Delving into the Latest Updates on Shanghai Affinity Biopharmaceutical Co., Ltd. with Synapse

Overview

Basic Info

Introduction

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

Urogenital Diseases

Respiratory Diseases

Small molecule-drug conjugates

Dual payload Antibody drug conjugate (Dual payload ADC)

Small molecule drug

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	22
Endocrinology and Metabolic Disease	4
Nervous System Diseases	2
Hemic and Lymphatic Diseases	1
Immune System Diseases	1
Infectious Diseases	1

Top 5 Drug Type	Count

Dual payload Antibody drug conjugate (Dual payload ADC)	5
Small molecule-drug conjugates	5
Small molecule drug	3
Antibody drug conjugate (ADC)	2
T cell engagers (TCE)	2

Top 5 Target	Count

CD47(Cluster of differentiation 47)	1
STING(Stimulator of interferon genes)	1
CDK4 x CDK6	1
PD-1(Programmed cell death protein 1)	1
CD3 x CLDN6	1

主要目标：1）评估IMD303在晚期恶性实体瘤受试者中的安全性和耐受性；2）确定最大可耐受剂量及推荐的II期研究剂量（RP2D）次要目标：1）描述IMD303（含CTLA-4抗体）的药代动力学（PK）特性；2）初步评估IMD303的抗肿瘤疗效；3）初步评估IMD303在晚期恶性实体瘤受试者中免疫原性的变化。

[Translation]

Primary objectives: 1) Evaluate the safety and tolerability of IMD303 in subjects with advanced malignant solid tumors; 2) Determine the maximum tolerated dose and recommended Phase II dose (RP2D). Secondary objectives: 1) Characterize the pharmacokinetic (PK) properties of IMD303 (a CTLA-4 antibody); 2) Preliminarily assess the anti-tumor efficacy of IMD303; and 3) Preliminarily evaluate the changes in the immunogenicity of IMD303 in subjects with advanced malignant solid tumors.

Start Date09 Feb 2026

Sponsor / Collaborator

Affinity (Chengdu) Pharmaceutical Co., Ltd.

ChiCTR2500105421

/ Not yet recruitingPhase 1/2IIT

A multicenter, open-label Ib/IIa phase clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of legobisone for injection in combination therapy in patients with advanced ovarian cancer and in patients with advanced recurrent/refractory choriocarcinoma treated with a single drug.

Start Date07 Apr 2025

Sponsor / Collaborator

Wuhan Xiehe Hospital Tower

[+1]

CTR20212527

/ CompletedPhase 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.

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

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

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

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

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Pipeline

Pipeline Snapshot as of 06 Nov 2026

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

11

Preclinical

IND Application

5

2

IND Approval

Phase 1

2

1

Phase 2

Phase 3

1

NDA/BLA

Other

38

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Legubicin ( DNA x Top II )	Soft Tissue Sarcoma More	Phase 3
Legutaxel ( Tubulin )	Advanced Malignant Solid Neoplasm More	Phase 1
IMD-101 ( IL-2 )	Solid tumor More	Phase 1
IMD303 ( CTLA4 )	Advanced Malignant Solid Neoplasm More	Phase 1
QHL-1231 ( AXL x VEGF x c-Met )	Advanced Malignant Solid Neoplasm More	IND Approval