RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)

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Sequence Code 616718896H

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Sequence Code 616718897L

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183

Clinical Trials associated with Disitamab Vedotin

NCT07279597

/ Not yet recruitingPhase 2IIT

An Open, Single-arm Clinical Study on the Efficacy and Safety of Toripalimab Combined With RC48-ADC in Radiotherapy for HER-2 Positive Muscle-invasive Bladder Cancer (MIBC) Patients for Bladder Preservation Treatment After Chemotherapy Induction

This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status. Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.

Start Date10 Dec 2025

Sponsor / Collaborator-

NCT07201675

/ Not yet recruitingPhase 2IIT

Vedisertib (RC48/ADC) Combined With Toripalimab in Bladder-preserving Treatment

This is a phase II clinical study to evaluate the efficacy of RC48-ADC combined with toripalimab bladder-sparing therapy.
The RC48-ADC dose in this study is 2.0 mg/kg Q2W and toripalimab is 3 mg/kg Q2W.
This study plans to enroll 59 participants. The participants will start drug therapy within 2 weeks after the first diagnostic resection in the first stage, receiving RC48-ADC combined with toripalimab 3 times. At the 8th week after enrollment, the second stage of cystectomy was performed, and RC48-ADC combined with toripalimab was treated every two weeks thereafter for a total of 3 treatments. After the completion of the two-stage treatment, the participants should be discharged from the group by cystoscopy or other imaging examinations. On the contrary, if the participants have complete remission or partial remission, continue to the third stage of treatment, that is, receive RC48-ADC combined with toripalimab every two weeks for a total of 6 treatments, followed by cystoscopy, imaging, or a third cystectomy. If the participants achieve complete remission of the disease, maintenance immunotherapy will be given for 12 months. If the participants show that there is still a tumor, the participants will be discharged from the group for other treatments. Due to disease progression, death, participants voluntarily requested termination of study treatment, toxicity intolerance, initiation of new anti-tumor therapy, pregnancy, serious violation of the study process stipulated by the protocol, termination of study treatment determined by the investigator based on the best interests of the participants, loss to follow-up, whichever occurred first.
During the study, the first and second electrotoxic tissues were sequenced using RNA and single-cell sequencing, and ctDNA was tested in urine before treatment, in the third month, and in the sixth month.

Start Date01 Dec 2025

Sponsor / Collaborator

Qilu Hospital of Shandong University

NCT07207824

/ Not yet recruitingPhase 3IIT

A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer

The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.

Start Date01 Dec 2025

Sponsor / Collaborator

Fudan University

[+2]

100 Clinical Results associated with Disitamab Vedotin

100 Translational Medicine associated with Disitamab Vedotin

100 Patents (Medical) associated with Disitamab Vedotin

659

Literatures (Medical) associated with Disitamab Vedotin

31 Dec 2025·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

Author: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Barzaghi-Rinaudo, Patrizia ; Sagar, Vivek ; Hainzl, Dominik ; Korn, Joshua ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; D’Alessio, Joseph A. ; Synan, Alyssa

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

31 Dec 2025·ANNALS OF MEDICINE

Disitamab vedotin plus programmed death-1 inhibitor for pre-treated HER2 overexpressed advanced gastric cancer: a multicentre retrospective real-world study

Article

Author: Li, Zhiwei ; Lai, Mingyu ; Ouyang, Kaobin ; Li, Fengping ; Huang, Kaihua ; Yang, Li ; Zhao, Liying ; Zhang, Huimin ; Zhong, Rou ; Xie, Qing ; Liang, Huayuan ; Yan, Xiao ; Xie, Zhong ; Huang, Tianying ; Qiu, Miaozhen ; Lai, Min

BACKGROUND:

The efficacy of pre-treated advanced gastric or gastroesophageal junction cancer (G/GEJC) with HER2 overexpressed (IHC 2+/3+) remains unsatisfactory. This retrospective real-world study aimed to analyse the safety and efficacy of disitamab vedotin (RC48) plus programmed death-1 (PD-1) inhibitor in pre-treated patients with advanced G/GEJC.

PATIENTS AND METHODS:

We retrospectively reviewed consecutive patients with HER2 2+/3+ advanced G/GEJC who received RC48 plus PD-1 inhibitor or RC48 monotherapy from four Chinese hospitals (July 2021 to September 2023). ORR and DCR were estimated by logistic regression. Survival was analysed via Kaplan-Meier method and log-rank tests. Subgroup and post hoc power analyses were performed.

RESULTS:

Fifty-seven patients were enrolled: 36 received RC48 plus PD-1 inhibitor (combination group) and 21 received RC48 alone (monotherapy group). The combination group demonstrated a significantly higher ORR than the monotherapy group (41.7% vs. 9.5%, p = 0.011). Although the DCR was not significantly different (75.0% vs. 57.1%, p = 0.162), the combination group showed a significantly prolonged mOS (13.2 months vs. 7.1 months, p = 0.040) and a trend towards longer mPFS (5.8 months vs. 2.9 months, p = 0.142). In the combination group, patients with initial HER2 3+, second-line treatment, or liver metastasis had more favourable outcomes. The incidence of grade 3-4 TrAEs was comparable between the two groups (41.7% vs. 38.1%).

CONCLUSIONS:

RC48 plus PD-1 inhibitor for pre-treated advanced G/GEJC patients with HER2 2+/3+ demonstrated superior efficacy than RC48 monotherapy and favourable safety. This combination represents a potential therapeutic strategy, but further large-scale prospective studies are still needed.

01 Dec 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

RC48-targeted two-dimensional black phosphorus nanoplatform for precise photothermal-immunotherapy of HER2-positive breast cancer

Article

Author: Ni, Wenxiu ; Lin, Haoyu ; Chen, Guanyuan ; Yang, Ruiqian ; Xiao, Feiyang ; Lu, Hongwei ; Zhou, Benqing ; Lin, Ziyang ; Li, Xinrui ; Liang, Yuanke ; Chen, Shuzhao ; Fang, Xinqiang

Despite advances in targeted therapy for HER2-positive breast cancer, tumor-intrinsic resistance mechanisms including defective antigen presentation and adaptive immune suppression remain a significant challenge, constraining therapeutic efficacy. In this study, we developed a multifunctional nanotherapeutic system based on tumor-selective antibody-drug conjugate (ADC) disitamab vedotin (RC48) that co-delivered PEGylated black phosphorus (BP) and resiquimod (R848, a TLR7/8 agonist), thereby enhancing photothermal tumor ablation while activating antitumor immunity in HER2-positive breast cancer. The formed BP-PEG-RC48-R848 nanocomposites exhibited favorable photothermal stability and effectively induced the maturation of dendritic cells while promoting the secretion of pro-inflammatory M1 cytokines. In vivo fluorescence imaging demonstrated specific accumulation of the nanocomposites within HER2-positive tumors. Under near-infrared laser irradiation, the HER2-targeting nanocomposites effectively ablated primary local tumors and elicited concomitant immune activation, collectively inhibiting tumor progression in vivo. By integrating ADC drugs with photothermal-immunotherapy, the nanocomposites demonstrated enhanced precision and synergistic antitumor efficacy of HER2-positive breast cancer.

News (Medical) associated with Disitamab Vedotin

20 Oct 2025

·www.prnewswire.com

ESMO Congress 2025 Presidential Symposium Oral Presentation | Disitamab Vedotin Achieves Major Breakthrough as First-Line Treatment for Urothelial Carcinoma

BERLIN, Oct. 20, 2025 /PRNewswire/ -- At the 2025 European Society for Medical Oncology (ESMO) Congress, a Phase III clinical study on disitamab vedotin plus toripalimab versus chemotherapy as first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (RC48-C016) sponsored by RemeGen Co., Ltd. was presented at the Presidential Symposium by Professor Jun Guo from Beijing Cancer Hospital. It's the first time a research led by Chinese scholars in the field of urological oncology has ever been selected in this honorable session. The full manuscript was simultaneously published online in The New England Journal of Medicine (NEJM). This marks the first time that the results of a Chinese evidence-based medical research in the field of urothelial carcinoma have been recognized by both an authoritative international academic conference and a top-tier journal. The results showed that the RC48-C016 study met the dual primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS). The Blinded Independent Central Review (BICR)-assessed median PFS reached 13.1 months, and the median OS reached 31.5 months, demonstrating both statistical and clinical significance. The RC48-C016 trial is by now the only randomized controlled study from China providing high-level evidence for HER2-ADC as a first-line treatment of HER2-expressing (IHC 1+/2+/3+) locally advanced/metastatic urothelial carcinoma (la/mUC). The results garnered high attention and sparked lively discussion among global scholars upon release. Comprehensive Superiority: Meeting Both PFS and OS Primary Endpoints On the afternoon of October 19 (local time), a pivotal moment arrived at the ESMO Congress: Professor Guo Jun, the principal investigator of the RC48-C016 study, delivered a featured oral presentation at the Presidential Symposium, unveiling the breakthrough results globally for the first time. The RC48-C016 study is a randomized controlled, multi-center, phase III clinical trial. It compares the efficacy and safety of disitamab vedotin combined with toripalimab versus gemcitabine combined with cisplatin or carboplatin in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who have not received systemic treatment and have HER2 expression (HER2 IHC 1+/2+/3+). The study was initiated in June 2022, with 76 clinical research centers across the country participating, and a total of 484 patients were enrolled. The dual primary endpoints of the study are PFS and OS, and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), and safety, etc. Results as of March 31, 2025, showed: Regarding PFS, the median PFS in the disitamab vedotin combination group reached 13.1 months, more than doubling the 6.5 months in the chemotherapy group and reducing the risk of disease progression or death by 64% (Hazard Ratio [HR] =0.36, 95% CI: 0.28 - 0.46, P < 0.0001). The OS data were equally exciting. In this interim survival analysis, the median OS in the disitamab vedotin combination group was 31.5 months, compared to 16.9 months in the platinum-based chemotherapy group. The delayed disease progression has been well translated into long-term survival benefit as the overall survival time almost doubled as compared to chemotherapy, with a 46% reduction in the risk of death (HR = 0.54, 95% CI: 0.41 - 0.73, P < 0.0001). Regarding tumor response, the ORR assessed by BICR reached 76.1% in the disitamab vedotin combination group, far exceeding the 50.2% in the chemotherapy group. For disease control, the DCR in the disitamab vedotin combination group reached 91.4%, significantly higher than the 77.6% in the chemotherapy group. In key subgroup analyses, significant improvements in median PFS and median OS were observed in the disitamab vedotin combination group compared to the platinum-based chemotherapy across subgroups, regardless of cisplatin eligibility, HER2 expression status, or primary tumor site. Furthermore, the combination regimen demonstrated a better safety profile. The overall incidence of Grade ≥3 treatment-related adverse events was only 55.1% in the disitamab vedotin combination group, significantly lower than the 86.9% in the chemotherapy group. "This is the world's first large-scale Phase III randomized controlled clinical study in the first-line treatment of HER2-expressing Chinese mUC patients, which demonstrated that HER2-ADC combined with immunotherapy was superior to standard platinum-based chemotherapy, potentially establishing the combination therapy of disitamab vedotin and immunotherapy as the standard of care in the first-line treatment of advanced HER2-expressing mUC. This not only signifies that China's innovative drug development is leading transformations in cancer treatment globally but also provides critical rationale for exploring similar combination strategies in treating other cancers." As Professor Guo Jun commented, the result of the RC48-C016 study confirmed that the efficacy of disitamab vedotin + toripalimab combination regimen surpassed that of traditional chemotherapy as first-line treatment for advanced mUC, potentially marking a major shift in the treatment landscape for urothelial carcinoma. It promotes innovation in Chinese diagnostic and treatment pathways while providing valuable evidence for global clinical practice. During the subsequent expert commentary session, Professor Andrea Necchi from Italy's IRCCS San Raffaele Hospital spoke highly of RC48-C016 study. He pointed out that the study represents a significant breakthrough in the treatment of HER2-positive urothelial carcinoma. Compared to chemotherapy, the combination therapy of disitamab vedotin and toripalimab significantly improves patients' PFS and OS, demonstrating substantial statistical significance and clinical value, thereby offering a novel treatment option for this patient population. Precision Treatment, Benefiting the Full Spectrum of HER2-Expressing Population (IHC 1+/2+/3+) Urothelial carcinoma is the most common malignant tumor of the urinary system, representing a significant area of clinical unmet need. Chinese researchers have been at the forefront of exploring HER2-ADC therapy for UC. The HER2-ADC disitamab vedotin was first approved in China in 2021 for the treatment of HER2-overexpressing (IHC 2+/3+) advanced or metastatic urothelial carcinoma, demonstrating excellent efficacy and consistent safety with that observed in prior clinical trials. RC48-C016 study prospectively extended its clinical design to the full HER2-expressing population (IHC 1+/2+/3+). Among 765 patients tested for HER2, 632 patients had HER2-expressing characteristics (IHC 1+/2+/3+), accounting for approximately 82.6% of the tested population. The study enrolled 484 patients, who were randomized in a 1:1 ratio to groups. Stratification factors were pre-specified in the study design, primarily including cisplatin eligibility, HER2 expression status (IHC 1+ vs. IHC 2+/3+), and presence of visceral metastasis. The results showed that the efficacy observed in the disitamab vedotin plus toripalimab regimen were consistent across all pre-specified subgroups. Regardless of HER2 expression status, cisplatin eligibility, or whether the tumor originated in the upper or lower urinary tract, disitamab vedotin combined with toripalimab significantly improved PFS and OS compared to chemotherapy, robustly demonstrating its benefit for the full demonstrating its benefit for the full HER2-expressing population (IHC 1+/2+/3+) with urothelial carcinoma. "The significant survival benefit achieved by disitamab vedotin combined with toripalimab is not subject to the level of HER2 expression or cisplatin eligibility status, delivering benefit to populations with different characteristics," Professor Guo Jun stated, noting that its benefit for the full HER2-expressing population (IHC 1+/2+/3+) is one of the most groundbreaking findings of this study. Disitamab Vedotin Combined with Immunotherapy, Establishing a New Benchmark in UC First-Line Treatment Undoubtedly, RC48-C016 study is a milestone in the global first-line treatment landscape for advanced urothelial carcinoma, signifying a fundamental shift in the treatment paradigm for HER2-expressing patients: Firstly, RC48-C016 study is the world's first Phase III head-to-head trial to demonstrate that the combination of HER2-ADC and immunotherapy is significantly superior to traditional platinum-based chemotherapy in the first-line treatment of HER2-expressing (IHC 1+/2+/3+) advanced urothelial carcinoma. The release of its outstanding data on PFS, OS, ORR, and safety provides strong decision-making basis for clinicians, which will promote this combination to become a new first-line treatment standard for Chinese mUC patients and is expected to rewrite clinical guidelines. Secondly, the study successfully implements the concept of precision medicine in urothelial carcinoma based on significant biomarker characteristics. By extending the beneficiary population from the traditional HER2-high (IHC 2+/3+) to the full HER2-expressing (IHC 1+/2+/3+) population, it enables over 80% of urothelial carcinoma patients to potentially benefit significantly from this treatment regimen. In the current clinical practice in China where HER2 routine detection in urothelial carcinoma has been achieved, the study provides a preferred precise treatment plan for the majority of patients and precise basis for anti-HER2 treatment, promoting a comprehensive upgrade in the global treatment concept and strategy for urothelial carcinoma and leading the continuous exploration of this combination therapy in different disease stages of urothelial carcinoma. Thirdly, this combination regimen substantially reduces the toxicity associated with traditional platinum-based chemotherapy, significantly improving patient treatment tolerance and compliance, and providing a foundation for subsequent continuous therapy, achieving an optimized balance between tumor control, long-term survival, and quality of life. Since its marketing four years ago, disitamab vedotin, relying on its outstanding efficacy, has achieved a progress from late-line to first-line treatment in the field of urothelial carcinoma, comprehensively breaking through the bottlenecks of traditional chemotherapy and continuously expanding the boundaries of its clinical value. The revelation of RC48-C016 study data once again demonstrates its huge clinical treatment potential. Based on the breakthrough results of the RC48-C016 study, RemeGen Co., Ltd. submitted a New Drug Application (NDA) in China in July of this year for the new indication of disitamab vedotin combined with toripalimab for the first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma. This will not only address domestic clinical needs but also holds the potential to become a "Chinese Solution" influencing the global treatment landscape. It is believed that with extended follow-up, disitamab vedotin will continue to yield clinical benefit data for broader treatment prospects. SOURCE RemeGen 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 3Drug ApprovalImmunotherapyNDA

24 Sep 2025

·www.fiercepharma.com

In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to Enhertu

Jiangsu Hengrui Pharmaceuticals is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to Glenmark. Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.The focus is on emerging markets; the partnership excludes the U.S., Canada, Europe, Japan, greater China, Central Asia and a few other countries.“This collaboration with Glenmark is a significant step in Hengrui’s ongoing strategy to deepen its presence in emerging markets,” Jo Feng, president of Hengrui Pharma, said in a Sept. 24 statement (PDF). “We look forward to working together to enhance the accessibility of innovative therapies and to bring new hope to patients in more countries and regions.”For Glenmark, the deal dovetails with the company’s strategy to expand its oncology pipeline, Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, said in a statement. Last year, the Indian pharma bagged rights in certain territories to envafolimab, a subcutaneous PD-L1 inhibitor developed by a trio of Chinese companies. However, that drug has since failed in a pivotal trial in undifferentiated pleomorphic sarcoma or myxofibrosarcoma, forcing its U.S. partner Tracon Pharmaceuticals to close up shop.Hengrui is angling trastuzumab rezetecan as a direct competitor to Enhertu, which generated $3.75 billion in global sales last year and $2.29 billion in the first half of 2025. Both ADCs use trastuzumab as the antibody guide and both utilize an exatecan derivative as the toxic payload. The Hengrui med carries rezetecan, whereas Enhertu leverages deruxtecan.Rezetecan “has high membrane permeability, enabling a bystander killing effect, which further enhances the antitumor efficacy,” Hengrui explained in a securities filing.Trastuzumab rezetecan was approved in China in May 2025 for the treatment of second-line non-small cell lung cancer with HER2-activating mutations, with a breast cancer application also under review by Chinese authorities. The Glenmark licensing deal follows the granting of an orphan drug designation from the FDA for the drug in combination with Hengrui’s PD-L1 inhibitor adebrelimab and chemo in stomach cancer.Besides Enhertu, Hengrui’s HER2 ADC faces another competitor in RemeGen’s China-approved disitamab vedotin, which has been out-licensed to Pfizer. Hengrui has been busy with business development lately. Its recent deals include a potential $12 billion biobucks, up-to-12-asset deal with GSK and a lipoprotein(a) cardiovascular partnership with Merck & Co. that could be worth nearly $2 billion.In addition to HER2, Hengrui’s ADC pipeline covers other popular targets such as TROP2 (targeted by Gilead Sciences’ Trodelvy and AZ and Daiichi’s Datroway), Nectin-4 (targeted by Pfizer and Astellas’ Padcev), Claudin 18.2 (Astellas’ Vyloy), HER3 (Merck and Daiichi’s patritumab deruxtecan) and CD79b (Roche’s Polivy).

License out/inDrug ApprovalOrphan DrugADC

19 Aug 2025

·www.prnewswire.com

RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries

YANTAI, China, Aug. 18, 2025 /PRNewswire/ -- RemeGen Co., Ltd. (Stock Code: 688331.SH/09995.HK, "RemeGen"), a leading Chinese biopharmaceutical company, announced today that it has entered into an agreement with Santen Pharmaceutical (China) Co., Ltd. ("Santen China"), a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd. ("Santen"). Under the agreement, Santen China has obtained exclusive rights to develop, manufacture, and commercialize RC28-E in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) as well as in South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. RemeGen will retain global exclusive rights to RC28-E outside these regions. RemeGen will receive upfront payment of RMB 250 million, development and regulatory milestone payments of up to RMB 520 million, and sales milestone payments of up to RMB 525 million. In addition, RemeGen will be entitled to tiered royalties based on net sales of the product in the licensed territories. RC28-E is a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases, independently developed by RemeGen. On May 7, 2025, the Phase II clinical trial results of RC28-E for diabetic macular edema (DME) were presented as an oral report at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting. The study demonstrated that RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), and was also well tolerated in patients with DME. In 2023, RemeGen initiated Phase III clinical trials for RC28-E in wet age-related macular degeneration (wAMD) and DME. RemeGen plans to submit a Biologics License Application (BLA) for the DME indication in China in the second half of 2025, followed by a BLA for wAMD in mid 2026. Dr. Jianmin Fang, CEO of RemeGen, stated: "Santen brings over 130 years of expertise in ophthalmology and a robust global sales network spanning 60+ countries and regions. RC28-E, a Class 1 proprietary drug developed by RemeGen, is approaching the critical stage of BLA submission. We believe this collaboration will fully leverage the strengths of both parties to maximize the potential of RC28-E, providing innovative and effective solutions for retinal diseases. This partnership not only lays a solid foundation for the future commercialization of RC28-E but also reflects international recognition of RemeGen's capabilities in ophthalmic drug development. We look forward to jointly advancing this breakthrough therapy with Santen to open a new chapter in eye care." Takeshi Ito, President & CEO of Santen, commented: "RemeGen has demonstrated outstanding capabilities and innovation in the field of novel drug development. As RemeGen's flagship pipeline in ophthalmology, RC28-E offers differentiated advantages by simultaneously targeting angiogenesis and fibrosis, potentially providing a new therapeutic approach and innovative option for the treatment of fundus diseases. Looking ahead, Santen are committed to strengthening cooperation and collaboration with all partners, by global-to-local synergy, to help advancing the high-quality development in ophthalmology, uncovering and addressing unmet patient needs, and aiming to realize 'Happiness with Vision 'for all." About RemeGen: RemeGen Co., Ltd. is a leading innovative biopharmaceutical company in China，headquartered in Yantai Economic & Technological Development Zone, China, with R&D centers and subsidiaries in Beijing, Shanghai, and California, USA. The company achieved dual listings on Main Board of The Stock Exchange of Hong Kong Limited (2020) and Shanghai Stock Exchange STAR Market (2022), becoming a dual-listed "A+H" company. The company focuses on discovering, developing, manufacturing, and commercializing novel biologic drugs with independent intellectual property rights. Focusing on critical therapeutic areas including autoimmune diseases, oncology, and ophthalmology, the company has successfully developed multiple biologic drugs with significant clinical value. In 2021, RemeGen's first-in-class drugs – Telitacicept (for systemic lupus erythematosus, rheumatoid arthritis, and myasthenia gravis) and Disitamab Vedotin (for gastric cancer, urothelial carcinoma, and breast cancer) – were approved for marketing with a total of 6 approved indications across these two innovative therapies. The company has established a comprehensive commercialization system encompassing production and sales, successfully initiating commercial transformation in both domestic and international markets. For more information, please visit RemeGen's website About Santen Pharmaceutical Co., Ltd.: As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of "Happiness with Vision" by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, "Tenki ni sanyo suru," Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen's mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience "Happiness with Vision." For more information, please visit Santen's website SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inPhase 1Phase 2Drug ApprovalClinical Result

100 Deals associated with Disitamab Vedotin

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Carcinoma Metastatic in the Liver	China	RemeGen Co., Ltd.	30 Apr 2025
HER2 Positive Transitional Cell Carcinoma	China	RemeGen Co., Ltd.	31 Dec 2021
HER2-positive gastric cancer	China	RemeGen Co., Ltd.	08 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2-Low Breast Carcinoma	NDA/BLA	China	RemeGen Co., Ltd.	04 Jun 2025
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	China	RemeGen Co., Ltd.	11 Dec 2025
HER2 Positive Stomach Adenocarcinoma	Phase 3	China	RemeGen Co., Ltd.	11 Dec 2025
HER2-Low Gastroesophageal Junction Cancer	Phase 3	China	RemeGen Co., Ltd.	15 May 2025
Gastroesophageal junction adenocarcinoma	Phase 3	China	RemeGen Co., Ltd.	22 Feb 2024
Metastatic urothelial carcinoma	Phase 3	United States	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Japan	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Argentina	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Australia	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Belgium	Seagen, Inc.	22 Sep 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SABCS2025	Not Applicable	HER2-Low Breast Carcinoma Neoadjuvant HER2-low expressing	20	Disitamab Vedotin (2.0 mg/kg IV) + Penpulimab (200 mg IV)	uvhhvhijyn(hymuezjedp) = yxakjgccil hyfnlsekvs (aedtqkebdt ) View more	Positive	11 Dec 2025
ChiCTR2400092028 (ESMO_ASIA2025) Manual	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma Adjuvant HER2 Expression	47	Disitamab vedotinDisitamab vedotin (2 mg/kg IV Q3W)Tislelizumabkg IV Q3W) + Tislelizumab (200 mg IV Q3W) (followed by Tislelizumab (200 mg IV Q3W) maintenance)	ipolzvobox(lskjxtnswr) = nxynmvljir qydobpzzxk (fxhpeqrzhr ) View more	Positive	06 Dec 2025
CTR20220348 \| NCT05302284 (Pubmed \| N Engl J Med) Manual	Phase 3	Advanced Urothelial Carcinoma First line HER2 Expression	484	Disitamab Vedotin + Toripalimab	nfsniildwy(pkrfigcppo) = joaqnotpxi oerjndqjcv (uiffsokwpf ) View more	Positive	19 Oct 2025
CTR20220348 \| NCT05302284 (Pubmed \| N Engl J Med) Manual	Phase 3	Advanced Urothelial Carcinoma First line HER2 Expression	484	Chemotherapy (gemcitabine + cisplatin or carboplatin)	nfsniildwy(pkrfigcppo) = cwuazxfstl oerjndqjcv (uiffsokwpf ) View more	Positive	19 Oct 2025
ChiCTR2300076740 (AK001, ESMO2025) Manual	Phase 2	Recurrent Cervical Cancer Second line	35	Cadonilimab + Disitamab Vedotin (HER2 IHC 1+∼3+)	icwduqkawa(dwmyqchzio) = kwlwjsjshe pxtmyfwhea (zydbuogqxs, 21.5 - 69.2) View more	Positive	17 Oct 2025
ChiCTR2300076740 (AK001, ESMO2025) Manual	Phase 2	Recurrent Cervical Cancer Second line	35	Cadonilimab + Nab‐paclitaxel (HER2 IHC 0)	icwduqkawa(dwmyqchzio) = brrzeoigig pxtmyfwhea (zydbuogqxs, 38.3 - 85.8) View more	Positive	17 Oct 2025
ChiCTR2400080767 (Formula-01, ESMO2025)	Phase 2	HER2-Expressing Non-Muscle Invasive Bladder Neoplasms HER2 high expression	78	Disitamab vedotin+BCG	fqbggladlr(nnuzejmluw) = wrvjhksafg gcggjfuaxn (efuoeirpvy ) View more	Positive	17 Oct 2025
NCT05302284 (RC48-C016, ESMO2025)	Phase 3	HER2 Positive Transitional Cell Carcinoma First line HER2 expression	484	Disitamab vedotin (DV) + toripalimab (T)	dljmrfaskh(epusocccbe) = izpwkyrpin kzdtfwkgxy (crynjrdyca ) View more	Positive	17 Oct 2025
NCT05302284 (RC48-C016, ESMO2025)	Phase 3		484	Chemotherapy (C) (gemcitabine+ cisplatin/carboplatin)	dljmrfaskh(epusocccbe) = cssjwsjwjr kzdtfwkgxy (crynjrdyca ) View more	Positive	17 Oct 2025
NCT06540729 (DAB-OCCC, ESMO2025)	Phase 2	Recurrent Ovarian Clear Cell Adenocarcinoma Second line HER2-positive	15	Disitamab vedotin+AK104+bevacizumab	xjmlllzerr(odzhjhzzgq) = towkjpebwm simkkzydjp (pzsimdejkl ) View more	Positive	17 Oct 2025
ESMO2025	Phase 2	Locally Advanced Bladder Carcinoma Neoadjuvant HER2-positive	56	RC48-ADC+tislelizumab	wazvhvrtio(iyzahgskuf) = ohdtcxeafb hoiwvgwoji (syowuecnlx ) View more	Positive	17 Oct 2025
ChiCTR2400080073 (PUNCH02, ESMO2025)	Phase 2	Muscle Invasive Bladder Carcinoma Her2-positive	28	Tislelizumab + Disitamab vedotin	ikjvjzmpdj(vjbxvzyjdi) = gqrocpbfdh zgagvmcmne (sgcvqesjqu, 51.1 - 86.1) View more	Positive	17 Oct 2025
ChiCTR2400080073 (PUNCH02, ESMO2025)	Phase 2	Muscle Invasive Bladder Carcinoma Her2-positive	28	Tislelizumab + Disitamab vedotin (Her2(3+))	ikjvjzmpdj(vjbxvzyjdi) = iabteeogmq zgagvmcmne (sgcvqesjqu, 61.5 - 100)	Positive	17 Oct 2025
NCT05912816 (DISTINCT-I, ESMO2025)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma	20	Disitamab vedotin + Tislelizumab	xxlqwjvupi(ifxdqbzbjj) = ohdvjaemom jkdzwzokdq (wbvrbuwzlk ) View more	Positive	17 Oct 2025

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