Top 5 Target	Count

Trop-2(Tumor-associated calcium signal transducer 2)	2
HER3(Receptor tyrosine-protein kinase erbB-3)	2
DLL3(Delta-like protein 3)	1
JAK1(Tyrosine-protein kinase JAK1)	1
TNF-α(Tumor necrosis factor α)	1

Drugs associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

Hemoporfin

Target-

Mechanism

Photosensitizers

Active Org.

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd. [+1]

Originator Org.

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

Active Indication

Nevus [+1]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date29 Sep 2016

Aminolevulinic Acid Hydrochloride

Target-

Mechanism

Photosensitizers

Active Org.

Sbi Alapharma Canada, Inc. [+15]

Originator Org.

DUSA Pharmaceuticals, Inc.

Active Indication

Carcinoma of urinary bladder, invasive [+25]

Inactive Indication

Onychomycosis [+3]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date03 Dec 1999

Timolol Maleate

Target

β-adrenoceptors

Mechanism

β-adrenoceptors antagonists

Active Org.

Shanghai Auson Pharmaceuticals Co., Ltd. [+8]

Originator Org.

Bausch Health Americas, Inc.

Active Indication

Cataract [+5]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date17 Aug 1978

Clinical Trials associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

NCT05171894 / RecruitingPhase 2

A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose in Subjects with Port-wine Birthmarks Treated with Hemoporfin Photodynamic Therapy

This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWB of face and/or neck area (except subjects for Stage One) will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.

Start Date21 Sep 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

NCT06519370 / RecruitingPhase 3

A Phase 3, Open-label, Randomised Study of FDA018-ADC Versus Investigator's Choice of Chemotherapy in Patients Who Recurred During or After Taxane Therapy in Locally Advanced or Metastatic Triple-negative Breast Cancer

This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent inoperable or metastatic Triple-negative Breast Cancer(TNBC) who are resistant to, or recurring during or after taxane therapy.

Start Date09 Aug 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

CTR20242630 / RecruitingPhase 3

评价FDA018抗体偶联剂对比研究者选择化疗方案在紫杉类治疗失败的局部晚期、复发或转移性三阴性乳腺癌患者中的随机、对照、开放性、多中心Ⅲ期临床研究

[Translation] A randomized, controlled, open-label, multicenter phase III clinical study to evaluate the efficacy of FDA018 antibody conjugate versus investigator-selected chemotherapy in patients with locally advanced, recurrent or metastatic triple-negative breast cancer who have failed taxane therapy

在紫杉类治疗失败的局部晚期、复发或转移性三阴性乳腺癌患者中，主要目的：比较FDA018-ADC与研究者选择化疗方案（ICC）治疗的有效性。次要目的：比较FDA018-ADC与ICC治疗的安全性和耐受性；评估FDA018-ADC的免疫原性；评估FDA018-ADC的药代动力学特征。探索性目的：初步评价肿瘤组织中Trop-2表达水平与FDA018-ADC抗肿瘤疗效的关系。

[Translation]

In patients with locally advanced, recurrent or metastatic triple-negative breast cancer who have failed taxane therapy, the primary objective is to compare the efficacy of FDA018-ADC with investigator-selected chemotherapy (ICC). Secondary objectives are to compare the safety and tolerability of FDA018-ADC with ICC; to evaluate the immunogenicity of FDA018-ADC; and to evaluate the pharmacokinetic characteristics of FDA018-ADC. Exploratory objectives are to preliminarily evaluate the relationship between the expression level of Trop-2 in tumor tissue and the anti-tumor efficacy of FDA018-ADC.

Start Date09 Aug 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

01 Jul 2024·Journal of Chromatography B

A native SEC-MS workflow and validation for analyzing drug-to-antibody ratio and drug load distribution in cysteine-linked antibody-drug conjugates

Article

Author: Wu, Gang ; Fu, Zhihao ; Yu, Chuanfei ; Wang, Junzhi ; Zhang, Yifan ; Wang, Lan ; Yin, Sicheng ; Du, Jialiang

The development and optimization of Antibody-Drug Conjugates (ADCs) hinge on enhanced analytical and bioanalytical characterization, particularly in assessing critical quality attributes (CQAs). The ADC's potency is largely determined by the average number of drugs attached to the monoclonal antibody (mAb), known as the drug-to-antibody ratio (DAR). Furthermore, the drug load distribution (DLD) influences the therapeutic window of the ADC, defining the range of dosages effective in treating diseases without causing toxic effects. Among CQAs, DAR and DLD are vital; their control is essential for ensuring manufacturing consistency and product quality. Typically, hydrophobic interaction chromatography (HIC) or reversed-phase liquid chromatography (RPLC) with UV detector have been used to quantitate DAR and DLD in quality control (QC) environment. Recently, Native size-exclusion chromatography-mass spectrometry (nSEC-MS) proves the potential as a platformable quantitative method for characterizing DAR and DLD across various cysteine-linked ADCs in research or early preclinical development. In this work, we established and assessed a streamlined nSEC-MS workflow with a benchtop LC-MS platform, to quantitatively monitor DAR and DLD of different chemotype and drug load level cysteine-linked ADCs. Moreover, to deploy this workflow in QC environment, complete method validation was conducted in three independent laboratories, adhering to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines. The results met the predefined analytical target profile (ATP) and performance criteria, encompassing specificity/selectivity, accuracy, precision, linearity, range, quantification/detection limit, and robustness. Finally, the method validation design offers a reference for other nSEC-MS methods that are potentially used to determine the DAR and DLD on cysteine-linker ADCs. To the best of our knowledge, this study is the first reported systematic validation of the nSEC-MS method for detecting DAR and DLD. The results indicated that the co-validated nSEC-MS workflow is suitable for DAR and DLD routine analysis in ADC quality control, release, and stability testing.

01 Jun 2024·Journal of Clinical Oncology

Dose escalation and expansion results from the phase I study of F0024, a trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors.

Author: Li, Xiaowen ; Wu, Fan ; Qing, Lihua ; Chen, Lilin ; Liu, Kezhen ; Wang, Jingfen ; Wang, Ying ; Meng, Yanchun ; Sun, Wenyi ; Zhang, Jian ; Chen, Yu ; Qiao, Yaya ; Du, Yiqun

e13131 Background: F0024 is an antibody-drug conjugate (ADC) targeting Trop-2, an intracellular calcium signaling transducer overexpressed on many epithelial tumors, for delivery of SN-38, the active metabolite of irinotecan. We assessed its safety and efficacy in patients with advanced solid tumors, mainly in triple negative breast cancer (TNBC). Methods: PTs with unresectable solid tumors refractory to/relapsed from standard treatment received F0024 on days 1 and 8 of 21-day treatment cycles. Primary objectives include maximum tolerated dose (MTD) identification, safety, and tolerability and secondary objectives include efficacy, pharmacokinetics, and incidence of anti-drug antibodies against F0024. Pts were eligible regardless of TROP2 level. Results: As of October 8, 2023, 62 pts were treated with≥1 dose of F0024. 21 pts were treated during dose escalation at 2.5 (n = 1), 5.0 (n = 3), 7.5 (n = 3), 10 (n = 4), 12 (n = 8), and 15 (n = 2) mg/kg and 41 pts with TNBC were treated in dose expansion at 10.0 (n = 30) and 12.0 (n = 11) mg/kg. 32 pts (51.6%) discontinued (20 (32.2%) due to disease progression per RECIST v1.1). Treatment emergent adverse events (TEAEs) regardless of causality were reported in 61 of 62 pts (98.4%; 34 pts [54.8%] experienced ≥grade 3, 9 pts [14.5%] had serious adverse events). Treatment related adverse events (TRAEs) were reported in 61 of 62 pts (98.4%; 32 pts [51.6%] experienced ≥grade 3, 4 pts [6.5%] had serious adverse events). The most common grade 3 TRAE were neutropenia (45.2%), leukopenia (33.9%), febrile neutropenia (4.8%), anemia (4.8%), and maculo-papular rash (4.8%). A total of 17 responses have been observed at the dose of 5.0 mg/kg or greater. 34 TNBC pts were dosed at 10 and 19 were dosed at 12 mg/kg with exposure to a median of 11.5 (1.0-26.0) and 4.0 (1.0-21.0) doses. 11 partial responses were achieved in 29 efficacy-evaluable TNBC pts at 10 mg/kg leading to an overall response rate (ORR) of 37.9% (95% CI 20.7% - 57.7%). The disease control rate of 10 mg/kg is 79.3% (95% CI 60.3%-92.0%). 5 escalation pts and 25 expansion pts remain on trial. Updated trial details/results will be presented. Conclusions: In this first-in-human study of F0024, treatment was generally well tolerated and MTD was not yet reached up to 12 mg/kg. F0024 demonstrated encouraging preliminary antitumor activity in heavily pretreated TNBC pts, especially in 10 and 12 mg/kg. Clinical trial information: NCT05174637 .

01 Mar 2021·Journal of the American Academy of DermatologyQ1 · MEDICINE

5-Aminolevulinic photodynamic therapy versus carbon dioxide laser therapy for small genital warts: A multicenter, randomized, open-label trial

Q1 · MEDICINE

Letter

Author: Zhang, Haiyan ; Gu, Heng ; Tu, Ping ; Wang, Xiuli ; Zheng, Heyi ; Zhu, Xuejun ; Tao, Jining ; Xu, Jinhua ; Wang, Hongwei

5-Aminolevulinic acid photodynamic therapy (ALA-PDT) has been reported as a better treatment of genital warts than carbon dioxide laser therapy (CO₂-LT) for atraumatic and low recurrence rates of ALA-PDT.However, most of the reports were based on clin. trials within a single center and with relatively small sample sizes.In this study, a multicenter, randomized, open-label trial was designed to evaluate the efficacy, recurrence rates, and the safety of ALA-PDT vs. CO₂-LT in patients with genital warts.After the first and second treatments, the clearance rate of the ALA-PDT group was significantly lower than that of the CO₂-LT group (P < .05). However, 1 wk after the last treatment, there was no significant difference in the clearance rates, which were 98.42% (497/505) in the ALA-PDT group and 100% (195/195) in the CO₂-LT group (P > .05). Overall, 325 and 111 patients were completely cured in the ALA-PDT and CO2-LT groups.No severe adverse events or systemic adverse effects were observed in either group. All patients in the ALA-PDT group experienced varying degrees of discomfort, but it was better tolerated than CO₂-LT (P <.05).In addition, the researchers and patients overall evaluations of the efficacy and safety were better in the ALA-PDT group than that in the CO₂-LT group.ALA-PDT has similar efficacy but lower recurrence rates compared with those of CO₂- LT for the treatment of genital warts. Because the treatment was better tolerated and caused no scars or urethral strictures, the results of this study have led to its adoption as one of many recommended treatments in China.

100 Deals associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

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

Preclinical

IND Approval

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Hemoporfin	Nevus More	Approved
Aminolevulinic Acid Hydrochloride	Condylomata Acuminata More	Approved
FDA018 Antibody Drug Conjugate(Shanghai Fudan Zhangjiang Bio Pharmaceutical) ( TOP1 x Trop-2 )	Triple Negative Breast Cancer More	Phase 3
Recombinant anti-VEGF humanized monoclonal antibody(Shanghai Fudan Zhangjiang Bio Pharmaceutical Co. Ltd.) ( VEGF )	-	Phase 3
FDA022 ( HER2 x TOP1 )	Advanced Malignant Solid Neoplasm More	Phase 2

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