Shanghai, China, Oct. 06, 2026 -- Allist Pharmaceuticals Co., Ltd. (“Allist”) (688578.SH) today announced that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR).  Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR.  Although not yet mature, a trend toward an improvement in overall survival was also observed.  The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.

Jie Hu, Vice Chairman and Deputy General Manager of Allist, stated,“Firmonertinib is an excellent third-generation EGFR-targeted therapy that has been thoroughly validated from clinical research to clinical practice. Multiple indications have been approved and included in national reimbursement, and several additional indications are under development. We are working with ArriVent to evaluate the complete FURVENT dataset in order to determine next steps. The Company will firmly step up the expansion of new indications for firmonertinib, firmly strengthen the R&D of innovative drugs, and firmly work closely with ArriVent led by Dr. Yao to fully advance all ongoing clinical programs and collaborative product development.”

Key Results from the FURVENT Phase III Trial

Blinded Independent Central Review (BICR)

Investigator Assessment

Abbreviations: HR, hazard ratio; CI, confidence interval; ORR, objective response rate.

The safety profile observed in the FURVENT trial was consistent with that seen in previous clinical studies of firmonertinib, with no new safety signals identified. The incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was 52%, 53%, and 55% in the firmonertinib 240 mg, 160 mg, and control groups, respectively; the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 26%, 22%, and 40%, respectively.

About FURVENT

FURVENT (NCT05607550) is a global, pivotal, three-arm Phase III clinical trial being conducted jointly with our partner ArriVent, studying firmonertinib as first-line treatment in patients with locally advanced or metastatic non-squamous NSCLC harboring exon 20 insertion mutations. The trial is designed to evaluate the safety and efficacy of once-daily firmonertinib at 160 mg or 240 mg, with each dose compared against the current first-line standard of care — platinum-based chemotherapy combined with pemetrexed. For patients with brain metastases at baseline, secondary endpoints include CNS objective response rate (CNS-ORR) and CNS progression-free survival (CNS-PFS) as assessed by modified RECIST (mRECIST). The study enrolled a total of 398 patients globally, with sites across the United States, Europe, and screened Asian countries including Japan and China.

About Firmonertinib

Firmonertinib is a China-originated, third-generation EGFR-TKI with independent intellectual property rights. It was approved in March 2021 and June 2022 for the second-line and first-line treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC, respectively, and both indications have been included in the National Reimbursement Drug List (NRDL). In February 2026, the second-line treatment indication of firmonertinib for EGFR exon 20 insertion-mutant NSCLC was approved and launched. Registrational clinical studies in NSCLC are progressing smoothly, including adjuvant treatment of EGFR-sensitizing mutations, first-line treatment of PACC-mutant NSCLC, treatment of EGFR-sensitizing mutation-positive NSCLC patients with brain metastases, and adjuvant treatment of EGFR-uncommon mutations. 

In June 2021, Allist entered into an exclusive overseas licensing agreement for firmonertinib with ArriVent Biopharma, Inc. Since then, global multicenter Phase III registrational clinical studies of firmonertinib as first-line treatment for patients with EGFR exon 20 insertion-mutant and PACC-mutant NSCLC have been successively initiated across multiple countries, including China, the United States, the United Kingdom, France, Japan, and South Korea. The indication of firmonertinib for the treatment of EGFR exon 20 insertion-mutant NSCLC has received Breakthrough Therapy Designation from both Chinese and U.S. regulatory authorities.

About Allist

Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. In accordance with its development concept “Advancing Long Life with Innovation of Science and Technology”, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After more than 20 years of endeavor, Allist has independently discovered and launched multiple approved innovative drugs and built comprehensive capabilities to continuously develop proprietary anti-tumor therapies with proven clinical efficacy. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578). 

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