Delving into the Latest Updates on BeiGene (Suzhou) Co. Ltd. with Synapse

Overview

Tags

Neoplasms

Other Diseases

Immune System Diseases

Small molecule drug

Proteolysis-targeting chimeras (PROTAC)

Bispecific antibody

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	12
Immune System Diseases	9
Hemic and Lymphatic Diseases	7
Endocrinology and Metabolic Disease	3
Nervous System Diseases	2

Top 5 Drug Type	Count

Small molecule drug	9
Proteolysis-targeting chimeras (PROTAC)	2
Bispecific antibody	1
Monoclonal antibody	1
Chemical drugs	1

Top 5 Target	Count

BTK(Tyrosine-protein kinase BTK)	2
Bcl-2(Apoptosis regulator Bcl-2)	2
PD-1(Programmed cell death protein 1)	1
IRAK4(Interleukin-1 receptor-associated kinase 4)	1
PRMT5(Protein arginine methyltransferase 5)	1

一项评价BGB-11417单药、BGB-11417联合地塞米松与BGB-11417联合地塞米松和卡非佐米、地塞米松和达雷妥尤单抗以及地塞米松和泊马度胺治疗携带t(11;14)的复发/难治性多发性骨髓瘤患者的安全性和有效性的1b/2期、剂量递增和队列扩展研究

[Translation] A Phase 1b/2, dose-escalation, and cohort expansion study evaluating the safety and efficacy of BGB-11417 alone, BGB-11417 plus dexamethasone, BGB-11417 plus dexamethasone and carfilzomib, dexamethasone and daratumumab, and dexamethasone and pomalidomide in patients with relapsed/refractory multiple myeloma harboring t(11;14)

第一部分主要目的：评价Sonrotoclax联合地塞米松与Sonrotoclax联合地塞米松和卡非佐米、地塞米松和达雷妥尤单抗以及地塞米松和泊马度胺治疗携带t(11;14)的R/R MM患者的安全性和耐受性；确定Sonrotoclax联合地塞米松与Sonrotoclax联合地塞米松和卡非佐米、地塞米松和达雷妥尤单抗以及地塞米松和泊马度胺治疗携带t(11;14)的R/R MM患者的最大耐受剂量（MTD）/最大评估剂量（MAD）和初步2期推荐剂量（RP2D）; 第二部分主要目的：评价在RP2D下Sonrotoclax单药与Sonrotoclax联合地塞米松治疗携带t(11;14)的R/R MM患者的安全性和耐受性；评价Sonrotoclax联合地塞米松和卡非佐米在推荐剂量组合下治疗携带t(11;14)的R/R MM患者的安全性和耐受性；通过总缓解率和其他缓解率指标评估Sonrotoclax单药、Sonrotoclax联合地塞米松、Sonrotoclax联合地塞米松和卡非佐米治疗携带t(11;14)的R/R MM患者的有效性。

[Translation]

The main objectives of the first part: To evaluate the safety and tolerability of Sonrotoclax combined with dexamethasone, Sonrotoclax combined with dexamethasone and carfilzomib, dexamethasone and daratumumab, and dexamethasone and pomalidomide in the treatment of R/R MM patients with t(11;14); To determine the maximum tolerated dose (MTD)/maximum assessed dose (MAD) and preliminary phase 2 recommended dose (RP2D) of Sonrotoclax combined with dexamethasone, Sonrotoclax combined with dexamethasone and carfilzomib, dexamethasone and daratumumab, and dexamethasone and pomalidomide in the treatment of R/R MM patients with t(11;14); The main objectives of the second part: To evaluate Sonrotoclax alone and Sonrotoclax combined with dexamethasone in the treatment of R/R MM patients with t(11;14) under RP2D Safety and tolerability in MM patients; Evaluate the safety and tolerability of Sonrotoclax combined with dexamethasone and carfilzomib in the treatment of R/R MM patients with t(11;14) at the recommended dose combination; Evaluate the efficacy of Sonrotoclax alone, Sonrotoclax combined with dexamethasone, and Sonrotoclax combined with dexamethasone and carfilzomib in the treatment of R/R MM patients with t(11;14) by overall response rate and other response rate indicators.

Start Date27 Dec 2023

Sponsor / Collaborator

BeiGene (Suzhou) Co. Ltd.

CTR20231287 / RecruitingPhase 1

一项Bcl-2抑制剂BGB-21447用于成熟B细胞恶性肿瘤患者的1/1b期、开放性、剂量递增研究（目前开展剂量探索部分）

[Translation] A Phase 1/1b, open-label, dose-escalation study of the Bcl-2 inhibitor BGB-21447 in patients with mature B-cell malignancies (dose-finding portion currently underway)

主要目的: 1.评价BGB-21447单药治疗的安全性和耐受性，并确定BGB-21447单药治疗复发或难治性（R/R）非霍奇金淋巴瘤（NHL）患者的最大耐受剂量（MTD）或最大给药剂量（MAD）以及初步2期推荐剂量（RP2D） 2.在评价的疾病类型中评价递增给药方案的安全性和耐受性次要目的: 评估BGB-21447的药代动力学（PK）特征评估BGB-21447单药治疗的初步抗肿瘤活性

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of BGB-21447 monotherapy and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and preliminary Phase 2 recommended dose (RP2D) of BGB-21447 monotherapy in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) 2. To evaluate the safety and tolerability of the escalating dosing regimen in the evaluated disease types Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of BGB-21447 To evaluate the preliminary anti-tumor activity of BGB-21447 monotherapy

Start Date27 May 2023

Sponsor / Collaborator

BeiGene (Suzhou) Co. Ltd.

100 Clinical Results associated with BeiGene (Suzhou) Co. Ltd.

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0 Patents (Medical) associated with BeiGene (Suzhou) Co. Ltd.

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100 Deals associated with BeiGene (Suzhou) Co. Ltd.

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100 Translational Medicine associated with BeiGene (Suzhou) Co. Ltd.

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Pipeline

Pipeline Snapshot as of 07 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

IND Application

3

2

IND Approval

Phase 1 Clinical

5

2

Phase 2 Clinical

Phase 3 Clinical

1

NDA/BLA

Approved

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pamiparib ( PARP1 x PARP2 )	BRCA-mutated Peritoneal Neoplasms More	Approved
Zanubrutinib ( BTK )	Follicular Lymphoma More	Approved
Zanidatamab ( HER2 )	HER2 positive Biliary Tract Neoplasms More	NDA/BLA
Tislelizumab ( PD-1 )	Hepatocellular Carcinoma More	Phase 3
Sonrotoclax ( Bcl-2 )	Waldenstrom Macroglobulinemia More	Phase 2