Befotertinib

Phase 2Small molecule

BBetta Pharmaceuticals Co., Ltd.

Befotertinib is one of 87 small molecule programs targeting Uncommon EGFR Mutations. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Uncommon EGFR MutationsRecruiting

Phase II Clinical StudyRecruiting

Lung CancerActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Uncommon EGFR MutationsPhase 2

Recruiting

Phase II Clinical StudyPhase 2

Recruiting

Lung CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Tabrecta

Novartis

Phase 3

8 2

Navelbine

PPierre Fabre Medicament

Phase 3

24 3

Pyrotinib

HHengrui Therapeutics, Inc.

Phase 3

3 4

Befotertinib

BBetta Pharmaceuticals Co., Ltd.

Phase 2

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Study completion

NCT07809815

Q4 2027

Phase 2Recruiting

Uncommon EGFR Mutations

NCT06517953

Phase 2Recruiting

Phase II Clinical Study

NCT06863506

Q4 2028

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT07181499

Q2 2029

Post-ApprovalRecruiting

Adjuvant Therapy

NCT06561620

Clinical

Trials by Indication[1]

Uncommon EGFR Mutations1 trial

Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

Recruiting·SSun Yat-sen University·Phase 2·NCT06517953·23 enrolled

Non-Small Cell Lung Cancer1 trial

Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

Recruiting·BBetta Pharmaceuticals Co., Ltd.·Phase 2·NCT07181499·28 enrolled

Lung Cancer1 trial

Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer

Active, not recruiting·BBetta Pharmaceuticals Co., Ltd.·Phase 2·NCT05007938·30 enrolled

ctDNA Monitoring1 trial

ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy

Not yet recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT07410611·84 enrolled

Adjuvant Therapy1 trial

Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients

Recruiting·FFudan University·Phase 4·NCT06561620·592 enrolled

2 more indications

Phase II Clinical Study1 trial

Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT06863506·78 enrolled

Unspecified1 trial

A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Befotertinib Capsules in Healthy Participants

Recruiting·BBetta Pharmaceuticals Co., Ltd.·Phase 1·NCT07809815·36 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Befotertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Befotertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Befotertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Betta Pharmaceuticals Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: BBetta Pharmaceuticals Co., Ltd.

Befotertinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q4 2028

Q2 2029

Trials by Indication[1]

Uncommon EGFR Mutations1 trial

Non-Small Cell Lung Cancer1 trial

Lung Cancer1 trial

ctDNA Monitoring1 trial

Adjuvant Therapy1 trial

Phase II Clinical Study1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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