Top 5 Target	Count

PDL1(Programmed death-ligand 1)	5
c-Met(Hepatocyte growth factor receptor)	2
KRAS G12C(GTPase KRas G12C)	2
CD47(Cluster of differentiation 47)	1
EGFR T790M(Epidermal Growth Factor Receptor T790M)	1

Drugs associated with Beta Pharma, Inc.

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, Inc.

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, Inc.

0 Patents (Medical) associated with Beta Pharma, Inc.

Literatures (Medical) associated with Beta Pharma, Inc.

01 Jun 2023·Lung cancer (Amsterdam, Netherlands)

Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies

Article

Author: Fan, Yun ; Xie, Congying ; Yang, Zhixiong ; Wang, Ke ; Zhou, Anqi ; Yi, Shanyong ; Guo, Yanzhen ; Liu, Jiwei ; Li, Xingya ; Shu, Yongqian ; Meng, Zili ; Cang, Shundong ; Wu, Lin ; Lu, Hong ; Chen, Gongyan ; Guo, Zhongliang ; Li, Jingzhang ; Zheng, Rongsheng ; Sun, Meili ; Chen, Zhendong ; Zhuang, Zhixiang ; Wu, Gang ; Wu, Shiman ; Yi, Tienan ; Liu, Zhefeng ; Zhong, Diansheng ; Zhou, Jianying ; Zhu, Bo ; Liu, Chunling ; Zhao, Yanqiu ; Zhao, Guofang ; Fang, Jian ; Huang, Jianan ; Pan, Yueyin ; Hu, Sheng ; Li, Wen ; Sun, Shenghua ; Zhao, Hui ; Zhang, Liangming ; Bi, Minghong ; Liu, Zheng ; Shi, Yuankai ; Yang, Sheng ; Zhang, Longzhen ; Huang, Meijuan ; Han, Zhigang ; Yu, Huiqing ; Greco, Michael ; Lin, Yingcheng ; Wang, Tingting ; Chen, Zhaohong ; Ma, Rui ; Yao, Wenxiu ; Guo, Shuliang ; Wang, Lijun ; Shi, Jianhua ; Wang, Donglin

BACKGROUND:

Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) which revealed the systematic and central nervous system (CNS) antitumor activities for EGFR T790M-mutated advanced NSCLC in previous clinical studies and is further analyzed here.

METHODS:

Eligible patients from the previous phase I and phase IIb studies of rezivertinib were included for pooled analysis. Post-progressive patients who received a prescribed dosage (≥180 mg) of rezivertinib orally once daily were included in full analysis set (FAS), while those with stable, asymptomatic CNS lesions, including measurable and non-measurable ones at baseline were included in CNS full analysis set (cFAS). Patients with measurable CNS lesions were included in CNS evaluable for response set (cEFR). BICR-assessed CNS objective response rate (CNS-ORR), CNS disease control rate (CNS-DCR), CNS duration of response (CNS-DoR), CNS progression-free survival (CNS-PFS), and CNS depth of response (CNS-DepOR) were evaluated.

RESULTS:

355 patients were included in FAS, among whom 150 and 45 patients were included in cFAS and cEFR. This pooled analysis showed the CNS-ORR was 32.0% (48/150; 95% CI: 24.6-40.1%) and the CNS-DCR was 42.0% (63/150; 95% CI: 34.0-50.3%) in cFAS, while that in cEFR were 68.9% (31/45; 95% CI: 53.4-81.8%) and 100% (45/45; 95% CI: 92.1-100.0%). In cEFR, the median CNS-DepOR and the mean of CNS-DepOR were -52.0% (range: -100.0 to 16.1%) and -46.8% (95% CI: -55.5 to -38.1%). In cFAS, the median CNS-DoR and CNS-PFS were 13.8 (95% CI: 9.6-not calculable [NC]) and 16.5 (95% CI: 13.7-NC) months.

CONCLUSIONS:

Rezivertinib demonstrated encouraging clinical CNS efficacy among advanced NSCLC patients with EGFR T790M mutation and CNS metastases.

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

INTRODUCTION:

Rezivertinib (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.

METHODS:

This 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.

RESULTS:

A 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.

CONCLUSIONS:

Rezivertinib was found to have promising efficacy with a manageable safety profile in patients with EGFR T790M-mutated advanced NSCLC. Further study is warranted.

01 May 2021·Journal of Thoracic Oncology

Beyond Osimertinib: The Development of Third-Generation EGFR Tyrosine Kinase Inhibitors For Advanced EGFR+ NSCLC

Review

Author: Ou, Sai-Hong Ignatius ; Nagasaka, Misako ; Greco, Michael ; Wu, Fengying ; Lim, Sun Min ; Zhu, Viola W

Single-agent osimertinib is the standard of care for the first-line treatment of advancedEGFR+ NSCLC and remained the only marketed third-generation EGFR tyrosine kinase inhibitor (TKI) until March 2020 when almonertinib (HS-10296) was approved in the People's Republic of China for the treatment of advanced EGFR T790M+ NSCLC based on a phase 2 expansion study of a phase 1/2 trial. In this review, we profiled many of the third-generation EGFR TKIs in late-stage clinical development (e.g., almonertinib, lazertinib, alflutinib¹, rezivertinib, ASK120069, SH-1028, D-0316, and abivertinib) based on their interim results from phase 1 and phase 2 trials, and included the designs of the phase 3 trials and their chemical structures when publicly available. We also listed other third-generation EGFR TKIs in pipeline development based on the search of clinical trial registration websites. In addition, we summarized the results of clinical trials that previously reported third-generation EGFR TKIs (rociletinib, olmutinib, nazartinib, mavelertinib), including phase 3 results of rociletinib and naquotinib. We further profiled combination clinical trial design of the third-generation EGFR TKIs including FLAURA2 (NCT04035486), MARIPOSA (NCT04487080), ACROSS1 (NCT04500704), and ACROSS2 (NCT04500717) that if positive can potentially usher in the next standard of care for advanced EGFR+ NSCLC.

News (Medical) associated with Beta Pharma, Inc.

10 May 2023

·www.businesswire.com

2023 State of the Biopharmaceutical Industry Report: Genomics, RWE, and IO will Dominate as the Most Impactful Trends - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "State of the Biopharmaceutical Industry 2023" report has been added to ResearchAndMarkets.com's offering. In this report, the publisher examines the business environment and trends that are going to shape the biopharmaceutical industry in 2023. The report highlights the most impactful emerging technologies, industry trends, regulatory trends, and microeconomic factors that are going to impact and dominate the industry throughout 2023. Synopsis The pharmaceutical industry is set to face new challenges such as inflation in a post-COVID-19 world. Genomics, RWE, and IO will dominate as the most impactful trends in the biopharmaceutical industry next year. Among the most impactful trends, genomics will be the key focus in 2023. Inflation and drug pricing pressures will be the top hindrances for pharmaceutical sector growth. Vertical integration, patent expiry of biologics, mega M&As, and ESG factors are anticipated to have the greatest positive impact on the pharmaceutical industry. Big data and AI will continue to dominate as transformational forces in the healthcare sector in 2023. Across the entire value chain, supply chains and manufacturing will be impacted the most by inflation in 2023. The biopharmaceutical industry is less optimistic about industry growth in the next 12 months compared to previous years. The pharmaceutical industry will continue to pursue its efforts to become more sustainable, with more companies committing to ESG strategies. Oncology, CNS, and infectious diseases will be the dominant areas for clinical trials initiated in 2023. Despite political rhetoric, COVID-19-induced pharmaceutical onshoring may not happen. While already met with skepticism by pharma, the Inflation Reduction Act will have to show if it can live up to its name. Key Highlights In 2023, economies and industries will continue to deal with inflationary pressures. Inflation will disrupt pharmaceutical manufacturing and supply chains. Genomics is the trend that will continue to have the greatest impact on the pharmaceutical industry in 2023. Inflation together with drug pricing and reimbursement-related concerns will be the leading impediment to industry growth. Vertical integration, patent expiry of biologics, mega M&As, and ESG factors will have the most positive impacts on industry. While less than in previous years, the biopharmaceutical industry is still optimistic about its growth in 2023. Scope Benchmark the impact of major themes on the biopharmaceutical industry in 2023, including: emerging technologies, regulatory trends, macroeconomic trends, industry trends. Identify themes that will have the greatest positive or negative impact in 2023. Capture opinions on these themes from industry respondents. Assess the impact of COVID-19 on the biopharmaceutical sector. Explore how inflation will affect the pharmaceutical industry in 2023. Reasons to Buy Stay up to date with the major emerging technologies, regulatory, macroeconomic, and industry trends that will impact the pharmaceutical industry in 2023. Explore how the biopharmaceutical landscape has changed. Identify the most impactful anticipated regulatory approvals and drug launches in the industry in 2023. Gain insight into the regulatory and microeconomics trends that will have positive and negative effects on the biopharmaceutical industry. Identify emerging industry trends and innovations to gain a competitive advantage. A selection of companies mentioned in this report includes AbbVie Acceleron Pharma Atara Biotherapeutics Beta Pharma BioMarin Pharmaceutical BioNTech Bio-Thera Solutions Boehringer Ingelheim Bristol-Myers Squibb Catalent Celerity Pharmaceuticals Celltrion Coherus BioSciences CSL Behring CStone Pharmaceuticals CVS Health Corp EirGenix Eli Lilly Exelead Exscientia Ferring Pharmaceuticals Fuji Pharma GSK Immunocore Insud Pharma InventisBio Johnson & Johnson Johnson Matthey Legend Biotech Loxo Oncology Medicaid Health Plans of America Merck Merck & Co Metrics Contract Services Midas Pharma Mirati Therapeutics National Institute for Health and Care Excellence Nippon Kayaku Novartis Ono Pharmaceutical Optum Organon OS Therapies PTC Therapeutics Regeneron Pharmaceuticals Samsung Bioepis Sandoz Sarepta Therapeutics Shanghai Junshi Bioscience Sino Biopharmaceutical Stada Arzneimittel Stelis Biopharma Sumitomo Dainippon Pharma Oncology Teva Pharmaceutical Industries TRACON Pharmaceuticals UnitedHealth Group Veranova Xbrane Biopharma For more information about this report visit https://www.researchandmarkets.com/r/fix73o About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

100 Deals associated with Beta Pharma, Inc.

100 Translational Medicine associated with Beta Pharma, Inc.

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Pipeline

Pipeline Snapshot as of 12 Mar 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

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

BPI-1178 ( CDK4 x CDK6 )	Advanced Malignant Solid Neoplasm More	Phase 1/2
Rezivertinib ( EGFR T790M )	metastatic non-small cell lung cancer More	Phase 1
BPI-9207 ( PDL1 )	Solid tumor More	Preclinical
BPI-9208 ( PDL1 )	Solid tumor More	Preclinical
BPI-9206 ( PDL1 )	Solid tumor More	Preclinical

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