A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Start Date01 Nov 2024

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

NCT06522828 / RecruitingPhase 2

A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients

This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.

Start Date10 Oct 2024

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

NCT06554847 / RecruitingPhase 3

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Start Date23 Sep 2024

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

100 Clinical Results associated with Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

0 Patents (Medical) associated with Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Literatures (Medical) associated with Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

28 Jun 2024·British Journal of Dermatology

P085 Efficacy and safety of 611 for the treatment of moderate-to-severe atopic dermatitis in adults

Author: Xu, Yuyu ; Zhou, Qinghong ; Zhao, Yan ; Zhang, Jianzhong

AbstractAtopic dermatitis (AD) is a chronic, recurring, inflammatory skin disease characterized by extensive rashes on the body, leading to symptoms such as persistent itching and exudation. There is still a need for safe and effective therapies to improve disease management for uncontrolled moderate-to-severe AD, as current treatments may not adequately control the disease. 611 is a novel monoclonal antibody that targets interleukin (IL)-4Rα. It can selectively bind to IL-4Rα, thereby obstructing the signalling pathways of both IL-4 and IL-13. This action aids in modulating immune function, offering potential relief for conditions such as AD and other related diseases. In this phase II study, the safety and efficacy of 611 was investigated in moderate-to-severe AD in adult patients. In total 93 patients were randomly assigned to three groups: group A received a loading dose of 600 mg of 611 followed by 300 mg every 2 weeks (Q2W), group B received a loading dose of 600 mg of 611 followed by 300 mg every 4 weeks (Q4W), and there was also a placebo group. The primary efficacy endpoint was the proportion of patients with Eczema Area and Severity Index (EASI) 75 response (≥ 75% reduction in score from baseline) at week 16. The results showed positive responses in primary and all secondary endpoints in adult patients with moderate-to-severe AD after treatment with 611. There was a significant difference between 611 and placebo in EASI 75 improvement, with a 60.0% response rate for 611 compared with 15.6% for placebo (P < 0.001). The percentage of patients achieving IGA 0/1 (Investigator’s Global Assessment score of 0 or 1, and ≥ 2-point reduction from baseline) also exhibited a significant difference in the groups receiving 611 or placebo, with rates of 35.5% and 9.4%, respectively (P < 0.05). The other endpoints, including EASI 90, EASI 50, and numerical rating scale reduction by ≥ 4 points, improved more in the groups receiving 611 than for placebo. Regarding safety data in the trial, treatment with 611 showed results comparable with placebo. 611 showed a positive effect in treatment of patients with moderate-to-severe AD in terms of efficacy and safety. 611 has potentially become a promising treatment product targeting IL-4Rα, following on from dupilumab.

15 Jul 2009·Clinical Cancer ResearchQ1 · MEDICINE

Targeted Delivery of Tumor Antigens to Activated Dendritic Cells via CD11c Molecules Induces Potent Antitumor Immunity in Mice

Q1 · MEDICINE

Article

Author: Wang, Suhui ; He, Jinqiu ; Guo, Huaizu ; Li, Bohua ; Hou, Sheng ; Wei, Huafeng ; Qian, Weizhu ; Wang, Hao ; Zhang, Dapeng ; Kou, Geng ; Guo, Yajun

AbstractPurpose: CD11c is an antigen receptor predominantly expressed on dendritic cells (DC), to which antigen targeting has been shown to induce robust antigen-specific immune responses. To facilitate targeted delivery of tumor antigens to DCs, we generated fusion proteins consisting of the extracellular domain of human HER or its rat homologue neu, fused to the single-chain fragment variable specific for CD11c (scFvCD11c-HER2/neu).Experimental Design: Induction of cellular and humoral immune responses and antitumoral activity of the fusion proteins admixed with DC-activating CpG oligonucleotides (scFvCD11c-HER2/neuCpG) were tested in transplantable HER2/neu-expressing murine tumor models and in transgenic BALB-neuT mice developing spontaneous neu-driven mammary carcinomas.Results: Vaccination of BALB/c mice with scFvCD11c-HER2CpG protected mice from subsequent challenge with HER2-positive, but not HER2-negative, murine breast tumor cells, accompanied by induction of strong HER2-specific T-cell and antibody responses. In a therapeutic setting, injection of scFvCD11c-HER2CpG caused rejection of established HER2-positive tumors. Importantly, antitumoral activity of such a fusion protein vaccine could be reproduced in immunotolerant BALB-neuT mice, where scFvCD11c-neuCpG vaccination significantly protected against a subsequent challenge with neu-expressing murine breast tumor cells and markedly delayed the onset of spontaneous mammary carcinomas.Conclusions: CD11c-targeted protein vaccines for in vivo delivery of tumor antigens to DCs induce potent immune responses and antitumoral activities and provide a rationale for further development of this approach for cancer immunotherapy.

01 Feb 2009·Clinical Cancer ResearchQ1 · MEDICINE

Genetically Targeted T Cells Eradicate Established Breast Cancer in Syngeneic Mice

Q1 · MEDICINE

Article

Author: Li, Bohua ; Qian, Weizhu ; Dai, Jianxin ; Zhang, Dapeng ; Kou, Gen ; Hou, Sheng ; Guo, Yajun ; Wang, Hao ; Wei, Huafeng ; Zhang, Ruiping

AbstractPurpose: The purpose of the present study was to evaluate the capacity and mechanisms of genetically modified erbB2-specific T cells to eradicate erbB2+ tumors in syngeneic mice.Experimental Design: Primary mouse T cells were modified to target the breast tumor–associated antigen erbB2 through retroviral-mediated transfer of a chimeric antigen receptor, termed single-chain antibody (scFv)–CD28–ζ. Antitumor efficacy of scFv-CD28-ζ–modified T cells was analyzed in mice bearing D2F2/E2 breast tumors.Results: The scFv-CD28-ζ–modified T cells were shown to specifically secrete T cytotoxic-1 cytokines and lyse erbB2+ breast tumor cells following receptor stimulation in vitro. Treatment with scFv-CD28-ζ–modified T cells was able to lead to long-term, tumor-free survival in mice bearing erbB2+ D2F2/E2 breast tumors. Importantly, the surviving mice developed a host memory response to D2F2/E2 tumor cells, and this host response was able to protect against a rechallenge with erbB2+ D2F2/E2 tumor cells and parental erbB2- D2F2 tumor cells. In addition, scFv-CD28-ζ T-cell expression of perforin and interferon-γ were essential for complete antitumor efficacy.Conclusions: Treatment with scFv-CD28-ζ–modified T cells was able to induce a host antitumor immunity in syngeneic mice. Complete tumor elimination by scFv-CD28-ζ–modified T cells required T cell–derived interferon-γ and perforin, indicating that cytotoxicity and cytokine secretion play a role in the in vivo response.

News (Medical) associated with Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

15 May 2024

·www.pharmaceutical-technology.com

University of Nottingham develops 3D-printed medication method

The interior structure of the tablet is intricately designed to time the dosage release precisely. Credit: The University of Nottingham. The University of Nottingham in the UK has announced the development of a new method enabling the creation of 3D-printed personalised pills. The innovative technology has been developed by scientists from the university’s Centre for Additive Manufacturing and its Schools of Pharmacy and Life Sciences. The technique utilises multi-material inkjet 3D printing to produce tablets with personalised drug release profiles, which can release drugs at a controlled rate. It leverages a unique ink formulation based on molecules sensitive to ultraviolet light. Upon printing, these molecules form a water-soluble structure. The interior structure of the tablet is intricately designed to time the dosage release precisely. See Also: SSGJ-707 by Dansheng Medical Technology (Shanghai) for Squamous Non-Small Cell Lung Cancer: Likelihood of Approval SSGJ-707 by Dansheng Medical Technology (Shanghai) for Non-Small Cell Lung Cancer: Likelihood of Approval Assistant Professor Dr Yinfeng He of the University of Nottingham’s Faculty of Engineering’s Centre for Additive Manufacturing stated: “This is an exciting step forward in the development of personalised medication. “This breakthrough not only highlights the potential of 3D printing in revolutionising drug delivery but also opens up new avenues for the development of next-generation personalised medicines.” The advancement is significant as it prints multiple drugs into a single tablet, streamlining complex medication regimens into one dose. This approach could be advantageous for developing medications that require timed drug release – critical for treating certain diseases. The potential for scalability of the approach was demonstrated by the ability to print 56 pills in a single batch. Professor Felicity Rose of the University of Nottingham’s School of Pharmacy stated: “The future of prescribed medication lies in a personalised approach. We know that up to 50% of people in the UK alone don’t take their medicines correctly and this has an impact on poorer health outcomes with conditions not being controlled or properly treated. “A single pill approach would simplify taking multiple medications at different times and this research is an exciting step towards that.”

09 Mar 2021

·www.globenewswire.com

Los Angeles, USA , March 09, 2021 (GLOBE NEWSWIRE) -- Age-related Macular Degeneration Pipeline Analysis of 70+ Key Companies and 70+ Key Therapeutic Products DelveInsight anticipates the launch of ABP 938, KSI-301, OPT-302, and RGX-314 in the Age-related Macular Degeneration Pipeline as the most promising therapies. DelveInsight’s Age-related Macular Degeneration (AMD) Pipeline Insights report provides a comprehensive outlook of the pipeline therapies that are in different clinical and preclinical stages of development, their launch, and how the market is expected to transform in the aftermath across the AMD domain. The AMD Pipeline Analysis report offers a 360° view of the therapeutics landscape by development stage, product type, route of administration, molecule type, and MOA for Age-related Macular Degeneration emerging therapies. The Age-related Macular Degeneration Pipeline report lays down the business opportunities, threats, prospective collaborations, strong competitors, and growth strategies. Some of the key takeaways from the Age-related Macular Degeneration Pipeline report: Request for Sample @ Age-related Macular Degeneration Pipeline Insights Age-related Macular Degeneration is a condition that impairs a small central area, macula, located at the center of the retina. It affects a person's central vision due to the formation of distorted, dark spots that gradually progress, thus, affecting the tasks like reading, and diving. Genetic mutations in- and around several complement gene systems, including the CFH gene, contribute to the risk of developing AMD. Further, changes on the long (q) arm of chromosome 10 in a region known as 10q26 are also associated with an increased risk of Age-related Macular Degeneration. Reach out for rich pipeline insights @ Age-related Macular Degeneration Drug Pipeline Age-related Macular Degeneration Drug Profiles KSI 301: Kodiak Sciences KSI 301 is an antibody biopolymer conjugate for the treatment of retinal vascular diseases. It is a novel anti-VEGF biologic designed to rapidly inhibit VEGF and provide extended durability of action to reduce the burden of frequent anti-VEGF injections. Kodiak Sciences is currently evaluating KSI 301 in Phase II/ III trial to evaluate its efficacy and safety versus Aflibercept in patients with Neovascular (Wet) Age-Related Macular Degeneration. Kodiak Sciences initiated a randomized, double-masked, active comparator-controlled, multi-center study (NCT04049266) to investigate the efficacy and safety of repeated intravitreal administration of KSI-301 in subjects with Neovascular (Wet) Age-related Macular Degeneration. For more information on drug profiles, visit Age-related Macular Degeneration Emerging Therapies Key Age-related Macular Degeneration Pipeline Age-related Macular Degeneration Therapeutic Assessment By Product Type By Stage By Route of Administration By Molecule Type By Mechanism of Action By Targets By Stage and Molecule TypeBy Stage and Route of AdministrationBy Stage and Product Type Dive deeper into Age-related Macular Degeneration Therapeutic Assessment Scope of the Report Coverage: GlobalKey Players: Amgen, Roche, Adverum Biotechnologies, AsclepiX Therapeutics, Bioeq/Formycon, Sinocelltech, RemeGen, Alkahest, Kyowa Kirin, EyePoint Pharmaceutical, IVERIC bio, Kodiak Sciences, Ribomic USA Inc, Sunshine Guojian Pharmaceutical (Shanghai), Lineage Cell Therapeutics, Graybug Vision, Sinocelltech, Luxa Biotechnology, CHABiotech, Shanghai Henlius Biotech, Bio-Thera Solutions, Alteogen, Samsung Bioepis, Outlook Therapeutics, Unity Biotechnology, Stealth BioTherapeutics, AiViva BioPharma, Ocular Therapeutix, AO GENERIUM, Gyroscope Therapeutics, Ionis Pharmaceuticals, Aerie Pharmaceuticals, Outlook Therapeutics, and several others. Key AMD Pipeline Therapies: Aflibercept biosimilar, Faricimab, ADVM 022, AXT 107, Ranibizumab biosimilar, SCT510A, RC 28 E, ALK4290, KHK4951, EYP-1901, Zimura, RBM-007 Injectable Solution, Drug 601, OpRegen, KSI 301, ABP 938, ADVM-022, SCT510A, GB-102, RPESC-RPE-4W, MA09-hRPE, SCD411, HLX04-O, BAT5906, LY09004, ASP7317 among others. Key Questions Answered Got queries? Reach out to us @ Age-related Macular Degeneration Drug Pipeline Table of Contents Related Reports Age-Related Macular Degeneration MarketDelveInsight's "Age-Related Macular Degeneration - Market Insights, Epidemiology, and Market Forecast-2030" report. Dry Age Macular Degeneration MarketDelveInsight's "Dry Age Macular Degeneration Market Insights, Epidemiology, and Market Forecast-2030" report Wet Age-Related Macular Degeneration MarketDelveInsight's "Wet Age-Related Macular Degeneration (Wet AMD) Market Insights, Epidemiology, and Market Forecast-2030" report. Vernal Keratoconjunctivitis MarketDelveInsight's "Vernal keratoconjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report. Allergic Conjunctivitis MarketDelveInsight's "Allergic Conjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report Allergic Rhino-Conjunctivitis MarketDelveInsight's "Allergic Rhino-Conjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report. Anterior Uveitis MarketDelveInsight's "Anterior Uveitis Market Insights, Epidemiology, and Market Forecast-2030" report. Bacterial Conjunctivitis MarketDelveInsight's "Bacterial Conjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report. Blepharitis MarketDelveInsight's "Blepharitis Market Insights, Epidemiology, and Market Forecast-2030" report. Central Retinal Vein Occlusion MarketDelveInsight's "Central Retinal Vein Occlusion Market Insights, Epidemiology, and Market Forecast-2030" report. Central Serous Chorioretinopathy MarketDelveInsight's "Central Serous Chorioretinopathy Market Insights, Epidemiology, and Market Forecast-2030" report. Choroidal Neovascularization MarketDelveInsight's "Choroidal Neovascularization Market Insights, Epidemiology, and Market Forecast-2030" report. Corneal Endothelial Dystrophy MarketDelveInsight’s ‘Corneal Endothelial Dystrophy (CED) Market Insights, Epidemiology, and Market Forecast—2030’ report. Diabetic Retinopathy MarketDelveInsight’s ‘Diabetic Retinopathy (DR) Market Insights, Epidemiology, and Market Forecast—2030’ report. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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100 Deals associated with Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 27 Dec 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

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IND Approval

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Phase 2 Clinical

Phase 3 Clinical

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Inetetamab ( HER2 )	Breast Cancer More	Approved
Etanercept biosimilar(Cipla Ltd.) ( LTα x TNF-α )	Ankylosing Spondylitis More	Approved
Recombinant humanized anti-CD25 monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.) ( IL2RA )	Renal transplant rejection More	Approved
Recombinant human interleukin-11(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.) ( IL-11RA )	Thrombocytopenia More	Approved
Recombinant anti-IL-4Rα humanized monoclonal antibody (Sunshine Guojian) ( IL-4Rα )	Chronic rhinosinusitis with nasal polyps More	Phase 3

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