ADO-Trastuzumab Emtansine

SHANGHAI, April 9, 2026 /PRNewswire/ -- DualityBio ("DualityBio" or the "Company", Stock Code: 9606.HK) today announced that the Biologics License Application (BLA) for the investigational antibody-drug conjugate ("ADC") trastuzumab pamirtecan ("T-Pam", also known as DB-1303 or BNT323), has been accepted for review by the China National Medical Products Administration (NMPA). With the BLA filing, DualityBio is seeking approval for trastuzumab pamirtecan as second-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. The application is based on positive interim results from the pivotal Phase III clinical trial (Study DB-1303-O-3001). The DB-1303-O-3001 trial is a randomized, controlled, open-label, multicenter Phase III clinical trial conducted in China. It aims to evaluate the efficacy and safety of trastuzumab pamirtecan compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy. As assessed by the Independent Data Monitoring Committee (IDMC), the trial has met its primary endpoint of statistically significant improvement of progression-free survival (PFS, assessed by Blinded Independent Central Review, BICR) for trastuzumab pamirtecan compared to T-DM1 at a pre-specified interim analysis. Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "China has over 350,000 new breast cancer cases annually [1], representing a high incidence rate and ranking as the second most common cancer among Chinese women. We are delighted to see that DB-1303/T-Pam has achieved a milestone in its commercialization progress, demonstrating its potential to provide an effective new treatment option for breast cancer patients. In the China market, we have entered into a collaboration with 3SBio to jointly advance the commercialization of multiple indications of DB-1303/T-Pam in Chinese mainland, Hong Kong and Macao. Globally, we will continue to deepen our global strategic partnership with BioNTech to further drive the global development of this product. DB-1303/T-Pam is a globally co-developed new drug with strong strategic partners in both China and global markets. We will work closely together to accelerate the product's marketing approval process, maximize its global clinical value, present more treatment options to patients worldwide." About trastuzumab pamirtecan (BNT323/DB-1303) Trastuzumab pamirtecan ("T-Pam", also known as BNT323 or DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 which is being developed by BioNTech and DualityBio. Trastuzumab pamirtecan was built from DualityBio's proprietary Duality Immune Toxin Antibody Conjugates ("DITAC") platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells, making it a potential target for innovative cancer therapeutics. The candidate has exhibited antitumor activity in both HER2-positive and HER2-low tumor models as well as in several solid tumor indications, including patients with breast and endometrial cancers, as well as other advanced solid tumors. Preclinical data and preliminary clinical data for trastuzumab pamirtecan indicate its potential to target HER2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window. Trastuzumab pamirtecan is currently being evaluated in multiple solid tumor types and innovative treatment combinations, including two global pivotal clinical trials in first-line HER2-low, hormone receptor positive ("HR+") metastatic breast cancer (DYNASTY-Breast02; NCT06018337) and second-line endometrial cancer (BNT323-01; NCT06340568), a novel-novel combination Phase 1/2 clinical trial (BNT323-03; NCT06827236) evaluating trastuzumab pamirtecan in combination with pumitamig in HR-positive or –negative, HER2-low, -ultra-low, or -null advanced/metastatic breast cancer and a Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer (NCT06340568) . The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the treatment of endometrial cancer in 2023. About DualityBio Duality Biotherapeutics (HKEX:09606) is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADCs to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries and has enrolled over 3,200 patients for multiple clinical-stage ADC candidates. Additionally, DualityBio has established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs, including bispecific ADC candidates, novel-payload ADC candidates, and autoimmune ADC candidates. For more information, please visit SOURCE DualityBio 21% more press release views with Request a Demo

SAN JOSE, Calif., April 09, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced the appointment of Dr. Sara Kenkare-Mitra as a Strategic Advisor. Dr. Kenkare-Mitra brings nearly three decades of experience in biologics and small molecule drug discovery and development, with a proven track record of global regulatory approvals and commercial launches across oncology, immunology, neurodegeneration, ophthalmology, and respiratory diseases. “Sara is a highly accomplished leader and respected drug developer, and we are thrilled to welcome her as a Strategic Advisor,” said Talat Imran, Chief Executive Officer of Rani. “Her experience across discovery, development, and commercialization of biologics will be invaluable as we refine our platform and asset strategy and prioritize the programs with the greatest potential to drive meaningful clinical and commercial impact. Her perspective will be particularly important as we build on our recent progress, including encouraging preclinical data with oral semaglutide and other RaniPill® programs.” In her advisory role, Dr. Kenkare-Mitra will provide strategic counsel across platform and clinical strategy, including therapeutic area focus, product and drug candidate selection, and development prioritization. She will also advise on aligning development plans with regulatory and market landscape considerations, with a focus on advancing programs that maximize the probability of clinical success and long-term value creation. Dr. Kenkare-Mitra is a seasoned biotechnology and pharmaceutical executive who most recently served as President and Head of Research and Development at Alector. Prior to that, she spent more than 20 years at Genentech, a member of the Roche Group, where she played a central role in the preclinical to clinical translation, development and approval of multiple first-in-class and best-in-class therapies and helped advance the company’s antibody-drug conjugate platform. Her teams contributed to the global development and approval of therapies including Xolair®, Tarceva®, Avastin®, Lucentis®, Kadcyla®, Venclexta®, Perjeta®, Tecentriq®, Ocrevus®, and Polivy®. Dr. Kenkare-Mitra is an elected member of the National Academy of Medicine and a Fellow of the American Association for the Advancement of Science. She currently serves on the Board of Directors of Unicycive Therapeutics and holds a Ph.D. in Pharmaceutical Chemistry from the University of California, San Francisco, where she also completed her postdoctoral training and Clinical Pharmacology fellowship. “I have been deeply impressed by the scientific foundation of the RaniPill platform and the consistency of the human pharmacokinetic data generated to date,” said Dr. Kenkare-Mitra. “The potential to deliver biologics orally with reproducible exposure has broad implications across multiple therapeutic areas. Oral delivery of biologics, once considered impossible, is now inevitable. I look forward to working with the team to prioritize and advance the programs with the greatest opportunity to benefit patients.” About Rani Therapeutics Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill® capsule technology. Investors Contact: investors@ranitherapeutics.com Media Contact: media@ranitherapeutics.com