pathogens. This treatment gained approval from the NMPA as an innovative drug for treating CABP and ABSSSI in adults, with its IV formulation included in the NRDL as of January 2023.

QINLOCK targets GIST patients and employs a dual mechanism of action to inhibit relevant kinases involved in cancer progression. It was first approved in March 2021 and subsequently included in the NRDL to ensure comprehensive care for GIST patients who have exhausted other treatments.

About Zai Lab Limited

Zai Lab Limited is committed to furthering innovative research and development in the biopharmaceutical field. Established in China and the United States, Zai Lab focuses on addressing substantial medical conditions across oncology, immunology, neuroscience, and infectious diseases with unmet needs. With a mission to enhance human health, Zai Lab is strategically working towards bringing transformative therapies to patients in China and around the globe.

Frequently Asked Questions

What is the significance of AUGTYRO's inclusion in the NRDL?

AUGTYRO's inclusion in the NRDL means increased accessibility to new treatment options for patients with ROS1+ NSCLC in China, enhancing potential outcomes.

Who are the key stakeholders in Zai Lab?

The key stakeholders at Zai Lab include Andrew Zhu, the Chief Commercial Officer, and Josh Smiley, the President and Chief Operating Officer, who are pivotal in guiding the company’s mission.

What types of cancers does Zai Lab focus on?

Zai Lab focuses on developing therapies for various cancers, prominently including NSCLC, GIST, and other solid tumors with high unmet medical needs.

What are the treatment options for CABP and ABSSSI?

NUZYRA is a treatment option approved for CABP and ABSSSI, with both oral and IV formulations available to address a range of bacterial infections.

How many products does Zai Lab have in the NRDL?

Zai Lab currently has six products included in the NRDL, showcasing its commitment to improving patient access to critical medicines.

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