Hyperway Pharm is a pharmaceutical company that prioritizes research and development in its operations. The company aims to establish a world-leading platform for the development of small molecule innovative drugs and high-end APIs. The core team of founders consists of highly skilled professionals with experience working at major pharmaceutical companies such as Bayer, Johnson & Johnson, Sanofi, Merck, Hengrui, Yangzijiang, Hai Cisco, Smart Chemical, and Bite Pharmaceutical.

Tags

Neoplasms

Immune System Diseases

Hemic and Lymphatic Diseases

Small molecule drug

Chemical drugs

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	8
Nervous System Diseases	3
Immune System Diseases	3
Hemic and Lymphatic Diseases	3
Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	11
Chemical drugs	1

Top 5 Target	Count

BTK C481S(Bruton Tyrosine Kinase C481S)	2
KRAS G12D(GTPase KRas G12D)	2
KARS(Lysine-tRNA ligase)	1
Nav1.8(Sodium channel protein type X alpha subunit)	1

Drugs associated with Hyperway Pharmaceutical Co., Ltd.

HBW-3220

Target

BTK C481S

Mechanism

BTK C481S inhibitors

Active Org.

Hyperway Pharmaceutical Co., Ltd.Startup

Originator Org.

Hyperway Pharmaceutical Co., Ltd.Startup

Active Indication

B-Cell Lymphoma [+2]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

HBW-3210

Target

BTK C481S

Mechanism

BTK C481S inhibitors

Active Org.

Hyperway Pharmaceutical Co., Ltd.Startup

Originator Org.

Hyperway Pharmaceutical Co., Ltd.Startup

Active Indication

B-Cell Lymphoma [+1]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

HBW-011

Target-

Mechanism-

Active Org.

Hyperway Pharmaceutical Co., Ltd.Startup

Originator Org.

Hyperway Pharmaceutical Co., Ltd.Startup

Active Indication

Mycoses

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Hyperway Pharmaceutical Co., Ltd.

CTR20233167 / Not yet recruitingPhase 1/2

HBW-3210胶囊在中国成熟B细胞淋巴瘤患者中的安全性、耐受性、有效性和药代动力学的多中心Ⅰ/Ⅱ期临床研究

[Translation] A multicenter phase I/II clinical study on the safety, tolerability, efficacy and pharmacokinetics of HBW-3210 capsules in Chinese patients with mature B-cell lymphoma

剂量爬坡阶段（I）1）主要目的：评估HBW-3210单药口服给药在B细胞淋巴瘤患者中的安全性和耐受性，确定最大耐受剂量（MTD）和剂量限制性毒性（DLT）。2）次要目的：评价HBW-3210在B细胞淋巴瘤患者的药代动力学特征。初步评估HBW-3210在B细胞淋巴瘤患者中的有效性。扩展队列阶段（II）1）主要目的：评估HBW-3210在B细胞淋巴瘤患者的客观缓解率（ORR，即CR+PR）。2）次要目的：评价HBW-3210在B细胞淋巴瘤患者的药代动力学特征；评价HBW-3210在B细胞淋巴瘤患者中的安全性；评价HBW-3210在B细胞淋巴瘤患者中的其它有效性指标，例如起效时间（TTR）、缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）、部分缓解率（PR）、完全缓解率（CR）、疾病控制率（DCR）。

[Translation]

Dose escalation phase (I) 1) Primary objective: To evaluate the safety and tolerability of oral monotherapy of HBW-3210 in patients with B-cell lymphoma, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). 2) Secondary objective: To evaluate the pharmacokinetic characteristics of HBW-3210 in patients with B-cell lymphoma. Preliminary evaluation of the efficacy of HBW-3210 in patients with B-cell lymphoma. Expansion cohort phase (II) 1) Primary objective: To evaluate the objective response rate (ORR, i.e. CR+PR) of HBW-3210 in patients with B-cell lymphoma. 2) Secondary objectives: To evaluate the pharmacokinetic characteristics of HBW-3210 in patients with B-cell lymphoma; To evaluate the safety of HBW-3210 in patients with B-cell lymphoma; To evaluate other efficacy indicators of HBW-3210 in patients with B-cell lymphoma, such as time to onset of response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), partial response rate (PR), complete response rate (CR), and disease control rate (DCR).

Start Date-

Sponsor / Collaborator

Hyperway Pharmaceutical Co., Ltd.Startup

CTR20231148 / RecruitingPhase 1

评价HBW-004285胶囊在健康受试者中单次/多次给药的安全性、耐受性、药代动力学和药效动力学的I期临床试验

[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single/multiple administration of HBW-004285 capsules in healthy subjects

主要目的：在健康成年受试者中评估HBW-004285单次给药和多次给药的安全性和耐受性；次要目的：在健康成年受试者中分别评估HBW-004285单次给药和多次给药后的药代动力学（PK）特征；评价食物对HBW-004285单次给药后药代动力学的影响；初步评价HBW-004285的代谢和排泄特征；评估HBW-004285对ECG参数的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of HBW-004285 after single and multiple administrations in healthy adult subjects; Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of HBW-004285 after single and multiple administrations in healthy adult subjects; To evaluate the effect of food on the pharmacokinetics of HBW-004285 after a single administration; To preliminarily evaluate the metabolism and excretion characteristics of HBW-004285; To evaluate the effect of HBW-004285 on ECG parameters.

Start Date20 Apr 2023

Sponsor / Collaborator

Shenzhen Haibowei Pharmaceutical Co., Ltd.

CTR20221130 / RecruitingPhase 1/2

HBW-3220胶囊在中国成熟B细胞淋巴瘤患者中的安全性、耐受性、有效性和药代动力学的多中心Ⅰ/II期临床研究

[Translation] A multicenter phase I/II clinical study on the safety, tolerability, efficacy and pharmacokinetics of HBW-3220 capsules in Chinese patients with mature B-cell lymphoma

剂量爬坡阶段（I） 1）主要目的：评估HBW-3220单药口服给药在复发/难治B细胞淋巴瘤患者中的安全性和耐受性，确定最大耐受剂量（MTD）和剂量限制性毒性（DLT）。 2）次要目的：评价HBW-3220在复发/难治B细胞淋巴瘤患者的药代动力学特征。初步评估HBW-3220在复发/难治B细胞淋巴瘤患者中的有效性。扩展队列阶段（II） 1）主要目的评估HBW-3220在继发性耐药或疾病进展的B细胞淋巴瘤患者的客观缓解率（ORR，即CR+PR）。 2）次要目的：评价HBW-3220在B细胞淋巴瘤患者的药代动力学特征。评价HBW-3220在B细胞淋巴瘤患者中的安全性。评价HBW-3220在B细胞淋巴瘤患者中的其它有效性指标，例如起效时间（TTR）、缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）、部分缓解率（PR）、完全缓解率（CR）、疾病控制率（DCR）。

[Translation]

Dose escalation phase (I) 1) Primary objective: To evaluate the safety and tolerability of oral monotherapy of HBW-3220 in patients with relapsed/refractory B-cell lymphoma, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). 2) Secondary objective: To evaluate the pharmacokinetic characteristics of HBW-3220 in patients with relapsed/refractory B-cell lymphoma. To preliminarily evaluate the efficacy of HBW-3220 in patients with relapsed/refractory B-cell lymphoma. Expansion cohort phase (II) 1) Primary objective To evaluate the objective response rate (ORR, i.e. CR+PR) of HBW-3220 in patients with B-cell lymphoma with secondary drug resistance or disease progression. 2) Secondary objective: To evaluate the pharmacokinetic characteristics of HBW-3220 in patients with B-cell lymphoma. To evaluate the safety of HBW-3220 in patients with B-cell lymphoma. To evaluate other efficacy indicators of HBW-3220 in patients with B-cell lymphoma, such as time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), partial response rate (PR), complete response rate (CR), and disease control rate (DCR).

Start Date09 May 2022

Sponsor / Collaborator

Hyperway Pharmaceutical Co., Ltd.Startup

100 Clinical Results associated with Hyperway Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Hyperway Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Hyperway Pharmaceutical Co., Ltd.

01 Jun 2024·Journal of Clinical Oncology

Preclinical characterization of HBW-012-E, a novel, potent, selective, safe, and orally active KRAS G12D inhibitor with superior pharmacokinetic (PK) properties and anti-tumor efficacy.

Author: Ren, Junfeng ; Li, Yingfu ; Lee, Ning ; Li, Jiang ; Liu, Guanfeng

3115 Background: HBW-012-E is a newly identified KRAS G12D small molecule inhibitor with improved oral bioavailability than MRTX1133, the more advanced clinical candidate with poor bioavailability. Methods: Small molecules were designed through our medicinal chemistry efforts, aiming to discover KRAS G12D inhibitors that are of good oral bioavailability. The compounds were screened via pERK and cell viability (CTG) assays in multiple cell types. The optimized compounds were further evaluated based on their PK properties and toxicity. The anti-tumor efficacy of the leads was confirmed in a mouse GP2D (with KRAS G12D) colon cancer model. Results: As shown in the table, HBW-012-E has better potency and PK characteristics than MRTX1133. In the GP2D model, comparing head-to-head with the same vehicle and protocol (50 mg/kg, BID, PO), HBW-012-E can not only inhibit tumor growth completely but also further regress tumor size by ~40%, whereas MRTX1133 can hardly inhibit tumor growth. HBW-012-E demonstrated anti-tumor efficacy in a dose-dependent manner; at a dose as low as 10 mg/kg, it achieved ~80 % tumor inhibition rate (TGI). Preliminary toxicity tests showed that HBW-012-E is safe: weak inhibition of CYP450 enzymes, negative mini-Ames test, excellent kinase selectivity, and no obvious abnormalities in the 14-day rat or mouse toxicity test. Conclusions: A new KRAS G12D inhibitor, HBW-012-E, was identified. Its preclinical profile, including potency, efficacy, and PK properties, are all superior to MRTX1133, and its safety meets the criteria of clinical development. It can potentially be used to treat intractable tumors mediated by KRAS G12D mutations, such as pancreatic cancer that still lacks effective treatments. [Table: see text]

01 Jun 2024·Journal of Clinical Oncology

A phase IIA clinical trial to evaluate a reversible Bruton’s tyrosine kinase inhibitor (BTKi) HBW-3220 capsules in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).

Author: Liu, Qingchun ; Li, Yingfu ; Mao, Yong ; Lee, Ning ; Li, Jiang ; Liu, Guanfeng

e19042 Background: This clinical study is to evaluate HBW-3220, a novel BTKi with an improved in vitro profile than the existing non-covalent drugs pirtobrutinib (approved) and nemtabrutinib (Phase III). HBW-3220 shows superior inhibition against BTK wild-type and several common mutants, such as C481S, C481R, T474I, T316A, and L528W (enriched in pirtobrutinib resistance), and hematopoietic cell kinase (HCK, a key contributor to BTKi resistance due to kinase-defective BTK). Methods: This phase IIA clinical study is conducted in R/R B-NHL patients who had received two or more prior lines of treatment. The dose escalation study adopts accelerated titration and a "3+3" design, with a daily single dose of 15, 30, 60, 90, 120, or 150 mg. During the dose escalation phase, the sponsor and investigators determine whether to expand the cohort of the previous dose based on the existing data. Adverse events (AEs) are assigned according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Response assessment is based on iwCLL 2018 guidelines for chronic lymphocytic leukemia (CLL), IWWM-7 consensus for Waldenstrom macroglobulinemia (WM), and Lugano 2014 guidelines for all other lymphomas, including small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). Results: 29 patients have been enrolled, and the dose escalation study has been completed. No dose-limiting toxicity (DLT) occurred in any patient, implicating good tolerability. Adverse events (AEs), similar to other BTKis, were mostly Grade 1 or 2, including fever (36%), diarrhea (32%), headache (18%), anemia (39%), infectious pneumonia (18%), decreased neutrophils count (39%), decreased platelet count (29%), increased alanine aminotransferase (21%), etc. Drug-related Grade 3 AEs included decreased neutrophil count (n=3, 11%), increased lymphocyte count (n=2, 7%), and infectious pneumonia (n=2, 7%). 23 patients underwent at least 1 response assessment. The overall response rate (ORR) in CLL/SLL (all with prior irreversible BTKi treatment, and 4 of them with additional BCL2 inhibitor treatment), MZL, MCL, and DLBCL patients were 83% (5/6), 50% (2/4), 40% (2/5) and 33% (1/3), respectively. Among the ORR, 90% (9/10) were in the 90 mg and above dose group, regardless of previous BTKi treatment history or mutation status of p53 and BTK. After oral administration, the drug exposures showed dose-dependent increases. The time to maximum plasma concentration (Tmax) was 2 hours, and the elimination half-life (T1/2) was 19 hours. Conclusions: The current data show that HBW-3220 is well tolerated with no DLT occurred at daily doses up to 150 mg, displaying most promising efficacy in patients with CLL/SLL, MZL, and MCL. Clinical trial information: ChiCTR2200062537.

05 Apr 2024·Cancer Research

Abstract CT147: Phase I clinical study of Bruton’s tyrosine kinase inhibitor (BTKi) HBW-3220 capsules in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL)

Author: Liu, Qingchun ; Li, Yingfu ; Mao, Yong ; Lee, Ning ; Li, Jiang ; Liu, Guanfeng

AbstractPurpose: This clinical study is to evaluate HBW-3220, a novel reversible BTK inhibitor (BTKi) with an improved in vitro profile than the existing non-covalent drugs pirtobrutinib (LOXO-305, approved) and MK-1026 (Phase III). HBW-3220 shows superior inhibition against BTK wild-type and several common mutants, such as C481S, C481R, T474I, T316A, and L528W (the one predominantly enriched in patients resistant to the newer-generation BTKis), and hematopoietic cell kinase (HCK), a key contributor to the development of ibrutinib resistance associated with kinase-defective BTK.Methods: This phase I clinical study was conducted in R/R B-NHL patients who had received two or more prior lines of treatments. The dose escalation study adopts accelerated titration and a "3+3" design, with a daily single dose of 15, 30, 60, 90, 120, or 150 mg. During the dose escalation phase, the sponsor and investigators determined whether to expand the cohort of the previous dose based on the existing data. Adverse events (AEs) were assigned according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Response assessment was based on the iwCLL 2018 guidelines, the IWWM-7 consensus, or the Lugano 2014 guidelines, according to the respective disease type.Results: 28 patients have been enrolled so far, and the dose escalation study has been completed. No dose-limiting toxicity (DLT) occurred in any patient, implicating good tolerability. Adverse events (AEs), similar to other BTKis, were mostly Grade 1 or 2, including fever (38%), diarrhea (35%), headache (19%), anemia (42%), infectious pneumonia (23%), decreased neutrophils (42%), decreased platelet count (27%), increased alanine aminotransferase (23%), etc. Drug-related Grade 3 AEs included neutrophil count decreased (n=3, 11%), increased lymphocyte count (n=2, 7%), and infectious pneumonia (n=2, 7%). 21 patients underwent at least 1 response assessment (4 chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); 4 marginal zone lymphoma (MZL); 5 mantle cell lymphoma (MCL); 3 diffuse large B-cell lymphoma (DLBCL); 5 other B-NHL), and the results are 1 complete response (CR), 6 partial response (PR), and 1 partial response with lymphocytosis (PR-L). The overall response rate (ORR) in CLL/SLL (all with prior irreversible BTKi treatment, and 2 of them with additional BCL2 inhibitor treatment), MZL, MCL, and DLBCL patients were 75% (3/4, including 1 PR-L), 50% (2/4), 40% (2/5) and 33% (1/3), respectively. Among the ORR (including CR, PR, and PR-L), 88% (7/8) were in the 90 mg and above dose group, regardless of previous BTKi treatment history or mutation status of p53 and BTK C481S. In the 90 mg and above dose group, the ORR is 47%. After oral administration, the drug exposures showed dose-dependent increases. The time to maximum plasma concentration (Tmax) was 2 hours, and the elimination half-life (T1/2) was 19 hours.Conclusions: The current data show that HBW-3220 is well tolerated, showing no DLT occurred at daily doses up to 150 mg, and has good efficacy in patients with CLL/SLL, MZL, and MCL.Citation Format: Ning Lee, Yingfu Li, Yong Mao, Guanfeng Liu, Jiang Li, Qingchun Liu. Phase I clinical study of Bruton’s tyrosine kinase inhibitor (BTKi) HBW-3220 capsules in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT147.

100 Deals associated with Hyperway Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Hyperway Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 16 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

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IND Application

Phase 1 Clinical

Phase 2 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

HBW-3220 ( BTK C481S )	B-Cell Lymphoma More	Phase 2 Clinical
HBW-3210 ( BTK C481S )	B-Cell Lymphoma More	Phase 2 Clinical
HBW-004285 ( Nav1.8 )	Pain More	Phase 1
HBW-011	Mycoses More	Phase 1
HBW-004	Pain More	IND Application

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