NECTAR Study: A Multicenter, Open-label, Randomized Phase II Study of Neoadjuvant Toripalimab Plus 9MW2821 Versus Upfront Radical Nephroureterectomy With/Without Lymph Node Dissection in Patients With Local Upper Tract Urothelial Carcinoma (UTUC)

The NECTAR study is a multicenter, open-label, randomized phase II clinical trial designed to evaluate a neoadjuvant treatment strategy in patients with localized upper tract urothelial carcinoma (UTUC).
In this study, eligible participants will be randomly assigned to receive either neoadjuvant treatment with toripalimab plus the investigational drug 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection, or upfront radical nephroureterectomy with or without lymph node dissection as standard of care. The purpose of the study is to compare the pathologic response at the time of surgery between the two treatment approaches and to assess treatment safety.
Participants will be monitored throughout treatment and follow-up for treatment response, adverse events, and other clinical outcomes. The information obtained from this study may help improve future treatment strategies for patients with localized UTUC.

Start Date01 Feb 2026

Sponsor / Collaborator

Peking University Third Hospital

[+4]

ChiCTR2600117688

/ Not yet recruitingPhase 2IIT

An open-label, single-center, randomized controlled phase II clinical study evaluating the safety and efficacy of neoadjuvant therapy with radiotherapy plus toripalimab versus 9MW2821 plus toripalimab in patients with upper tract urothelial carcinoma (UTUC)

Start Date01 Feb 2026

Sponsor / Collaborator

Peking University Third Hospital

NCT07045311

/ RecruitingPhase 2

JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)

This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.

Start Date17 Sep 2025

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

100 Clinical Results associated with Bulumtatug fuvedotin

100 Translational Medicine associated with Bulumtatug fuvedotin

100 Patents (Medical) associated with Bulumtatug fuvedotin

424

Literatures (Medical) associated with Bulumtatug fuvedotin

01 Dec 2025·JOURNAL OF BIOLOGICAL CHEMISTRY

Structural basis of nectin-4 recognition by the antibody–drug conjugate 9MW2821

Article

Author: Wu, Hai ; Wen, Haiying ; Wang, Jin ; Zhu, Xiaohong ; Sun, Xiaowei ; Li, Wendi ; Zhou, Wei ; You, Meng ; Fang, Peng ; Shi, Lei ; Cao, Yuxia ; Tan, Xiaoding ; Li, Kaiying

Nectin-4, a membrane protein highly expressed in multiple solid tumors, has become an attractive target for antibody-drug conjugate development. We designed and developed 9MW2821, an anti-nectin-4 antibody-drug conjugate with an enzymatically cleavable valine-citrulline linker and monomethyl auristatin E as the payload. Although 9MW2821 has shown good efficacy and safety in multiple solid tumors in clinical trials, the interaction between 9MW2821 and nectin-4 at the molecular level remains unclear. In this study, we solved the structure of the antigen-binding fragment of 9MW2821 in complex with nectin-4 at a resolution of 3.26 Å using single-particle cryo-EM. The structure shows that 9MW2821 binds the front β-sheet of nectin-4 D1 through three complementarity-determining region loops from the heavy chain and two complementarity-determining region loops from the light chain. The binding involves extensive hydrogen bonds and hydrophobic interactions. The buried surface area is more than 1600 Å². Mutagenesis studies revealed that four residues (Q77, E78, H83, and E95) of nectin-4 contributed significantly to the binding of 9MW2821 monoclonal antibody (mAb). The structure also shows that 9MW2821 mAb blocks nectin-4 homodimer formation by competing with the nectin-4 partner D1 domain for part of the nectin-4 surface area. Furthermore, 9MW2821 mAb prevents nectin-4 from interacting with nectin-1 and T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain, enhancing the activation of NK cells. Based on the structure of the nectin-4 D1-9MW2821 antigen-binding fragment complex resolved in this study, we have elucidated the molecular mechanism of 9MW2821 in cancer therapy. The findings provide a basis for optimizing future mAbs targeting nectin-4.

01 Aug 2025·ANNALS OF ONCOLOGY

Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody–drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study

Article

Author: X Wang ; D Liu ; Z Feng ; S Gao ; J Liu ; X Yao ; Z Gong ; B Hu ; D Xu ; X Chen ; P Zhao ; G Li ; X Li ; X Zhang ; S Wang ; R Liu ; H Huang ; J Zhang ; Y Li ; B Shi ; F Yuan ; C Hu ; M Zhang ; H Yang ; P Wang ; M Feng ; H Guo ; J Chen ; F Qiu ; H Lou

BACKGROUND:

A first-in-human study was carried out to assess the safety and preliminary antitumor activity of bulumtatug fuvedotin (BFv; 9MW2821), a next-generation monoclonal antibody-drug conjugate (ADC) that delivers monomethylauristatin E (MMAE) to cells expressing Nectin-4, in patients with advanced solid tumors.

PATIENTS AND METHODS:

This was a first-in-human, open-label, multicenter study and included dose escalation, dose expansion and cohort expansion periods. Patients with advanced solid tumors who failed one or more lines of systemic therapy were recruited to receive BFv by intravenous (IV) infusion at doses of 0.33-1.5 mg/kg on days 1, 8 and 15 of each 28-day cycle. Primary objective was assessment of safety and preliminary efficacy. (NCT05216965, CTR20220106).

RESULTS:

Between 11 June 2022 and 3 Apr 2024, 274 patients were enrolled, including 51 with urothelial cancer, 62 with cervical cancer, 49 with esophageal cancer, 20 with triple-negative breast cancer and 92 with other solid tumors. In the dose escalation phase, one dose-limiting toxicity was observed in the 1.5 mg/kg group, which was grade 4 neutropenia that lasted >5 days. Maximum tolerated dose of BFv was not reached. However, the recommended phase II dose was identified as 1.25 mg/kg based on a balance of safety and efficacy. The most common grade ≥3 treatment-related adverse events were decreased neutrophil count, decreased white blood cell count, anemia, increased gamma-glutamyl transferase (GGT) with rash, and peripheral sensory neuropathy in the 1.25 mg/kg group. Among 221 patients assessable for efficacy in 1.25 mg/kg group, objective response rates were 54.1%, 32.1%, 14.0% and 50% in urothelial cancer, cervical cancer, esophageal cancer and triple-negative breast cancer, respectively.

CONCLUSIONS:

The results suggest that BFv was tolerable and clinically significant in efficacy in various types of solid tumors besides urothelial cancer. Several pivotal trials are currently in progress (NCT06196736, NCT06592326, NCT06692166).

12 Jun 2025·ACS Medicinal Chemistry Letters

Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy

Article

Author: Kwon, Se Jeong ; Son, Jinyoung ; Chung, Sang J.

Nonsmall cell lung cancer (NSCLC) presents significant therapeutic challenges, causing advancements in targeted therapies. We have developed a site-selective antibody-drug conjugate (ADC), durvalumab-monomethyl auristatin E (MMAE), with a drug-antibody ratio (DAR) of 4, specifically targeting programmed death-ligand 1 (PD-L1), aimed at enhancing NSCLC therapy. Utilizing the innovative AbClick Pro linker, this ADC ensures stable, site-specific conjugation of MMAE to durvalumab, preserving antibody functionality and integrity. In vivo studies demonstrate that durvalumab-MMAE achieves substantial tumor growth inhibition in NSCLC xenograft models, with an impressive tumor growth inhibition rate of over 60% at lower dosages without significant toxicity. These results, combined with a favorable pharmacokinetic profile featuring extended half-life and low clearance, highlight the potential of durvalumab-MMAE (DAR4) as a potent next-generation ADC for treating PD-L1-expressing cancers, offering a promising avenue for improved NSCLC patient outcomes.

News (Medical) associated with Bulumtatug fuvedotin

05 Jun 2025

·www.prnewswire.com

Highlights in Oral Presentation of Mabwell's 9MW2821 at 2025 ASCO

SHANGHAI, June 5, 2025 /PRNewswire/ -- At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, from May 30 to June 3, the results of the Phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) were presented by Prof. Xinan Sheng, Chief Physician of the Department of Urologic Oncology, Beijing Cancer Hospital, on behalf of the research team, with key highlights as below: Oral Presentation Background: Urothelial carcinoma (UC) is a common malignant tumor worldwide. Global cancer statistics released in 2024 showed that bladder cancer is the ninth most commonly diagnosed cancer in the world, with about 614,000 new cases and 220,000 deaths annually. The burden and morbidity of bladder cancer is significantly higher in men than in women. It is the sixth most common cancer and the ninth leading cause of cancer death in men [1]. 9MW2821 (Bulumtatug Fuvedotin, BFv) is a next-generation Nectin-4 targeting antibody-drug conjugate. Previous study of BFv has shown promising efficacy in la/mUC patients who progressed on/after platinum-based chemotherapy and immune checkpoint inhibitors [2]. A pivotal phase 3 study of BFv is ongoing in China (NCT06196736, CTR20234024). Toripalimab is a novel recombinant humanized anti-PD-1 monoclonal antibody that has been approved in multiple countries including China and the USA. It is the first time to report in detail on the efficacy and safety of 9MW2821 in combination with Toripalimab in patients with la/mUC. Method: This is a phase Ib/II, open-label, multicenter study of BFv and Toripalimab in la/mUC in China. Every 21 days per cycle, patients received BFv (1.0 or 1.25mg/kg, on day 1 and 8) and Toripalimab (240mg, on day 1). Treatment until disease progression or unacceptable toxicity. Results: As of Apr. 30, 2025, 52 patients with la/mUC were enrolled. Among the 40 assessable patients (treatment-naive for la/mUC) with the median age of 67, 70% of patients were male, 72.5% had an Eastern Cooperative Oncology Group (ECOG) score of 1, 55% with tumor primary site at upper urinary tract, 15% had liver metastases, 82.5% were Nectin-4 positive and 20% were PD-L1 positive. The Objective Response Rate (ORR) was 87.5% (95% CI: 73.2, 95.8), confirmed ORR was 80%, complete response (CR) rate was 12.5%, Disease Control Rate (DCR) was 92.5% (95% CI: 79.6, 98.4). 97.5% of assessable patients had tumor reduction, 57.5% of assessable patients had tumor reduction of 50% above. The ORR in selected subgroups was consistent with results in overall population. Different subgroups of treatment-naive patients could benefit from BFv and Toripalimab regardless of primary tumor site, liver metastasis, expression of Nectin-4 and PD-L1. The ORR was 100% (24/24) in patients older than 65, 94.44% (17/18) in patients with tumor primary site at lower urinary tract, 83.33% (5/6) in patients with liver metastasis, 100% (7/7) in nectin-4 negative patients, and 100% (8/8) in PD-L1 positive patients. As of April 30, 2025, 45% (18/40) of subjects experienced disease progression or death, with a median progression-free survival (mPFS) of 12.5 months (95% CI: 6.47-NA), and a median duration of response (mDoR) that has not been reached. Median follow-up time was 10.8 months, thus mPFS and mDoR was not mature. The incidence rate of treatment-related adverse events (TRAE) was 98.1%, and most of the TRAEs were grade 1-2. The incidence rate of TRAEs ≥grade 3 was 42.3%, mainly characterized by neutrophil counts decreased (11.5%), alanine aminotransferase increased (5.8%), and white blood cell decreased (5.8%). The incidence rate of serious TRAEs was 28.8%, and no TRAEs leading to death occurred. BFv and Toripalimab showed well-tolerated safety profile. No new safety signals of BFv or Toripalimab were observed in this study. Conclusion: BFv combined with Toripalimab has demonstrated encouraging efficacy and manageable safety profile in la/mUC. Patients with advanced age, liver metastases and negative expression of Nectin-4 also achieved considerable response in this study, suggesting that BFv in combination with Toripalimab may provide a new treatment option for patients with advanced UC who are intolerant of or potentially have a poor prognosis with platinum-based chemotherapy. A pivotal phase 3 study of BFv combined with Toripalimab vs platinum-based chemotherapy is ongoing in China (NCT06592326, CTR20242828). About 9MW2821 9MW2821 is a novel Nectin-4 targeting ADC, which achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process of Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it's the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for UC have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA). About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 4 products have been approved and commercialized, 1 product filed for pre-NDA meeting, 2 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect", "anticipate", "intend", "plan", "believe", "estimate", "potential", "predict", "project", "should", "would", and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultBreakthrough TherapyPhase 3Fast TrackASCO

23 May 2025

·www.prnewswire.com

Mabwell Announces Clinical Data of Multiple ADCs to be presented at 2025 ASCO Annual Meeting

SHANGHAI, May 23, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced multiple clinical research results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including phase Ib/II clinical study data of 9MW2821 (Bulumtatug Fuvedotin, BFv), a novel Nectin-4 targeting ADC, in combination with Toripalimab in locally advanced or metastatic uroepithelial carcinoma to be presented as oral presentation, and clinical study data of 7MW3711 and 9MW2921, a novel B7-H3 targeting ADC and a novel Trop-2 targeting ADC respectively, to be presented as poster presentations. The study of 9MW2821 was the only selected Chinese oral presentation in the field of urothelial carcinoma at this meeting. Nectin-4 ADC (9MW2821): In the phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUc), a total of 40 patients with previously untreated for la/mUC were enrolled in the study and were treated with 9MW2821 (1.25 mg/kg) and Toripalimab (240 mg). As of December 19, 2024, the objective response rate (ORR) was 87.5% and the confirmed ORR was 80%. The disease control rate (DCR) was 92.5%. Median progression-free survival (PFS) and duration of response (DoR) have not been achieved. No new safety signals of 9MW2821 or Toripalimab were observed in this study. 9MW2821 stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it's the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. Currently, 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for urothelial carcinoma have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA). B7-H3 ADC (7MW3711): 7MW3711 has enrolled 43 patients as of January 2, 2025 in a phase I/II clinical study in patients with advanced solid tumors. During the dose-escalation phase, dose-limiting toxicity (DLT) was not observed and the maximum tolerated dose (MTD) has not been reached. In patients evaluated at doses of 4.5 mg/kg or higher, the ORR for esophageal cancer, ovarian cancer, and prostate cancer was 33.3%, 60.0%, and 50.0%, respectively, and the DCR was 100%. In the phase I/II clinical study in lung cancer patients, 37 lung cancer patients were enrolled as of January 8, 2025, including 16 small cell lung cancer (SCLC) patients and 21 non-small cell lung cancer (NSCLC) patients. Common grade ≥3 adverse reactions were neutrophil count decreased, white blood cell count decreased, anemia, lymphocyte count decreased, and platelet count decreased. Among the 25 patients who received 7MW3711 at a dose of 4.5 mg/kg or greater and completed at least one tumor evaluation, the ORR was 36.0% and the DCR was 96.0%; of these, the ORR and DCR were 62.5% and 100.0%, respectively, for patients with small-cell lung cancer at a dose of 4.5 mg/kg. Among squamous lung cancer (Sq-NSCLC) patients with a B7-H3 H-score >5, the ORR and DCR were 37.5% and 87.5%, respectively. The study results suggest that 7MW3711 has a tolerable safety profile and good anti-tumor activity in patients with advanced tumors such as lung, esophageal, prostate and ovarian cancers. 7MW3711 was developed with Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform. It consists of an innovative antibody molecule, a novel linker, and a novel payload: Mtoxin™, which is a topoisomerase I inhibitor. It has been granted ODD by the FDA for the treatment of SCLC. Trop-2 ADC (9MW2921): In the first-in-human clinical study in patients with advanced solid tumors, a total of 39 patients were enrolled as of November 12, 2024. The most common ≥3 grade adverse were stomatitis, anemia, white blood cell count decreased, neutropenia, lymphocyte count decreased, etc. The ORR of 3.0 mg/kg dose group was 42.1% and the DCR was 84.2%. Under this dose level, the ORR and DCR was 75% and 100% for endometrial cancer, 50% and 75% for HR+/HER2- breast cancer, 50% and 100% for gastric cancer, 25% and 100% for non-squamous non-small cell lung cancer. The study result suggests that 9MW2921 has a tolerable safety profile and good anti-tumor activity in patients with advanced tumors. 9MW2921 was developed with Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform. It consists of an innovative antibody molecule, a novel linker, and a novel payload: Mtoxin™, which is a topoisomerase I inhibitor. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackASCOClinical ResultOrphan DrugBreakthrough Therapy

24 Apr 2025

·www.prnewswire.com

Mabwell to Present Clinical Data of 9MW2821 Combined with Toripalimab in Patients with UC in an Oral Presentation at 2025 ASCO

SHANGHAI, April 24, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with an entire industry chain, announced that the Phase Ib/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, USA, May 30-June 3, 2025. Clinical data from 3 ADC clinical studies will also be published as poster presentations at the meeting. Oral Presentation 1. Title: 9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naive patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study. Abstract Number for Publication: 4519 Presenter: Prof. Sheng Xinan, Chief Physician, Dept. of Urologic Oncology (Beijing Cancer Hospital) Session Type and Title: Rapid Oral Abstract-Genitourinary Cancer-Kidney and Bladder Session Date and Time: 5/31/2025, 1:15 PM-2:45 PM CDT Poster Presentation 1. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with advanced solid tumors. Abstract Number: 3035 Session Type and Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Poster Board: 350 Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT 2. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer. Abstract Number: 3036 Session Type and Title: Poster Session - Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Board: 351 Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT 3. Title: A first-in-human clinical study of 9MW2921, a novel TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumors. Abstract Number: 3029 Session Type and Title: Poster Session - Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Board: 344 Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOADCPhase 1

100 Deals associated with Bulumtatug fuvedotin

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Carcinoma to the Uterine Cervix	Phase 3	China	Mabwell (Shanghai) Bioscience Co., Ltd.	10 Sep 2024
Uterine Cervical Cancer	Phase 3	China	Jiangsu Maiweikang New Drug R & D Co Ltd	10 Sep 2024
Urothelial Carcinoma of the Urinary Bladder	Phase 3	China	Mabwell (Shanghai) Bioscience Co., Ltd.	22 Aug 2024
Triple Negative Breast Cancer	Phase 2	China	Shanghai Junshi Biosciences Co., Ltd.	17 Sep 2025
Endometrial Carcinoma	Phase 2	China	Jiangsu Maiweikang New Drug R & D Co Ltd	07 Apr 2025
Ovarian Cancer	Phase 2	China	Jiangsu Maiweikang New Drug R & D Co Ltd	07 Apr 2025
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 2	China	Mabwell (Shanghai) Bioscience Co., Ltd.	17 Jan 2025
Urothelial carcinoma recurrent	Phase 2	China	Mabwell (Shanghai) Bioscience Co., Ltd.	17 Jan 2025
Advanced Triple-Negative Breast Carcinoma	Phase 2	China	Mabwell (Shanghai) Bioscience Co., Ltd.	26 Jul 2024
Metastatic Triple-Negative Breast Carcinoma	Phase 2	China	Mabwell (Shanghai) Bioscience Co., Ltd.	26 Jul 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20220106 \| NCT05216965 (Pubmed \| Ann Oncol) Manual	Phase 1/2	Esophageal Carcinoma \| Advanced Malignant Solid Neoplasm \| Triple Negative Breast Cancer ... View more	274	9MW2821 (urothelial cancer)	yoiccqddqn(dufcaxijsp) = wuebbfijwm qjuclnhiik (fdvcdnjzok ) View more	Positive	01 Aug 2025
CTR20220106 \| NCT05216965 (Pubmed \| Ann Oncol) Manual	Phase 1/2		274	9MW2821 (cervical cancer)	yoiccqddqn(dufcaxijsp) = zfmqdclyfg qjuclnhiik (fdvcdnjzok ) View more	Positive	01 Aug 2025
NCT06592326 (ASCO2025 \| PRNewswire) Manual	Phase 1/2	Transitional Cell Carcinoma First line	40	9MW2821 + toripalimab	hglehmpxhg(cnsgmietsb) = lczhsucwjt fersqheaiv (njtgdgtbsp ) View more	Positive	30 May 2025
NCT06079112 (PRNewswire) Manual	Phase 3	Unresectable Urothelial Carcinoma First line	40	9MW2821 + Toripalimab	panqsskokl(uddyxisbdu) = pomrtihlnr qoubjzqezv (cocuuxjwsj ) View more	Positive	09 Jan 2025
PRNewswire Manual	Not Applicable	Uterine Cervical Cancer PVRL4	53	9MW2821	bcgqekiwta(ijbnoycyys) = nafskgnucz ytoetmdnim (rsiogdofpv ) View more	Positive	23 Aug 2024
PRNewswire Manual	Not Applicable	Uterine Cervical Cancer PVRL4	53	9MW2821 (Nectin-4 IHC 3+)	bcgqekiwta(ijbnoycyys) = qjsqbhidhy ytoetmdnim (rsiogdofpv )	Positive	23 Aug 2024
NCT05216965 (NEWS \| ASCO2024) Manual	Phase 1/2	Esophageal Carcinoma \| Advanced Malignant Solid Neoplasm \| Triple Negative Breast Cancer ... First line Nectin-4 positive View more	240	9MW2821 at 1.25mg/kg or above (UC)	lqxdbcplgg(ioiapmpgoc) = dsjkucebxa quyxseqsky (syvhnyezaw, 44.76 - 77.54) View more	Positive	25 May 2024
NCT05216965 (NEWS \| ASCO2024) Manual	Phase 1/2		240	9MW2821 at 1.25mg/kg or above (CC)	lqxdbcplgg(ioiapmpgoc) = dibbghprjq quyxseqsky (syvhnyezaw, 23.77 - 53.46) View more	Positive	25 May 2024
NCT05216965 (PRNewswire) Manual	Phase 1/2	Metastatic Triple-Negative Breast Carcinoma \| Advanced Triple-Negative Breast Carcinoma	20	9MW2821	kttefunrtb(gavxkvaiep) = syzznrqupy puvebxlwxl (vsrxtayavd ) View more	Positive	13 May 2024
Corporate Publications Manual	Phase 1/2	Uterine Cervical Cancer NECTIN4 Positive	40	9MW2821	fsjmqwguuk(mhirguczon) = ijluwrrecs buvijreyww (ndinigrmov ) View more	Positive	18 Mar 2024
CTR20220106 (NEWS)	Phase 2	Esophageal Carcinoma	30	9MW2821	lhtckkupuo(ngnpzkubaa) = dgxyorjwra exwztkrboj (pslkziminf ) View more	Positive	26 Feb 2024
NEWS Manual	Phase 2	Transitional Cell Carcinoma	-	9MW2821 1.25mg/kg	vawaqcotch(cucgtotxkk) = vsrgintwwf fbfdcgrwdn (ccszyyzntk, 44.8 - 77.5) View more	Positive	07 Dec 2023
NCT05216965 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Solid tumor	-	9MW2821	lmuldisrnh(zfydvhzazt) = froztrwmxi kapilbikbp (abunvduqvw ) View more	Positive	23 Oct 2023

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