Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

Start Date01 Dec 2025

Sponsor / Collaborator

Sonire Therapeutics Inc

NCT05700448

/ Not yet recruitingPhase 3

A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

Start Date01 Dec 2025

Sponsor / Collaborator

CStone Pharmaceuticals Co. Ltd.

NCT07129772

/ Not yet recruitingPhase 2

A Multicenter, Single Arm Phase II Study on Pembrolizumab and Chemotherapy as Perioperative Treatment Followed by Nasopharyngectomy and Maintenance Pembrolizumab for Locally Recurrent Nasopharyngeal Carcinoma (PINNACLE)

Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China and southeast Asia. Despite intensive radical therapy, between 15% and 30% of NPC patients develop relapse. Recent phase III randomized-controlled trials conducted in China demonstrated an improvement of progression-free survival with combinational therapy immune checkpoint inhibitors (ICI) (camrelizumab, toripalimab, and tislelizumab, respective) and chemotherapy gemcitabine (G) and cisplatin (P) compared with chemotherapy GP alone for recurrent or metastatic NPC. However, none of these studies have described in details the treatment outcomes of those subjects with locally recurrent NPC only, and whether any of these patients would undergo radical surgery to remove the residual locally recurrent NPC after ICI and chemotherapy. Continuation of the same ICI as maintenance therapy may only be the treatment option for these patients who were recruited into these phase III trials, unless if they withdrew from the study and opted for radical resection. While continuing the same ICI may still lead to persistent objective response and disease control, there is a possibility of tumor recurrence leading to unresectable disease and a worse survival outcome, or unexpected, rare but recognized immune-related emergent adverse events with ICI. Radical resection after maximal response to ICI and chemotherapy for patients with locally recurrent NPC only may provide a chance of cure of the disease and these patients may be obviated from continuous exposure to ICI therapy.
In view of the above, we are now proposing a phase II single-arm study on perioperative pembrolizumab and chemotherapy followed by radical surgery for locally recurrent NPC. As a collateral study, we will also perform single-cell DNA and RNA sequencing and proteomics study to observe the tumor and immune microenvironment which certainly helps us decipher the mechanisms of tumor response at genomic, transcriptomic and proteomic levels.

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Hong Kong

[+3]

100 Clinical Results associated with Gemcitabine

100 Translational Medicine associated with Gemcitabine

100 Patents (Medical) associated with Gemcitabine

27,356

Literatures (Medical) associated with Gemcitabine

01 Feb 2026·BIOMATERIALS

Mitocytosis-inducing nanoparticles alleviate gemcitabine resistance via dual disruption of pyrimidine synthesis and redox homeostasis in pancreatic ductal adenocarcinoma

Article

Author: Song, Haolin ; Sun, Tao ; Jiang, Chen ; Fan, Hongrui ; Cheng, Leilei ; Chen, Qinjun ; Su, Boyu ; Li, Xuwen ; Wang, Yu

Metabolic reprogramming in pancreatic ductal adenocarcinoma (PDAC) poses a significant challenge to the efficacy of gemcitabine-based chemotherapy. Aberrant activation of intracellular pyrimidine metabolism is a key factor contributing to the reduced effectiveness of gemcitabine. Combining gemcitabine with metabolic regulators targeting critical pathways may alleviate gemcitabine resistance. In this study, we focus on the abnormal activation of dihydroorotate dehydrogenase (DHODH) in PDAC cells, a pivotal enzyme in the de novo pyrimidine synthesis pathway that diminishes cellular sensitivity to gemcitabine and catalyzes the reduction of ubiquinone to ubiquinol, playing an essential role in maintaining cellular redox homeostasis. To address these challenges, we developed GE11 peptide-modified polyphenol-iron chelate nanoparticles for co-delivery the long carbon chain-modified gemcitabine and the DHODH inhibitor leflunomide, with peptide modification enabling nanoparticles to target PDAC cells with high expression of epidermal growth factor receptor. The nanoparticles demonstrated the ability to induce mitocytosis and achieve deep tumor penetration in PDAC tissues. Upon drug release at the core lesion, the three components, modified gemcitabine, leflunomide and iron ions synergistically enhanced tumor cell killing by alleviating gemcitabine resistance and disrupting cellular redox homeostasis to induce multimodal cell death. In an in situ pancreatic cancer mouse model, this strategy exhibited superior anti-tumor efficacy compared to the standard AG chemotherapy regimen (nab-paclitaxel and gemcitabine), even at a 6.3-fold lower gemcitabine concentration. These findings underscore the potential of this approach as a highly effective therapeutic strategy for PDAC treatment.

31 Dec 2025·Molecular & Cellular Oncology

CHK1 inhibition overcomes gemcitabine resistance in non-small cell lung cancer cell A549

Article

Author: Ma, Xuan ; Liang, Ai-Ling ; Fu, Tian ; Wang, Wen-Xuan ; Ke, Zhi-Yin ; Wang, Xue-Chun ; Liu, Yong-Jun ; Yin, Hai-Han

The purpose of the study is mainly to investigate anti proliferation of non-small cell lung cancer A549 cells and its mechanism by inhibition of CHK1 expression combined with gemcitabine. The mRNA and protein levels of genes were analyzed by RT-qPCR and Western blot, respectively. Cell viability was detected by CCK-8 assay and clone formation assay. The detection of the cell cycle was used by Annexin V/7-amino-actinomycin D apoptosis detection kit. Analysis of DNA damage was done by immunofluorescence and alkaline comet assay. The results showed that inhibition of CHK1 and gemcitabine combination significantly reduced the proliferation ability of the two cell lines. We also revealed the degradation of full-length PARP and reduced Bcl-2/Bax ratio on increased apoptosis. Inhibition of CHK1 expression leads to DNA damage, induces phosphorylation of γ-H2AX, and affects the repair of homologous recombination ability through Rad51. Mechanistically, gemcitabine increased phosphorylation-ATR and phosphorylation-CHK1, indicating activation of the DNA repair system and ATR-CHK1-CDC25A pathway. Inhibition of CHK1 resulted in increased synthesis of CDK2/Cyclin A2 and CDK2/Cyclin E1 complexes, and more cells entered the subsequent cell cycle, leading to S phase arrest and mitotic catastrophe. We identified inhibition of CHK1 as a potential treatment for NSCLC and confirmed that inhibition of this kinase could overcome acquired gemcitabine resistance.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

913

News (Medical) associated with Gemcitabine

19 Aug 2025

·www.prnewswire.com

Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC

CHENGDU, China, Aug. 19, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) announced that clinical data from a Phase II study evaluating novel TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with PD-L1 monoclonal antibody (mAb) tagitanlimab for the first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) have been published in Nature Medicine (Impact Factor: 58.7). The publication highlighted initial findings from the Phase II OptiTROP-Lung01 study, evaluating the efficacy and safety results of sac-TMT in combination with tagitanlimab as a first-line treatment of advanced or metastatic NSCLC patients without actionable genomic alterations. The study was led by Prof. Zhang Li's team at the Center for Cancer Prevention and Control, Sun Yat-sen University, China. Patients in Cohort 1A received sac-TMT (5 mg/kg, Q3W) plus tagitanlimab (1200 mg, Q3W) in a three-week cycle, while patients in Cohort 1B were treated with sac-TMT (5 mg/kg, Q2W) plus tagitanlimab (900 mg, Q2W) in a four-week cycle. Patients received sac-TMT in combination with tagitanlimab in a non-randomized manner until disease progression or unacceptable toxicity. Median follow-ups for Cohort 1A and Cohort 1B were 19.3 months and 13.0 months, respectively (Data cutoff date: May 27, 2024). The study results demonstrated promising anti-tumor activity, and manageable safety of sac-TMT in combination with tagitanlimab as a first-line treatment for advanced or metastatic NSCLC patients. A total of 40 patients in Cohort 1A and 63 patients in Cohort 1B were included in the full analysis set (FAS) for efficacy assessment. In Cohort 1A and Cohort 1B, respectively, the confirmed objective response rates (ORRs) were 40.0% (95% CI: 24.9–56.7) and 66.7% (95% CI: 53.7–78.0), and the ORRs were: 44.4% and 64.7% among patients with non-squamous carcinoma, 36.4% and 69.0% with squamous carcinoma; 41.7% and 57.1% among patients with PD-L1 tumor proportion score (TPS) <1%; 38.5% and 63.2% for TPS 1–49%; 40.0% and 78.3% for TPS ≥50%. The median progression-free survival (mPFS) for Cohort 1A was 15.4 months (95% CI: 6.7–17.9) and not reached (95% CI: 9.6–NE) for Cohort 1B. The most common grade ≥3 treatment-related adverse events (TRAEs) for both Cohorts 1A and 1B were decreased neutrophil count, decreased white blood cell count and anemia. No treatment-related deaths were observed. Subgroup analyses showed consistent efficacy across PD-L1 and TROP2 expression levels, as well as in both squamous and non-squamous histological subtypes. Dr. Michael Ge, CEO of Kelun-Biotech, commented: "The OptiTROP-Lung01 study supports the promising efficacy and safety of sacituzumab tirumotecan in combination with tagitanlimab as a first-line treatment for patients with advanced NSCLC. The results were observed across PD-L1/TROP2 expression levels and histological subtypes and support the advancement potential of sac-TMT from later-line to front-line therapy. The publication of results from several studies in top-tier international journals reflects the recognition of our innovation-driven development strategy. We will continue to work to address critical clinical challenges and unmet medical needs, striving to deliver more therapeutic options and improve quality of life for patients." About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . Media: [email protected] SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Drug ApprovalPriority Review

18 Aug 2025

·www.prnewswire.com

KELUN-BIOTECH ANNOUNCES 2025 INTERIM RESULTS

Revenue reached approximately RMB950.4 million, with total commercial sales RMB309.8million, representing a significant increase in proportion Research and development expenses was approximately RMB611.5 million Loss for the period was RMB145.2 million; adjusted loss for the period[1] was RMB69.4 million Cash and cash equivalents[2] amounted to approximately RMB4527.8 million, reflecting ample cash reserves CHENGDU, China, Aug. 18, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (" Kelun-Biotech" or the " Company", Stock Code: 6990.HK) announced its unaudited interim results for the six months ended 30 June 2025 (the " Reporting Period"). In the first half of 2025, China's biopharmaceutical industry reached an inflection point for high-quality growth, driven by accelerated innovation in drug research and development, the rollout of favorable policies, increasing momentum in industry collaboration and mergers and acquisitions. Kelun-Biotech capitalized on these opportunities by its proprietary technology platforms, innovation-led R&D, and a well-established commercialization infrastructure. These elements have worked together to enable the Company to establish a fully integrated model covering R&D, clinical development, manufacturing, and commercialization. Focusing on addressing significant unmet medical needs in both oncology (such as breast cancer (BC), non-small cell lung cancer (NSCLC), and gastrointestinal (GI) cancers including gastric cancer (GC) and colorectal cancer (CRC)) and non-oncology diseases, the Company has developed a rich and diverse pipeline of over 30 candidates. More than 10 of these candidates have already entered clinical stage. At the same time, the Company continues to invest in next-generation conjugation technologies and a diversified portfolio of assets, aiming to deliver innovative therapies for patients worldwide and contribute to the improvement of global healthcare. ADC & novel DC assets b reakthroughs are redefining the treatment landscape. sac-TMT (sacituzumab tirumotecan, SKB264/MK-2870, 佳泰萊 ® ) The first TROP2 ADC drug approved for marketing in LC globally. TNBC : Approved by the National Medical Products Administration ("NMPA") for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC. HR+/HER2- BC. In May 2025, the NDA for sac-TMT for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the NMPA, and was included in the priority review and approval process. A Phase 3 registrational study of sac-TMT versus investigator's choice of chemotherapy for treatment of patients with unresectable locally advanced, recurrent or metastatic HR+/HER2- BC who received prior endocrine therapy is in progress. EGFR-mutant NSCLC. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS compared with docetaxel. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress. EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT in combination with pembrolizumab are in progress. In June 2025, sac-TMT in combination with tagitanlimab was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations. Other indications. The Company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC and HNSCC. Global clinical development . As of August 18, 2025, MSD is progressing 14 ongoing Phase 3 global, multi-center clinical studies for sac-TMT for several types of cancer including BC, LC, gynecological cancer and GI cancer. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing. Trastuzumab Botidotin (HER2 ADC, A166 , 舒泰萊 ® [1] ) In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ and advanced HER2+ BC based on results from the primary analysis, and the NDA has been submitted to the NMPA. The Company has initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase 1 inhibitor ADC. Other ADC Products SKB315 (CLDN18.2 ADC) : the company is conducting a Phase 1b clinical trial of SKB315 and have initiated the exploration in combination with immunotherapy for the treatment of GC/GEJC. Results of a Phase 1 study of SKB315 will be presented at 2025 ESMO Congress in October 2025. SKB410/MK-3120 (Nectin-4 ADC) : has shown promising Phase 1 clinical data. MSD, as the partner, has launched the global Phase 1/2 clinical trial of SKB410. SKB571/MK-2750 : a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 2 clinical trial in China is to be initiated. SKB518, SKB535/MK-6204 and SKB445 : novel ADC drugs with potential FIC targets. The Phase 2 clinical trial for SKB518 and the Phase 1 clinical trials for SKB535 and SKB445 are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535. SKB500 and SKB501 : novel ADC drugs with verified targets but differentiated payload-linker strategies. The company been received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA. SKB107 : a RDC drug jointly developed by the Company and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting bone metastases in solid tumors. In March 2025, an IND application for SKB107 was approved by the NMPA and the Phase 1 study is ongoing. Non-DC asset advancements are diversifying the innovation pipeline. Tagitanlimab (PD-L1 mAb ; A167 ; 科泰莱 ® ) : The first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. We have received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, we received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA. Cetuximab N01 (EGFR mAb; A140; 达泰莱 ® ) An EGFR mAb compared with Cetuximab Solution for Injection (Erbitux ® ) In February 2025, we received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC. A400/EP0031 (RET inhibitor) : The Company is currently conducting pivotal clinical studies for 1L & 2L+ advanced RET+ NSCLC as well as a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China. Through the Company's collaboration and license agreement, Ellipses Pharma is progressing their phase 2 clinical study globally outside of China. SKB378/WIN378 (TSLP mAb): In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA. The Company's collaboration partner, Windward Bio, has launched the Phase 2 POLARIS trial in patients with asthma. SKB336 (FXI/FXI a mAb): The Phase 1 clinical trial has been completed in China. A296 (STING agonist): A Phase 1 trial is being carried out in China. Commercialization Accelerates: Sales & Market Access Expanding Footprint Sac- TMT (佳泰莱®), tagitanlimab (科泰莱®) and Cetuximab N01 (达泰莱®) have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin (舒泰莱®) in the China market and file one NDA for A400 in the second half of 2025. Sales performance: The total commercial sales reached RMB309.8 million for the first half of 2025. Among them, the sales of sac-TMT (佳泰莱®) accounted for 97.6%. At the same time, all accounts receivables from sales of pharmaceutical products were collected within the payment period, ensuring efficient and stable cash flow. Market coverage and academic promotion: Currently, the company's businesses have covered 30 provinces, over 300 prefectures, and over 2,000 hospitals, where over 1,000 hospitals generated sales, and reached tens of thousands of healthcare professionals through various types of marketing campaigns to convey product and medical professional information. In addition, the company has obtained authoritative endorsement for its products from experts in clinical guidelines, providing further support for the commercialization process. Commercialization system: The Company has established a fully-fledged marketing team of over 350 people, with a departmental structure that includes marketing, sales, medical affairs, strategic planning and commercial excellence, among other departments, as well as marketing compliance and KA functions. Through the efficient execution of the marketing team, the company has established relationships with multiple leading commercial and distribution groups, including 60+ Tier 1 distributors and 400+ DTP pharmacies. A hierarchical management system for pharmacy retail has been adopted and trainings have been provided to around 4,500 pharmacists in the first half of 2025. By organizing nationwide pharmacy trainings, the company has significantly enhanced the professionalism of terminal services and improved the ability to provide patients with medication guidance. Market a ccess: In the first half of 2025, sac-TMT (佳泰莱®), tagitanlimab (科泰莱®) and Cetuximab N01 (达泰莱®) have been included in 29, 25 and 15 provincial networks, respectively, ensuring rapid market access through provincial procurement channels. Meanwhile, preparations for the National Reimburesement Drug List (國家醫保藥品目錄) access of marketed products are underway. Currently, sac-TMT (佳泰莱®), tagitanlimab (科泰莱®) and Cetuximab N01 (达泰莱®) have all passed the preliminary formal examination of National Reimbursement Drug List. Meanwhile, to further reduce the burden of patients and implement the concept of inclusive healthcare, the company been proactively facilitating the enrollment of sac-TMT (佳泰莱®) in provincial and prefecture city level Inclusive Insurance (惠民保). As at the end of the Reporting Period, sac-TMT (佳泰莱®) has been enrolled in more than 7 provinces and 20 cities. Global m arket : Globally, we will continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide. Global Collaboration Network Expansion & Authoritative Industry Recognition In the first half of 2025, the Company continued to expand its global collaboration network and deepen partnerships. Working closely with collaborators, it is advancing clinical research worldwide with the goal of maximizing the global value of its pipeline, delivering high-quality medical solutions to patients, and strengthening its leading position in the biopharmaceutical sector. Collaboration with MSD : As of the date of this announcement, MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as monotherapy or in combination with pembrolizumab or other agents, for several types of cancer including BC, LC, gynecological cancer and GI cancer. In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios. Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has been cleared by the FDA to progress into Phase 2 clinical development. As of June 30, 2025, Ellipses Pharma had set up a total of 36 clinical sites in the United States, Europe and UAE for EP0031. Collaboration with Windward Bio : In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). In the first half of 2025, the Company earned high recognition from professional institutions and industry associations for its outstanding corporate management, product innovation, and strong performance in the capital market. In May 2025, the Company received "Asia's Best Company" award from FinanceAsia (亞洲金融), as well as a series of awards from Extel, including "Most Honored Company", "Best Company Board", "Best CEO", "Best CFO", "Best ESG" and etc.. The Company was also awarded "IRM OF CHINESE LISTED COMPANIES" by Securities Times (證券時報). In July 2025, the Company was recognized with the "China Pharmaceutical Emerging Innovative Force Award" by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心). Additionally, the Company continues to strengthen its ESG strategy and improve its ESG governance structure to support sustainable development. The Company has established a comprehensive three-tier ESG governance structure consisting of the Board of Directors, ESG Working Group and ESG Executive Body. Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability. Outlook In the second half of 2025, the Company will continue to advance its differentiated pipelines targeting indications with significant medical needs, innovate and optimize payload-linker strategies, novel DC designs and structures, and expand application to non-oncology diseases. Meanwhile, the Company will further enhance its end-to-end drug development capabilities, advance towards commercialization and actively expand global footprints and strategic partnerships to maximize the value of its pipelines. In addition, the Company will continuously optimize its operation system to become a leading global biopharmaceutical company. About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, production, commercialization, and international collaboration of innovative biotechnology and small-molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, inflammation, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 3 projects that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC development platform, OptiDCTM, with 1 ADC project approved for market launch, 1 ADC project at the NDA stage, and several ADC or novel ADC projects in clinical or preclinical development. For more information, please visit the official website: . For further information, please contact: Wonderful Sky Financial Group Ltd. Angie Li & Jason Lai Tel: (852) 6150 8598 / (852) 9798 0715 Email: [email protected] SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 2Phase 3Drug ApprovalLicense out/in

12 Aug 2025

·pipelinereview.com

KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery

First and only systemic therapy to improve survival when used before and after surgery for patients with MIBC who are ineligible for cisplatin-based chemotherapy First ever positive Phase 3 study in this cisplatin-ineligible patient population, representing significant advancement in MIBC RAHWAY, NJ, USA I August 12, 2025 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. In this study, KEYTRUDA ® (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to surgery (radical cystectomy) alone. “Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen any treatment advance beyond surgery and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed,” said Dr. Christof Vulsteke, MD, PhD, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. “The KEYNOTE-905 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet need.” The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer (previously Seagen) and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer. The trial is continuing to evaluate the secondary EFS, OS, and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature. “There is a real and pressing need for more effective options for patients with bladder cancer who are ineligible for cisplatin-based treatment,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The compelling survival results observed in this study reinforce the potential of combining KEYTRUDA with an antibody-drug conjugate to help address a significant unmet need in this vulnerable population.” The safety profile of KEYTRUDA plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide and will present the data at an upcoming medical meeting. KEYTRUDA plus Padcev is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA as monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC). Five additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Three of these studies are in MIBC including KEYNOTE-866 ( NCT03924856 ), KEYNOTE-992 ( NCT04241185 ) and KEYNOTE-B15 ( NCT04700124 ), which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas. KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 ( NCT03711032 ) trial, and as adjuvant treatment in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma KEYNOTE-123 ( NCT03244384 ). About KEYNOTE-905/EV-303 KEYNOTE-905, also known as EV-303, is an open-label, randomized, multi-arm, controlled, Phase 3 trial (ClinicalTrials.gov, NCT03924895 ) evaluating perioperative KEYTRUDA, with or without Padcev, versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. The trial enrolled 595 patients who were randomized to receive either: The primary objective of this trial was to compare EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. The key secondary objectives were to compare OS and difference in pCR rate between arm C and arm B, as well as EFS, OS and the difference in pCR rate between arm A and arm B. The study remains ongoing to test hypotheses between arm A and arm B. About bladder cancer Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases. The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone. About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with more than 25 ongoing registrational studies across multiple types of cancer. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . About the Merck, Pfizer and Astellas collaboration Merck previously entered a clinical collaboration agreement with Seagen and Astellas to evaluate the combination of Merck’s KEYTRUDA ® (pembrolizumab) and Seagen’s and Astellas’ Padcev ® (enfortumab vedotin-ejfv) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. Padcev ® and the Padcev device are trademarks jointly owned by Agensys, Inc., and Seagen Inc. Pfizer Inc. completed its acquisition of Seagen on December 14, 2023. SOURCE: Merck

Clinical ResultPhase 3Drug ApprovalAccelerated Approval

100 Deals associated with Gemcitabine

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KEGG	Wiki	ATC	Drug Bank
D02368	Gemcitabine	L01BC05	DB00441

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	-	RenovoRx, Inc.	01 Jun 2023
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	Australia	Panbela Therapeutics, Inc.	04 Aug 2022
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	United States	RenovoRx, Inc.	12 Mar 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	Belgium	RenovoRx, Inc.	12 Mar 2018
Advanced Lung Squamous Cell Carcinoma	Phase 3	United States	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Belgium	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Canada	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	France	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Germany	Sanofi	01 Mar 2010
Advanced Lung Squamous Cell Carcinoma	Phase 3	Hungary	Sanofi	01 Mar 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02807181 (SIRCCA, CTgov)	Phase 2/3	Unresectable Intrahepatic Cholangiocarcinoma	89	gemcitabine+Cisplatin (Chemotherapy (Cisplatin-Gemcitabine))	qhsgqgzqcf(vwvaewwlch) = hanwyyeysd daquzwjesx (zjtugcauuf, vgqxjbrfis - gszbkhrdqo) View more	-	09 May 2025
NCT02807181 (SIRCCA, CTgov)	Phase 2/3	Unresectable Intrahepatic Cholangiocarcinoma	89	Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)+gemcitabine+Cisplatin (Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine))	qhsgqgzqcf(vwvaewwlch) = aybrobbcxy daquzwjesx (zjtugcauuf, fsreuaoogz - pzxqudtimd) View more	-	09 May 2025
NCT04602078 (AUREA \| SOGUG-AUREA, CTgov)	Phase 2	Urothelial Carcinoma of the Urinary Bladder \| Locally Advanced Urothelial Carcinoma \| Metastatic urothelial carcinoma	82	Cisplatin 70 mg/m2+Gemcitabine 1000 mg/m2+Atezolizumab 1200 mg/m2	hxxezdjiwe = dqxywnvovt mfgsesnyqp (cgaqxdhtfk, rxmdheuysl - gfhdmolvtn) View more	-	24 Apr 2025
ASCO_GU2025	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	30	Intravesical Gemcitabine and Docetaxel	xbgezozdmb(jlknhkeodl) = rpizlkgssc ddfbbpvbaq (xtcgxhxdnh ) View more	Positive	13 Feb 2025
NCT01972919 (CTgov)	Phase 2	Pancreatic carcinoma non-resectable	23	Radiation Therapy+Gemcitabine+Capecitabine	rzyqzuukfi = zfxtglzljv dcgliklaia (wutprgowmr, jmhozvfant - znwrobhbls) View more	-	10 Feb 2025
NCT03257033 (TIGeR-PaC, ASCO_GI2025)	Phase 3	Locally Advanced Pancreatic Adenocarcinoma	19	Intra-arterial gemcitabine	ftbtgglgro(flidlsbmrm) = epgokwhuhk invcxtqxws (tudcxqtjpo )	Positive	23 Jan 2025
NCT03257033 (TIGeR-PaC, ASCO_GI2025)	Phase 3	Locally Advanced Pancreatic Adenocarcinoma	19	Intravenous gemcitabine	ftbtgglgro(flidlsbmrm) = zknqbcaogr invcxtqxws (tudcxqtjpo )	Positive	23 Jan 2025
ACTRN12623000223639 (ASCO_GI2025)	Not Applicable	Advanced Pancreatic Ductal Adenocarcinoma	30	Gemcitabine + Nab-paclitaxel + LSTA-1 + Durvalumab	zqmfvzmjzi(nopxkhmzsc) = vucsenqfpl uhxfnmvdoo (mcvjszdjny )	Positive	23 Jan 2025
NCT04229004 (Precision Promise (PrP), ASCO_GI2025)	Phase 2/3	Metastatic Pancreatic Cancer Second line	317	Pamrevlumab plus nab-paclitaxel/gemcitabine (Pam + GA)	wyvxtdzjdt(mzoqhuguzw): HR = 1.18 (95% CI, 0.88 - 1.56), P-Value = 0.14 View more	Negative	23 Jan 2025
NCT04229004 (Precision Promise (PrP), ASCO_GI2025)	Phase 2/3	Metastatic Pancreatic Cancer Second line	317	Gemcitabine/Abraxane (GA)		Negative	23 Jan 2025
ASH2024	Not Applicable	Classical Hodgkin's Lymphoma	-	Pembrolizumab Gemcitabine Vinorelbine and Liposomal Doxorubicin (P-GVD)	zciyeerlve(gwqdszefoa) = corwaicxtd cwthhxpsck (dwanzlgcji ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Glofitamab with Gemcitabine and Oxaliplatin	sductbhbcu(cvjdgeukgc) = xwqbssekkx vjiduwlcqq (xjvptgjxto, NA) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Rituximab with Gemcitabine and Oxaliplatin	sductbhbcu(cvjdgeukgc) = qwisvwzgkk vjiduwlcqq (xjvptgjxto, NA) View more	-	09 Dec 2024
ASH2024	Not Applicable	Refractory Hodgkin Lymphoma	-	Pembrolizumab Maintenance	bsbeffaaiy(zduvuxbpxq) = omvrczrtut uqrdzhluxa (ttvjeurcgg, 33 - 80)	-	08 Dec 2024

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