Drugs / PLB1004
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | 2025-05-22 | “苯甲酸安达替尼胶囊 (PLB1004 胶囊) NDA 申请获正式受理并纳入优先审评” avistonebio.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06046495 | Jul 2024 → Feb 2028 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05347628 | Aug 2020 → Apr 2023 | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07285148 | Jun 2026 → Dec 2029 expected | non-small cell lung carcinoma | Beijing Pearl Biotechnology Limited Liability Company | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07063329 | Aug 2025 → Mar 2028 expected | non-small cell lung carcinoma | Avistone Pharmaceutical (Ningbo) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06343064 | Jun 2023 → Dec 2026 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06574347 | Aug 2024 → Oct 2026 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06015503 | Jul 2023 → Mar 2025 overdue | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06970782 | May 2025 → Dec 2027 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06281964 | Dec 2023 → Jun 2028 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | Avistone Biotechnology Co., Ltd. | Regulatory 重磅 | 鞍石生物科技-安比锐®（苯甲酸安达艾替尼）治疗 EGFR ex20ins突变非小细胞肺癌（NSCLC）适应症中国获批上市 avistonebio.com ↗
这是安达艾替尼在国内首个申报获批的适应症，将为EGFR ex20ins突变这一难治性亚型NSCLC患者带来精准靶向治疗的新选择，并将填补临床未被满足的治疗需求。 |
| 2025-12-05 | Avistone Biotechnology Co., Ltd. | Results 【ESMO ASIA 2025速递】鞍石生物科技创新研究成果重磅发布，MET异常NSCLC患者EGFR-TKI耐药后治疗添新证 avistonebio.com ↗
IHC 3+亚组（含FISH阴性患者，n=51）疗效良好， ORR为59.1%（95% CI：43.2-73.7），mPFS为 8.3 个月（95% CI：5.6-13.8）（数据详见壁报Figure3、Table2）。 |
| 2025-04-17 | Avistone Biotechnology Co., Ltd. | Regulatory 鞍石生物科技伯瑞替尼联合安达替尼（PLB1004）胶囊获CDE突破性疗法认定 avistonebio.com ↗
中国国家药品监督管理局药品审评中心（“CDE”）官网最新公示，北京鞍石生物科技股份有限公司（“鞍石生物科技”）申报的伯瑞替尼肠溶胶囊（“伯瑞替尼”）联合EGFR抑制剂安达替尼（PLB1004）胶囊1获突破性疗法认定，拟定适应症为：适用于治疗既往接受EGFR-TKI治疗失败后，具有表皮生长因子受体(EGFR)突变、间质-上皮转化因子(MET)扩增和/或过表达的局部晚期或转移性非小细胞肺癌(NSCLC)的患者2。 |
| 2023-05-15 | Avistone Biotechnology Co., Ltd. | Results EGFR罕见突变迎来新突破，这家Biotech公司为何能建起BIC、FIC管线？ avistonebio.com ↗
PLB1004的客观缓解率ORR达到57.7%-，疾病控制率（DCR）则为100%。 |
| 2023-04-19 | Avistone Biotechnology Co., Ltd. | Results 鞍石生物PLB1004首次亮相AACR大会鞍石生物在研产品—PLB1004 I期临床试验部分结果于2023年4月18日在第114届美国癌症研究协会（AACR）年会上公布。 这是鞍石生物自主研发的创新药品，继PLB1001（Vebreltinib 伯瑞替尼）后再度亮相全球最有影响力的肿瘤行业年会—AACR大会。 关于PLB1004 大会速递 avistonebio.com ↗
截至2022年7月31日，≥160mg QD剂量水平共29例，其中26例受试者至少完成一次肿瘤评估，经研究者评估达到客观缓解的15例，ORR为57.7%（15/26）；42.3%（11/26）的受试者达到疾病稳定（SD），疾病控制率（DCR）为100%。 |
| 2022-12-22 | Avistone Biotechnology Co., Ltd. | Regulatory 鞍石生物PLB1004（安达替尼）在中国获批开展联合用药临床研究创始人寄语关于PLB1004（安达替尼）关于伯瑞替尼关于鞍石 avistonebio.com ↗ |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | Avistone Biotechnology Co., Ltd. | 重磅 | 鞍石生物科技-安比锐®（苯甲酸安达艾替尼）治疗 EGFR ex20ins突变非小细胞肺癌（NSCLC）适应症中国获批上市 avistonebio.com ↗ |
| 2025-12-05 | Avistone Biotechnology Co., Ltd. | 【ESMO ASIA 2025速递】鞍石生物科技创新研究成果重磅发布，MET异常NSCLC患者EGFR-TKI耐药后治疗添新证 avistonebio.com ↗ |
| 2025-04-17 | Avistone Biotechnology Co., Ltd. | 鞍石生物科技伯瑞替尼联合安达替尼（PLB1004）胶囊获CDE突破性疗法认定 avistonebio.com ↗ |
| 2023-05-15 | Avistone Biotechnology Co., Ltd. | EGFR罕见突变迎来新突破，这家Biotech公司为何能建起BIC、FIC管线？ avistonebio.com ↗ |
| 2023-04-19 | Avistone Biotechnology Co., Ltd. | 鞍石生物PLB1004首次亮相AACR大会鞍石生物在研产品—PLB1004 I期临床试验部分结果于2023年4月18日在第114届美国癌症研究协会（AACR）年会上公布。 这是鞍石生物自主研发的创新药品，继PLB1001（Vebreltinib 伯瑞替尼）后再度亮相全球最有影响力的肿瘤行业年会—AACR大会。 关于PLB1004 大会速递 avistonebio.com ↗ |
| 2022-12-22 | Avistone Biotechnology Co., Ltd. | 鞍石生物PLB1004（安达替尼）在中国获批开展联合用药临床研究创始人寄语关于PLB1004（安达替尼）关于伯瑞替尼关于鞍石 avistonebio.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PLB1004 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07285148 ↗ |
| Action | Inhibit | “Oral EGFR Inhibitor PLB1004” NCT06046495 ↗ |
| Modality | Small molecule | “a mono-anilino-pyrimidine compound” NCT06046495 ↗ |
| Route | Oral | “PLB1004 will be orally self-administered by the patient” NCT06046495 ↗ |
| Target | EGFR | “Oral EGFR Inhibitor PLB1004” NCT06046495 ↗ |