Delving into the Latest Updates on Convalife (Shanghai) Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Convalife Pharmaceutical Co., Ltd. is a global-oriented innovative drug development enterprise, dedicated to developing innovative drugs in the field of oncology and age-related diseases. Guided by unmet clinical medication needs worldwide, the company designs and develops original new drugs with "First-in-Class" or "Best-in-Class" potential, and enters the international pharmaceutical market. Headquartered in Shanghai, with offices in Guangzhou, Boston, and other locations. In 2019, it was recognized as a high-tech enterprise in Shanghai.

Tags

Neoplasms

Skin and Musculoskeletal Diseases

Digestive System Disorders

Small molecule drug

Chemical drugs

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	9
Hemic and Lymphatic Diseases	4
Infectious Diseases	3
Nervous System Diseases	3
Immune System Diseases	3
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	8
Chemical drugs	2
Unknown	1
Bispecific antibody	1

Top 5 Target	Count

CDK4 x CDK9	1
PARP1 x PARP2	1
CD38(Lymphocyte differentiation antigen CD38)	1
EGFR x HER2 x HER4	1
HDAC1 x HDAC3 x HDAC6	1

主要研究目的 :评价CVL006单药在晚期实体瘤患者中的安全性和耐受性；观察CVL006单药在晚期实体瘤中的剂量限制性毒性（DLT），评估最大耐受剂量（MTD）及推荐的II期临床研究的使用剂量（RP2D）。次要研究目的：观察CVL006注射液单药在晚期实体瘤患者中的药代动力学（PK）特征；初步评价CVL006单药在晚期实体瘤患者中的有效性（包括客观缓解率[ORR]、肿瘤缓解持续时间[DoR]、疾病控制率[DCR]、最佳反应率[BOR]、无进展生存期[PFS]）。（根据RECIST1.1标准）；评价CVL006的免疫原性。

[Translation]

Main study objectives: To evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors; To observe the dose-limiting toxicity (DLT) of CVL006 monotherapy in advanced solid tumors, and to evaluate the maximum tolerated dose (MTD) and the recommended dose for Phase II clinical studies (RP2D). Secondary study objectives: To observe the pharmacokinetic (PK) characteristics of CVL006 injection monotherapy in patients with advanced solid tumors; To preliminarily evaluate the effectiveness of CVL006 monotherapy in patients with advanced solid tumors (including objective response rate [ORR], duration of tumor response [DoR], disease control rate [DCR], best response rate [BOR], progression-free survival [PFS]). (According to RECIST1.1 criteria); To evaluate the immunogenicity of CVL006.

Start Date05 Dec 2024

Sponsor / Collaborator

Zhejiang Fukang Pharmaceutical Co., Ltd.

[+1]

NCT06621615

/ Not yet recruitingPhase 1

An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of CVL006 Injection in Patients With Advanced Solid Tumors.

Evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors; Observe the dose limiting toxicity (DLT) of CVL006 monotherapy in patients with advanced solid tumors, evaluate the maximum tolerated dose (MTD), and recommend the dosage for phase II clinical trials (RP2D).

Start Date20 Nov 2024

Sponsor / Collaborator

Convalife (Shanghai) Co. Ltd.

NCT06519110

/ Not yet recruitingPhase 2

A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets Monotherapy in the Treatment of Advanced Solid Tumors With HER2 Mutations

Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.

Start Date10 Aug 2024

Sponsor / Collaborator

Convalife (Shanghai) Co. Ltd.

100 Clinical Results associated with Convalife (Shanghai) Co. Ltd.

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0 Patents (Medical) associated with Convalife (Shanghai) Co. Ltd.

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11

Literatures (Medical) associated with Convalife (Shanghai) Co. Ltd.

21 Apr 2025·Cancer Research

Abstract 835: A potent and selective small molecule inhibitor of CD38

Author: Liu, Yunli ; Huang, Jinwen ; Song, Zeng ; Li, Zhongyuan ; Shen, Steve

AbstractBackground:CD38 is a multifunctional ectoenzyme involved in NAD metabolism and is highly expressed in various hematological malignancies, making it a critical therapeutic target in oncology. By depleting NAD and producing immunosuppressive metabolites such as adenosine, CD38 supports tumor growth and creates an immunosuppressive microenvironment. Compared to CD38 antibodies, small-molecule inhibitor offer advantages, including better tissue penetration, oral bioavailability, and cost-effectiveness. CD38 inhibition may restore NAD levels, reverse immunosuppression, and enhance antitumor immune responses, potentially synergizing with immune checkpoint inhibitors (ICIs), providing a promising strategy for cancer therapy.Methods and Materials:Accelerated by the "Right 6D+AI" platform, AI-based screening and multi-angle evaluation were conducted on over 5, 000 virtual molecules, yielding candidate molecule N066 with IC50 activity below 1 nM. To explore the therapeutic potential, oral administration of N066 in mice assessed dose-dependent effects on NAD+ elevation and ADPR reduction in tissues such as the spleen and liver. In syngeneic cancer models, CD38 protein expression was evaluated using immunohistochemistry (IHC) following ICI treatment. In mouse solid tumor models, N066 was administered as monotherapy or combined with ICIs.Results:The small-molecule inhibited intracellular CD38 activity in cultured human primary T cells, increasing intracellular NAD+ levels. In mice, oral administration of the inhibitor resulted in a dose-dependent increase in NAD+ levels and a decrease in ADPR levels in tissues such as the spleen and liver. In syngeneic cancer models, monotherapy with the N066 showed antitumor activity correlated with changes in NAD+ and ADPR levels. In B16-F10 tumor-bearing mice, combining N066 with anti-PD-L1 therapy enhanced antitumor activity.Conclusion:CD38 small-molecule inhibitors N066 demonstrates good antitumor activity, highlighting its therapeutic potential.Citation Format:Jinwen Huang, Zhongyuan Li, Zeng Song, Yunli Liu, Steve Shen. A potent and selective small molecule inhibitor of CD38 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 835.

21 Apr 2025·Cancer Research

Abstract 836: A phase Ib/II study of PARPi Mefuparib Hydrochloride (CVL218) in combination with PD-1 inhibitor plus chemotherapy in metastatic or recurrent triple-negative breast cancer (TNBC)

Author: Zhang, Jian ; Shen, Steve ; Liu, Rujiao

AbstractBackground:BRCA 1 and /or BRAC 2 mutation accounts for about 15% of all TNBC and remains poor outcomes. Mefuparib hydrochloride (CVL218) is a second generation in PARPi with low hematological toxicity and high ability to cross the blood-brain barrier. This study is to explore efficacy and safety of CVL218 combined with PD-1antibody and paclitaxel nanoparticle albumin-bound in patients with TNBC who have failed previous first-line treatment.Methods:This open- labeled, phase Ib/II clinical study NCT06078670 explores efficacy and safety of three drugs combination . 500mg BID CVL218 was administered orally in combination with toripalimab 240 mg on Day 1 of every 21-day cycle and paclitaxel nanoparticle albumin-bound 125 mg/m2 on Day 1 of every 21-day cycle. Patients in cohort A were advanced TNBC with either CPS ≥ 1 or HRD gene pathogenic variants.Results:From July 2023 to 15 July 2024 data, 6 subjects were enrolled in Phase Ib and 5 subjects were enrolled in Phase II. In phase Ib, The RP2D of CVL218 was identified as 500 mg BID. The preliminary efficacy was perfomed every 6 weeks in the first half a year and then once every 12 weeks thereafter in both phase Ib and II by RECISTv 1.1. Among 11 patients, ORR was 72.7% (8 PR, 2 SD), and DCR (Disease Control Rate) was 90.9%. The most common Grade 3 or higher treatment-related AEs (TRAEs) were hepatic function injury (2.6%), adynamia (1.8%), creatinine increased (0.8%), neutrophils decreased (0.8%), white blood cell decreased (0.8%), exanthema (0.8%), and peripheral sensory nerve disorder (0.8%), No Grade 5 TRAE. A total of 9 treatment-related SAEs in 6 patients (54.5%) were observed, including 2 aspartate aminotransferase increased, 2 alanine aminotransferase increased, 1 creatinine increased, 1 liver function injury, 1 adynamia, 1 neutrophils decreased, 1 fever, and 1 ventricular premature beats. All these SAEs recovered after symptomatic treatment.Conclusion:CVL218 combined with PD-1 antibody and chemotherapy appears to be well tolerated and has good preliminary efficacy in TNBC patients.Citation Format:Jian Zhang, Rujiao Liu, Steve Shen. A phase Ib/II study of PARPi Mefuparib Hydrochloride (CVL218) in combination with PD-1 inhibitor plus chemotherapy in metastatic or recurrent triple-negative breast cancer (TNBC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 836.

21 Apr 2025·Cancer Research

Abstract 511: Neratinib monotherapy in advanced non-small cell lung cancer with EGFR exon 18 mutations in China

Author: Wu, Lin ; Liu, Baogang ; Cheng, Ying ; Fang, Wenfeng ; Li, Ning ; Wang, Qiming ; Wang, Haiyong ; Shen, Steve ; Yang, Runxiang

AbstractBackground:In NSCLC patients, EGFR exon 18 mutations account for approximately 3-5% and are associated with a poor prognosis. In phase 2 SUMMIT global trial, 29 metastatic NSCLC patients with EGFR exon 18 mutations received neratinib monotherapy, having good result. The objective response rate (ORR) was 35%. However, only 1 (4.5%) Asian individual is enrolled in study. Therefore, there is an urgent need to explore the effect of neratinib monotherapy in Chinese NSCLC patients with EGFR exon 18 mutation.Methods:Planned 14 patients with EGFR exon 18-mutated NSCLC who had failed first-line standard chemotherapy were enrolled in this study(NCT06029816). The primary endpoint is the ORR by the investigator according to RECISTv1.1 and the secondary endpoints are DCR (Disease Control Rate), PFS (Progression-Free Survival).Results:To date, 7 advanced NSCLC patients with exon 18 mutations after receiving Neratinib treatment following the failure of standard first-line therapy. The ORR is 42.9% (3 PR, 4 SD) and DCR is 100.0%. The common 1-2 grade treatment-related adverse events (AEs) occur in 82% of patients. 28.6% of patients have Diarrhea (CTCAE Grade 2), and that can be managed after loperamide intervention within 3 days. To date, there have been no grade 4- 5 AEs in any of the patients.Conclusion:Neratinib monotherapy has demonstrated tolerable safety and encouraging preliminary efficacy in NSCLC with EGFR exon 18 mutations. This study is expected to provide more treatment options for Chinese patients with NSCLC who have EGFR exon 18 mutations.Citation Format:Wenfeng Fang, Ning Li, Runxiang Yang, Ying Cheng, Baogang Liu, Haiyong Wang, Lin Wu, Qiming Wang, Steve Shen. Neratinib monotherapy in advanced non-small cell lung cancer with EGFR exon 18 mutations in China [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 511.

100 Deals associated with Convalife (Shanghai) Co. Ltd.

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100 Translational Medicine associated with Convalife (Shanghai) Co. Ltd.

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Pipeline

Pipeline Snapshot as of 08 May 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

3

Preclinical

Phase 1 Clinical

2

3

Phase 2 Clinical

Phase 3 Clinical

1

2

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

KA-2237 ( PI3Kβ x PI3Kδ )	Activated PI3K-delta Syndrome More	Phase 3 Clinical
Mefuparib Hydrochloride ( PARP1 x PARP2 )	Breast Cancer More	Phase 2
SHEN-211 ( SARS-CoV-2 3CLpro )	COVID-19 More	Phase 2
Neratinib maleate ( EGFR x HER2 x HER4 )	HER2 Positive Stomach Adenocarcinoma More	Phase 2
CVL-006 ( PDL1 x VEGF )	Advanced Malignant Solid Neoplasm More	Phase 1