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

Recurrent Chronic Lymphoid LeukemiaSmall Lymphocytic LymphomaRefractory Mature B-Cell Non-Hodgkin Lymphoma+ [4]

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-

Login to view timeline

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

Login to view more data

100 Translational Medicine associated with HBW-3220

Login to view more data

100 Patents (Medical) associated with HBW-3220

Login to view more data

100 Deals associated with HBW-3220

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Chronic Lymphoid Leukemia	Phase 3	China	Hyperway Pharmaceutical Co., Ltd.	15 Dec 2025
Small Lymphocytic Lymphoma	Phase 3	China	Hyperway Pharmaceutical Co., Ltd.	15 Dec 2025
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 2	China	Hyperway Pharmaceutical Co., Ltd.	15 Jul 2022
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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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	btdfhzwytv(bgsiqbeavu) = bigpqbubgq hvowldqxip (jgealshuzh ) View more	Positive	30 May 2025
NEWS Manual	Not Applicable	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma BTK C481S	7	HBW-3220 Capsule	lorxxkahua(mjnzbgyjxr) = hppwozvugg ywfdyhqzsh (ohaucfnqjm )	Positive	28 Feb 2025
AACR2024 Manual	Phase 1	B-Cell Lymphoma	28	HBW-3220	ncjlbnnlrg(jfwtunevgx) = 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. ebcyeefgmx (ibqxicagkq ) View more	Positive	05 Apr 2024
CTR20221130 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	B-cell lymphoma refractory	11	HBW-3220	henlhcibkq(wpcvdiyspn) = yfrridzapc ozuqvkhdvl (oasnpllbci ) View more	Positive	31 May 2023