Disitamab Vedotin

SHANGHAI, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its 2026 interim financial results and provided corporate updates. FINANCIAL HIGHLIGHTS As of June 30, 2026, the company’s total revenue was approximately RMB1,696 million for the first half of 2026 (2026H1), a 45% increase compared to 2025, which was made possible by the rise in sales revenue of pharmaceutical products. In particular, the domestic sales revenue of our core product, toripalimab, reached approximately RMB1,299 million, around 36% more than in 2025. In addition, out-licensing revenue also increased by approximately RMB152 million, an approximately 149% improvement from 2025. Total research and development (“R&D”) expenses of the company were approximately RMB644 million for 2026H1, which was primarily used to advance the construction of our R&D technology platforms, explore potential drug targets and strengthen our clinical pipelines. Profit attributable to owners of the company increased to RMB26 million for 2026H1, representing an increase of approximately RMB439 million compared to 2025. When excluding the effects of share-based payment, profit attributable to owners of the company reached RMB153 million, representing an increase of approximately RMB566 million compared to 2025. Net cash inflow from financing activities was approximately RMB1,643 million, which fully covered the cash outflows in operating and investing activities, leading to an increase in bank balances and cash. A successful issuance of the 2026 first tranche of technology innovation bonds generated a net cash inflow of approximately RMB1,000 million for the company. As of June 30, 2026, the company’s aggregate of bank balances, cash, and financial products reached approximately RMB3,670 million, providing a relatively sufficient cash position for further development. BUSINESS HIGHLIGHTS During 2026H1, we remained steadfast in tackling patients’ “unmet medical needs” and realizing our goal of “improving quality, reducing cost and enhancing efficiency.” We continued to ensure all-rounded, high-quality compliance, and made breakthrough progress in discovery, clinical development and commercialization of innovative drugs and business operations with accelerating international development. Advancements in the pipeline : Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecule drugs, antibody drug conjugates (“ADC”), bi-specific or multi-specific antibodies, fusion protein, nucleic acid drugs and vaccines, as well as the exploration of next-generation innovative therapies including those for cancer and autoimmune diseases. To date, a total of four drugs (TUOYI®, JUNMAIKANG, MINDEWEI and JUNSHIDA) have been commercialized, five products are in phase 3 clinical studies (including two products currently awaiting new drug application [the “NDA”] acceptance), and various innovative drugs that are competitive in the international market are undergoing accelerated clinical trials. In February 2026, the indications of toripalimab for the first-line treatment of nasopharyngeal carcinoma (“NPC”) and the first-line treatment of esophageal squamous cell carcinoma (“ESCC”) were approved for marketing in Oman and Qatar. In March 2026, the NDA for JS001sc (toripalimab injection [subcutaneous injection]) for 12 indications in the treatment of tumors were accepted by the National Medical Products Administration (the “NMPA”). In April 2026, the indication expansion of toripalimab for the first-line treatment of ESCC was approved for marketing in Singapore. In May 2026, the supplemental new drug application (“sNDA”) for the new indication of TUOYI® in combination with disitamab vedotin for the treatment for patients with human epidermal growth factor receptor 2 (“HER2”)-expressing (which is defined as achieving score of 1+, 2+ or 3+ in HER2 immunohistochemistry test) locally advanced or metastatic urothelial carcinoma (“UC”) was approved by the NMPA. In May 2026, the phase 3 clinical study of TUOYI® in combination with chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer (“NSCLC”) patients met the primary endpoint in the final analysis. In July 2026, the supplemental application for the indication of TUOYI® in combination with chemotherapy as perioperative treatment for resectable stage II-III NSCLC patients was accepted. In May 2026, the indications of toripalimab for the first-line and second-line or later treatment of NPC were approved for marketing in Malaysia and South Africa. In June 2026, the indications of toripalimab for the first-line treatment of NPC and first-line treatment of ESCC were approved for marketing in Peru. In June 2026, the indications of toripalimab for the first-line and second-line or later treatment of NPC were approved for marketing in Brazil. Updates on external collaborations In June 2026, JunTop Biosciences, a controlling subsidiary of the company, reached a collaborative agreement with the Institute of Microbiology, Chinese Academy of Sciences. JunTop Biosciences was granted the exclusive global license rights for quadrivalent recombinant dengue vaccine. In June 2026, the company entered into a license agreement with Fosun Wanbang, a wholly-owned subsidiary of Fosun Pharma. The company granted Fosun Wanbang the right to develop, register, manufacture and commercialize roconkibart (“JS005” or “anti-IL-17A monoclonal antibody”) in the Greater China region. Under the agreement, the company will receive an upfront payment of RMB215 million, which shall be non-deductible and non-refundable, and will be eligible to receive milestone payments for product development and sales of RMB1,125 million, as well as double-digit tiered royalties based on net sales in the Greater China region. Updates on other significant events From November 2025 to March 2026, Mr. Xiong Jun, one of the controlling shareholders and actual controllers, and the chairman of the Board of the Directors of Junshi Biosciences, increased his shareholding of the company by 3,259,495 A shares and H shares in aggregate, accounting for 0.32% of the total share capital of the company, with a total transaction amount of RMB100,638,052.19. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. With our outstanding capacity for innovative drug discovery, strong biotechnology R&D capability, and large-scale production capacity, we have successfully developed a drug candidate portfolio with global competitiveness and a well-structured research pipeline, which covers therapeutic areas including cancer, autoimmune, metabolic, and infectious diseases. Our innovative field spans cutting-edge therapeutic modalities, including mAbs, small-molecule drugs, ADCs, bsAb/msAb, fusion proteins, nucleic acid drugs and vaccines. Five of the company’s products have received marketing authorizations in China and international markets, one of which is toripalimab, China’s domestically developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 50 countries and regions including China, the US, and Europe. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts over 3,000 employees mainly in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou). For more information, please visit: Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800

Shanghai Junshi Biosciences (HKEX: 1877; SSE: 688180) has received approval from China’s National Medical Products Administration (NMPA) for Tuoyi (toripalimab) in combination with disitamab vedotin as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (UC). This week’s new approval nod marks the 13th approved indication for toripalimab in mainland China and the first approval in the country specifically targeting HER2-expressing UC in the first-line setting. The approval covers patients with HER2-positive tumors who are systemic-treatment-naive, a broad biomarker definition that encompasses a substantial proportion of the UC patient population. Disitamab vedotin, an antibody-drug conjugate (ADC) independently developed by RemeGen Co., Ltd, is directed against HER2 and delivers a cytotoxic payload selectively to HER2-expressing tumor cells. Toripalimab, an anti-PD-1 monoclonal antibody, blocks PD-1 interactions with PD-L1 and PD-L2 and induces PD-1 receptor internalization, augmenting T-cell-mediated anti-tumor activity. The combination pairs targeted cytotoxicity with immune checkpoint inhibition in a biomarker-selected population. Clinical evidence from the RC48-C016 study The approval is supported by data from the RC48-C016 study (NCT05302284), a Phase III, multi-center, randomized, open-label, controlled trial conducted across 74 clinical centers in China. The trial enrolled systemic-treatment-naive patients with HER2-expressing locally advanced or metastatic UC and compared toripalimab plus disitamab vedotin against gemcitabine combined with cisplatin or carboplatin. The co-primary endpoints were progression-free survival assessed by blinded independent review and overall survival. Results published in the New England Journal of Medicine in October 2025 and presented at the ESMO 2025 Presidential Symposium showed the combination more than doubled median PFS compared with chemotherapy — 13.1 months versus 6.5 months (hazard ratio 0.36, 95% CI 0.28–0.46; p \< 0.0001). Median OS was 31.5 months in the combination arm versus 16.9 months with chemotherapy (HR 0.54, 95% CI 0.41–0.73; p \< 0.0001). The objective response rate was 76.1% versus 50.2%, and median duration of response was 14.6 months versus 5.6 months. Mechanistic rationale and competitive context The pairing of a HER2-directed ADC with a PD-1 inhibitor reflects a broader strategy of combining targeted tumor killing with immune activation. Disitamab vedotin delivers its cytotoxic payload to HER2-expressing cells, and the resulting immunogenic cell death may enhance the anti-tumor immune response that toripalimab sustains by relieving PD-1-mediated T-cell suppression. The broad HER2 biomarker definition — extending to IHC 1+ — expands the eligible population beyond the HER2-high subset typically targeted in breast or gastric cancer settings, which is clinically relevant given the distribution of HER2 expression across UC tumors. In the global first-line urothelial cancer therapy landscape, the most structurally comparable approved regimen is enfortumab vedotin plus pembrolizumab, which received full US FDA approval in December 2023 based on the EV-302 trial. That combination — a Nectin-4-directed ADC paired with an anti-PD-1 inhibitor — is biomarker-agnostic and has established itself as a benchmark for first-line locally advanced or metastatic UC. The toripalimab plus disitamab vedotin regimen differs in its HER2-directed mechanism and biomarker-selected population, and the RC48-C016 data were generated in a Chinese patient cohort without direct cross-trial comparison to EV-302. The NMPA approval positions the combination as a first-line option specifically for the HER2-expressing UC population in China, where the incidence of UC has been rising. The company reported 92,900 new UC cases in China in 2022, with more than 40,000 deaths, citing data from the National Cancer Center. Toripalimab had previously received NMPA approval in 2021 for second-line and above treatment of advanced UC in a non-biomarker-selected population, making this new indication an expansion into the first-line HER2-selected setting. With 13 approved indications in mainland China, toripalimab now spans a broad range of tumor types including lung, nasopharyngeal, esophageal, bladder, breast, liver, renal, and skin cancers. The first 12 indications have been included in China’s National Reimbursement Drug List (2025 edition). Internationally, toripalimab has received marketing authorization in more than 40 countries and regions, including the US, EU, UK, Australia, and India. The RC48-C016 data represent one of the more mature readouts for an ADC plus PD-1 inhibitor combination in UC, with both PFS and OS endpoints met and results published in a high-profile journal prior to regulatory approval. It remains to be seen whether the HER2-targeting approach will translate to regulatory submissions outside China. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.