Delving into the Latest Updates on HBW-3220 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HBW 3220, HBW-3-10, HBW-3-20

+ [3]

Target

BTK C481S

Action

inhibitors

Mechanism

BTK C481S inhibitors(Bruton Tyrosine Kinase C481S inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaB-cell lymphoma recurrent+ [3]

Inactive Indication-

Originator Organization

Hyperway Pharmaceutical Co., Ltd.

Active Organization

Hyperway Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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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.

100 Clinical Results associated with HBW-3220

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100 Translational Medicine associated with HBW-3220

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100 Patents (Medical) associated with HBW-3220

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100 Deals associated with HBW-3220

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 3	China	Hyperway Pharmaceutical Co., Ltd.	15 Dec 2025
Small Lymphocytic Lymphoma	Phase 3	China	Hyperway Pharmaceutical Co., Ltd.	15 Dec 2025
B-cell lymphoma recurrent	Phase 2	China	Hyperway Pharmaceutical Co., Ltd.	09 May 2022
B-cell lymphoma refractory	Phase 2	China	Hyperway Pharmaceutical Co., Ltd.	09 May 2022
Autoimmune Diseases	Phase 1	China	Hyperway Pharmaceutical Co., Ltd.	-
Glomerulonephritis	IND Approval	China	Hyperway Pharmaceutical Co., Ltd.	30 Jun 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20221130 (Phase I/IIa clinical study of 4th generation BTK inhibitor HBW-3220 capsules, ASCO2025)	Phase 1/2	Chronic Lymphocytic Leukemia BTK wild-type \| C481S \| L528W ... View more	48	HBW-3220 capsules	jvkqovibdk(yhtdaztjgk) = tebesrdvhz fnjwvaswjp (duzgsmajjw ) View more	Positive	30 May 2025
NEWS Manual	Not Applicable	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma BTK C481S	7	HBW-3220 Capsule	fqrhsdsfvv(ubbbihigfw) = jchrlxhpff lfdbsxhykl (gugokvwwcp )	Positive	28 Feb 2025
AACR2024 Manual	Phase 1	B-Cell Lymphoma	28	HBW-3220	uixvmfqfan(qblquuvnxx) = 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. hzmvvodtxy (hpqbajrvpd ) View more	Positive	05 Apr 2024
CTR20221130 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	B-cell lymphoma refractory	11	HBW-3220	hdvwivivna(lwocutpyhb) = hntuujhgro eywsjcfbab (wlkbxjbqzc ) View more	Positive	31 May 2023