Delving into the Latest Updates on Zhejiang Fukang Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Urogenital Diseases

Digestive System Disorders

Small molecule drug

Bispecific antibody

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	2
Hemic and Lymphatic Diseases	1
Immune System Diseases	1
Infectious Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	2
Bispecific antibody	1

Top 5 Target	Count

PDL1 x VEGF	1
PI3Kβ x PI3Kδ	1

主要研究目的 (1)Ib期：评价CVL237联合斯鲁利单抗注射液在PTEN缺失或低表达的晚期实体瘤患者中的安全性和耐受性； (2)Ib期：观察CVL237联合斯鲁利单抗注射液在PTEN缺失或低表达的晚期实体瘤患者中的剂量限制性毒性(DLT)、最大耐受剂量(Maximal Tolerated Dose，MTD)，确定II期临床研究推荐剂量(Recommended Phase 2 Dose，RP2D)。 (3)II期：评价CVL237联合斯鲁利单抗注射液在PTEN缺失或低表达的晚期实体瘤患者中的疗效。次要研究目的（1）Ib期和II期：初步评价CVL237联合斯鲁利单抗注射液在PTEN缺失或低表达的晚期实体瘤患者中的有效性；（2）II期：评价CVL237联合斯鲁利单抗注射液的安全性；（3）Ib期和II期：评价CVL237联合斯鲁利单抗注射液的药代动力学（PK）特征。

[Translation]

Main study objectives (1) Phase Ib: To evaluate the safety and tolerability of CVL237 combined with slulizumab injection in patients with advanced solid tumors with PTEN deficiency or low expression; (2) Phase Ib: To observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CVL237 combined with slulizumab injection in patients with advanced solid tumors with PTEN deficiency or low expression, and to determine the recommended dose (Recommended Phase 2 Dose, RP2D) for Phase II clinical studies. (3) Phase II: To evaluate the efficacy of CVL237 combined with slulizumab injection in patients with advanced solid tumors with PTEN deficiency or low expression. Secondary study objectives (1) Phase Ib and Phase II: Preliminary evaluation of the efficacy of CVL237 combined with slulizumab injection in patients with advanced solid tumors with PTEN deletion or low expression; (2) Phase II: Evaluation of the safety of CVL237 combined with slulizumab injection; (3) Phase Ib and Phase II: Evaluation of the pharmacokinetic (PK) characteristics of CVL237 combined with slulizumab injection.

Start Date-

Sponsor / Collaborator

Zhejiang Fukang Pharmaceutical Co., Ltd.

[+1]

CTR20253553

/ Not yet recruitingPhase 1/2

CVL006联合治疗在晚期实体瘤的I/II期研究

[Translation] Phase I/II study of CVL006 combination therapy in advanced solid tumors

主要研究目的： I期确定CVL006联合培美曲塞+卡铂/ SKB264/ DS-8201a/ Enfortumab Vedotin在晚期实体瘤患者中的剂量限制性毒性（DLT）以及II期推荐剂量（RP2D）。 II期初步评价 CVL006联合培美曲塞+卡铂/ SKB264/ DS-8201a/ Enfortumab Vedotin治疗晚期实体瘤的疗效性。次要研究目的：观察CVL006联合培美曲塞+卡铂/ SKB264/ DS-8201a/ Enfortumab Vedotin在晚期实体瘤患者中的药代动力学（PK）特征； I期初步评价CVL006联合培美曲塞+卡铂/ SKB264/ DS-8201a/ Enfortumab Vedotin在晚期实体瘤患者中的有效性。 II期 CVL006联合培美曲塞+卡铂/ SKB264/ DS-8201a/ Enfortumab Vedotin治疗晚期实体瘤的安全性；评价CVL006的免疫原性。

[Translation]

Primary Study Objectives: Phase I study to determine the dose-limiting toxicity (DLT) and recommended Phase II dose (RP2D) of CVL006 in combination with pemetrexed + carboplatin/SKB264/DS-8201a/enfortumab vedotin in patients with advanced solid tumors. Phase II study to preliminarily evaluate the efficacy of CVL006 in combination with pemetrexed + carboplatin/SKB264/DS-8201a/enfortumab vedotin in the treatment of patients with advanced solid tumors. Secondary Study Objectives: To observe the pharmacokinetic (PK) characteristics of CVL006 in combination with pemetrexed + carboplatin/SKB264/DS-8201a/enfortumab vedotin in patients with advanced solid tumors. Phase I study to preliminarily evaluate the efficacy of CVL006 in combination with pemetrexed + carboplatin/SKB264/DS-8201a/enfortumab vedotin in patients with advanced solid tumors. Phase II study to evaluate the safety of CVL006 in combination with pemetrexed and carboplatin/SKB264/DS-8201a/enfortumab vedotin in the treatment of patients with advanced solid tumors; Evaluate the immunogenicity of CVL006.

Start Date-

Sponsor / Collaborator

Zhejiang Fukang Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Zhejiang Fukang Pharmaceutical Co., Ltd.

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

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100 Deals associated with Zhejiang Fukang Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Zhejiang Fukang Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 14 Nov 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

Discovery

1

IND Approval

Phase 2

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

KA-2237 ( PI3Kβ x PI3Kδ )	Advanced Malignant Solid Neoplasm More	Phase 2
CVL-006 ( PDL1 x VEGF )	Advanced Malignant Solid Neoplasm More	Phase 1/2
Neratinib maleate ( EGFR x HER2 x HER4 )	Metastatic HER2 positive gastroesophageal junction cancer More	IND Approval
WO2024131886 Patent Mining	Infectious Diseases More	Discovery