Top 5 Target	Count

PDL1(Programmed death-ligand 1)	5
CDK4 x CDK6	1
FGFRs(Fibroblast growth factor receptors)	1
EGFR T790M(Epidermal Growth Factor Receptor T790M)	1
CD47(Cluster of differentiation 47)	1

Drugs associated with Beta Pharma (Shanghai) Co., Ltd.

Rezivertinib

Target

EGFR T790M

Mechanism

EGFR T790M inhibitors

Active Org.

Beta Pharma (Shanghai) Co., Ltd.

Originator Org.

Beta Pharma (Shanghai) Co., Ltd.

Active Indication

EGFR-mutated non-small Cell Lung Cancer [+3]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date15 May 2024

BPI-1178

Target

CDK4 x CDK6

Mechanism

CDK4 inhibitors [+1]

Active Org.

Beta Pharma (Suzou) Co., Ltd.

Originator Org.

Beta Pharma (Suzou) Co., Ltd.

Active Indication

Advanced breast cancer [+3]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

BPI-9303A

Target-

Mechanism-

Active Org.

Beta Pharma (Shanghai) Co., Ltd.

Originator Org.

Beta Pharma (Shanghai) Co., Ltd.

Active Indication

Solid tumor

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Beta Pharma (Shanghai) Co., Ltd.

NCT03866499

/ Active, not recruitingPhase 3

A Randomized, Double-blind, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of BPI-7711 Capsule in Locally Advanced or Recurrent/Metastatic Treatment-naïve Non-small Cell Lung Cancer Patients With EGFR Mutation

A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation

Start Date30 Apr 2021

Sponsor / Collaborator

Beta Pharma (Shanghai) Co., Ltd.

CTR20192519

/ CompletedPhase 1

[14C]BPI-7711在中国非小细胞肺癌患者中的物质平衡与生物转化的I期临床试验

[Translation] Phase I clinical trial of [14C]BPI-7711 mass balance and biotransformation in Chinese patients with non-small cell lung cancer

考察非小细胞肺癌患者单次口服[14C]BPI-7711后全血和血浆中的总放射性强度及分配情况；分析口服[14C]BPI-7711后排泄物中的总放射性强度，获得人体物质平衡数据和主要排泄途径；获得[14C]BPI-7711在非小细胞肺癌患者体内放射性代谢物谱；分析药代动力学参数；测定血浆中主要代谢产物的浓度；观察给药后患者的安全性；

[Translation]

To investigate the total radioactivity intensity and distribution in whole blood and plasma of patients with non-small cell lung cancer after a single oral administration of [14C]BPI-7711; to analyze the total radioactivity intensity in excreta after oral administration of [14C]BPI-7711, to obtain the material balance data and the main excretion pathways in the human body; to obtain the radioactive metabolite spectrum of [14C]BPI-7711 in patients with non-small cell lung cancer; to analyze the pharmacokinetic parameters; to determine the concentration of the main metabolites in plasma; and to observe the safety of patients after administration;

Start Date24 Jun 2020

Sponsor / Collaborator

Beta Pharma (Shanghai) Co., Ltd.

CTR20192521

/ RecruitingPhase 1/2

评估BPI-1178胶囊在晚期实体瘤患者中的耐受性、安全性及药代动力学和初步疗效的I期临床研究及联合内分泌治疗在HR+/HER2-的晚期/复发乳腺癌患者中疗效与安全性的IIa期临床研究

[Translation] A Phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of BPI-1178 capsules in patients with advanced solid tumors, and a Phase IIa clinical study to evaluate the efficacy and safety of combined endocrine therapy in patients with HR+/HER2- advanced/recurrent breast cancer

I期研究主要评估BPI-1178单次及多次口服给药在晚期实体瘤患者中的耐受性和安全性及其药代动力学特征；并初步考察其对晚期实体瘤的疗效、初步进行血浆代谢产物的鉴定。IIa期研究主要评估BPI-1178联合内分泌治疗在HR+/HER2-的晚期乳腺癌患者中的疗效和安全性。如数据允许，初步考察BPI-1178及其代谢产物（如适用）的暴露-效应关系。

[Translation]

The Phase I study mainly evaluates the tolerability and safety of BPI-1178 in patients with advanced solid tumors after single and multiple oral administrations and its pharmacokinetic characteristics; and preliminarily investigates its efficacy in advanced solid tumors and preliminarily identifies plasma metabolites. The Phase IIa study mainly evaluates the efficacy and safety of BPI-1178 combined with endocrine therapy in patients with HR+/HER2- advanced breast cancer. If data permit, the exposure-effect relationship of BPI-1178 and its metabolites (if applicable) will be preliminarily investigated.

Start Date15 Jun 2020

Sponsor / Collaborator

Beta Pharma (Suzou) Co., Ltd.

100 Clinical Results associated with Beta Pharma (Shanghai) Co., Ltd.

0 Patents (Medical) associated with Beta Pharma (Shanghai) Co., Ltd.

Literatures (Medical) associated with Beta Pharma (Shanghai) Co., Ltd.

01 Jun 2022·Journal of Clinical Oncology

Efficacy and safety of rezivertinib (BPI-7711) in patients with locally advanced or metastatic/recurrent EGFR T790M-mutated NSCLC: A phase IIb, multicenter, single-arm, open-label study.

Author: Fang, Jian ; Huang, Meijuan ; Greco, Michael ; Zhu, Bo ; Cang, Shundong ; Wang, Lijun ; Yao, Wenxiu ; Wang, Tingting ; Shi, Yuankai ; Wu, Shiman ; Shi, Jianhua ; Chen, Gongyan ; Li, Xingya ; Fan, Yun ; Wu, Lin ; Chen, Zhaohong ; Yang, Zhixiong ; Pan, Yueyin ; Sun, Meili ; Wang, Ke

9098 Background: Rezivertinib (BPI-7711) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both EGFR-sensitizing mutations and EGFR T790M mutation. This study aimed to evaluate the efficacy and safety of Rezivertinib in patients with locally advanced or metastatic/recurrent EGFR T790M mutated non-small cell lung cancer (NSCLC). Methods: Locally advanced or metastatic/recurrent NSCLC patients with histologic or cytologic or plasmatic confirmation of EGFR T790M mutations who progressed after first/second generation EGFR-TKIs therapy or primary EGFR T790M mutations were enrolled. Patients received Rezivertinib at 180mg orally once daily until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was objective response rate (ORR) assessed by blinded independent central review (BICR) per RECIST1.1. The efficacy for patients with central nervous system (CNS) metastases was measured by BICR according to the Response Assessment in Neuro-Oncology Brain Metastases. Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Safety was assessed as per CTCAE 4.03. Results: A total of 226 patients were enrolled from Jul 5, 2019, to Jan 22, 2020. 91 (40.3%) patients had brain metastases. The tissue sample and plasma sample were positive for EGFR T790M in 120 (53.1%) and 116 (51.3%) patients, respectively. By the data cutoff date on Dec 23, 2021, the ORR by BICR was 64.6% (95%CI:58.0-70.8) and DCR was 89.8% (95%CI:85.1-93.4). The median DoR was 12.5 (95%CI:10.0-13.9) months and median PFS was 12.2 (95%CI:9.6-13.9) months. The median OS was 23.9 (95%CI:20.0-NC) months. Subgroup ORR: exon 19 deletion 72.4% (95%CI:64.4-79.5), L858R 51.9% (95%CI:40.4-63.3), tissue T790M positive 70% (95%CI:61.0-78.0), plasma T790M positive 56.9% (95%CI:47.4-66.1). Subgroup PFS: exon 19 deletion 12.4 (95%CI:8.8-15.1) months, L858R 10.3 (95%CI:8.3-13.9) months, tissue T790M positive 13.9 (95%CI:11.3-17.9) months, plasma T790M positive 9.6 (95%CI:7.0-11.0) months. Among 91 patients with CNS metastases, 29 patients had at least one brain target lesion whose CNS-ORR and CNS-DCR were 69.0% (95%CI:49.2-84.7) and 100% (95%CI:88.1-100), respectively. Time to progression of CNS was 16.5 (95%CI:9.7-NC) months. 188 of 226 (83.2%) patients had at least one adverse drug reaction, with the most common being white blood cell count decreased (27.9%), platelet count decreased (23.0%), anemia (22.6%). No interstitial lung disease was reported. Conclusions: Rezivertinib demonstrated promising efficacy and favorable safety for locally advanced or metastatic/recurrent NSCLC patients with EGFR T790M mutation. Clinical trial information: NCT003812809.

01 May 2022·Journal of Thoracic Oncology

Safety, Efficacy, and Pharmacokinetics of Rezivertinib (BPI-7711) in Patients With Advanced NSCLC With EGFR T790M Mutation: A Phase 1 Dose-Escalation and Dose-Expansion Study

Article

Author: Shi, Yuankai ; Zhang, Longzhen ; Yang, Sheng ; Zhang, Liangming ; Wang, Donglin ; Chen, Gongyan ; Yu, Huiqing ; Huang, Jianan ; Greco, Michael ; Wu, Gang ; Guo, Zhongliang ; Shu, Yongqian ; Zhuang, Zhixiang ; Zhang, Yu ; Zhao, Yanqiu ; Zheng, Rongsheng ; Shi, Jianhua ; Li, Xiao ; Fang, Jian ; Li, Xingya ; Zhou, Jianying ; Zhu, Bo

INTRODUCTIONRezivertinib (BPI-7711) is a novel third-generation EGFR tyrosine kinase inhibitor selective for EGFR-sensitizing and T790M mutations. This study was designed to evaluate the safety, efficacy, and pharmacokinetics of rezivertinib for patients having advanced NSCLC with EGFR T790M mutation.METHODSThis phase 1 study (NCT03386955) was conducted across 20 sites in the People's Republic of China. Patients received rezivertinib at six oral dose levels (30 mg, 60 mg, 120 mg, 180 mg, 240 mg, 300 mg) once daily until disease progression, unacceptable toxicity, or patient withdrawal. The primary end points were safety for the dose-escalation phase and objective response rate by the blinded independent central review for the total study population.RESULTSA total of 19 patients in dose-escalation phase using the standard 3 + 3 design principle and 153 patients in dose-expansion phase were enrolled from September 11, 2017, to August 23, 2019. The data cutoff date was on June 15, 2020. No dose-limiting toxicity occurred in the dose-escalation phase. The treatment-related adverse events were observed in 82.0% (141 of 172) of patients, and 17.4% (30 of 172) had grade greater than or equal to 3, among which decreased neutrophil count (2.9%), leukopenia (2.9%), and pneumonia (2.9%) were the most common. The overall blinded independent central review-evaluated objective response rate was 59.3% (102 of 172, 95% confidence interval: 51.6-66.7), and the median progression-free survival was 9.7 (95% confidence interval: 8.3-11.1) months.CONCLUSIONSRezivertinib was found to have promising efficacy with a manageable safety profile in patients with EGFR T790M-mutated advanced NSCLC. Further study is warranted.

Rezivertinib versus Gefitinib as First-line Therapy for EGFR-mutated Locally Advanced or Metastatic NSCLC Patients (REZOR): A Multicenter, Double-blinded, Randomized Phase 3 Study

Author: Yi, Tienan ; Shi, Huaqiu ; Zhao, Wenhua ; Wang, Haitao ; Li, Manxiang ; Wang, Tingting ; Yang, Sheng ; Li, Wen ; Yang, Minglei ; Zhang, Hua ; Zhang, Liangming ; Li, Xingya ; Liu, Zheng ; Zhou, Rui ; Fan, Yun ; Yao, Wenxiu ; Zhao, Yanqiu ; Shi, Yuankai ; Guo, Yanzhen ; Gao, Jinghua ; Chen, Zhaohong ; Hu, Sheng ; Wang, Lijun ; Shen, Haijiao ; Shi, Jianhua ; Han, Zhigang ; Wang, Ke ; Zhu, Bo ; Lu, Hong ; Zhou, Anqi ; Fang, Jian ; Qin, Jianwen ; Yi, Shanyong ; Zhong, Diansheng ; Peng, Jirong ; Cui, Jiuwei ; Zhang, Yan ; Ye, Feng ; Sun, Shenghua ; Yu, Zhuang ; Zhang, Don ; Wu, Lin ; Shu, Yongqian ; Zhou, Xiangdong ; Guo, Shuliang ; Pan, Yueyin ; Jiang, Mingyan ; Gao, Feng ; Bi, Minghong ; Cang, Shundong ; He, Zhiyong ; Ma, Rui ; Ji, Hongbo ; Lin, Yingcheng ; Yu, Huiqing ; Sun, Meili ; Wen, Meiling

Abstract

REZOR is a multicenter, double-blinded, randomized phase 3 study aimed to compare the efficacy and safety of rezivertinib (BPI-7711) and gefitinib as first-line therapies in patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC). The study included eligible patients from 50 hospitals across China. Those who had been histologically or cytologically confirmed NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation by central laboratory were randomly assigned (1:1) to receive once daily either rezivertinib 180 mg or gefitinib 250 mg. The primary endpoint was progression-free survival (PFS) evaluated by blinded independent central review (BICR), which was significantly superior in the rezivertinib group than the gefitinib group (19.3 versus 9.6 months, HR = 0.48, P <��

100 Deals associated with Beta Pharma (Shanghai) Co., Ltd.

100 Translational Medicine associated with Beta Pharma (Shanghai) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 13 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

Preclinical

Phase 2 Clinical

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Rezivertinib ( EGFR T790M )	EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma More	Approved
BPI-1178 ( CDK4 x CDK6 )	Hormone receptor positive HER2 negative breast cancer More	Phase 2 Clinical
BPP-2001	Hyperglycemia More	Preclinical
BPI-9208 ( PDL1 )	Solid tumor More	Preclinical
BPI-2491 ( KRAS G12D )	Solid tumor More	Preclinical

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