May 22, 2025 - Shanghai Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced today that its innovative drug Airuikai^® (Glecirasib Citrate Tablets), a KRAS-G12C inhibitor, has been officially approved for market launch by the National Medical Products Administration (NMPA). The approval allows Airuikai^® to be used for the treatment of adult patients withKRAS^G12C-mutated advanced non-small cell lung cancer (NSCLC) who have previously received at least one line of systemic therapy. This marks another innovative lung cancer therapy approved for Allist Pharmaceuticals, offering a new treatment option for patients with KRAS^G12C-mutated non-small cell lung cancer (NSCLC) and helping to reshape the treatment landscape for this hard-to-treat cancer subtype.

Lung cancer remains one of the most common and deadliest cancers worldwide, with NSCLC making up roughly 85% of all cases. Among NSCLC patients, the KRAS^G12Cmutation is the most prevalent driver mutation after EGFR, occurring in approximately 4% of cases. KRAS^G12C mutations are also frequently observed in other cancers, including colorectal and pancreatic tumors.

The approval is based on results from a pivotal Phase II single-arm study evaluating the safety, tolerability, and effectiveness of Glecirasib monotherapy in patients with advanced non-small cell lung cancer harboring KRAS^G12Cmutations who had either failed or were intolerant to standard treatments.

The results demonstrated that Goleresai is both effective and well-tolerated. As of September 28, 2024, a total of 119 NSCLC patients were included in the analysis. The confirmed objective response rate (cORR), as assessed by the Independent Review Committee (IRC), was 49.6% (40.2%-59.0%), with a disease control rate (DCR) of 86.3% (78.7%-92.0%). The median duration of response (DOR) was 14.5 months (9.6 months to not estimable), median progression-free survival (PFS) was 8.2 months (5.2–11.1), and median overall survival (OS) was 17.5 months (13.6 months to not estimable).

Thanks to its innovative drug co-crystal approach and stable approach, Gleceresib demonstrates a favorable safety profile, with a lower incidence of grade ≥3 treatment-related adverse events and excellent gastrointestinal tolerability. Gleceresib is the only KRAS-G12C inhibitor currently approved in China that offers once-daily oral dosing, providing greater convenience for patients.

Professor Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences stated, "The approval of Glecirasib marks a significant milestone in the field of KRAS^G12C-targeted therapy. Its outstanding efficacy and safety profile provide patients a superior treatment option. Moreover, the convenience of once-daily dosing significantly improves treatment adherence."

In addition to its approved indication, clinical studies are currently ongoing to evaluate the combination of Gleceresib with the SHP2 inhibitor (AST 24082) as a first-line treatment for non-small cell lung cancer, as well as Gleceresib monotherapy in various other tumor types.

With this approval, the commercial launch of Gleceresib will officially begin. To maximize the clinical benefits of Glecirasib and broaden patient access, Allist Pharmaceuticals has established a dedicated commercial team. The company is also actively working toward securing Glecirasib's inclusion in China’s National Reimbursement Drug List (NRDL) to make this breakthrough therapy more accessible to lung cancer patients.

Moving forward, Allist remains committed to addressing unmet medical needs, accelerating innovation, and fulfilling its mission of “Advancing Long Life with Innovation of Science and Technology” - delivering better treatments and improved survival outcomes for Chinese patients.