EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases

Active Indication

EGFR ex20ins mutation in non-small cell lung cancerEGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaEGFR positive Neoplasms+ [10]

Inactive Indication

EGFR positive Adenocarcinoma of LungMetastatic Non-Squamous Non-Small Cell Lung Carcinoma

Originator Organization

Shanghai Allist Pharmaceuticals Co., Ltd.

Active Organization

Shanghai Allist Pharmaceuticals Co., Ltd.

Arrivent BioPharma, Inc.

Inactive Organization-

License Organization

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Shanghai Allist Pharmaceuticals Co., Ltd.

Arrivent BioPharma, Inc.

Drug Highest PhaseApproved

First Approval Date

China (03 Mar 2021),

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC29H35F3N8O5S

InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N

CAS Registry2130958-55-1

Clinical Trials associated with Alflutinib Mesylate

NCT06962865

/ Not yet recruitingPhase 2

A Randomized, Open, Controlled, Multicenter Phase II Clinical Study of RC108 in Combination With Furmonertinib Versus Furmonertinib for the First-Line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC

Start Date15 Jun 2025

Sponsor / Collaborator

RemeGen Co., Ltd.

NCT06945705

/ RecruitingPhase 2IIT

A Prospective, Single-arm, Multi-center Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis.

EGFR mutation-positive NSCLC patients have a higher risk of developing brain metastases. The prognosis is poor for patients presenting with brain or leptomeningeal metastases at any stage, particularly those with such metastases at initial diagnosis, who have the worst prognosis. Furmonertinib, as a novel EGFR-TKI, enhances its lipophilicity by incorporating a trifluoroethoxy pyridine group. Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution. This provides strong theoretical support for the effective treatment of lung cancer brain metastasis patients with Furmonertinib.
EGFR TKI-based combination therapies, as a strategy to delay disease progression, have consistently been a focal point in medical research. Among these, antiangiogenic agents are increasingly recognized for their synergistic effects when combined with TKIs, jointly inhibiting tumor growth, proliferation, and metastasis.Such combinations have demonstrated clear efficacy and manageable safety profiles.
Based on this, the current study aims to explore the efficacy and safety of first-line treatment with 160 mg Furmonertinib combined with anlotinib for advanced NSCLC patients with EGFR-sensitive mutations and brain metastases.

Start Date02 Apr 2025

Sponsor / Collaborator

Henan Cancer Hospital

NCT06861218

/ Not yet recruitingPhase 2IIT

Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Meningeal Metastases: a One-arm, Phase II Clinical Study

With the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. High-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. However, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. In this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose EGFR-targeted drug in patients with leptomeningeal metastases from EGFR-positive NSCLC.

Start Date01 Apr 2025

Sponsor / Collaborator

Zhejiang Cancer Hospital

100 Clinical Results associated with Alflutinib Mesylate

100 Translational Medicine associated with Alflutinib Mesylate

100 Patents (Medical) associated with Alflutinib Mesylate

106

Literatures (Medical) associated with Alflutinib Mesylate

01 Jun 2025·BIOORGANIC & MEDICINAL CHEMISTRY

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer

Review

Author: Patel, Harun M ; Patil, Chandragouda R ; Gawli, Chandrakant S

"Epidermal growth factor receptor (EGFR)" mutations are pivotal in the pathogenesis of "Non-Small Cell Lung Cancer (NSCLC)," which is associated with high morbidity and mortality rates. The advent of third and fourth-generation EGFR tyrosine kinase inhibitors (TKIs) has significantly advanced the therapeutic landscape for EGFR-mutant NSCLC, particularly in overcoming resistance mutations such as T790M and C797S. This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib. Furthermore, it explores emerging fourth-generation EGFR TKIs designed to address resistance mechanisms beyond those targeted by their predecessors. Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation. The review emphasizes the importance of these advanced inhibitors in enhancing "progression-free survival and overall survival rates". By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors.

01 Apr 2025·INVESTIGATIONAL NEW DRUGS

Rare exon 18 G719A and exon 21 L833V compound EGFR mutations show favorable response to Third-Generation TKI Furmonertinib: A case report and literature review

Review

Author: Zhang, Dongdong ; Zhao, Jijun ; Wu, Tao ; Yuejian

EGFR exon 19 deletions and exon 21 point mutations are the most common mutations in lung adenocarcinoma, with patients deriving significant clinical benefits from EGFR tyrosine kinase inhibitors (TKIs). However, the efficacy of TKIs in rare compound EGFR mutations remains uncertain. We report a case of lung adenocarcinoma with concurrent EGFR exon 18 G719A and exon 21 L833V mutations, showing a favorable response to third-generation TKI treatment. We reported a case of a 63-year-old female patient with brain, bone, and adrenal metastases from lung adenocarcinoma. Next-generation sequencing analysis identified a rare EGFR exon 18 G719A mutation in combination with an EGFR exon 21 L833V mutation. The patient received furmonertinib as first-line treatment and achieved a sustained response lasting over 12 months. This is the first reported case highlighting the efficacy of a third-generation TKI in treating lung adenocarcinoma with this rare compound mutation. Our findings suggest that third-generation TKIs may be a viable therapeutic option for prolonging progression-free survival in this patient subset.

01 Apr 2025·ANTI-CANCER DRUGS

The effectiveness of sequential afatinib and furmonertinib in an advanced lung adenocarcinoma with rare compound EGFR mutation (L833V/H835L)

Article

Author: Gu, Yongyao ; Wang, Shaoxi ; Li, Huiling ; Chen, Quanfang ; Yan, Lingxin ; Pan, Yanqing ; Yu, Pengli

Uncommon atypical mutations account for 10–15% of all epidermal growth factor receptor (EGFR) activating mutations in nonsmall-cell lung cancer (NSCLC). Tumors harboring rare EGFR mutations show highly heterogeneous responses to EGFR tyrosine kinase inhibitors (TKIs). There is insufficient clinical evidence for uncommon types of EGFR mutations, especially those with compound EGFR mutations. In addition, for those with uncommon compound EGFR mutations, few studies have focused on acquired resistance mechanisms and subsequent treatment strategies after disease progression on EGFR-TKIs. Here, a 66-year-old smoking male was diagnosed with lung adenocarcinoma accompanied by pleural metastasis. A rare L833V/H835L compound mutation in exon 21 of EGFR was detected in tumor biopsy by next-generation sequencing. Afatinib was used as first-line therapy and showed favorable efficacy. The patient continued afatinib treatment for a duration of 24 months. A new T790M mutation was detected with a rebiopsy after progression on afatinib. Then the patient received cryoablation therapy and a third-generation EGFR-TKI, furmonertinib. Our case suggests that a comprehensive screening for EGFR mutations should be conducted before and during treatment in clinical practice, and afatinib and furmonertinib could be first- and second-line treatment options in NSCLC patients harboring EGFR L833V/H835L mutations.

News (Medical) associated with Alflutinib Mesylate

12 May 2025

·www.globenewswire.com

ArriVent BioPharma Reports First Quarter 2025 Financial Results

Completed enrollment in global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutationsPlanned update for development of firmonertinib in first-line NSCLC PACC mutations in Q2 2025First IND for ARR-217 (MRG007), an antibody drug conjugate (ADC) targeting CDH17, submitted in China Cash, cash equivalents and marketable securities of $205.5 million as of March 31, 2025 NEWTOWN SQUARE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the first quarter ended March 31, 2025, and highlighted recent Company progress. “We continued our strong execution across our oncology-focused pipeline and are preparing for several near-term milestones. Importantly, our late-stage firmonertinib program continues to show differentiated potential to address unmet needs across EGFR-mutant non-small cell lung cancer (NSCLC),” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “ARR-217 (MRG007), our recently acquired antibody drug conjugate (ADC) targeting the gastrointestinal marker CDH17 with best-in-class potential, is expected to be the first ADC from our pipeline to enter the clinic.” Dr. Yao continued, “In the year ahead, we plan to present updated data for firmonertinib in first line EGFR PACC mutant NSCLC, including Progression Free Survival (PFS) and duration of response, and provide our clinical development plan on the PACC program in the second quarter of 2025. We expect topline data in 2025 in our event-driven global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutations.” First Quarter 2025 and Recent Highlights Firmonertinib Completed enrollment for pivotal trial. During the first quarter of 2025, we completed enrollment in the the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population. Pipeline Expanded our pipeline to include ARR-217 (MRG007). In January 2025, ArriVent entered into a collaboration agreement with Lepu Biopharma for ARR-217, a CDH17-targeted ADC with the potential to treat gastrointestinal cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China. In March 2025, our first IND was submitted in China with an initial clinical development focus in colorectal, pancreatic and other GI cancers. Pre-clinical data presented recently at the American Association of Cancer Research (AACR) annual meeting in April 2025 demonstrated compelling antitumor activity in multiple GI cancer models and a favorable safety profile. Upcoming Milestones EGFR PACC plans. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations. ArriVent expects to provide an update on our plans to develop firmonertinib in EGFR PACC mutant NSCLC in Q2 2025.Topline pivotal Phase 3 firmonertinib data. ArriVent anticipates having topline firmonertinib monotherapy data from the event-driven global pivotal FURVENT Phase 3 (NCT05607550) study in 2025 and expects to provide an update on timing of the topline Phase 3 data release in Q2 2025. Corporate Updates Appointed Merdad Parsey, M.D., Ph.D., to the Board of Directors. In April 2025, ArriVent announced the appointment of Merdad Parsey to the ArriVent Board of Directors. Dr. Parsey brings decades of executive experience leading global clinical development in the biopharmaceutical industry, most recently serving as Chief Medical Officer and Executive Vice President of Gilead Sciences, Inc. He currently serves on the Board of Directors of Sagimet Biosciences, Inc., formerly 3-V Biosciences, Inc. following his tenure as President and Chief Executive Officer. 2025 Financial Results As of March 31, 2025, the Company had cash,cash equivalents and marketable securities of $205.5 million, which is expected to fund operations into the second half of 2026. Net cash used in operations was $68.0 million and $18.6 million for the quarters ended March 31, 2025 and 2024, respectively. The increase in net cash used in operations in the first quarter of 2025 was primarily driven by the one-time upfront payment of $40 million made to Lepu Biopharma.Research and development expenses were $61.3 million and $17.0 million for the quarters ended March 31, 2025 and 2024, respectively. The increase in expense was primarily due to an one-time upfront payment made to Lepu Biopharma for our collaboration that began in January 2025, along with increased headcount and clinical expense related to firmonertinib.General and administrative expenses were $5.5 million and $3.7 million for the quarters ended March 31, 2025 and 2024, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.Net loss was $64.4 million and $17.4 million for the quarters ended March 31, 2025 and 2024, respectively. About ArriVentArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. About Firmonertinib Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 1b study, which includes a cohort evaluating firmonertinib in patients with EGFR PACC mutations (FURTHER; NCT05364043). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd. About EGFR mutant NSCLC Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need. About EGFR PACC mutations P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients. Forward-Looking StatementsThis press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, cash runway, differentiation of firmonertinib, activity of firmonertinib compared to available therapies, the timing of anticipated near-term clinical milestones, the timing of our planned update of data of firmonertinib in first-line NSCLC PACC mutations and corresponding clinical development plan for a potential pivotal study of firmonertinib in patients with NSCLC EGFR PACC mutations, the timing of top-line pivotal Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations, the differentiation of ARR-217 compared to other members of the same class, and the timing of ARR-217’s planned entry into the clinic, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2024, to be filed with the Securities and Exchange Commission on March 3, 2025 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. ARRIVENT BIOPHARMA, INC. CONDENSED BALANCE SHEETS(in thousands, except share and per share data)(Unaudited) March 31, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $49,865 $74,293 Short-term investments 126,212 144,570 Prepaid expenses and other current assets 9,708 8,116 Total current assets 185,785 226,979 Long-term investments 29,414 47,683 Right of use assets – operating leases 120 154 Other assets 176 126 Total assets $215,495 $274,942 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $4,364 $3,782 Accrued expenses 8,451 13,330 Operating lease liabilities 138 162 Total current liabilities 12,953 17,274 Operating lease liabilities, net of current amount — 14 Total liabilities 12,953 17,288 Stockholders’ equity: Preferred stock $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding — — Common stock $0.0001 par value, 200,000,000 shares authorized; 34,040,996 and 33,706,765 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 4 3 Additional paid-in capital 505,275 496,195 Accumulated deficit (302,720) (238,333)Accumulated other comprehensive loss (17) (211)Total stockholders’ equity 202,542 257,654 Total liabilities and stockholders’ equity $215,495 $274,942 ARRIVENT BIOPHARMA, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share data)(Unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $61,289 $16,975 General and administrative 5,483 3,699 Total operating expenses 66,772 20,674 Operating loss (66,772) (20,674)Interest and investment income 2,385 3,257 Net loss (64,387) (17,417)Unrealized gain on marketable securities 194 — Total other comprehensive gain 194 — Total comprehensive loss $(64,193) $(17,417) Share information: Net loss per share attributable to common stockholders, basic and diluted $(1.90) $(0.70)Weighted-average shares of common stock outstanding, basic and diluted 33,898,870 25,046,531 Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com

Phase 1Breakthrough TherapyPhase 3Executive ChangeLicense out/in

28 Apr 2025

·www.globenewswire.com

ArriVent BioPharma Appoints Merdad Parsey, M.D., Ph.D. to its Board of Directors

NEWTOWN SQUARE, Pa., April 28, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the appointment of Merdad Parsey, M.D., Ph.D. to its Board of Directors. Dr. Parsey brings decades of executive experience leading global clinical development in the biopharmaceutical industry, most recently serving as Chief Medical Officer and Executive Vice President of Gilead Sciences, Inc. “Dr. Parsey is a seasoned executive who has driven therapeutic innovation and strategic growth at prominent pharmaceutical and biotech companies across a broad array of therapeutic areas,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “We are thrilled to have him join our Board of Directors at this important time and leverage his experience as firmonertinib progresses towards registration and we advance our antibody drug conjugate (ADC) pipeline.” Dr. Parsey added, “ArriVent is poised to broadly change the cancer treatment landscape with differentiated candidates like firmonertinib that address key unmet needs and their pipeline of next-generation ADC programs that use diverse approaches. I am excited to partner with management and the Board of Directors to help shape the clinical development and commercial strategy for their growing portfolio.” Prior to Gilead, Dr. Parsey held positions of increasing responsibility at Genentech, Inc., a member of the Roche Group, most recently as Senior Vice President in Genentech Research and Early Development, overseeing clinical development, quality, compliance, informatics and clinical operations functions. He also served as President and Chief Executive Officer of 3-V Biosciences, Inc., now Sagimet Biosciences, Inc., and has served on the Board of Directors since 2010. Earlier in his career he held development roles at Sepracor, Inc., Regeneron Pharmaceuticals, Inc. and Merck, Inc. and served as Assistant Professor of Medicine and Director of Critical Care Medicine at New York University School of Medicine. Dr. Parsey completed his M.D. and Ph.D. in immunology at the University of Maryland, Baltimore, his residency in Internal Medicine at Stanford University and his fellowship in Pulmonary and Critical Care Medicine at the University of Colorado. About ArriVentArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. Forward-Looking StatementsThis press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding ArriVent’s ability to develop drugs that help to address the unmet needs of cancer patients, the timing, progress and results of pre-clinical studies and clinical trials for firmonertinib, including our product development plans and strategies, ArriVent’s clinical programs, future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in ArriVent’s annual report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 3, 2025, and its other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. ArriVent Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com

Executive ChangeADC

11 Mar 2025

·www.prnewswire.com

TAGRISSO Sets the Stage for Market Leadership in Oncology with Strong Growth Prospects | DelveInsight

TAGRISSO has become a standard treatment due to its strong efficacy in both first-line and adjuvant settings. The growing prevalence of EGFR mutations, a rise in lung cancer diagnoses, and broader approvals for early-stage treatment all contribute to its promising growth potential. LAS VEGAS , March 11, 2025 /PRNewswire/ -- DelveInsight's " TAGRISSO Market Size, Forecast, and Market Insight Report" highlights the details around TAGRISSO, a kinase inhibitor of the EGFR, which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately nine-fold lower concentrations than wild-type. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TAGRISSO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. AstraZeneca's TAGRISSO (osimertinib) Overview TAGRISSO is a prescription medication for adults with non-small cell lung cancer (NSCLC) that carries specific EGFR gene mutations. It is used to help prevent cancer recurrence after surgical tumor removal, as a first-line treatment for metastatic NSCLC, or for patients whose cancer has spread and no longer responds to prior EGFR TKI therapy. As a kinase inhibitor, TAGRISSO irreversibly targets specific mutant forms of EGFR (T790M, L858R, and exon 19 deletions) with significantly higher selectivity than the wild-type EGFR. After oral administration, two active metabolites (AZ7550 and AZ5104) circulate at around 10% of the parent drug and exhibit similar inhibitory effects as osimertinib. In vitro studies also show that osimertinib inhibits HER2, HER3, HER4, ACK1, and BLK at clinically relevant levels. The recommended TAGRISSO dosage is 80 mg once daily, taken with or without food, and continued until disease progression or unacceptable toxicity occurs. Learn more about TAGRISSO projected market size for EGFR mNSCLC @ TAGRISSO Market Potential EGFR is a protein that plays a crucial role in cell growth. When mutations occur in the EGFR gene, they can lead to excessive cell growth, potentially causing cancer. These mutations can take various forms, including deletions, insertions, and point mutations. Among the most common EGFR mutations detected in test results are the EGFR exon 19 deletion and the EGFR L858R point mutation. In non-small cell lung cancer, targeted therapies primarily focus on EGFR-sensitizing mutations and EGFR exon 20 insertions. The most frequently observed EGFR mutations include exon 19 deletions and exon 21 L858R mutations. To address these, the FDA has approved several tyrosine kinase inhibitors (TKIs). In 2023, the EGFR-mutated NSCLC market across the 7MM was valued at approximately USD 4 billion. The NSCLC treatment landscape is becoming increasingly biomarker-driven, with EGFR emerging as one of the most lucrative targets. TAGRISSO remains the leading therapy in this segment, maintaining a strong market presence. However, resistance to EGFR TKIs, particularly after TAGRISSO treatment, is a growing challenge. Developing treatments for patients who experience resistance remains one of the most pressing unmet needs in this space. Discover more about the EGFR mNSCLC market in detail @ EGFR Metastatic Non-small Cell Lung Cancer Market Report Emerging Competitors of TAGRISSO The promising candidates in EGFR NSCLC pipeline include Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Zipalertinib (Cullinan Oncology/Taiho Pharma), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Savolitinib (AstraZeneca/Hutchison MediPharma), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), BNT327/PM8002 (Biotheus/BioNTech), Zanidatamab (Jazz Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sasanlimab (Pfizer), Pamvatamig (MCLA-129) (Merus), REQORSA (quaratusugene ozeplasmid) (Genprex), PT-112 (Promontory Therapeutics), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), Carotuximab (ENV-105) (Kairos Pharma), and others. To know more about the number of competing drugs in development, visit @ TAGRISSO Market Positioning Compared to Other Drugs Key Milestones of TAGRISSO In December 2024, TAGRISSO was approved in Europe for patients with unresectable EGFR-mutated lung cancer based on the results of the LAURA Phase III study. In September 2024, TAGRISSO was approved in the US for patients with unresectable stage III EGFR-mutated lung cancer based on LAURA Phase III trial results. In July 2024, TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, was approved in Europe for the first-line treatment of adult patients with advanced EGFR-mutated NSCLC whose tumors have exon 19 deletions or exon 21 (L858R) mutations. Approval was based on the results from the Phase III FLAURA2 study. In June 2024, TAGRISSO in combination with chemotherapy was approved in Japan as a first-line treatment for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In June 2024, TAGRISSO was granted priority review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer. TAGRISSO was also recently granted BTD by the FDA in this setting. In February 2024, TAGRISSO in combination with chemotherapy was approved in the US for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In October 2023, TAGRISSO plus chemotherapy was granted priority review in the US for patients with EGFR-mutated advanced lung cancer based on FLAURA2 Phase III trial results. In August 2022, TAGRISSO was approved in Japan for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the positive results from the global ADAURA Phase III trial. In May 2021, TAGRISSO was approved in Europe for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In December 2020, TAGRISSO was approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In October 2020, TAGRISSO granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the data from the ADAURA Phase III trial. In July 2020, TAGRISSO was granted BTD in the US for the adjuvant treatment of patients with Stage IB–IIIA EGFR-mutated lung cancer based on unprecedented results from the Phase III ADAURA trial. In August 2018, the MHLW approved TAGRISSO for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive NSCLC In June 2018, the EC granted marketing authorization for TAGRISSO as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. In April 2018, the US FDA approved TAGRISSO for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. In April 2018, Molecular Partners and AstraZeneca announced a clinical collaboration for MP0250 in EGFR-mutated NSCLC with osimertinib. Under the collaboration, AstraZeneca will supply osimertinib for the clinical study. In April 2017, the EC granted full marketing authorization for TAGRISSO for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. In March 2017, the US FDA granted full approval for TAGRISSO for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. TAGRISSO was granted accelerated approval for this indication in November 2015 based on tumor response rate and duration of response. In 2017, TAGRISSO was granted BTD and priority review by the US FDA for the first-line treatment of patients with metastatic NSCLC. In March 2016, the MHLW approved TAGRISSO for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR-TKI. In January 2016, AstraZeneca and Incyte Corporation announced a clinical trial collaboration to evaluate the efficacy and safety of INCB39110 in combination with osimertinib. In September 2014, the US FDA granted ODD to TAGRISSO for treating EGFR mutation-positive NSCLC. In April 2014, TAGRISSO received BTD from the US FDA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. In November 2013, TAGRISSO was granted FTD for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. Discover how TAGRISSO is shaping the EGFR NSCLC treatment landscape @ TAGRISSO NSCLC TAGRISSO Market Dynamics TAGRISSO, developed by AstraZeneca, is a third-generation EGFR TKI that has become a key player in the treatment of NSCLC with EGFR mutations. Since its approval, TAGRISSO has gained significant traction due to its efficacy in treating both first-line and post-resistance settings, particularly in patients with the T790M resistance mutation. The drug's ability to penetrate the blood-brain barrier and show strong efficacy against brain metastases has further strengthened its market positioning, leading to widespread adoption among oncologists. A major driver of TAGRISSO's market dynamics is its dominance as the preferred first-line treatment for EGFR-mutated NSCLC. This shift from earlier-generation TKIs has been supported by clinical data demonstrating superior progression-free survival (PFS) and overall survival (OS) benefits. The expansion of TAGRISSO's indications, including its approval in the adjuvant setting for early-stage EGFR-mutated NSCLC, has further broadened its market reach. Additionally, AstraZeneca has aggressively pursued global regulatory approvals, ensuring market access across multiple geographies, particularly in high-prevalence regions such as East Asia, where EGFR mutations are more common. However, TAGRISSO faces growing challenges, including the emergence of resistance mechanisms such as MET amplification and C797S mutations, which limit long-term efficacy. To counteract this, AstraZeneca is exploring combination strategies with MET inhibitors and other targeted therapies. Furthermore, increasing competition from next-generation EGFR TKIs, such as those under development by companies like Takeda and Johnson & Johnson, poses a potential threat. Pricing and reimbursement pressures, particularly in cost-sensitive markets, also impact its commercial strategy, necessitating a balance between pricing optimization and maintaining accessibility. Despite these challenges, TAGRISSO remains a blockbuster drug with robust revenue growth, driven by strong clinical performance and strategic lifecycle management. Ongoing clinical trials evaluating its use in earlier disease stages and in combination therapies could further extend its market leadership. With its strong foothold in the EGFR-mutated NSCLC landscape, TAGRISSO is expected to remain a key driver of AstraZeneca's oncology portfolio in the foreseeable future. Dive deeper to get more insight into TAGRISSO's strengths & weaknesses relative to competitors @ TAGRISSO Market Drug Report Table of Contents Related Reports EGFR Non-small Cell Lung Cancer Market EGFR Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Genentech/Roche, Eli Lilly, Hansoh Pharmaceutical, J&J Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Black Diamond Therapeutic, J INTS BIO, NALO Therapeutics, Scorpion Therapeutics, ORIC Pharmaceuticals, among others. EGFR Non-small Cell Lung Cancer Pipeline EGFR Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key EGFR non-small cell lung cancer companies, including Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Priority ReviewAccelerated ApprovalASCO

100 Deals associated with Alflutinib Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB16087

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	28 Jun 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	China	Shanghai Allist Pharmaceuticals Co., Ltd.	03 Mar 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR positive Neoplasms	Phase 3	China	Shanghai Allist Pharmaceuticals Co., Ltd.	19 Nov 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 3	China	Shanghai Allist Pharmaceuticals Co., Ltd.	19 Nov 2024
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	China	Shanghai Allist Pharmaceuticals Co., Ltd.	26 Sep 2024
Lung Cancer with Brain Metastasis	Phase 3	China	Shanghai Allist Pharmaceuticals Co., Ltd.	26 Sep 2024
Non-squamous non-small cell lung cancer	Phase 3	United States	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	Japan	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	Australia	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	France	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	Netherlands	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	Spain	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ELCC2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer Adjuvant EGFR mutations	135	Furmonertinib 80 mg	jgedbiouac(cxmponqjnt) = iqknheqmkj fqaohunpvs (eqlrxbhhyt ) View more	Positive	26 Mar 2025
ESMO_ELCC2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer uncommon EGFR mutations \| exon 20 insertion mutations	31	Furmonertinib	ooewpfqkec(clluxwjihg) = no grade 4 adverse events or treatment-related deaths uwqwwccsyp (vpfblvxkaz ) View more	Positive	26 Mar 2025
NCT04895930 (FOCUS-A, ESMO_ELCC2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer	40	Firmonertinib 80 mg qd + Anlotinib 10 mg qd	ebrgdaoagf(bmgluupild) = kludmxveoo ssrorsrzvr (pagjzghvbc, 73.2 - 95.8) View more	Positive	26 Mar 2025
ESMO_TAT2025	Not Applicable	Second line EGFR-TKIs	37	Furmonertinib	rndudysiff(mgzlljzuzv) = 11 [29.7%] xtjvcewvui (puqlfgeiem ) View more	Positive	03 Mar 2025
NCT05379803 (ESMO_ASIA2024) Manual	Phase 2	EGFR positive non-small cell lung cancer First line EGFR Exon 19 Deletion \| EGFR L858R	30	Furmonertinib	hngwmuehpl(eidhsnwxos) = jcxccnnvkd pztfqcqvxz (fkytmceaum ) View more	Positive	07 Dec 2024
ChiCTR2200060897 (ESMO_ASIA2024) Manual	Phase 1	Non-Small Cell Lung Cancer First line EGFR L858R	33	Furmonertinib	vnlwmtfchu(jmltcbfmve) = bsfpfddpaa rfuomqpwas (pdimvynidx ) View more	Positive	07 Dec 2024
NCT05364073 (FURTHER, NEWS) Manual	Phase 1	HER2 Mutation Lung Cancer First line	-	Firmonertinib 240 mg	aholjabzmq(nmjthccwsx) = fawhzakpwm pcesmdhauj (rfozixexfi, 40.7 - 82.8) View more	Positive	10 Sep 2024
NCT05364073 (FURTHER, NEWS) Manual	Phase 1	HER2 Mutation Lung Cancer First line	-	Firmonertinib 160 mg	aholjabzmq(nmjthccwsx) = jpwrznsbwd pcesmdhauj (rfozixexfi, 16.4 - 57.3) View more	Positive	10 Sep 2024
WCLC2024 Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutation-positive	72	Furmonertinib	sibbghmezr(wztnequeop) = rxvacmrarp ujjyfjcjng (jnxvlhhxjp, 14.4 - 25.4) View more	Positive	07 Sep 2024
ChiCTR2300072092 (ASCO2024) Manual	Not Applicable	Metastatic Malignant Neoplasm to the Leptomeninges \| EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	48	Furmonertinib 240mg	qcyhbrwhca(nbrkdonsgu) = jgfcwclagg lmruawlhmi (ccasvkkpcc, 5.481 - 11.386) View more	Positive	24 May 2024
ASCO2024	Not Applicable	-	-	Furmonertinib 240 mg	mrgvayoyaf(euizaldxzz) = The most common AEs were rash, diarrhea and decreased appetite. However, most AEs were grade 1-2. cbxyptuzeh (vdikimqlqn ) View more	-	24 May 2024
ASCO2024	Not Applicable	-	-	Furmonertinib 160 mg		-	24 May 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis