SHR-A2102

SHANGHAI, April 21, 2026 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industrial chain, announced that a recent clinical case report on its self-developed novel Nectin-4 ADC (bulumtatug fuvedotin, R&D code: 9MW2821) for the treatment of cervical cancer has been published in The New England Journal of Medicine (NEJM, Impact Factor: 78.5), a leading international medical journal. The article, published by the team of Dr. Wang Shanbing, Director of the Oncology Center at the Second People's Hospital of Yibin, reveals for the first time globally a rare case of hepatic "pseudoprogression" phenomenon observed in a patient with advanced cervical cancer following treatment with the novel Nectin-4 ADC (9MW2821). Pseudoprogression generally refers to a phenomenon where existing lesions temporarily enlarge or new lesions appear early in immunotherapy, without clinical deterioration, followed by subsequent stabilization or shrinkage—typically not representing true tumor progression. This article reports the case of a patient with metastatic cervical squamous-cell carcinoma whose disease was refractory to platinum–taxane chemotherapy with no prior immunotherapy. After just two cycles of treatment with 9MW2821, the patient's baseline metastatic lesions showed substantial regression, and serum squamous cell carcinoma (SCC) antigen levels dropped precipitously—from 37.0 ng/mL to 1.2 ng/mL (normal range ≤1.5). However, despite comprehensive improvement across multiple indicators, a CT scan unexpectedly revealed a "new hypoattenuating lesion " measuring 1.8 cm × 2.5 cm in the medial segment of the left lobe of the liver. A liver biopsy showed dense infiltration of lymphocytes, plasma cells, and neutrophils, with no evidence of granulomas, spindle cell proliferation, or viable tumor cells. The biopsy results ruled out disease progression, sarcoid-like reactions, or inflammatory pseudotumor. Given the patient's p16-positive status (implying high HPV antigenicity) and the absence of previous immunotherapy, Dr. Wang Shanbing's team hypothesized that the antibody-drug conjugate (ADC) targeted occult micrometastases, inducing immune-cell death and releasing damage-associated molecular patterns that triggered this robust inflammatory influx. The patient continued treatment, and subsequent imaging showed gradual resolution of the liver lesion, with no reappearance during two years of follow-up. ADCs are hailed as "magic bullets" for precisely targeting tumors. Previously, pseudoprogression has been predominantly observed in immunotherapies such as PD‑1/PD‑L1 inhibitors, whereas its occurrence in ADC therapy for solid tumors is considered exceedingly rare. This finding by Dr. Wang Shanbing's team carries significant implications for the clinical management of advanced cervical cancer. The article strongly emphasizes that treatment that could prolong life should not be prematurely discontinued based solely on radiographic "false impressions," providing a valuable reference for the clinical application of ADCs and safeguarding optimal therapeutic benefits for oncology patients. 9MW2821 is the world's first Nectin-4 ADC candidate to enter Phase III clinical trials for cervical cancer. Currently, enrollment for the monotherapy Phase III trial has been completed. Interim analysis is expected to be conducted and pre-NDA to be submitted in H2 2026. The first-line combination study with toripalimab is in Phase II. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is "Explore Life, Benefit Health" and its 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 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 21% more press release views with Request a Demo

Fast Track designation underscores the potential for ADRX-0706 to address the high unmet need in advanced cervical cancer SAN DIEGO, May 6, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program, ADRX-0706, for the treatment of patients with locally advanced or metastatic squamous cell cervical cancer. Continue Reading ADRX-0706 is a Nectin-4 ADC being evaluated in the Phase 1b portion of an ongoing Phase 1a/b clinical trial (NCT06036121) for the treatment of select advanced solid tumors, including cervical cancer. The company will present interim data from the completed Phase 1a dose escalation portion at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Early findings demonstrated a differentiated safety and pharmacokinetic profile, including a notably lower incidence of adverse events such as peripheral neuropathy, along with preliminary efficacy signals across multiple tumor types. The FDA's Fast Track designation has potential to accelerate drug development and review process for ADRX-0706 Post this Cervical cancer represents a significant unmet need, particularly for patients whose disease progresses following initial treatment. Nectin-4 is highly expressed in cervical cancer, making it a compelling tumor type for treatment with a Nectin-4 ADC. "The Fast Track designation granted by the FDA underscores the significant unmet need in advanced cervical cancer and marks another meaningful milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "This recognition, together with the early clinical signals observed for ADRX-0706, reinforces the best-in-class potential of our Nectin-4 ADC and provides the opportunity for enhanced regulatory dialogue as we continue advancing this important program through clinical development." The FDA's Fast Track program is designed to accelerate the development and review of therapies for serious conditions with unmet medical needs, with the goal of getting important new treatments to patients sooner. The designation enables earlier and more frequent communication with the FDA throughout development and may offer regulatory advantages such as eligibility for Accelerated Approval, Priority Review, and Rolling Review, which allows completed sections of a New Drug Application (NDA) or Biologic License Application (BLA) to be reviewed, rather than waiting for the entire completed application. About ADRX-0706 ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs. The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-Conjugation® technology platform – a core component in the design of the company's ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. For more information about the ongoing ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov. About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit . Contact Information: Investor Relations [email protected] SOURCE Adcentrx Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED