A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma

This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Start Date01 Sep 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

CTR20253019

/ RecruitingPhase 2

SHR2554片联合其他抗肿瘤治疗在晚期胃癌或胃食管结合部癌（GC/GEJC）受试者中的安全性、耐受性及有效性的多中心、开放II期临床研究

[Translation] A multicenter, open-label, phase II clinical study of the safety, tolerability, and efficacy of SHR2554 tablets combined with other anti-tumor therapies in subjects with advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC)

评估SHR2554片联合其他抗肿瘤治疗在晚期GC/GEJC受试者中的安全性、耐受性、客观缓解率(ORR)、缓解持续时间（DoR）、疾病控制率（DCR）、无进展生存期（PFS）和总生存期（OS）；评价SHR2554和或SHR-A1811、SHR-A1904在晚期GC/GEJC受试者中的PK特征与免疫原性。

[Translation]

To evaluate the safety, tolerability, objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) of SHR2554 tablets combined with other anti-tumor therapies in subjects with advanced GC/GEJC; to evaluate the PK characteristics and immunogenicity of SHR2554 and/or SHR-A1811, SHR-A1904 in subjects with advanced GC/GEJC.

Start Date22 Aug 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Zeprumetostat

100 Translational Medicine associated with Zeprumetostat

100 Patents (Medical) associated with Zeprumetostat

Literatures (Medical) associated with Zeprumetostat

01 Sep 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Inhibition of EZH2 by SHR2554 modifies subset ratios and suppresses polyfunctional responses of peripheral blood T cells from hematopoietic stem cell donors

Article

Author: Yuan, Jing ; Li, Jundong ; Liu, Xuan ; Zhou, Ziwei ; Hua, Huan ; Wang, Fuxu

BACKGROUND:

T cells play pivotal roles in orchestrating immune responses after allogeneic hematopoietic stem cell transplantation. Donor T cells facilitate the reconstitution of the recipient's immune system and Enhancer of Zeste Homolog 2 (EZH2) is crucial for T-cell differentiation and plasticity. Inhibitors of EZH2 may protect patients undergoing allogeneic stem cell transplantation from developing graft-versus-host disease without compromising the beneficial graft-versus-leukemia effect. Here, we investigated the impact of SHR2554, a novel and highly selective EZH2 inhibitor, on the subset ratios and polyfunctional responses of peripheral T-cells from hematopoietic stem cell donors METHODS: Cell proliferation, cell cycle, and apoptosis were analyzed using Cell Counting Kit-8 assays and flow cytometry. Western blotting was employed to detect the abundance of related proteins. RNA-sequencing was used to analyze gene expression after SHR2554 treatment RESULTS: SHR2554 inhibited proliferation, promoted apoptosis, and induced cell cycle arrest in donor T cells. SHR2554 also preserved CD4+/CD8+ T cell ratios while selectively depleting naïve (T_N) and terminally differentiated effector (T_Eff) subsets and concurrently expanding central memory (T_CM), effector memory (T_EM), and regulatory T cell (Treg) subsets across CD3+/CD4+/CD8+ populations. SHR2554 significantly attenuated CD107a expression and IFNγ/TNFα secretion from CD3+/CD4+/CD8+ T cells, thereby suppressing polyfunctional responses across T cell subsets CONCLUSIONS: SHR2554, a potent and highly selective small-molecule inhibitor of EZH2, demonstrated a remarkable anti-proliferative effect on donor peripheral blood T cells, and modified T cell ratios and suppressed their polyfunctional responses. SHR2554 therefore has potential for treating graft-versus-host disease.

01 Sep 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Pharmacokinetic interaction between SHR2554 and fluconazole: A single-center, open-label and one-sequence crossover phase I trial in healthy Chinese subjects

Article

Author: Yuan, Weilan ; Hu, Minwan ; Li, Shaorong ; Wu, Feng ; Han, Ying ; Zhao, Xiuli ; Zhu, Zhenyu ; Dai, Yuyang ; Guo, Shaojie ; Ni, Siyang

SHR2554, a highly selective oral EZH2 inhibitor, shows promise in treating hematologic malignancies. However, its metabolism via CYP3A4 raises concerns about drug-drug interactions. This study evaluates the impact of fluconazole, a moderate CYP3A4 inhibitor, on the pharmacokinetics and safety implications of SHR2554. We conducted a single-center, open-label, single-dose, single-sequence crossover phase I trial. 18 Chinese healthy subjects were orally administered SHR2554 100 mg on Day 1, fluconazole 400 mg on Day 4 and 200 mg QD from Days 5 to 6. SHR2554 100 mg co-administrated with fluconazole 200 mg on Day 7, and fluconazole 200 mg QD from Days 8 to 9. Pharmacokinetic parameters were compared after subjects were administered SHR2554 alone and in combination with fluconazole. C_max, AUC_0-t, and AUC_0-∞ were significantly increased when SHR2554 was co-administered with fluconazole. The co-administration led to a 3.29-, 4.79-, and 4.13-fold increase in C_max, AUC_0-t, and AUC_0-∞, respectively. Safety evaluations indicated that the observed treatment-emergent adverse events were mild and transient. These findings underline the necessity of caution when co-administered SHR2554 with moderate CYP3A4 inhibitors in clinical settings, providing crucial insights for optimizing future clinical trials.

01 Apr 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Enhancer of Zeste Homolog 2 Inhibitor SHR2554 in Relapsed or Refractory Peripheral T-cell Lymphoma: Data from the First-in-Human Phase I Study

Article

Author: Qi, Junyuan ; Huang, Yanhua ; Cai, Zhen ; Su, Hang ; Zuo, Xuelan ; Li, Kunyan ; Li, Yijing ; Wu, Jianyuan ; He, Chuan ; Zhou, Hui ; Liu, Yanyan ; Hao, Siguo ; Li, Zhi-Ming ; Li, Lanfang ; Xiao, Zhenyu ; Zhu, Jun ; Li, Dengju ; Li, Zengjun ; Jin, Zhengming ; Wu, Meng ; Song, Yuqin ; Shen, Jie ; Sun, Xiuhua

Abstract:

Purpose::

Patients with peripheral T-cell lymphomas (PTCL) in the relapsed or refractory (r/r) setting have only a limited number of therapies available, and the prognosis is extremely poor. SHR2554 is an oral inhibitor against EZH2, a rational therapeutic target for lymphomas.

Patients and Methods::

This was a multicenter, two-part, phase I study of SHR2554 in r/r mature lymphoid neoplasms. In part I, 350 mg twice daily was established as the recommended phase II dose (RP2D) based on the findings during dose escalation and expansion; subsequently, selected lymphoma subtypes were recruited in clinical expansion cohorts to receive SHR2554 at RP2D. Here, we provide an in-depth assessment of SHR2554 at RP2D in subpopulation with r/r PTCL.

Results::

Twenty-eight patients were included for analysis (17 angioimmunoblastic T-cell lymphoma and 11 not otherwise specified). Eighteen (64%) patients had received ≥2 lines of previous anticancer therapies. The objective response rate was 61% [95% confidence interval (CI), 41–78]. Responses were still ongoing in 59% (10/17) of the responders; estimated median duration of response was 12.3 months (95% CI, 7.4–not reached). Median progression-free survival was 11.1 months (95% CI, 5.3–22.0), and 12-month overall survival rate was 92% (95% CI, 72–98). The most common grade 3 or 4 treatment-related adverse events were decreased platelet count [nine (32%)] as well as decreased white blood cell count, decreased neutrophil count, and anemia [four (14%) for each]. No treatment-related deaths were reported.

Conclusions::

This extended follow-up analysis further supports SHR2554 as a therapeutic opportunity for patients with r/r PTCL.

News (Medical) associated with Zeprumetostat

28 Nov 2024

·www.prnewswire.com

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma 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: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, 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

ImmunotherapyLicense out/inPhase 3VaccineCell Therapy

14 Aug 2023

·firstwordpharma.com

Jiangsu Hengrui inks deal with One Bio for ex-China rights to SHR-1905

Jiangsu Hengrui Pharmaceuticals has out-licensed global rights, excluding China, for its anti-TSLP monoclonal antibody SHR-1905 to One Bio. The deal comes with a $21.5-million upfront payment, but Jiangsu Hengrui could be entitled to over $1 billion in development and sales milestones if the drug is approved in the US, Japan and select European countries. It is also eligible for double-digit tiered royalties.Given that TSLP is an upstream mediator triggered early in the inflammatory response, Jiangsu Hengrui says SHR-1905 could be suitable for patients with severe asthma, regardless of phenotype and biomarker limitations, allowing for "greater market potential compared to other target drugs." Regulators in China greenlit SHR-1905 for clinical trials to treat asthma in 2021 and for chronic sinusitis with nasal polyps this past May. Both are currently in Phase II."This marks the second out-licensing deal by Jiangsu Hengrui this year, demonstrating its strong R&D strength and pipeline quality," Morgan Stanley analysts remarked in a note to clients. The company licensed its EZH2 inhibitor SHR-2554 to Treeline Biosciences in February as part of a deal potentially worth as much as $706 million. Jiangsu Hengrui is developing SHR-2554 in China as a treatment for peripheral T-cell lymphoma.Meanwhile, AstraZeneca and Amgen's Tezspire (tezepelumab-ekko), another TSLP-blocking drug, is approved to treat severe asthma regardless of phenotype or biomarker limitations in several markets, including the US, EU and Japan. Amgen recently reported that the drug's sales more than doubled to reach $133 million in the second quarter, benefitting from the introduction of a self-administered, pre-filled, single-use pen approved by the FDA earlier this year.

License out/inDrug ApprovalPhase 2

100 Deals associated with Zeprumetostat

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral T-cell lymphoma unspecified recurrent	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	29 Aug 2025
Peripheral T-cell lymphoma unspecified refractory	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	29 Aug 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Peripheral T-Cell Lymphoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Jan 2024
Gastroesophageal junction adenocarcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Sep 2025
Metastatic Gastric Carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Sep 2025
stomach adenocarcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Sep 2025
Advanced gastric carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	22 Aug 2025
Gastrooesophageal junction cancer	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	22 Aug 2025
Advanced Prostate Carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Sep 2024
Follicular Lymphoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Apr 2024
Refractory Follicular Lymphoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Apr 2024
Refractory Classic Hodgkin Lymphoma	Phase 2	China	Chinese People's Liberation Army General Hospital	14 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06122389 (EHA2025 \| NEWS) Manual	Phase 1	Peripheral T-Cell Lymphoma	67	SHR2554	kpujwvhhns(jsdafcewip) = evidbrothk uudyvovsya (jcrpbcebsm, 51.5 - 75.5) Met View more	Positive	12 Jun 2025
NCT03603951 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Peripheral T-Cell Lymphoma	28	SHR2554 350 mg twice daily	yaircdvcze(bjyfysfrqb) = gqdpkvtxoz hyxpxioibl (ohhbhumimr, 41 - 78) View more	Positive	01 Apr 2024
NCT04407741 (ASCO2023) Manual	Phase 1	Solid tumor \| Advanced Lymphoma	32	SHR-1701 + SHR2554	mwfwjuicrt(jirlkxmjym) = SHR2554 350mg bid plus SHR-1701 30mg/kg q3w ecytkkwusm (spbjxjslbc ) View more	Positive	31 May 2023
NCT03603951 (Pubmed \| Lancet Haematol) Manual	Phase 1	Lymphoma	113	SHR 2554	exkdnvypjw(dxhfwfoypv) = ryhutmqmli omsdnkkobg (vujmubjlmu ) View more	Positive	01 Jul 2022
NCT03603951 (ASCO2022)	Phase 1	Lymphoid neoplasm	113	SHR2554	dywzuzxokq(luorokggae) = berxcdjcxy nteuhydqhg (hpebafhrog, 42.1 - 73.7) View more	-	02 Jun 2022

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