Suzhou Zelgen Biopharmaceuticals Co., Ltd. is dedicated to the independent research and development, production, and commercialization of innovative drugs. Zelgen Biopharmaceuticals, with its rich experience and professional knowledge in new drug development, has successfully established two core technology platforms, namely the research and development and industrialization platform for small molecule drugs, and the research and development and industrialization platform for complex recombinant protein new drugs and antibody new drugs. Relying on these two technology platforms, the company has developed a rich product pipeline of small molecule new drugs and recombinant protein new drugs, covering various cancers and blood tumors such as liver cancer, non-small cell lung cancer, colorectal cancer, thyroid cancer, nasopharyngeal cancer, myeloproliferative neoplasms, as well as multiple therapeutic areas such as hemorrhage, immunoinflammatory diseases, and hepatobiliary diseases.

Tags

Neoplasms

Digestive System Disorders

Other Diseases

Bispecific antibody

Small molecule drug

Monoclonal 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	20
Endocrinology and Metabolic Disease	3
Hemic and Lymphatic Diseases	3
Immune System Diseases	2
Infectious Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Bispecific antibody	9
Small molecule drug	6
Monoclonal antibody	2
Antibody fusion proteins	1
Fusion protein	1

Top 5 Target	Count

TGF-β x VEGF	2
TLR8(Toll like receptor 8)	1
CRAF x PDGFR x VEGFR	1
thrombin(Factor IIa)	1
LRRC15(Leucine-rich repeat-containing protein 15)	1

Drugs associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Recombinant human thrombin (Zelgen Biopharma)

Target

prothrombin

Mechanism

prothrombin modulators [+1]

Active Org.

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Originator Org.

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Active Indication

Hemorrhage

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date26 Dec 2023

Donafenib Tosylate

Target

CRAF x PDGFR x VEGFR

Mechanism

CRAF inhibitors [+2]

Active Org.

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Originator Org.

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Active Indication

Thyroid Cancer [+3]

Inactive Indication

Advanced gastric carcinoma [+9]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date08 Jun 2021

Jaktinib Hydrochloride

Target

ALK2 x JAK1 x JAK2 x JAK3 x TYK2

Mechanism

ALK2 inhibitors [+4]

Active Org.

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Originator Org.

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Active Indication

Post-essential thrombocythemia myelofibrosis [+12]

Inactive Indication

Bone Marrow Neoplasms [+4]

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

137

Clinical Trials associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

NCT04971551 / Not yet recruitingPhase 2

A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.

Start Date01 Dec 2024

Sponsor / Collaborator

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

NCT06592638 / Not yet recruitingPhase 1

A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients with Small Cell Lung Cancer

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.

Start Date01 Dec 2024

Sponsor / Collaborator

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

NCT06558227 / Not yet recruitingPhase 2

A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma

This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.

Start Date01 Sep 2024

Sponsor / Collaborator

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

0 Patents (Medical) associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Literatures (Medical) associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

01 Apr 2024·American Journal of Hematology

Efficacy, safety, and survival findings after long‐term follow‐up of ZGJAK002: A phase 2 study comparing jaktinib at 100 mg twice daily (BID) and 200 mg once daily (QD) in patients with myelofibrosis

Letter

Author: Suo, Shanshan ; Zhu, Huanling ; Wu, Dengshu ; Zhou, Hu ; Xia, Ruixiang ; Jin, Jie ; Hu, Yu ; Jiang, Zhongxing ; Yu, Wenjuan ; Yin, Hewen ; Wang, Xiuli ; Jin, Chenghao ; Wu, Liqing ; Zhang, Feng ; Li, Wei ; Liu, Jing ; Zhou, Zeping ; Sun, Kai ; Zhuang, Junling ; Zhang, Yi ; Yang, Linhua ; Li, Fei ; Huang, Jinwen ; Hu, Jianda ; Jiang, Qian ; Li, Yan ; Du, Xin

Jaktinib, a novel JAK and ACVR1 inhibitor, has exhibited promising results in treating patients with myelofibrosis (MF). ZGJAK002 is a Phase 2 trial aimed to assess the efficacy and safety of jaktinib 100 mg BID (N = 66) and 200 mg QD (N = 52) in JAK inhibitor-naive patients with intermediate- or high-risk MF. We herein present the long-term data with a median follow-up of 30.7 months. At data cutoff, 30.3% of patients in 100 mg BID and 28.8% in 200 mg QD were still continuing their treatment. The 100 mg BID group displayed a numerically higher best spleen response compared with the 200 mg QD group (69.7% vs. 46.2%), with 50.4% from the BID and 51.2% from the QD group maintaining spleen responses over 120 weeks. The 36-month survival rates were 78.2% in BID and 73.6% in QD group. The tolerability of jaktinib remained well, and common grade ≥3 adverse drug reactions included anemia (15.2% vs. 21.2%), thrombocytopenia (15.2% vs. 11.5%), and infectious pneumonia (10.6% vs. 1.9%) in BID and QD groups, respectively. By comparing the two groups, the incidence of adverse events (AEs) were similar, except for drug-related serious AEs (24.2% vs. 9.6%) and AEs leading to treatment discontinuation (15.2% vs. 7.7%), which were higher in BID group. The percentages of AEs resulting in death were comparable, with 6.1% in BID and 5.8% in QD group. These analyses further support the long-term durable efficacy and acceptable safety of jaktinib at 100 mg BID and 200 mg QD doses for treating MF.

02 Nov 2023·Blood

ZGGS15, a Novel IgG4 Bispecific Monoclonal Antibody Targeting Both LAG-3 and Tigit, Demonstrates Outstanding Anti-Tumor Activity and Can be Used As Monotherapy or in Combination with Anti-PD-1 Antibodies for Cancer Immunotherapy

Author: Zhang, Bin ; Lv, Binhua ; Dai, Tongcheng ; Liban, Tyler ; Yu, Jifeng ; Jiang, Zhongxing ; Sheng, Zelin ; Sheng, Jackie ; Sun, Hao ; Song, Yongping ; Ochoa, Jessica

BackgroundThis study aims to evaluate the anti-tumor efficacy of ZGGS15, a novel IgG4 bispecific monoclonal antibody (BsAb) targeting TIGIT and LAG-3, for cancer immunotherapy.Methods:ZGGS15 was generated in-house with the standard recombinant BsAb technology. ZGGS15 proteins were purified with protein A affinity column chromatography and evaluated for purity by size-exclusion high-performance liquid chromatography. The ZGGS15 affinity was assessed using a biolayer interferometry (BLI) assay. The EC50s of ZGGS15 binding to TIGIT and LAG-3 were determined using the ELISA technique. The EC50s of ZGGS15 binding to REH, Hela, MCF-7, and HCC1954 cells were measured by flow cytometry. Antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities were also evaluated by flow cytometry. BALB/c-hPD-1/hLAG-3 and BALB/c-hPD-1/hTIGIT subcutaneously transplanted with CT26.WT tumor mouse models, and peripheral blood mononuclear cells (PBMC) -humanized NOG bearing A375 tumor mouse model were used for in vivo anti-tumor efficacy evaluation.ResultsZGGS15 binds specifically to activated CD4 + and CD8 + T cells and human LAG-3 and TIGIT proteins expressed by CHO-K1 cells identically with a dose-dependent nanomolar affinity of 0.69 nM and 1.87 nM for human LAG-3 and TIGIT, respectively. In vitro kinetic analysis BLI results revealed ZGGS15 has high affinity for human LAG-3 and human TIGIT proteins, with KDs of 3.05 nM and 2.65 nM, respectively. ZGGS15 binds to human LAG-3 and human TIGIT simultaneously with similar affinity. Furthermore, ZGGS15 competitively inhibited the binding of LAG-3 to MHC-II (IC50 = 0.77 nM) and the binding of TIGIT to CD155 (IC50=0.24 nM).ZGGS15 induced better T cell activation than single anti-LAG3 or anti-TIGIT mAb agent or combined with different stimuli with or without cancer cells. When combined with nivolumab, ZGGS15 can further enhance the T cell activation in a dose-dependent manner. ADCC/CDC assay results showed that ZGGS15 binding to target cells does not induce ADCC or CDC. ZGGS15 interacts with the human neonatal Fc receptor in a pH-dependent manner, which can promote recirculation of ZGGS15 with a prolonged half-life in plasma. Besides, ZGGS15 interacts with human Fc-γ receptors and the human complement component, C1q, with low binding affinities. However, ZGGS15 does not induce obvious cytokine production from PBMCs, including IFN-γ, IL-2, IL-6, IL-10, and TNF-α.In vivo anti-tumor efficacy for ZGG15 in PBMC humanized NOG mice bearing A375 tumors showed that ZGGS15 had significant anti-tumor effects in the subcutaneous A375 xenograft model. ZGGS15 showed a better anti-tumor inhibition than single anti-LAG-3 or anti-TIGIT agent and a synergetic effect when combined with nivolumab. On day 18 post-treatment, the ZSAB015 plus nivolumab treatment demonstrated a significantly tumor growth inhibition (TGI) of 95.80% ( p =0.001), compared with the vehicle group.In vivo efficacy tests in BALB/c-hPD-1/hLAG-3 mice subcutaneously transplanted with CT26.WT tumor model showed that both high and low doses of ZGGS15 could inhibit the growth of CT26.WT colon cancer. The combination of high-dose ZGGS15 plus nivolumab has better efficacy than high-dose ZGGS15 and is slightly better than nivolumab alone. The tumor volume inhibition rate (TGITV) for ZGGS15 at 2 mg/kg was 69.70%, and for ZGGS15 at 5 mg/kg plus nivolumab at 1 mg/kg, it was 94.03% ( p < 0.001). During the experiment, the tumor-bearing mice tolerated it well, and no adverse reactions were observed. In vivo efficacy tests of ZGG15 in BALB/c-hPD-1/hTIGIT mice subcutaneously transplanted with CT26.WT tumor model showed that ZGGS15 at a low dose (1.5 mg/kg) demonstrated a significant tumor inhibitory effect, with the TGITV of 51.42% ( p < 0.01). The combination of ZGGS15 high-dose with nivolumab (5 mg/kg + 1 mg/kg) showed a better tumor inhibitory effect compared with ZGGS15 high-dose (5 mg/kg), with the TGITV of 81.15% and 41.54%, respectively ( p < 0.05).ConclusionsZGGS15 has excellent anti-tumor activity by inhibiting LAG-3 and TIGIT as a new IgG4 BsAb. ZGGS15 also exhibits potent anti-tumor efficacy in transgenic mouse models combined with nivolumab. Additionally, ZGGS15 does not elicit ADCC or CDC, therefore avoiding the cross-reaction of non-target binding. Finally, ZGGS15 does not induce cytokine production, mitigating any potential adverse effects of CRS.

01 Oct 2023·American journal of hematology

Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are intolerant to ruxolitinib: A single-arm, open-label, phase 2, multicenter study.

Article

Author: Lu, Binhua ; Wu, Liqing ; Zhou, Hu ; Du, Xin ; Hong, Mei ; Ma, Liangming ; Chang, Chunkang ; Jin, Jie ; He, Guangsheng ; Wang, Wei ; Xiao, Zhijian ; Gao, Sujun ; Liu, Qingchi ; Li, Junmin ; Zhao, Qingwei ; Yang, Haiping ; Zhu, Huanling ; Duan, Minghui ; Zhang, Yi ; Suo, Shanshan ; Li, Xin ; Xu, Na ; Jing, Hongmei ; Yin, Hewen

Although ruxolitinib improves splenomegaly and constitutional symptoms in patients with myelofibrosis (MF), a substantial proportion of patients discontinue ruxolitinib because of intolerance. This phase 2 trial investigated the safety and efficacy of jaktinib, a novel JAK inhibitor in patients with ruxolitinib-intolerant MF. The primary endpoint was the proportion of patients with ≥35% reduction in spleen volume (SVR35) at week 24. The secondary endpoints included change of MF-related symptoms, anemic response, and safety profiles. Between December 18, 2019, and November 24, 2021, 51 patients were enrolled, 45 treated with jaktinib 100 mg bid (100 mg bid group) and six received non-100 mg bid doses (non-100 mg bid group). The SVR35 at week 24 in the 100 mg bid group was 43.2% (19/44, 95% CI 29.7%-57.8%). There were 41.9% (13/31) of transfusion-independent patients with hemoglobin (HGB) ≤100 g/L who had HGB elevation ≥20 g/L within 24 weeks. The proportion of patients with a ≥50% decrease in the total symptom score (TSS 50) at week 24 was 61.8% (21/34). The most commonly reported grade ≥3 treatment-emergent adverse events (TEAEs) in the 100 mg bid group were anemia 31.1%, thrombocytopenia 22.2%, and infectious pneumonia 17.8%. A total of 16 (35.6%) in the 100 mg bid group had serious adverse events, and 4 (8.9%) were considered possibly drug related. These results indicate jaktinib can provide a treatment option for patients with MF who are intolerant to ruxolitinib.

News (Medical) associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

22 Oct 2024

·www.prnewswire.com

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inAcquisitionOrphan Drug

09 Sep 2024

·www.prnewswire.com

Idiopathic Pulmonary Fibrosis Treatment Drug Market to Increase 2 Folds by 2034 | DelveInsight

The emerging therapies for the treatment of idiopathic pulmonary fibrosis include a great deal of emerging drugs Tyvaso (treprostinil), BI 1015550, and others. The emerging therapies in the pipeline have the potential to change the IPF market size and manage the disease burden and progression. LAS VEGAS, Sept. 9, 2024 /PRNewswire/ -- Idiopathic pulmonary fibrosis (IPF) is when the lungs become scarred, and breathing becomes increasingly difficult. Damage to the alveolar epithelium and abnormal wound repair are theorized to be key factors in the development of this disease. Although the cause of IPF is unknown, researchers postulate that the disease probably results from genetic and environmental factors. There is a strong possibility that genetic changes increase a person's risk of developing IPF and subsequent exposure to certain environmental factors that further trigger the disease. However, much is still unknown about this emerging field of study. As per DelveInsight analysis, the total diagnosed prevalent cases of IPF in the 7MM was 193K cases in 2023 which are expected to rise, at a significant CAGR during the study period (2020–2034). The therapeutic approach of IPF involves both nonpharmacological and pharmacological strategies. The goal of the treatment is to slow disease progression, reduce symptoms, prevent acute exacerbations, and prolong survival. Currently, two drugs, OFEV (nintedanib) and ESBRIET (pirfenidone), are approved for treating IPF. These drugs are classified as anti-fibrotic agents, which clinical trials have shown to slow down lung fibrosis or scarring. Pirfenidone is a modified pyridine small molecule with anti-fibrotic, anti-inflammatory, and antioxidant properties. Learn more about the FDA-approved IPF drugs @ Drugs for Idiopathic Pulmonary Fibrosis Treatment Pirfenidone reduces the likelihood of respiratory-related hospitalization over a year of treatment. It is generally well-tolerated, with mild side effects such as skin rash, weight loss, nausea, and fatigue. However, there have been instances of abnormal liver function, including elevated serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, necessitating regular liver function monitoring for patients on pirfenidone. Nintedanib is an intracellular tyrosine kinase inhibitor that binds to adenosine triphosphate binding sites, thus inhibiting the signaling pathways associated with vascular endothelial growth factor receptor, fibroblast growth factor receptor 1–3, and platelet-derived growth factor receptor α and β. The main side effects are diarrhea and nausea, which are manageable with medication, but hepatotoxicity can occur in rare cases. Before May 2022, ESBRIET and OFEV were the only approved treatments for IPF available on the market. However, Sandoz Pharmaceutical recently launched a generic version of pirfenidone in the US. This new entry is expected to significantly impact Hoffmann-La Roche's ESBRIET market and disrupt the market for OFEV as well. Over the years, various drugs have been studied for treating IPF. With the ongoing need for more advanced and specific treatment approaches, new therapies beyond conventional methods are being developed for IPF. To know more about IPF treatment options, visit @ New Treatment for Idiopathic Pulmonary Fibrosis Companies across the globe are diligently working toward the development of novel treatment therapies with a considerable amount of success over the years. To date, there are several emerging market players, United Therapeutics, Boehringer Ingelheim, Pliant Therapeutics, Inc., and others that are developing drugs for the treatment of IPF. Discover which therapies are expected to grab major IPF market share @ Idiopathic Pulmonary Fibrosis Market Report Tyvaso (treprostinil), developed by United Therapeutics, is a prostacyclin mimetic approved to treat pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), aiming to enhance exercise capacity. The company is currently conducting a global Phase III clinical trial called TETON 1 to evaluate Tyvaso for the treatment of patients with IPF. BI 1015550, an experimental oral PDE4B inhibitor with both antifibrotic and anti-inflammatory properties, is under development by Boehringer Ingelheim. Recently, the company released encouraging 12-week Phase II data demonstrating a reduction in lung function decline in IPF patients. The drug is now in Phase III of clinical trials. PLN-74809, the leading program from Pliant Therapeutics, is an oral, small-molecule dual selective inhibitor targeting αVβ1 and αVβ6 integrins, under development for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). These integrins are responsible for the upstream activation of TGF-β1 in fibrotic tissues. By inhibiting these integrins, PLN-74809 aims to block TGF-β1 activation, thus preventing the growth of fibrotic tissue in the lungs and bile ducts. The drug is currently in Phase II of clinical development. Fipaxalparant (HZN-825), developed by Horizon Therapeutics/Amgen, is an oral selective lysophosphatidic acid receptor 1 (LPAR-1) antagonist that has demonstrated promising early clinical results in treating systemic sclerosis. The company is now conducting a Phase II pivotal trial to assess HZN-825 for the treatment of IPF. Discover more about drugs for IPF in development @ Idiopathic Pulmonary Fibrosis Clinical Trials The anticipated launch of these emerging therapies for IPF are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the IPF market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for IPF is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the increasing prevalent cases over the globe and thus the surge in treatment options. The expected launch of emerging therapies for IPF treatment is expected to boost the market in the forecast period (2023–2034). DelveInsight's latest published market report titled as Idiopathic Pulmonary Fibrosis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the IPF country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The IPF market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis Gender-specific Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis Age-specific Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis Severity-specific Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM IPF market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this IPF market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the IPF market. Also, stay abreast of the mitigating factors to improve your market position in the IPF therapeutic space. Related Reports Idiopathic Pulmonary Fibrosis Pipeline Idiopathic Pulmonary Fibrosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key idiopathic pulmonary fibrosis companies, including FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, AstraZeneca, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd, Ark Biosciences, Ocean Biomedical, among others. Cough in Idiopathic Pulmonary Fibrosis Market Cough in Idiopathic Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cough in idiopathic pulmonary fibrosis companies, including NeRRe Therapeutics, Trevi Therapeutics, Algernon Pharmaceuticals, Seyltx Inc., Melius Pharma AB, Cellular Sciences, Emphycorp, among others. Pulmonary Fibrosis Pipeline Pulmonary Fibrosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. Pulmonary Fibrosis Market Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 2Drug Approval

03 Sep 2024

·www.prnewswire.com

Global Gastric Cancer Diagnostics Market is Expected to Expand at a CAGR of ~7% by 2030 | DelveInsight

The increasing global incidence of gastric cancer is a major factor driving the demand for gastric cancer diagnostics. The market is also being fueled by the rising prevalence of GERD and other stomach-related conditions, along with the growing number of stomach infections such as H. Pylori and gastroenteritis. Additionally, the surge in obesity and smoking, which are linked to the development of stomach cancer, are significant contributors to the market's growth during the forecast period from 2024 to 2030. LAS VEGAS, Sept. 3, 2024 /PRNewswire/ -- DelveInsight's Gastric Cancer Diagnostics Market Insights report provides the current and forecast market analysis, individual leading gastric cancer diagnostics companies' market shares, challenges, gastric cancer diagnostics market drivers, barriers, trends, and key market gastric cancer diagnostics companies in the market. Key Takeaways from the Gastric Cancer Diagnostics Market Report As per DelveInsight estimates, North America is anticipated to dominate the global gastric cancer diagnostics market during the forecast period. In the product type segment of the gastric cancer diagnostics market, the reagents & kits category generated a significant revenue share in the gastric cancer diagnostics market in 2023. Notable gastric cancer diagnostics companies such as Abbott, BD, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Thermo Fisher Scientific Inc., Pillar Biosciences Inc., Hologic, Inc., CD Genomics, Natera, Inc., Biodesix, Illumina, Inc., Quest Diagnostics, Agilent Technologies, Inc., FUJIFILM Holdings Corporation, NeoGenomics Laboratories, Guardant Health, Myriad Genetics, Inc., Invitae Corporation, Danaher, and several others, are currently operating in the gastric cancer diagnostics market. In March 2024, AI Medical Service Inc. announced that it had launched gastroAI-model G, an AI-based endoscopic diagnostic support device that operates within the stomach. The diagnostic device operates by scanning for potential lesions, utilizing images derived from the video processor of the endoscopy system. Upon determining that a lesion appears suspicious for early gastric cancer and requires additional evaluation, the program notifies the physician and offers diagnostic support by presenting a highlighted area within the endoscopic display. In November 2023, Dedalus Group in collaboration with Ibex Medical Analytics, announced the launch of a fully integrated AI-powered digital pathology solution for gastric cancer diagnosis. In August 2023, Mirxes Pte Ltd announced that its flagship product GASTROClear, a PCR-based in vitro diagnostic test for early detection of gastric (stomach) cancer, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). It is a molecular blood test for the early detection of gastric cancer that helps to cure cancer with affordable treatment. To read more about the latest highlights related to the gastric cancer diagnostics market, get a snapshot of the key highlights entailed in the Global Gastric Cancer Diagnostics Market Report Gastric Cancer Diagnostics Overview Gastric cancer, or stomach cancer, is typically diagnosed through a combination of clinical evaluation, imaging techniques, and tissue biopsy. The diagnostic process often begins with a patient's history and physical examination, focusing on symptoms like persistent indigestion, weight loss, and abdominal pain. Imaging studies, such as upper gastrointestinal endoscopy, are crucial as they allow direct visualization of the stomach lining. During an endoscopy, a flexible tube with a camera is inserted through the mouth into the stomach, enabling doctors to identify suspicious lesions or tumors. Additional imaging techniques, such as computed tomography (CT) scans or positron emission tomography (PET) scans, may be used to determine the extent of the cancer and to detect possible metastasis to other organs. Confirming a diagnosis of gastric cancer requires a biopsy, where tissue samples are taken during an endoscopy and examined under a microscope for cancerous cells. Histopathological analysis of the biopsy helps determine the type and grade of the cancer, which is critical for guiding treatment options. Molecular testing on the biopsy sample can also identify specific genetic mutations or protein expressions, such as HER2, which may influence targeted therapy decisions. Blood tests for tumor markers like carcinoembryonic antigen (CEA) and CA 19-9 are sometimes used to support diagnosis or monitor treatment response, although these markers are not specific to gastric cancer. Early and accurate diagnosis is essential in improving the prognosis and survival rates for patients with gastric cancer. Gastric Cancer Diagnostics Market Insights In 2023, North America held the largest share of the gastric cancer diagnostics market. This dominance is attributed to the increasing prevalence of gastric cancer and related stomach diseases, along with the region's growing geriatric population and advancements in early cancer detection technologies. Data from the American Cancer Society, published in January 2024, predicts approximately 26,890 new cases of stomach cancer in the United States for 2024, with 16,160 cases among men and 10,730 among women. Stomach cancer accounts for about 1.5% of all new cancer diagnoses annually in the country. The higher incidence of gastric cancer among older adults is linked to age-related risk factors such as stomach infections and gastroesophageal reflux disease (GERD). As a result, the expanding elderly population is expected to drive the growth of the gastric cancer diagnostics market in the region. In March 2024, Ibex Medical Analytics launched Galen, an AI-powered diagnostic platform that offers accurate cancer diagnoses, reduces manual tasks, and is used for diagnosing gastric cancer, H. pylori, and other gastric lesions like adenoma and low-grade dysplasia. This increase in R&D activities by major players to develop advanced diagnostic solutions is expected to further boost the North American gastric cancer diagnostics market. To know more about why North America is leading the market growth in the gastric cancer diagnostics market, get a snapshot of the Gastric Cancer Diagnostics Market Outlook Gastric Cancer Diagnostics Market Dynamics The gastric cancer diagnostics market is evolving rapidly, driven by technological advancements, increasing awareness, and a growing focus on early detection. Gastric cancer, which remains one of the leading causes of cancer-related mortality worldwide, particularly in Asia and Eastern Europe, has led to a pressing need for improved diagnostic methods. Traditional diagnostic techniques like endoscopy and biopsy are now being complemented and, in some cases, replaced by innovative, non-invasive technologies such as liquid biopsy, molecular diagnostics, and advanced imaging techniques. These new modalities offer the potential for earlier detection, more accurate staging, and better monitoring of disease progression, which is critical for improving patient outcomes. A significant dynamic in the market is the integration of molecular diagnostics, including next-generation sequencing (NGS), which allows for the detection of specific genetic mutations and biomarkers associated with gastric cancer. These advancements are not only enhancing the precision of diagnosis but also paving the way for personalized medicine, where treatment can be tailored based on an individual's genetic profile. The push towards personalized medicine is further fueling the demand for diagnostic tools that can provide comprehensive genomic data, leading to an increase in partnerships between diagnostic companies and pharmaceutical firms aiming to develop targeted therapies. Furthermore, the rise of artificial intelligence and machine learning in diagnostics is another key trend shaping the gastric cancer diagnostics market. AI and ML are being integrated into imaging and pathology tools to improve the accuracy of cancer detection and reduce the chances of human error. These technologies can analyze large datasets, identify patterns, and make predictions that can assist clinicians in making more informed decisions. The growing adoption of AI-driven diagnostic platforms is expected to enhance the efficiency of gastric cancer screening programs and reduce the time required for diagnosis. The market is also influenced by the increasing prevalence of gastric cancer in aging populations, particularly in regions with high incidence rates. This demographic shift is expected to drive the demand for more accessible and cost-effective diagnostic solutions. Governments and healthcare organizations in these regions are investing in public health initiatives aimed at improving cancer screening and early detection rates, which is likely to further boost the market for diagnostic products and services. However, the market faces challenges, such as high costs associated with advanced diagnostic technologies and the need for specialized expertise to interpret complex diagnostic results. Additionally, disparities in healthcare infrastructure and access to advanced diagnostics between developed and developing regions may limit market growth in certain areas. Despite these challenges, the overall outlook for the gastric cancer diagnostics market remains positive, with continuous innovations and increasing emphasis on early detection poised to significantly impact the landscape in the coming years. Get a sneak peek at the gastric cancer diagnostics market dynamics @ Gastric Cancer Diagnostics Market Dynamics Analysis Gastric Cancer Diagnostics Market Assessment Gastric Cancer Diagnostics Market Segmentation Gastric Cancer Diagnostics Market Segmentation By Product Type: Instruments, Reagents & Kits Gastric Cancer Diagnostics Market Segmentation By Test Test: Imaging Test [Upper Endoscopy, Barium Swallow/X-Rays, CT Scan, Laparoscopy, MRI, Stomach Ultrasound, and Others], Laboratory Test [Biopsy, Blood Test, and Others] Gastric Cancer Diagnostics Market Segmentation By End Users: Hospitals, Diagnostic Laboratories, Academic & Research Institutes, Diagnostic Centers, and Others Gastric Cancer Diagnostics Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the gastric cancer diagnostics market are set to emerge as the trendsetter explore @ Gastric Cancer Diagnostics Companies Table of Contents Interested in knowing the gastric cancer diagnostics market by 2030? Click to get a snapshot of the Gastric Cancer Diagnostics Market Trends Related Reports Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including Hanmi Pharmaceuticals, Merck, Minneamrita Therapeutics, Taiho Pharmaceuticals, Bayer, among others. Gastric Cancer Pipeline Gastric Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Base Therapeutics, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others. Gastroesophageal Reflux Disease Market Gastroesophageal Reflux Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key GERD companies, including Phathom Pharmaceuticals, Inc., Microbiome Health Sciences, Takeda, Braintree Laboratories, AstraZeneca, among others. Gastroesophageal Reflux Disease Pipeline Gastroesophageal Reflux Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GERD companies, including Cinclus Pharma, Onconic Therapeutics, Renexxion, Addpharma, Trio Medicines, Chong Kun Dang Pharmaceutical, HK inno.N Corporation, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Breakthrough Therapy

100 Deals associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

100 Translational Medicine associated with Suzhou Zelgen Biopharmaceuticals Co., Ltd.

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Pipeline Snapshot as of 23 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

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Donafenib Tosylate ( CRAF x PDGFR x VEGFR )	Thyroid Cancer More	Approved
Recombinant human thrombin (Zelgen Biopharma) ( prothrombin )	Hemorrhage More	Approved
Jaktinib Hydrochloride ( ALK2 x JAK1 x JAK2 x JAK3 x TYK2 )	Post-essential thrombocythemia myelofibrosis More	NDA/BLA
Recombinant human thyrotropin(Suzhou Zelgen Biopharmaceuticals Co., Ltd.) ( TSHR )	Differentiated Thyroid Gland Carcinoma More	NDA/BLA
ZG-005 ( PD-1 x TIGIT )	Advanced Hepatocellular Carcinoma More	Phase 2

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