相关临床试验
10
6 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2021
进行中（未招募）
4
40.0%
尚未招募
2
20.0%
招募中
4
40.0%
暂无批准数据
- ArriVent BioPharma expects topline data from the global pivotal FURVENT Phase 3 trial of firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC in the second half of 2026. - The company advanced ARR-217, a CDH17-targeted ADC for gastrointestinal cancers, into Phase 1b dose optimization and plans first-patient dosing for ARR-002, a dual-targeting MUC16/NaPi2b ADC, in Q3 2026. - Firmonertinib holds FDA Breakthrough Therapy and Orphan Drug designations and is also being studied in the ALPACCA Phase 3 trial for EGFR PACC-mutant NSCLC. - ArriVent reported $373.1 million in cash and investments as of June 30, 2026, expected to fund operations into 2028.
- The global EGFR inhibitors market reached USD 7 billion in 2025 across the 7MM, with the United States accounting for approximately 60% of total market share. - A wave of emerging therapies including zipalertinib, firmonertinib, ivonescimab, and multiple ADC candidates is expected to reshape the treatment landscape for EGFR-mutated cancers. - The FDA has set PDUFA action dates for ivonescimab (November 14, 2026) and zipalertinib (February 27, 2027), signaling imminent regulatory decisions for two novel agents. - EGFR exon 20 insertion mutations have emerged as a key competitive arena, with approvals of amivantamab and sunvozertinib creating a distinct market segment.
- ArriVent BioPharma has dosed the first patient in the global pivotal Phase 3 ALPACCA trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant non-small cell lung cancer. - The randomized study compares firmonertinib 240 mg once daily against investigator's choice of osimertinib or afatinib, targeting an underserved population with limited treatment options. - PACC mutations represent approximately 12% of all EGFR mutations and affect an estimated 42,000 patients globally and 6,200 patients annually in the US. - The trial is designed to support potential accelerated and full regulatory approvals based on compelling prior data showing 16-month median progression-free survival and 68% overall response rate.
- The FDA granted accelerated approval to Dato-DXd in June 2025 for adults with locally advanced or metastatic EGFR-mutated NSCLC who progressed after prior EGFR-targeted therapies and platinum-based chemotherapy. - Johnson & Johnson's Phase 3 MARIPOSA study demonstrated that the combination of RYBREVANT and LAZCLUZE significantly improved overall survival compared to osimertinib in EGFR-mutated NSCLC patients. - Over 25 companies are developing 30+ therapies for EGFR-mutated NSCLC across various clinical phases, including novel small molecules, monoclonal antibodies, and combination treatments. - Recent clinical milestones include BlossomHill Therapeutics initiating the SOLARA Phase 1/2 trial for BH-30643 and AstraZeneca receiving Priority Review for Dato-DXd's BLA application.
- ArriVent BioPharma has appointed Brent S. Rice as Chief Commercial Officer, bringing over 25 years of biotechnology and pharmaceutical commercial experience to the clinical-stage company. - Rice previously served as global Chief Commercial Officer at Autolus Therapeutics, where he successfully transitioned the company from clinical-stage to commercial operations and led the launch of their first commercial product. - The appointment comes as ArriVent's lead candidate firmonertinib approaches potential approval for EGFR mutant non-small cell lung cancer, with the company also developing a pipeline of antibody drug conjugates. - Rice's expertise in launching novel therapies and building commercial organizations positions ArriVent for success as it prepares for potential product commercialization in oncology markets.
- ArriVent BioPharma successfully priced a $75 million public offering of common stock and pre-funded warrants at $19.50 per share to fund its oncology pipeline development. - The proceeds will support the company's lead candidate firmonertinib and other pipeline programs including next-generation antibody drug conjugates for cancer treatment. - Goldman Sachs, Citigroup, and Guggenheim Securities are serving as joint book-running managers for the offering, which is expected to close on July 3, 2025. - ArriVent is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics to address unmet medical needs in cancer treatment.
• ArriVent BioPharma secures exclusive global rights to MRG007, a promising antibody-drug conjugate from Lepu Biopharma, with FDA IND submission planned for early 2025. • The company's lead drug firmonertinib demonstrates impressive 63.6% objective response rate in Phase 1b FURTHER trial for EGFR PACC-mutated non-small cell lung cancer patients. • H.C. Wainwright analyst raises price target to $39, citing strategic portfolio expansion and encouraging clinical data in addressing unmet medical needs.
