Serplulimab

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Congress 2026, taking place on October 23-27, 2026, in Madrid, Spain. Notably, results from two positive Phase III studies evaluating the savolitinib and osimertinib combination have been selected for oral presentations. Results from the global SAFFRON study will be featured in the Presidential Symposium session, while results from the SANOVO study in China will be presented in a Proffered Paper session, both highlighting important new clinical data. Having two Phase III studies featured as late-breaking abstracts underscores the potential of this all-oral, chemo-free combination to deliver meaningful advancements for patients with non-small cell lung cancer (“NSCLC”). The SAFFRON Global Phase III Study has been selected for a Presidential Symposium oral presentation. The study evaluated the combination in patients with epidermal growth factor receptor (EGFR)-mutated NSCLC with MET overexpression or amplification following disease progression on osimertinib. The trial reported positive high-level results on August 17, 2026, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) and overall survival (“OS”) compared to doublet platinum-based chemotherapy. The SANOVO China Phase III Study has been selected for a Proffered Paper oral presentation. The study evaluated the combination in previously untreated patients with locally advanced or metastatic NSCLC harboring activating EGFR mutations and MET overexpression. The trial reported positive high-level results on August 31, 2026, demonstrating a statistically significant and clinically meaningful improvement in PFS and a clinically meaningful benefit in OS versus osimertinib monotherapy. Details of the presentations are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results Shun Lu (Shanghai, China) LBA6 Presidential Symposium II Alicante Auditorium - Hall 6 Sunday, October 25, 2026 16:30 - 18:15 CEST Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study Yi-Long Wu (Guangzhou, China) LBA69 Proffered paper 2: NSCLC, metastatic Alicante Auditorium - Hall 6 Monday, October 26, 2026 08:30 - 10:00 CEST Updated results from a fruquintinib Expanded Access Program for patients with previously treated metastatic colorectal cancer Stefan Kasper (Essen, Germany) 848P Poster Session: Colon cancer Association between dose adjustment and treatment outcomes in patients with advanced renal cell carcinoma receiving fruquintinib plus sintilimab: A post-hoc analysis of the FRUSICA-2 trial Yuanyuan Qu (Shanghai, China) 3655eP E-poster Session: Renal cancer Efficacy of fruquintinib plus sintilimab in special populations with advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang (Beijing, China) 3667eP E-poster Session: Renal cancer Final phase 2 analysis of surufatinib plus camrelizumab, nab-paclitaxel and gemcitabine in first-line metastatic pancreatic cancer Shukui Qin (Nanjing, China) 3156P Poster Session: Pancreatic cancer INVESTIGATOR-INITIATED STUDIES Fruquintinib plus capecitabine maintenance after first-line anti-EGFR antibody plus chemotherapy in RAS/BRAF wild-type metastatic colorectal cancer: A phase Ib/II study Lin Yang/ Letian Zhang (Beijing, China) 877eP E-poster Session: Colon cancer Real-world effectiveness and safety of fruquintinib in patients with metastatic colorectal cancer in Spain: The FrESP study Ana Fernandez Montes (Ourense, Spain) 880eP E-poster Session: Colon cancer CONCEPT (COmbinatioN of CEtuximab Plus fruquintinib Treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Kefeng Ding (Hangzhou, China) 890eP E-poster Session: Colon cancer A real-world study of low-dose fruquintinib combined with trifluridine/tipiracil hydrochloride (TAS-102) in the third-line and beyond treatment of metastatic colorectal cancer Yuehong Cui/ Li Liang (Shanghai, China) 903eP E-poster Session: Colon cancer Real-world outcomes with fruquintinib in heavily pretreated metastatic colorectal cancer: Impact of patient and disease characteristics Maria Maddalena Laterza (Pozzuoli, Italy) 964eP E-poster Session: Colon cancer A phase II, open-label, randomized study of doublet chemotherapy (FOLFOX or FOLFIRI) plus fruquintinib compared with doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab in second line setting for a metastatic colorectal cancer: ULYSSE- FFCD2406 - PRODIGE115 (trials in progress) Jean Marc Phelip (Saint-Étienne, France) 991eTiP E-poster Session: Colon cancer Phase II study of fruquintinib plus utidelone in platinum-resistant recurrent ovarian cancer (FRUTD Trial) Zheng Feng (Shanghai, China) 1283P Poster Session: Gynaecological cancers Fruquintinib plus eribulin in patients with metastatic HR+, HER2 - breast cancer after progression on endocrine therapy plus CDK4/6 inhibitor: Updated results from a phase II study Yuan Yuan (Nanjing, China) 1896eP E-poster Session: HR+ breast cancer Fruquintinib plus sintilimab and XELOX as first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase II study Hua Wang (Nanchang, China) 2980eP E-poster Session: Oesophagogastric cancer Fruquintinib plus cadonilimab and S-1 in previously treated unresectable locally advanced or metastatic esophageal squamous cell carcinoma: preliminary efficacy and safety results from a phase Ib/II study Huiyan Luo (Guangzhou, China) 2981eP E-poster Session: Oesophagogastric cancer Nanoliposomal irinotecan (nal-IRI) combined with fruquintinib as second-line treatment for advanced gastric cancer: A single-arm, open-label, dose-escalation and expansion phase I/II trial Jieer Ying/ Qi Xu (Hangzhou, China) 2986eP E-poster Session: Oesophagogastric cancer FRUQUITAS trial: ENGIC intergroup randomized phase III of trifluridine/tipiracil +/- fruquintinib in pre-treated metastatic gastro-oesophageal adenocarcinoma David Tougeron (Poitiers, France) 3079eTiP E-poster Session: Oesophagogastric cancer CHOICE III: short-course preoperative radiotherapy followed by fruquintinib plus anti–PD-1 antibody (serplulimab) for neoadjuvant treatment of pMMR/MSS mid-to-low locally advanced rectal cancer: A single-arm, single-center, prospective phase II study Wei Zhang (Shanghai, China) 3582eTiP E-poster Session: Rectal and anal cancer First-line fruquintinib plus serplulimab for metastatic non-clear cell renal cell carcinoma: Updated results from the phase II FRONTIER study Jiwei Huang (Shanghai, China) 3614P Poster Session: Renal cancer Latest efficacy and safety analysis of surufatinib combined with EP regimen and serplulimab as first-line treatment for extrapulmonary neuroendocrine carcinoma Tao Zhang/ Zhenyu Lin (Wuhan, China) 2394RO Rapid Oral Session: NETs and endocrine tumours Pamplona Auditorium - Hall 5 Friday, October 23, 2026 16:15 - 17:45 CEST Surufatinib combined with toripalimab and nab-paclitaxel/ gemcitabine chemotherapy as first-line treatment for advanced pancreatobiliary-type ampullary carcinoma: A prospective phase II Clinical Trial Juan Du (Nanjing, China) 507eP E-poster Session: Biliary tract cancer, incl. cholangiocarcinoma Efficacy and safety of surufatinib in combination with CAPTEM in advanced G2/G3 Neuroendocrine Tumors: Results from a single-arm, phase II Trial Wei Wang (Guangzhou, China) 2403P Poster Session: Neuroendocrine tumours Surufatinib plus S-1/temozolomide as first-line therapy in MGMT-low advanced pancreatic neuroendocrine tumours (SUSTEM-p): An open-label, single-centre phase Ib/II trial Yihebali Chi (Beijing, China) 2411P Poster Session: Neuroendocrine tumours Updated results of a prospective, open-label study of surufatinib plus CAPTEM as conversion therapy for unresectable pancreatic neuroendocrine tumors Ziyao Wang (Chengdu, China) 2412P Poster Session: Neuroendocrine tumours Matching-adjusted indirect comparison of surufatinib versus high-dose OCT-LAR in patients with advanced GEP-NETs who progressed on prior SSA Therapy Jianming Xu (Beijing, China) 2415P Poster Session: Neuroendocrine tumours Surufatinib combined with octreotide LAR for the treatment of G1/G2 GEP-NETs: A single-arm, prospective, open-label phase II study Xiaofeng Sun (Nanjing, China) 2439eP E-poster Session: Neuroendocrine tumours Six weeks of induction gemcitabine plus nab paclitaxel (AG) followed by sequential surufatinib plus AG or AG alone as first line therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC): A single center, two cohort, phase II study Jin Xu/ Jialin Li (Shanghai, China) 3168P Poster Session: Pancreatic cancer A phase Ib/II study of radiotherapy combined with surufatinib and sintilimab for localized high-risk limb and trunk soft tissue sarcomas: A prospective single-center trial Yan Wang (Shanghai, China) 3739P Poster Session: Sarcoma Surufatinib plus serplulimab, etoposide, and carboplatin as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC): Updated results from a single-arm, phase Ia/Ib trial Haipeng Xu/ Longfeng Zhang (Fuzhou, China) 3831P Poster Session: Small cell lung cancer About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE ® . Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA ® . About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS ® . About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA ® . HUTCHMED currently retains all rights to surufatinib worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first four medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether any studies on fruquintinib, surufatinib and savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib and savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib and savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab and toripalimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

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