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

Overview

Tags

Neoplasms

Hemic and Lymphatic Diseases

Digestive System Disorders

Small molecule drug

Chemical drugs

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	14
Immune System Diseases	7
Hemic and Lymphatic Diseases	6
Endocrinology and Metabolic Disease	5
Nervous System Diseases	2

Top 5 Drug Type	Count

Small molecule drug	10
Proteolysis-targeting chimeras (PROTAC)	2
Chemical drugs	1
Bispecific antibody	1
Monoclonal antibody	1

Top 5 Target	Count

Bcl-2(Apoptosis regulator Bcl-2)	2
CDK2(Cyclin-dependent kinase 2)	1
PD-1(Programmed cell death protein 1)	1
BTK(Tyrosine-protein kinase BTK)	1
SMAC x XIAP x cIAP1	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 total 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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1

Literatures (Medical) associated with BeiGene (Suzhou) Co. Ltd.

Chinese Journal of New Drugs

Application of high-throughput miniature bioreactors in biopharmaceuticals

Author: Zhang Lei ; Ji Yu ; Zha Xin-hua ; Pei Xin ; Yao Xiao-yuan

With the rapid development of biopharmaceutical industry, high-throughput miniature bioreactor systems have been widely used in recent years.The high-throughput miniature bioreactor system has the advantages of small size, high-throughput and good scalability, as well as the capability of online anal. and feedback control.At present, it is mainly applied in cell line selection, process optimization and process characterization.High-throughput technologies combining with exptl. design can shorten the product development timelines significantly, improve the process robustness and product quality control, and accelerate the delivery of projects into clin. and com. phase.This review mainly describes several common high-throughput miniature bioreactor systems and describes their applications in the biopharmaceutical industry, using Ambr system as an example.

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 23 Feb 2025

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

1

2

IND Approval

Phase 1

7

1

Phase 2

Phase 3

2

1

NDA/BLA

Approved

2

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pamiparib ( PARP1 x PARP2 )	BRCA-mutated Fallopian Tube Carcinoma More	Approved
Sonrotoclax ( Bcl-2 )	Mantle-Cell Lymphoma More	Phase 3
Zanidatamab ( HER2 )	HER2 Positive Gastroesophageal Adenocarcinoma More	Phase 3
Tislelizumab ( PD-1 )	Hepatocellular Carcinoma More	Phase 3
Zanubrutinib ( BTK )	Glomerulonephritis, Membranous More	Phase 2/3