Top 5 Target	Count

ALK(Anaplastic lymphoma kinase)	1
WEE1(Serine/threonine-protein kinase WEE1)	1
JAK1 x JAK2 x ROCK1 x ROCK2	1
CDK4 x CDK6	1
RET(Tyrosine-protein kinase receptor RET)	1

Drugs associated with Shouyao Holdings (Beijing) Co. Ltd.

Conteltinib

Target

ALK x FAK x IGF-1R x PYK2

Mechanism

ALK inhibitors [+3]

Active Org.

Zhejiang University [+3]

Originator Org.

Centaurus Biopharma Co Ltd

Active Indication

ALK positive Non-Small Cell Lung Cancer [+2]

Inactive Indication-

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

Rovadicitinib

Target

JAK1 x JAK2 x ROCK1 x ROCK2

Mechanism

JAK1 inhibitors [+3]

Active Org.

Centaurus Biopharma Co Ltd [+1]

Originator Org.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Active Indication

Myelofibrosis [+12]

Inactive Indication

High Risk Myelodysplastic Syndrome [+1]

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

SY-5007

Target

RET

Mechanism

RET inhibitors

Active Org.

Shouyao Holdings (Beijing) Co. Ltd.

Originator Org.

Shouyao Holdings (Beijing) Co. Ltd.

Active Indication

RET fusion-positive Non-Small Cell Lung Cancer [+2]

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shouyao Holdings (Beijing) Co. Ltd.

CTR20243551 / RecruitingPhase 1

评价TQ05105片在不同级别肾功能受试者中药代动力学和安全性的开放、平行、单次给药I期临床研究

[Translation] An open, parallel, single-dose phase I clinical study to evaluate the pharmacokinetics and safety of TQ05105 tablets in subjects with different grades of renal function

主要研究目的: 评价TQ05105片在不同级别肾功能受试者中单次给药后的药代动力学（PK）特征。次要研究目的：（1）评价TQ05105片在不同级别肾功能受试者中单次给药后的尿液中药物排泄情况。（2）评价TQ05105片在不同级别肾功能受试者中单次给药后的安全性。

[Translation]

Main study objectives: To evaluate the pharmacokinetic (PK) characteristics of TQ05105 tablets after a single dose in subjects with different levels of renal function. Secondary study objectives: (1) To evaluate the drug excretion in urine of TQ05105 tablets after a single dose in subjects with different levels of renal function. (2) To evaluate the safety of TQ05105 tablets after a single dose in subjects with different levels of renal function.

Start Date12 Oct 2024

Sponsor / Collaborator

Centaurus Biopharma Co Ltd

[+2]

CTR20241152 / Active, not recruitingPhase 1

[14C]SY-5007在中国健康成年男性受试者体内的物质平衡研究

[Translation] Study on the material balance of [14C]SY-5007 in healthy adult male subjects in China

主要目的：1.定量分析健康受试者口服[14C]SY-5007后全血与血浆总放射性、获得血浆中总放射性的PK参数，并考察全血和血浆中的总放射性分配情况。2.定量分析健康受试者口服[14C]SY-5007后排泄物中的总放射性，获得人体放射性回收率数据和主要排泄途径。3.鉴定健康受试者口服[14C]SY-5007后人体血、尿、粪样的代谢物谱和主要代谢产物，确定主要生物转化途径。次要目的：1.采用已验证的液相色谱质谱联用法（LS-MS/MS）方法定量分析血浆中SY-5007及其代谢物（如适用）的浓度，获得SY-5007及其代谢物（如适用）的PK参数。2.观察[14C]SY-5007单次给药后受试者的安全性。

[Translation]

Primary objectives: 1. Quantitatively analyze the total radioactivity in whole blood and plasma after oral administration of [14C]SY-5007 to healthy subjects, obtain the PK parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma. 2. Quantitatively analyze the total radioactivity in excreta after oral administration of [14C]SY-5007 to healthy subjects, obtain the data of human radioactivity recovery rate and the main excretion pathway. 3. Identify the metabolite profile and main metabolites of human blood, urine and feces samples after oral administration of [14C]SY-5007 to healthy subjects, and determine the main biotransformation pathway. Secondary objectives: 1. Quantitatively analyze the concentration of SY-5007 and its metabolites (if applicable) in plasma using a validated liquid chromatography-mass spectrometry (LS-MS/MS) method, and obtain the PK parameters of SY-5007 and its metabolites (if applicable). 2. Observe the safety of subjects after a single dose of [14C]SY-5007.

Start Date01 Jul 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

NCT06037317 / RecruitingPhase 1

A Phase Ib, Multi-center, Open-Lable, Dose-Escalation and Dose-Expansion Study of Efficacy and Safety of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors

This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK fusion-positive solid tumor who have progressed on or are intolerant to prior standard therapy.

Start Date30 May 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

100 Clinical Results associated with Shouyao Holdings (Beijing) Co. Ltd.

0 Patents (Medical) associated with Shouyao Holdings (Beijing) Co. Ltd.

Literatures (Medical) associated with Shouyao Holdings (Beijing) Co. Ltd.

01 Jun 2024·Journal of Thoracic Oncology

Ficonalkib (SY-3505) in Advanced ALK-Positive NSCLC: A Multicenter, Open-Label, Single-Arm, Phase 1/2 Study

Article

Author: Gong, Caifeng ; Mei, Qi ; Dong, Xiaorong ; Jiang, Liyan ; Wang, Pingli ; Wang, Ke ; Li, Xingya ; Sun, Yinghui ; Li, Yongsheng ; Hu, Xingsheng ; Liu, Baogang ; Meng, Xiangjiao ; Yang, Runxiang ; Wang, Huijuan ; Luo, Yongzhong ; Zhang, Shucai ; Shi, Yuankai ; Yang, Limin

INTRODUCTIONTreatment options for second-generation (2^nd-gen) ALK tyrosine kinase inhibitor (TKI)-resistant patients are limited. We evaluated the safety, pharmacokinetics, and efficacy of ficonalkib (SY-3505), a third-generation (3^rd-gen) ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer.METHODSThis first-in-human, phase 1/2 study (Chinese Clinical Trial Registry identifier: ChiCTR1900025619; ClinicalTrials.gov identifier: NCT05257512) had two parts. Phase 1 included a dose-escalation phase (25-800 mg quaque die [QD]) and a dose-expansion phase (500 mg QD or 600 mg QD). Phase 2 enrolled patients treated at recommended phase 2 dose. Primary end points were safety in phase 1 and objective response rate (ORR) in phase 2.RESULTSBetween April 21, 2020, and August 31, 2023, a total of 127 patients with advanced ALK-positive non-small cell lung cancer were enrolled, with 62 in phase 1. Ficonalkib was well absorbed and tolerated, with one dose-limited toxicity event occurring at 800 mg QD. Treatment-related adverse events occurred in 85.5% of patients, with 19.4% experienced greater than or equal to grade 3 events. The ORR was 38.3% (23 of 60, 95% confidence interval [CI]: 26.1%-51.8%) in phase 1, and 600 mg QD was established as recommended phase 2 dose. In phase 2, a total of 65 patients received ficonalkib at 600 mg QD. In total, 88 patients received ficonalkib at 600 mg QD in phase 1/2, and all had received prior 2^nd-gen ALK TKI treatment. Furthermore, 90.9% of the patients experienced treatment-related adverse events and 14.8% experienced greater than or equal to grade 3 events. The ORR in efficacy-assessable patients who received ficonalkib at 600 mg QD was 47.5% (38 of 80, 95% CI: 36.2%-59.0%), with an intracranial ORR of 37.5% (12 of 32, 95% CI: 21.1%-56.3%) in these patients with measurable brain lesions at baseline.CONCLUSIONSFiconalkib (SY-3505) was well tolerated, with favorable safety profiles and promising efficacy in patients resistant to prior 2^nd-gen ALK TKI.

01 Jun 2024·Journal of Clinical Oncology

Efficacy and safety of SY-5007, a highly potent and selective RET inhibitor, in Chinese patients with advanced RET-fusion positive non-small cell lung cancer (NSCLC): Results from a multicenter, single-arm, phase II study.

Author: Luo, Hui ; Fang, Jian ; Yu, Qitao ; Ye, Feng ; Tan, Liping ; Li, XingYa ; Wang, Ying ; Zhao, Mingfang ; Huang, Dingzhi ; Sun, Yinghui ; Xiong, Anwen ; Zhou, Caicun ; Yang, Nong ; Zhang, Yiping ; Meng, Xiangjiao ; Liu, Baogang ; Wang, Qiming ; Wang, Yongsheng ; Song, Zhengbo

3106 Background: Lung cancer is the leading cause for all cancer-related death, with NSCLC accounting for 85% of all cases. The oncogenic RET-fusion is identified in 1-2% of NSCLC patients. Several RET inhibitors have been approved. This pivotal phase II study aimed to evaluate the efficacy and safety of SY-5007, a novel, highly selective RET inhibitor, in Chinese patients with advanced, positive RET NSCLC. Methods: This trial enrolled two cohorts of patients with RET-fusion positive NSCLC. Cohort 1 comprised treatment-naive patients, and cohort 2 included those previously treated with systemic therapy. Both cohorts received oral SY-5007 at 160 mg twice daily in a 28-day cycle. Primary endpoint was overall response rate (ORR) assessed by blinded independent central review (BICR) per RESICST v1.1. Secondary endpoints included ORR assessed by investigators, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: As of the data cutoff date on January 16, 2024, the trial enrolled 105 patients, with a median follow-up of 4.57 months (95% confidence interval [CI] 0.2-10.3). The BICR-assessed overall ORR was 77.1% (95% CI 67.9-84.8) and DCR was 83.8% (95% CI 75.3-90.3). The investigator-assessed overall ORR was 77.1% (95% CI 67.9-84.8) and DCR was 90.5% (95% CI 83.2-95.3). In treatment-naive patients (cohort 1, n=56), SY-5007 showed an ORR of 83.9% (95% CI 71.4-92.4) and a DCR of 91.1% (95% CI 80.4-97.0). In pre-treated patients (cohort 2, n=49), SY-5007 exhibited an ORR of 69.4% (95% CI 54.6-81.7) and a DCR of 89.8% (95% CI 77.8-96.6). For 29 patients with baseline brain metastasis, the ORR and DCR were 69.0% (95% CI 49.2-84.7) and 86.2% (95% CI 68.3-96.1). Meanwhile, the ORR and DCR for 76 patients without baseline brain metastasis were 80.3% (95% CI 69.5-88.5) and 92.1% (95% CI 83.6-97.0). Among 10 patients with baseline intracranial target lesions, intracranial ORR and DCR were 80.0% (95% CI 44.4-97.5) and 100% (95% CI 47.8-100). Median PFS, DoR or OS were not reached. Treatment-related adverse events (TRAEs) were reported in 96.2% of patients, with common events (≥ 30%) including increased AST, increased ALT, decreased neutrophil count, decreased white blood cell count and decreased platelet count. Grade ≥ 3 TRAEs and treatment-related serious adverse events were observed in 42.9% and 10.5% of patients. TRAE-induced dose interruption and dose reduction occurred in 39.0% and 23.8% of patients, respectively. TRAEs led to SY-5007 discontinuation in two patients (1.9%), with no deaths due to TRAE. Conclusions: SY-5007 demonstrated promising efficacy and safety for advanced NSCLC with positive RET. Clinical trial information: NCT05278364 .

22 Mar 2024·Cancer Research

Abstract 1928: Targeting FAK to improve the therapy of KRAS G12C mutant cancers

Author: Zhu, Yan ; Liu, Shuang ; Zhang, Miao ; Shi, Junfen ; Li, Jijun ; Lu, Chang ; Sun, Yinghui ; Xin, Ying ; Luo, Hong

AbstractDespite the pivotal role of KRAS G12C in tumor initiation and progression, currently available KRAS G12C inhibitors have relatively modest activity compared to other approved therapies targeting other classic oncogenic drivers. Fortunately, efforts to improve the anti-tumor response to KRAS G12C targeted therapy have benefited from the use of combination approaches. Here, we found that treatment with KRAS G12C inhibitors induces sustained activation of focal adhesion kinase (FAK) in KRAS G12C mutant cell lines from various cancer types, including non-small cell lung cancer, colorectal cancer, and pancreatic cancer. These results suggest a potential role for FAK in adaptive resistance to KRAS G12C inhibition and encourage us to explore the anticancer effects of combining the KRAS G12C inhibitor SY-5933 with a FAK inhibitor, CT-707. The cell viability and clonogenic assays using various KRAS G12C mutant cancer cell lines showed that the combination of SY-5933 and CT-707 synergistically inhibited cell growth. Mechanistically, this enhanced anti-proliferative effect is associated with a significant decrease in FAK activity and a more pronounced induction of cell cycle arrest and apoptosis. In vivo efficacy studies in multiple cell line derived xenograft (CDX) models, the combination of SY-5933 plus CT-707 consistently induced a more potent anti-tumor response than either monotherapy alone. In conclusion, our results demonstrate that CT-707 has the potential to enhance the efficacy of SY-5933 by suppressing adaptive FAK activation under KRAS G12C inhibition. This provides a rationale for an innovative combination therapy to improve outcomes in patients with KRAS G12C mutated cancers.Citation Format: Shuang Liu, Junfen Shi, Chang Lu, Miao Zhang, Ying Xin, Yan Zhu, Jijun Li, Hong Luo, Yinghui Sun. Targeting FAK to improve the therapy of KRAS G12C mutant cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1928.

100 Deals associated with Shouyao Holdings (Beijing) Co. Ltd.

100 Translational Medicine associated with Shouyao Holdings (Beijing) Co. Ltd.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

IND Approval

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Conteltinib ( ALK x FAK x IGF-1R x PYK2 )	ALK positive Non-Small Cell Lung Cancer More	NDA/BLA
TQB-3454 ( IDH1 )	Hematologic Neoplasms More	Phase 3
SY-5007 ( RET )	RET fusion-positive Non-Small Cell Lung Cancer More	Phase 3
Ficonalkib ( ALK )	ALK positive Non-Small Cell Lung Cancer More	Phase 3
Rovadicitinib ( JAK1 x JAK2 x ROCK1 x ROCK2 )	Myelofibrosis More	Phase 2

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