Drugs / Befotertinib
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07458919 | Mar 2026 → Oct 2030 expected | lung cancer | Fuzhou General Hospital | Not yet recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT07809815 | Sep 2026 → Apr 2027 expected | — | Betta Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06015568 | Sep 2023 → Nov 2028 expected | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04464551 | Dec 2020 → Aug 2021 | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03452150 | Jan 2018 → Aug 2020 | non-small cell lung carcinoma | InventisBio Co., Ltd | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07410611 | Feb 2026 → Feb 2030 expected | non-small cell lung carcinoma | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07181499 | Sep 2025 → Nov 2028 expected | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06863506 | Oct 2024 → Jun 2027 expected | non-small cell lung carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06517953 | Jul 2024 → Jul 2026 overdue | non-small cell lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05007938 | Aug 2021 → Dec 2024 overdue | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03861156 | Feb 2019 → Aug 2021 | non-small cell lung carcinoma | InventisBio Co., Ltd | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04206072 | Dec 2019 → Jul 2022 | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06041776 | Mar 2023 → Apr 2028 expected | non-small cell lung carcinoma | Betta Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT06755684 Background | Nov 2024 → Dec 2025 overdue | non-small cell lung carcinoma | Peng Zhang | Recruiting | No outcome recorded |
| Phase 4 | NCT06561620 Comparator | May 2024 → May 2027 expected | — | Fudan University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Betta Pharmaceuticals Co., Ltd. | Results 2025 ESMO Asia丨贝福替尼联合埃克替尼一线治疗晚期EGFR敏感突变NSCLC探索性研究亮相 bettapharma.com ↗
客观缓解率（ORR）为86.96%，其中部分缓解（PR）20例；疾病控制率（DCR）为100%。 |
| 2023-05-25 | Betta Pharmaceuticals Co., Ltd. | Results 贝达药业贝福替尼一线临床研究结果在《柳叶刀·呼吸医学》全文发表 bettapharma.com ↗
5月25日，国际领先期刊《柳叶刀·呼吸医学》杂志（The Lancet Respiratory Medicine）全文在线发表贝福替尼一线研究结果。 |
| 2022-12-02 | Betta Pharmaceuticals Co., Ltd. | Results 贝达药业甲磺酸贝福替尼一线研究最新数据亮相2022 ESMO Asia bettapharma.com ↗
IRC评估的中位PFS分别为22.1个月（17.9-NE）和13.8个月（12.4-15.2）（HR 0.49; 95%CI 0.36-0.68; P＜0.0001）。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Betta Pharmaceuticals Co., Ltd. | 2025 ESMO Asia丨贝福替尼联合埃克替尼一线治疗晚期EGFR敏感突变NSCLC探索性研究亮相 bettapharma.com ↗ |
| 2023-05-25 | Betta Pharmaceuticals Co., Ltd. | 贝达药业贝福替尼一线临床研究结果在《柳叶刀·呼吸医学》全文发表 bettapharma.com ↗ |
| 2022-12-02 | Betta Pharmaceuticals Co., Ltd. | 贝达药业甲磺酸贝福替尼一线研究最新数据亮相2022 ESMO Asia bettapharma.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Befotertinib | “Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor.” PMID 37244266 ↗ May 202312“Befotertinib (D-0316) is a novel, third-generation EGFR tyrosine kinase inhibitor (TKI).” PMID 35724798 ↗ Jun 2022 “Befotertinib: Oral administration, taken on an empty stomach or with food.” NCT07458919 ↗ |
| Known as | D-0316 | “Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor.” PMID 37244266 ↗ May 20234“Befotertinib (D-0316) is a novel, third-generation EGFR tyrosine kinase inhibitor (TKI).” PMID 35724798 ↗ Jun 2022 “Drug:Befotertinib (75 mg or 100 mg orally, once daily) Other name:D-0316” NCT06015568 ↗ |
| Action | Inhibit | “EGFR mutant-selective inhibitor” PMID 35274722 ↗ Mar 2022 |
| Modality | Small molecule | “Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor.” PMID 37244266 ↗ May 2023 |
| Route | Oral | “daily oral D-0316 administration” PMID 35274722 ↗ Mar 2022 |
| Target | EGFR | “Befotertinib (D-0316) is a novel, third-generation EGFR tyrosine kinase inhibitor (TKI).” PMID 35724798 ↗ Jun 2022 |