Etesevimab

SHANGHAI, March 13, 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 financial results for the full year of 2025 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue of Junshi Biosciences was approximately RMB2,498 million in 2025, representing an increase of approximately 28% compared to 2024, which was mainly due to the increase in revenue from sales of pharmaceutical products, in particular the domestic sales revenue of the company’s core product, toripalimab, was approximately RMB2,068 million, representing an increase of approximately 38% compared to 2024. Total research and development (“R&D”) expenses of the company were approximately RMB1,384 million in 2025, representing an increase of approximately 9% compared to 2024. The increase in R&D expenses was mainly due to the company’s focus on more competitive and innovative R&D pipelines and accelerated clinical development in 2025. Net cash inflow from financing activities was approximately RMB2,232 million, which fully covered the cash outflows in operating and investing activities, leading to an increase in bank balances and cash. A successful placing of new H shares on 20 June 2025 generated a net cash inflow of approximately RMB940 million for the company. As of the end of 2025, the company’s aggregate balance of bank balances and cash and financial products was approximately RMB3,195 million, providing a relatively sufficient cash position to support the company’s development. BUSINESS HIGHLIGHTS During 2025, our commitment to addressing “unmet medical needs” has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. Here are the notable achievements and milestones: 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, polypeptide drugs, antibody drug conjugates (ADC), bi-specific or multi-specific antibodies, bispecific antibody drug conjugates, fusion protein, nucleic acid drugs and vaccines, as well as the exploration of next-generation innovative therapies, including those for cancer and autoimmune diseases. A total of four drugs have been commercialized, a number of products are undergoing phase 3 clinical studies or in the stage of marketing application, and various innovative drugs that are competitive in the international market are undergoing accelerated clinical trials. In January 2025, the indication of toripalimab for the treatment of unresectable or metastatic melanoma after failure of standard systemic therapy was approved by the National Medical Products Administration of China (the “NMPA”) for conversion from conditional approval to regular approval. In January 2025, the investigational new drug (“IND”) application for JS212 [a recombinant humanized epidermal growth factor receptor (“EGFR”) and human epidermal growth factor receptor 3 (“HER3”) bispecific ADC] was accepted by the NMPA. It was approved by the NMPA in March 2025. The IND application of JS212 multi-cohort combined drug application was approved by the NMPA in November 2025. In December 2025, the IND application for JS212 for the treatment of advanced solid tumors was approved by the U.S. Food and Drug Administration (“FDA”). In January 2025, the indication of VV116/JT001 (MINDEWEI) for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”) was approved by the NMPA for conversion from conditional approval to regular approval. In January 2025, the New Chemical Entity (“NCE”) application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (“NPC”) and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy was approved by the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”). Toripalimab became the first immuno-onocology treatment for NPC in Australia. In February 2025, the IND application for JS213 (a PD-1 and interleukin-2 (“IL-2”) bifunctional antibody fusion protein) was approved by the NMPA. In March 2025, the supplemental new drug application (the “sNDA”) for toripalimab in combination with bevacizumab for the first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (“HCC”) was approved by the NMPA. In March 2025, the new drug application (the “NDA”) for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC was approved by the Singapore Health Sciences Authority (the “HSA”). Toripalimab became the first approved immuno-oncology treatment for NPC in Singapore. In April 2025, the sNDA for toripalimab for the first-line treatment of unresectable or metastatic melanoma was approved by the NMPA. This is the 12th indication of toripalimab approved in Chinese Mainland. In May 2025, the two sNDAs for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) for: 1) adult patients with heterozygous familial hypercholesterolemia (“HeFH”); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated, were approved by the NMPA. Ongericimab became the first domestic PCSK9-targeted drug approved for statin-intolerant patients. In June 2025, the IND application for the JT118 injection (“JT118”) was accepted. It was approved by the NMPA in September 2025. JT118 is a “two-in-one” recombinant protein vaccine composed of a tandem fusion of monkeypox virus antigens A35 (an extracellular enveloped virus antigen) and M1 (an intracellular mature virus antigen), and is intended mainly for the prevention of monkeypox virus infection. In June 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of esophageal squamous cell carcinoma (“ESCC”) were officially approved for marketing in the United Arab Emirates (the “UAE”) and Kuwait. In August 2025, the sNDA for toripalimab in combination with disitamab vedotin as the treatment of HER2-expressing (HER2 expression is defined as HER2 immunohistochemistry results of 1+, 2+, or 3+) locally advanced or metastatic UC was accepted by the NMPA. In September 2025 and October 2025, the two indications for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC, and toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy were approved for marketing in Pakistan and Canada, respectively. In October 2025, the IND application for an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study comparing JS207 (recombinant humanized anti-PD-1/VEGF bispecific antibody), to nivolumab for the neoadjuvant treatment of patients with stage 2/3, resectable, actionable genomic aberration (AGA)-negative, non-small cell lung cancer (“NSCLC”) was approved by the FDA. In November 2025, a new indication of toripalimab in combination with chemotherapy as first-line treatment of ESCC was approved in Hong Kong SAR, China. In November 2025, the multi-center, open-label, randomized controlled phase 3 clinical study comparing JS001sc (toripalimab injection for subcutaneous use) to toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic non-squamous NSCLC met its primary endpoints. In December 2025, the NDA for JS005 (roconkibart injection, a recombinant humanized anti-IL-17A monoclonal antibody injection), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy was accepted. In December 2025, toripalimab, with two new indications, and JUNSHIDA was successfully included in Category B of the National Drug List for Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance (Year 2025) (the “NRDL”). In December 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of ESCC were approved for marketing in Bahrain. Update on external collaborations In January 2025, TopAlliance Biosciences Inc. (“TopAlliance”), a wholly-owned subsidiary of the company, entered into a distribution and marketing agreement with LEO Pharma A/S (“LEO Pharma”). TopAlliance will grant LEO Pharma the exclusive right to store, distribute, promote, market and sell toripalimab in all current member states and any future member states of the European Union (the “EU”) and the European Economic Area (the “EEA”), Switzerland as well as the United Kingdom (the “UK”) (the “Territory”). LEO Pharma shall pay TopAlliance an upfront payment of EUR15 million, milestone payment(s) for any subsequent approved indication(s) for toripalimab in the Territory, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the Territory. Update on business operations In June 2025, Suzhou Union Biopharm Biosciences Co., Ltd. (“Suzhou Union”), a wholly-owned subsidiary of the company, underwent and passed an unannounced inspection (i.e., an inspection conducted without prior notification during routine operations) in respect of Current Good Manufacturing Practice (“CGMP”) by the FDA. In June 2025, the company completed the placing of new H shares under general mandate (the “Placing”), pursuant to which an aggregate of 41,000,000 H shares (the “Placing Shares”) were successfully allotted and issued at HK$25.35 per H share. The net proceeds (after deduction of commissions and estimated expenses) amounted to approximately HK$1,026 million, which shall be used for innovative drug development and general corporate purposes such as replenishment of working capital. In September 2025, the 2025 A Share Option Incentive Scheme and the 2025 H Share Option Incentive Scheme and related resolutions were considered and approved at a general meeting held by the company. 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. The company has established a diversified R&D pipeline with therapeutic focus areas covering cancer, autoimmune, metabolic and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI ® , and other novel therapies for the prevention and treatment of COVID-19. 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 nearly 3,000 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). 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, Feb. 24, 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 that the company has entered into the strategic collaboration with Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK). Under the collaboration, the parties will jointly evaluate the synergistic therapeutic potential of Junshi Biosciences’ JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, in combination with Antengene’s ATG-037, an oral small-molecule CD73 inhibitor, in patients with solid tumors in Chinese Mainland, with the goal of identifying clinical signals across multiple tumor types. JS207, Junshi Biosciences’ independently developed recombinant humanized anti-PD-1/VEGF bispecific antibody, has demonstrated promising anti-tumor activity and a manageable safety pro both preclinical and clinical studies. JS207’s preclinical studies demonstrated its robust anti-tumor efficacy in multiple tumor models and supported a differentiated mechanism of action, with VEGFA shown to enhance JS207’s antigen binding activity, T-cell activation potency and internalization of cell-surface PD-1. In a poster presented at ESMO Asia 2025, JS207 monotherapy showed encouraging efficacy across solid tumors. 62 patients with PD-L1 positive non-small cell lung cancer (NSCLC) received JS207 monotherapy as first-line treatment, and achieved an objective response rate (ORR) of 58.1% and a disease control rate (DCR) of 87.1%. Clinical activity has also been observed in additional tumor types, including hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC), supporting the potential of PD-1/VEGF dual targeting across multiple tumor settings. To date, JS207 has 11 ongoing phase 2 clinical studies, exploring its use in combination with chemotherapy, monoclonal antibodies (mAb), antibody-drug conjugates (ADCs) and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types, with nearly 500 patients enrolled. Based on the accumulated data from these studies, the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application, allowing Junshi Biosciences to initiate an open-label, two-arm, randomized, active-controlled, Phase 2/3 clinical study comparing JS207 to nivolumab for the neoadjuvant treatment of patients with stage 2/3, resectable, actionable genomic aberration (AGA)-negative NSCLC. ATG-037, Antengene’s orally administered small-molecule CD73 inhibitor, offers significant advantages over anti-CD73 mAbs. In preclinical studies, ATG-037 demonstrated stronger inhibition of cell-surface CD73 enzymatic activity and overcame the “hook effect” commonly observed with antibody-based approaches. In addition, ATG-037’s higher tissue penetration compared with antibodies may facilitate complete CD73 inhibition at the cellular level. ATG-037 has demonstrated encouraging clinical activity in combination with anti-PD-1 therapy in patients with checkpoint inhibitor-resistant melanoma and NSCLC, based on the latest data presented at Antengene’s R&D Day in November 2025. In the ongoing Phase 1/1b STAMINA-01 study, the combination achieved an ORR of 33.3% with a DCR of 100% in patients with CPI-resistant melanoma, and an ORR of 21.4% with a DCR of 71.4% in patients with CPI-resistant NSCLC. The dataset was generated in Australia in patients with CPI-refractory solid tumors, with pembrolizumab and/or nivolumab as the predominant prior anti-PD-1 therapies, and more than 70% of melanoma patients were refractory to both anti-PD-1 mAb and anti-CTLA-4 mAb (ipilimumab). These results support ATG-037’s clinically meaningful activity across multiple tumor types, particularly in patients with prior immunotherapy resistance. Importantly, ATG-037 has demonstrated a favorable safety and tolerability pro combination treatment, with no new or unexpected safety signals observed, including in patients receiving long-term therapy. Grade 3 or higher treatment-related adverse events only occurred in 7.9% of patients. Responses have also shown encouraging durability, including a patient who achieved a complete response and has remained on study for over three years and is currently receiving ATG-037 monotherapy for more than a year, as well as multiple patients with durations of response exceeding 12 months. These data support ATG-037’s potential role as a backbone agent for next-generation immuno-oncology combination regimens. The scientific rationale for the collaboration is based on the complementary and potentially synergistic mechanisms of CD73 inhibition and dual PD-1/VEGF targeting. CD73 is recognized as a key regulator of immune suppression and angiogenesis within the tumor microenvironment through the generation of adenosine, which can dampen anti-tumor immune responses. In both clinical and preclinical settings, CD73 inhibitors have demonstrated meaningful synergy with anti-PD-1 mAbs. In addition, CD73 activity has been shown to promote angiogenesis, including through upregulation of VEGF signaling, and may contribute to the development of resistance to anti-VEGF therapies. Given the broad relevance of immune suppression, angiogenesis and adenosine signaling across solid tumors, this combination strategy has the potential to be applicable across multiple tumor types. Taken together, these observations suggest that combining CD73 blockade with PD-1/VEGF-directed approaches has the potential to enhance and sustain therapeutic effects. Together, the combination of ATG-037 with JS207 represents a potential “triple-axis” approach that simultaneously modulates immune checkpoint signaling, angiogenesis, and the adenosine pathway. With the potential to deepen responses while maintaining a favorable safety profile, the combination of ATG-037 with JS207 may further improve the durability of benefit and may translate into improved overall survival. We look forward to the close collaboration between Junshi Biosciences and Antengene, leveraging their respective expertise in target biology and clinical development to accelerate the evaluation of JS207 in combination with ATG-037 across multiple solid tumor types, with the goal of identifying clinical signals and delivering more innovative treatment options for patients in Chinese Mainland. About JS207 JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, was independently developed by Junshi Biosciences for the treatment of advanced malignant tumors. To date, JS207 has been approved for conducting phase 2/3 clinical study, and it has 11 ongoing phase 2 clinical studies, exploring its use in combination with chemotherapy, mAbs, ADCs and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types. Preclinical results of JS207 have been published in Frontiers in Immunology , while early-stage clinical data were first presented in a poster session at ESMO ASIA 2025. JS207 can simultaneously bind to PD-1 and VEGFA with high affinity, effectively blocking the binding of PD-1 to PD-L1 and PD-L2 while also inhibiting the binding of VEGF to its receptor. JS207 has the efficacy of both immunotherapeutic drugs and anti-angiogenic drugs. Through the neutralization of VEGF, JS207 inhibits the proliferation of vascular endothelial cells, improves the tumor microenvironment, and increases the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-neoplasm activity. JS207’s design is based on the high-affinity, clinically proven and differentiated anti-PD-1 drug, toripalimab as the backbone. The anti-PD-1 moiety of JS207 adopts a Fab structure to maintain binding affinity to PD-1, thereby attaining better enrichment in the tumor microenvironment. The anti-VEGF moiety has a binding affinity for human vascular endothelial growth factor that is comparable to that of bevacizumab. In non-clinical in vitro cytological tests, compared with the combination of an anti-PD-1/PD-L1 monoclonal antibody and a VEGF monoclonal antibody, a bispecific antibody simultaneously targeting PD-1/PD-L1 and VEGF demonstrated significantly enhanced PD-1 antigen binding and internalization, as well as synergistic enhancement of the NFAT signaling pathway, thereby better activating immune cells in the tumor microenvironment. 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. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. 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 approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). 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