Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Over the last ten years, cell-based immunotherapy has emerged as a promising approach for treating solid tumors. Several companies, including Iovance Biotherapeutics, Obsidian Therapeutics, Biosyngen, KSQ Therapeutics, and others, are currently engaged in the development and production of TIL therapies, which have the potential to significantly impact and enhance the TIL therapies market. LAS VEGAS, Aug. 12, 2025 /PRNewswire/ -- DelveInsight's Tumor-Infiltrating Lymphocyte Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as melanoma, cervical cancer, non-small cell lung cancer (NSCLC), endometrial cancer, head and neck squamous cell carcinoma (HNSCC), colorectal cancer, and other solid tumors. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging tumor-infiltrating lymphocyte therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Tumor-Infiltrating Lymphocyte Therapies Market Report As per DelveInsight's analysis, the total market size of tumor-infiltrating lymphocyte therapies in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as melanoma, cervical cancer, non-small cell lung cancer (NSCLC), endometrial cancer, head and neck squamous cell carcinoma (HNSCC), colorectal cancer, and other solid tumors. Leading tumor-infiltrating lymphocyte therapies companies, such as Obsidian Therapeutics, Biosyngen, KSQ Therapeutics, and others, are developing novel tumor-infiltrating lymphocyte therapies that can be available in the tumor-infiltrating lymphocyte therapies market in the coming years. Some of the key tumor-infiltrating lymphocyte therapies in the pipeline include OBX-115, BST02, KSQ-001 EX, KSQ-004 EX, and others. In June 2025, Iovance Biotherapeutics announced that the Journal of Clinical Oncology has published the final analysis from the Phase II C-144-01 clinical trial evaluating the individualized T cell therapy AMTAGVI in patients with advanced melanoma. These five-year follow-up results are being simultaneously presented during an oral session today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In June 2025, Obsidian Therapeutics announced initial Phase I safety and efficacy data from the Phase I/II Agni-01 multicenter study of OBX-115 a summarized the data will be presented by the Director and Chief Administrative Officer of UofL Health – Brown Cancer Center/Oncology Service Line at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In April 2025, KSQ Therapeutics announced the first patient dosed in the Phase I/II clinical study of KSQ-004EX, a novel CRISPR-engineered Tumor Infiltrating Lymphocyte (eTIL) therapy. KSQ-004EX consists of eTIL in which the SOCS1 and Regnase-1 genes are inactivated by CRISPR/Cas9 gene editing, giving it the potential to be a best-in-class treatment for a variety of solid tumor indications. KSQ's CRISPRomics platform identified SOCS1 and Regnase-1 as key genes inhibiting the ability of TIL to eradicate solid tumors in preclinical models. Discover which indication is expected to grab the major tumor-infiltrating lymphocyte therapies market share @ Tumor-Infiltrating Lymphocyte Therapies Market Report Tumor-Infiltrating Lymphocyte Therapies Market Dynamics The tumor-infiltrating lymphocyte therapies market is poised for transformative growth, driven by increasing interest in personalized and cell-based immunotherapies for solid tumors. The market gained significant momentum following the U.S. FDA approval of Iovance Biotherapeutics' AMTAGVI in 2024 for advanced melanoma, marking the first regulatory validation of a TIL therapy and paving the way for wider clinical adoption and investor confidence. A major driver of the market is the growing unmet need in solid tumor treatment, where conventional immunotherapies like checkpoint inhibitors have limited efficacy for many patients. TIL therapies offer a more tailored solution, capable of overcoming tumor immune evasion by targeting multiple neoantigens. Advances in cell manufacturing, automation, and closed-system bioprocessing are also contributing to improved scalability and reduced turnaround times, addressing one of the historic limitations of TILs, the complex and time-intensive production process. The competitive landscape is becoming increasingly dynamic, with numerous biotechnology firms and academic institutions entering the TIL space. Strategic partnerships, technology licensing, and mergers & acquisitions are prevalent as players aim to build robust manufacturing capabilities and differentiate their platforms using gene editing, selection techniques, or combination regimens with checkpoint inhibitors. However, the market faces several challenges, including high production costs, patient-specific manufacturing logistics, and the need for specialized infrastructure. Reimbursement hurdles, regulatory complexities, and the need for biomarker-based patient selection also represent significant barriers to widespread commercialization. Nonetheless, continued progress in artificial intelligence for neoantigen identification, cryopreservation methods, and decentralized manufacturing models could mitigate many of these issues over time. In conclusion, the TIL therapies market is at an inflection point, transitioning from early-stage development to commercial viability. The combination of strong clinical data, regulatory tailwinds, and technological innovation is expected to drive robust growth in the coming decade. As more TIL therapies move into late-stage trials and receive regulatory approval, their role in the broader oncology treatment landscape is likely to expand, especially for cancers with high unmet needs and limited therapeutic options. Tumor-Infiltrating Lymphocyte Therapies Treatment Market TIL therapies represent a new generation of personalized immunotherapy designed to leverage a patient's own immune system to combat solid tumors. This approach involves extracting TILs from a patient's tumor, expanding and modifying them outside the body, and then reinfusing them to stimulate a targeted immune response. After years of academic research, the field reached a significant milestone in 2024 with the FDA approval of AMTAGVI by Iovance Biotherapeutics for treating advanced melanoma. AMTAGVI is an autologous T cell therapy derived from a patient's tumor, approved for adult patients with unresectable or metastatic melanoma who have previously received a PD-1 inhibitor. For those with a BRAF V600 mutation, prior treatment with a BRAF inhibitor, with or without a MEK inhibitor, is also required. Although its exact mechanism of action is not fully understood, AMTAGVI is believed to work by utilizing the patient's own TILs. These TILs naturally develop in response to cancer and are capable of recognizing and attacking tumor-specific markers. However, as cancer progresses, the effectiveness of these native TILs diminishes. AMTAGVI seeks to restore and enhance its function by reintroducing activated TILs into the patient. The therapy is also being evaluated in late-stage clinical trials, both as a standalone treatment and in combination with pembrolizumab, for other cancers such as non-small cell lung cancer and cervical cancer. Learn more about the tumor-infiltrating lymphocyte therapies @ Tumor-Infiltrating Lymphocyte Therapies Analysis Key Emerging Tumor-Infiltrating Lymphocyte Therapies and Companies TIL therapies have a pipeline, with candidates such as O BX-115, BST02, KSQ-001 EX, and KSQ-004 EX in early Phase (I/II) trials targeting diverse indications like advanced gastric, gastroesophageal junction, and other solid tumors. OBX‑115 is an advanced tumor-infiltrating lymphocyte (TIL) therapy developed using Obsidian's proprietary cytoDRIVE platform. This therapy involves genetically modifying TILs to express membrane-bound interleukin-15 (mbIL‑15), which enhances T cell proliferation, durability, and antitumor effectiveness—eliminating the need for high-dose IL‑2, a key source of toxicity in traditional TIL therapies. The OBX‑115 TILs are engineered to produce mbIL‑15 linked to a drug-responsive domain, enabling controlled, dose-dependent increases in mbIL‑15 levels when an FDA-approved stabilizing agent, acetazolamide (ACZ), is administered. This approach further removes the requirement for IL‑2. In September 2024, Obsidian Therapeutics announced that the U.S. FDA granted OBX‑115 Regenerative Medicine Advanced Therapy (RMAT) designation for treating patients with unresectable or metastatic melanoma that no longer responds to immune checkpoint inhibitors (ICIs). The anticipated launch of these emerging therapies are poised to transform the tumor-infiltrating lymphocyte therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the tumor-infiltrating lymphocyte therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about tumor-infiltrating lymphocyte therapies clinical trials, visit @ Tumor-Infiltrating Lymphocyte Therapies Treatment Tumor-Infiltrating Lymphocyte Therapies Overview Tumor-infiltrating lymphocyte (TIL) therapy is an advanced type of adoptive cell therapy (ACT) that involves isolating naturally occurring, polyclonal T cells from within a patient's tumor microenvironment, expanding them outside the body, and reintroducing them after the patient undergoes non-myeloablative lymphodepletion. Unlike engineered approaches such as CAR-T or TCR therapies, TIL therapy leverages the natural tumor-targeting ability of the patient's own T cells, which are already primed to detect a broad range of tumor-specific neoantigens. The strategy is based on the idea that these tumor-resident T cells can generate a more effective and biologically relevant immune response. Once infused back into the patient, the expanded TILs can survive, home in on tumor sites, and exert cytotoxic effects on cancer cells. This approach has shown lasting clinical responses, especially in immunologically active cancers like metastatic melanoma, cervical cancer, and non-small cell lung cancer (NSCLC), including in cases resistant to immune checkpoint inhibitors. Tumor-Infiltrating Lymphocyte Therapies Epidemiology Segmentation The tumor-infiltrating lymphocyte therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for TIL Therapies Total Eligible Patients of the Selected Indications of TIL Therapies Total Treated Cases in Selected Indications for TIL Therapies Scope of the Tumor-Infiltrating Lymphocyte Therapies Market Report Tumor-Infiltrating Lymphocyte Therapies Therapeutic Assessment: Tumor-Infiltrating Lymphocyte Therapies' current marketed and emerging therapies Tumor-Infiltrating Lymphocyte Therapies Market Dynamics: Conjoint Analysis of Emerging Tumor-Infiltrating Lymphocyte Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Tumor-Infiltrating Lymphocyte Therapies Market Access and Reimbursement Discover more about tumor-infiltrating lymphocyte therapies in development @ Tumor-Infiltrating Lymphocyte Therapies Clinical Trials Table of Contents Related Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer 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 NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, Pfizer, GSK, Gilead Sciences, BieGene, Nuvalent, among others. 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The FDA on Tuesday greenlit Insmed's Brinsupri (brensocatib), making the DPP1 inhibitor the first drug approved to treat non-cystic fibrosis bronchiectasis (NCFB). Patients with the chronic disease have permanently widened airways and are susceptible to persistent inflammation and infection, reducing lung function and causing lasting damage. The oral, once-daily drug — cleared for patients aged 12 and older — is designed to block the activation of neutrophil serine proteases in neutrophils that are responsible for the underlying inflammation in NCFB. "For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations," commented Doreen Addrizzo-Harrisa, a professor of pulmonary, critical care and sleep medicine at the New York University Grossman School of Medicine and director of the NYU Langone Health Bronchiectasis and NTM Program. "Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care," Addrizzo-Harrisa added. She also served as an investigator on Brinsupri's pivotal ASPEN study.The Phase III trial randomised 1680 adults and 41 adolescents to receive either a daily 10-mg or 25-mg dose of the DPP1 inhibitor, or placebo, for 52 weeks. Compared with placebo, the low and high doses of Brinsupri led to statistically significant 21.1% and 19.4% reductions in the annualised rate of pulmonary exacerbations, respectively, achieving the primary endpoint. Both doses also met several secondary endpoints, including prolongation of time to first pulmonary exacerbation and increase in the odds of remaining exacerbation free.The drug was well tolerated, with the most common adverse reactions occurring in ≥2% of APSEN participants being upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis and hypertension.What's next?Insmed's shares jumped about 6% on the approval news Tuesday. Brinsupri is immediately available to US patients — and the drugmaker has already financially readied for the rollout. It raised a $750-million follow-on in June in part to fund the NCFB treatment's commercialisation. Outside the US, Insmed has already submitted regulatory applications in the EU and UK, and is planning a Japanese filing this year. If approved, the company plans to launch Brinsupri in these additional regions next year. Competition could also be incoming for Brinsupri, though not for several years. On Monday, Expedition Therapeutics paid $17 million upfront for ex-China rights to Shanghai Fosun Pharmaceutical's XH-S004, an oral small molecule in mid-stage testing for NCFB.

SHANGHAI, Aug. 11, 2025 /PRNewswire/ -- On August 11, Fosun Pharma (SSE:600196, HKEX: 02196) announced that its subsidiary Fosun Pharma Industrial has signed a License Agreement with Expedition Therapeutics Inc.(Expedition) to grant Expedition the rights to develop, manufacture, and commercialize XH-S004, an orally administered dipeptidyl peptidase 1 (DPP-1) inhibitor independently developed by Fosun Pharma, in all regions globally except Chinese Mainland, Hong Kong SAR and Macau SAR. Fosun Pharma will retain the rights to develop, manufacture, and commercialize XH-S004 in Chinese Mainland, Hong Kong SAR and Macau SAR. Under the agreement, Expedition will pay Fosun Pharma up to US$120 million including upfront payment and development milestone payments. In addition, based on the annual net sales of XH-004 in the licensed territories, Expedition will pay up to US$525 million in sales milestone payments as stipulated in the contract. XH-S004 is a small molecule orally administered DPP-1 inhibitor independently developed by Fosun Pharma. It reduces inflammatory responses and blocks the infection cycle and airway structural damage by inhibiting DPP-1 and the neutrophil serine proteases activated by it. As of now, XH-S004 is in Phase II clinical trials in China for the treatment of non-cystic fibrosis bronchiectasis and in Phase 1b clinical trials for the treatment of chronic obstructive pulmonary disease(COPD). Currently, no small molecule orally administered inhibitors with the same mechanism of action have been approved for marketing worldwide. "We are very pleased to have reached this collaboration with Expedition. XH-S004 is an innovative drug independently developed by Fosun Pharma for the treatment of respiratory system diseases, and its unique mechanism and clinical value have been highly recognized by our partners." Chen Yuqing, Chairman of Fosun Pharma said, "By working together with Expedition, the professional teams and rich industry experience of both parties will provide strong support for the global development and commercialization of XH-S004, further expanding the accessibility of this product and enabling global patients to benefit from this innovative therapy as soon as possible." "We are pleased to be working with Fosun Pharma, one of the leading pharmaceutical companies in China. XH-S004 is an exciting compound that targets neutrophilic inflammation, an important underlying driver of a number of chronic respiratory diseases." Yi Larson, Chairman and CEO of Expedition said, "We look forward to partnering with Fosun Pharma in the development of XH-S004 for COPD and other neutrophilic inflammatory diseases to address the significant unmet medical need." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy - Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence, and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide. About Expedition Expedition Therapeutics was incorporated in Delaware in March 2024. It is a biotechnology company specializing in the research and development of innovative therapies for autoimmune diseases with a core management team of experienced professionals with deep expertise in multinational pharmaceutical and biotechnology companies R&D, business development and operational excellence. Expedition's current investors include several well-known investment institutions in the United States with extensive industry investment experience. SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED