Shenzhen Xbiome Biotechnology Co., Ltd.

Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities. LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD). As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034. Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy. Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development. To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market. Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics. Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment CSL Behring's ZEMAIRA CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD. Equillium/Biocon's EQ001 EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance. Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for GvHD.In March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data. Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market MaaT Pharma's MaaT013 MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA. In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD. medac's MC0518 MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment. The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models. Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials The anticipated launch of these emerging therapies for GvHD 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 GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight's latest published market report, titled as Graft versus Host Disease 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 GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total allogenic transplant cases Total Graft Versus Host Disease Cases Type-specific Cases of Graft Versus Host Disease Acute Graft Versus Host Disease Cases by Grading Acute Graft Versus Host Disease Cases by Organ Involvement Chronic Graft Versus Host Disease Cases by Grading Chronic Graft Versus Host Disease Cases by Organ Involvement Total Treated Cases of Graft Versus Host Disease Mortality Adjusted Treated Cases of Graft Versus Host Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include: 10-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 GvHD 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 GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space. Related Reports Graft versus Host Disease Epidemiology Forecast Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan. Graft versus Host Disease Pipeline Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen , among others. Acute Graft versus Host Disease Pipeline Acute Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation , among others. Ocular Graft versus Host Disease Pipeline Ocular Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine , 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

Huili Bio, a Hong Kong-based biotech, has reeled in “hundreds of million RMB,” which equates to at least $15 million, in a Series A financing. The four-year-old startup is using synthetic biology to computationally design enzymes. The financing round will bankroll hiring, research and development for “new product pipelines” and ramp up the construction of “large-scale production facilities,” the company said Thursday. Legend Capital led the financing round. Huili Bio’s goal is to reduce the costs of developing pharmaceutical products from lab to industrial production to commercialization. “The synthetic biomaterials market is vast and an important area in the green and low-carbon direction. As the core component of synthetic biology, the design and transformation of enzymes will benefit more traditional biotechnology industries with low-cost and sustainable green production methods,” Legend Capital executive director Henry Ji said in a statement. Legend also invested in the $150 million Series E for China and US CRO ClinChoice earlier this week. The investor has also backed the likes of microbiome startup Xbiome. — Kyle LaHucik Precision Autoimmune Therapeutics received RMB 140 million (about $21 million) in its first round of financing, partner and 15% stakeholder CASI Pharmaceuticals said Friday. The biotech, formerly known as Beijing Tianshi Tongda Pharmaceuticals Technology Co, will use the funds to develop drugs for autoimmune and inflammatory diseases, hence the company’s new name. PAT teamed up with CASI in late May on the US biotechs’ CID-103 program in autoimmune indications. As part of the financing round, PAT will deliver $5 million to CASI in the first of two upfront payment installments. That gives PAT access to a worldwide sub-license for the investigational anti-CD38 monoclonal antibody. CASI keeps exclusive US commercialization and co-marketing rights in autoimmune indications. For hematology indications in China, CASI maintains the co-commercial rights but isn’t obligated to co-commercialize those programs in that market, the company said. — Kyle LaHucik A biotech based in Guangzhou, China, specializing in live biotherapeutics has netted another round of funding. Zhiyi Biotech announced on Thursday that the company has raised an additional $15 million in its B++ funding round, bringing the Series B funding round to a total of $45 million . According to the company, the funds will be used for the clinical development of the company’s live biotherapeutic products (LBPs) pipelines. According to the company’s website, the company has six projects in its arsenal with most products in the pre-clinical stage. Their lead candidate, dubbed SK08, was approved for clinical trials in November 2019 and has advanced as far as a Phase II trial. “Zhiyi has been always focusing on the unmet medical needs and dedicating to developing accessible drugs to benefit more patients. We are looking forward to strengthening our international collaboration with peer companies, to promote the development of the whole LBPs industry,” said Ye Wang, CEO of Zhiyi. The investors in the round included Qingkong SinoKing Capital, SDIC Venture Capital and KIP, among others. — Tyler Patchen

Xbiome Inc, an AI-focused microbiome therapeutics developer has acquired a new clinical asset – M201 for ulcerative colitis (UC) – from Assembly Biosciences, a biotech specializing in viral diseases such as hepatitis B. The M201 program is designed for patients with mild to moderate UC. The therapeutic consists of a mix of commensal bacteria selected for their ability to modulate UC-related cellular mechanisms in human cell-based assays and animals. Taking the reins of M201 from Assembly, Xbiome will use its AI-based microbiology platform to develop M201. The platform, called X-Optim, claims to accelerate microbiome drug discovery with machine learning. Xbiome’s drug discovery approach involves screening early drug candidates based on their mechanism of action, then validating and optimizing candidates on its microbiology platform. According to Xbiome Founder and CEO Yan Tan, M201 is expected to head into Phase1b in 2022 in the US, and will receive development support from Xbiome’s tech team in Europe and Asia. The M201 acquisition marks Xbiome’s third clinical-stage addition to its pipeline. The company first stepped into human trials with XBI-302, Asia’s first FDA-approved Fecal Microbiota Transplantation (FMT) human trial on graft-versus-host disease. Xbiome’s second clinical-phase program targets diabetic foot ulcers, chronic wounds and inflammatory diseases. The program was licensed from Aurealis Therapeutics for development and commercialization. Earlier-stage programs in Xbiome’s pipeline target the autism spectrum and immuno-oncology. Besides FMT, Xbiome’s other modalities include live biotherapeutic product (LBP) and small molecule microbiome modulators (SMMM). To support these programs, Xbiome last December completed a $100 million Series B financing round joined by a cluster of Chinese investors, including Legend Capital, Gaborone Capital, 5Y Capital, Primavera Capital Group, Wuyuan Capital, Chunhua HIKE Capital and Tiantu Capital. The company previously raised $7.5 million in Series A in 2018. For a startup founded in 2017, Xbiome has since expanded across seven cities and grown its staff to over 200. The company recently set up US headquarters in Cambridge, Massachusetts for its business leadership and R&D.