HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), HER3 modulators(Receptor tyrosine-protein kinase erbB-3 modulators), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases

Active Indication

Advanced Malignant Solid NeoplasmEGFR-mutated non-small Cell Lung CancerSolid tumor+ [2]

Inactive Indication-

Originator Organization

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Active Organization

Suzhou Suncadia Biopharmaceuticals Co., Ltd.Shandong Suncadia Medicine Co., Ltd.Startup

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (United States)

Structure/Sequence

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Clinical Trials associated with SHR-A2009

NCT06671379

/ RecruitingPhase 3

A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.

Start Date29 Nov 2024

Sponsor / Collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

CTR20244118

/ RecruitingPhase 3

SHR-A2009对比含铂化疗治疗表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗失败的EGFR突变晚期或转移性非小细胞肺癌的随机对照、开放性、多中心III期研究

[Translation] A randomized, controlled, open-label, multicenter phase III study of SHR-A2009 versus platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations who have failed EGFR tyrosine kinase inhibitor (TKI) therapy

评估 SHR-A2009 对比含铂化疗治疗 EGFR TKI 治疗失败的 EGFR突变晚期或转移性非小细胞肺癌患者的无进展生存期（PFS）（基于盲态独立中心评估）、总生存期（OS）及其它有效性指标，包括PFS（研究者评估）、客观缓解率（ORR）、缓解持续时间（DoR）、疾病控制率（DCR），以及评估患者的安全性。

[Translation]

To evaluate SHR-A2009 in comparison with platinum-based chemotherapy in patients with EGFR-mutated advanced or metastatic NSCLC who have failed EGFR TKI therapy in terms of progression-free survival (PFS) (based on blinded independent central review), overall survival (OS), and other efficacy indicators, including PFS (investigator-assessed), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and to evaluate the safety of patients.

Start Date29 Nov 2024

Sponsor / Collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

NCT06649331

/ RecruitingPhase 2IIT

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer：A Prospective, Open-label, Multicenter, Phase II Trial

This is a prospective, open-label, multicenter, phase II platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.

Start Date21 Oct 2024

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with SHR-A2009

100 Translational Medicine associated with SHR-A2009

100 Patents (Medical) associated with SHR-A2009

100 Deals associated with SHR-A2009

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 3	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	29 Nov 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 3	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	29 Nov 2024
Breast Cancer	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.Startup	20 Feb 2024
Solid tumor	Phase 2	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
Advanced cancer	IND Approval	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	20 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05114759 (ESMO2024) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	103	SHR-A2009 9.0 mg/kg	bvphghchqy(xzuifnuuck) = 56.3% of 103 pts, with all occurring in ≥5% being hematotoxicities. ckzvmoueeh (ocbogyhsxv ) View more	Positive	14 Sep 2024
				SHR-A2009 9.0 mg/kg (Prior PBC treated)
NCT05114759 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors EGFR mutations	42	SHR-A2009	jqmiisgmqm(qkixircfvy) = jkkaojmnnz ckxspfjbbv (fbriofxgbj ) View more	Positive	23 Oct 2023
				SHR-A2009 (1.5 mg/kg)	emwdxboyiz(olpygpwyyf) = dqojglpgmm zimpkyeqtj (fhcytbngfc ) View more

Translational Medicine

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Biosimilar

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Regulation

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