Shanghai Affinity Biopharmaceutical Co.,Ltd. is a subsidiary of Yafei (Shanghai) Biomedical Technology Co., Ltd. and is based in China. The company specializes in the production of pharmaceuticals used in the treatment of cancer.

Tags

Neoplasms

Digestive System Disorders

Skin and Musculoskeletal Diseases

Small molecule-drug conjugates

Antibody drug conjugate (ADC)

Bispecific T-cell Engager (BiTE)

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	32
Nervous System Diseases	2
Endocrinology and Metabolic Disease	2
Infectious Diseases	1
Immune System Diseases	1
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Small molecule-drug conjugates	11
Antibody drug conjugate (ADC)	9
Bispecific T-cell Engager (BiTE)	4
Dual payload Antibody drug conjugate (Dual payload ADC)	3
Probody	1

Top 5 Target	Count

PDL1(Programmed death-ligand 1)	2
CD276(CD276 antigen)	2
EGFR x TLR7 x TLR8 x Trop-2	1
FGFs x VEGF	1
CD3 x CLDN6	1

Drugs associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

Dexamethasone

Target

Mechanism

GR agonists

Active Org.

Janssen Research & Development LLC [+36]

Originator Org.

Merck & Co., Inc.

Active Indication

Immunoglobulin Light-Chain Amyloidosis [+72]

Inactive Indication

Acute otitis externa [+62]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date30 Oct 1958

Legubicin

Target

DNA x Top II

Mechanism

DNA intercalators [+1]

Active Org.

Shanghai Affinity Biopharmaceutical Co., Ltd.

Originator Org.

Shanghai Affinity Biopharmaceutical Co., Ltd.

Active Indication

Soft Tissue Sarcoma [+11]

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

Legutaxel

Target

Tubulin

Mechanism

Tubulin inhibitors

Active Org.

Shanghai Affinity Biopharmaceutical Co., Ltd.

Originator Org.

Shanghai Affinity Biopharmaceutical Co., Ltd.

Active Indication

Advanced Malignant Solid Neoplasm [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

CTR20250876

/ Not yet recruitingPhase 1/2

评价注射用莱古比星联合纳武利尤单抗在晚期或转移性非小细胞肺癌患者中的安全性、耐受性、药代动力学特征以及初步疗效的开放、剂量递增及扩展的Ib/II期临床研究

[Translation] An open-label, dose-escalation, and expanded phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of legubicin for injection combined with nivolumab in patients with advanced or metastatic non-small cell lung cancer

[Translation]

An open-label, dose-escalation, and expanded phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of legubicin for injection combined with nivolumab in patients with advanced or metastatic non-small cell lung cancer

Start Date-

Sponsor / Collaborator

Shanghai Affinity Biopharmaceutical Co., Ltd.

CTR20212527

/ Active, not recruitingPhase 2

评价注射用莱古比星在晚期软组织肉瘤患者中的安全性和有效性的多中心、随机、双盲、阳性药对照的Ⅱ/Ⅲ期临床研究

[Translation] A multicenter, randomized, double-blind, active-controlled phase II/III clinical study to evaluate the safety and efficacy of legubicin for injection in patients with advanced soft tissue sarcoma

主要目的：评估注射用莱古比星治疗晚期软组织肉瘤受试者的有效性是否非劣/优效于注射用盐酸多柔比星；评估注射用莱古比星治疗晚期软组织肉瘤受试者的心脏毒性是否低于注射用盐酸多柔比星。次要目的：评价注射用莱古比星在晚期软组织肉瘤受试者中的客观缓解率（ORR）、总生存期（OS）、疾病控制率（DCR）；评价注射用莱古比星在晚期软组织肉瘤受试者中的安全性。

[Translation]

Primary objectives: To evaluate whether the effectiveness of Legubicin for Injection in treating subjects with advanced soft tissue sarcoma is non-inferior/superior to Doxorubicin Hydrochloride for Injection; To evaluate whether the cardiotoxicity of Legubicin for Injection in treating subjects with advanced soft tissue sarcoma is lower than that of Doxorubicin Hydrochloride for Injection. Secondary objectives: To evaluate the objective response rate (ORR), overall survival (OS), and disease control rate (DCR) of Legubicin for Injection in subjects with advanced soft tissue sarcoma; To evaluate the safety of Legubicin for Injection in subjects with advanced soft tissue sarcoma.

Start Date11 Feb 2022

Sponsor / Collaborator

Shanghai Affinity Biopharmaceutical Co., Ltd.

CTR20192606

/ RecruitingPhase 1

评价注射用莱古比星治疗晚期恶性实体瘤患者的安全性、耐受性、药代动力学特征以及初步疗效的Ⅰ期临床试验

[Translation] A phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Legubicin for injection in the treatment of patients with advanced malignant solid tumors

主要目的：评价注射用莱古比星单药在标准治疗失败的晚期恶性实体瘤患者中的安全性和耐受性，并探索注射用莱古比星的最大耐受剂量（MTD），确定II期临床试验推荐剂量（RP2D）。次要目的： 1）评价注射用莱古比星的药代动力学（PK）特征； 2）初步评价注射用莱古比星的抗肿瘤疗效。 3）探索注射用莱古比星的药效学指标。

[Translation]

Primary objective: To evaluate the safety and tolerability of Legubicin for Injection as a single agent in patients with advanced malignant solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of Legubicin for Injection and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of Legubicin for Injection; 2) To preliminarily evaluate the anti-tumor efficacy of Legubicin for Injection. 3) To explore the pharmacodynamic indicators of Legubicin for Injection.

Start Date14 May 2020

Sponsor / Collaborator

Shanghai Affinity Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

Literatures (Medical) associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

21 Apr 2025·Cancer Research

Abstract 6024: A novel chemical conjugated anti-CTLA-4 antibody with tumor microenvironment activation

Author: Liu, Yuan ; He, Ying ; Liu, Cheng ; Ding, Chengli

AbstractAnti-CTLA-4 antibody is considered the “forefront” of immune checkpoint inhibitors as it plays a critical role in preventing CTLA-4 mediated inhibitory signals that downregulate T-cell immune responses, and functioning early at the initial phase of naive T-cell activation. However, CTLA-4 is not a tumor associated antigen and it’s expressed in a variety of normal tissues such as lymph nodes, tonsil and lung, therefore anti-CTLA-4 antibody can trigger severe on-target, off-tumor toxicities and immune-related adverse events (irAEs), substantially restricting its clinical applications and potential. IMD-303 is a novel Tumor MicroEnvironment Activated Antibody (TMEAbody) engineered through chemical conjugation of a legumain-activated chemical linker together with a 20kDa masking group at the variable region. The activating protease, legumain (AEP), is a tumor-specific, acid endopeptidase with tumor site over-expression and a strict specificity for one particular amino acid (Asn), making it a first-in-class, highly specific and pan-solid tumor target in novel drug design. Through screening of TME-activated linkers, glycosylation and masking structures, IMD-303 TMEAbody is inert in circulation as its binding to T cells is blocked in normal tissues, ensuring minimal immunogenicity and systemic toxicities; when entering the Tumor MicroEnvironment (TME), IMD-303 becomes rapidly activated and unmasked by legumain, effectively stimulating CD8+ T-cell proliferation and depleting Treg cells by antibody-dependent cellular cytotoxicity (ADCC). Preclinical pharmacological studies showed that the unmasked IMD-303 exhibited strong binding to CTLA-4, efficiently blocking its interaction with CD80/CD86 in the TME, and high affinity to CD16a, CD32a, and CD64 Fc receptors, enhancing ADCC/ADCP effector functions of Treg depletion locally within the TME. And IMD-303 with masking has greatly improved the safety profile due to the fact that it reduced binding to CTLA-4, CD16a, CD32b (FcγRIIb), and C1q far more than that of CD32a and CD64 in circulation. In animal models, IMD-303 demonstrated strong anti-tumor activities as single agent in multiple syngeneic murine tumor models, and it displayed significant synergistic effects when combined with IMD101 (a TMEA-Cytokine releasing IL-2) in EMT6 tumor model, in which IMD-303 can eliminate the number of Treg cells in tumors that are slightly up-regulated by IMD101. Preclinical toxicology studies showed that the favorable safety profile of IMD-303 allows for continued treatment with repeated dosing, and it’s well-tolerated with a weekly repeated regimen of 200mg/kg in cynomolgus monkeys. All these findings indicate that IMD-303, with its preferential activation within tumors, exhibits superior efficacy and safety performances and has the potential to successfully transform the cold tumor microenvironment which lacks T-cell infiltration and immune responses.Citation Format:Cheng Liu, Yuan Liu, Chengli Ding, Ying He. A novel chemical conjugated anti-CTLA-4 antibody with tumor microenvironment activation [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 6024.

21 Apr 2025·Cancer Research

Abstract 1805: Dual-payload TME-activated ADC platform

Author: Liu, Yuan ; Liu, Cheng ; Zhang, Rui

AbstractThe combination of Antibody-Drug Conjugates (ADCs) and Immuno-Oncology (IO) agents is regarded as one of the most exciting and promising trends in the rapidly evolving field of cancer treatment. Affinity Biopharma has developed the Tumor MicroEnviroment Activated (TMEA) platform, with proprietary TMEA linkers applicable in both Small Molecule Drug Conjugates (SMDCs), ADCs and dual-payload ADCs. The TMEA linkers could achieve extracellular activation of payloads in the Tumor MicroEnviroment (TME) by a tumor-specific protease Legumain (AEP), which is an acid endopeptidase with tumor site over-expression and a strict specificity for one particular amino acid (Asn), making it a first-in-class, highly specific and pan-solid tumor target in novel drug design. Compared to GGFG linkers cleaved by lysosomal enzymes such as cathepsins B and L, the TMEA linkers exhibited superior stability in human plasma at 37°C, and demonstrated higher cleavage efficiency under identical condition in tumor homogenates (pH=6.5), generating a remarkably clean cleavage profile with minimal to no inactive intermediates. Such advantageous characteristics of TMEA linkers could be supported by a TMEA-SMDC drug Legubicin in clinical trial that releases payload Doxorubicin. For dual-payload TMEA-ADCs, each hydrophilic TMEA linker is paired with two insoluble payloads such as TLR7/8 agonists and topoisomerase I inhibitors, which show similar maximum tolerated doses (MTD) in mice as linker-single-payload. Dual-payload TMEA-ADCs have effectively addressed the CMC challenges and enabled homogenous formation of 8-DAR dual-payload design. In various PBMCs-CDX models, dual-payload TMEA-ADCs such as IMD526 (HER2-ADC), IMD2126 (PD-L1-ADC) and IMD2113 (EGFR&TROP2-ADC) have displayed significant dose-dependent antitumor activities and induced complete tumor regressions with no observable toxicities. Compared to mono- or combo treatments with single-payload ADCs, IMD526 validated its superiority in the in-vivo CT26-HER+ syngeneic mouse model, and long-term elimination of detectable tumors was achieved with IMD526 both alone and combined with IMD101 (a TMEA-Cytokine releasing IL-2). In tumor re-challenge studies, mice that were cured exhibited immune memory and were resistant to tumor re-implantation. In non-human primate (NHP) studies, dual-payload TMEA-ADCs showed excellent stability in circulation and a strong safety profile, indicating a greatly expanded therapeutic window. And different from the tumor cell endocytosis activation by GGFG-DXd ADCs, the bio-distribution of TMEA-ADCs resulted in faster and higher levels of payload accumulation in the tumor local tissues. In summary, by integrating antibody targeting, TME activation, cytotoxic therapy, and I/O therapy into one single molecule, the dual-payload TMEA-ADCs has demonstrated the synergistic effects of ADCs conjugated with 16 insoluble payloads from 2 distinct mechanisms of action in tumor models.Citation Format:Cheng Liu, Yuan Liu, Rui Zhang. Dual-payload TME-activated ADC platform [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 1805.

01 Dec 2022·iScience

High-level of intratumoral GITR+ CD4 T cells associate with poor prognosis in gastric cancer

Article

Author: Xie, Feng ; Zhu, Chunchao ; Wang, Zeyu ; Guo, Yixian ; Li, Bin ; Zhao, Wenyi ; Yu, Fengrong ; Xu, Danhua ; Chen, Jieqiong ; Ke, Shouyu ; Xia, Xiang ; Geng, Haigang ; Liu, Xu ; Zhang, Zizhen ; Zhao, Gang ; Yu, Yimeng

Immunotherapy targeting glucocorticoid-induced TNFR-related protein (GITR) exhibited strong anti-tumor capacity in mouse model but poor efficacy in clinical trials. This may be attributed to the different GITR expression mode between human and mouse. In this study, we analyzed single-cell RNA sequencing (scRNA-seq) data of human gastric cancer (GC) and used flow to explore the GITR expression across T cell subsets and tissue types in GC patients. We revealed that GITR+ CD4 T cells, including regulatory CD4 T (Treg) cells and conventional CD4 T (Tconv) cells, might contribute to the immunosuppressive microenvironment in GC. The enrichment of these cells was associated with a worse prognosis. Moreover, we found the cellular distribution of GITR protein in Treg cells was microenvironment dependent. In conclusion, GITR is still an important immune checkpoint need to be studied.

100 Deals associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

100 Translational Medicine associated with Shanghai Affinity Biopharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 17 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

Preclinical

IND Application

Phase 1 Clinical

Phase 3 Clinical

NDA/BLA

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Dexamethasone ( GR )	-	NDA/BLA
Legubicin ( DNA x Top II )	Soft Tissue Sarcoma More	Phase 3
IMD-101 ( IL-2 )	Bladder Cancer More	Phase 1
Legutaxel ( Tubulin )	Advanced Malignant Solid Neoplasm More	Phase 1
QHL-339 ( DNA )	Solid tumor More	IND Application

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