A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic Profiles, and Immunogenicity of JS026 and JS026 in Together With JS016 Administered Intravenously to Healthy Chinese Subjects

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous infusion of JS026 and JS026 + JS016 Injection in healthy subjects.
In this study, the single ascending dose design will be adopted, JS026 will be administered sequentially from low dose group to high dose group, and each subject can only receive an intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1. Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will be enrolled in each of other dose groups, totally 48 subjects.

Start Date16 Dec 2021

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

EUCTR2021-004035-88-IT

/ Not yet recruitingPhase 3IIT

A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotrovimab versus Standard of Care in patients with mild to moderate COVID-19 disease (AntiCov)

Start Date26 Aug 2021

Sponsor / Collaborator-

NCT04790786

/ TerminatedPhase 4IIT

The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial

Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select populations, and are routinely used in the UPMC Health System, which has made expanded access a priority. However, the comparative effectiveness of these mABS is unknown. The National Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical use of mABs, noting it is "critical to collect data and evaluate whether they are working as predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes EUAs), UPMC Health System policies and the evaluated mABs will accordingly change.

Start Date10 Mar 2021

Sponsor / Collaborator

University of Pittsburgh Medical Center

[+1]

100 Clinical Results associated with Etesevimab

100 Translational Medicine associated with Etesevimab

100 Patents (Medical) associated with Etesevimab

151

Literatures (Medical) associated with Etesevimab

01 Jun 2026·TRANSFUSION AND APHERESIS SCIENCE

Drug-induced thrombocytopenia after SARS CoV-2 monoclonal antibody administration treated with plasma exchange

Article

Author: Irani, Mehraboon S ; Hiskey, Matthew M

A number of different therapeutic modalities have been tried for SARS CoV-2 infection, including monoclonal antibodies against the spike protein such as imdevimab/casirivimab (REGEN-COV). We report a case of severe thrombocytopenia due to REGEN-COV that was treated successfully with a course of plasma exchange. An 84 y M who lived alone was hospitalized with fatigue and dyspnea, and hematuria. He had a history of atrial fibrillation for which he was taking rivaroxaban. On admission he was mildly anemic with normal platelets. Testing was positive for SARS C0V-2 by PCR. The rivaroxaban was discontinued and a cystoscopy showed two bleeding sites which were treated by cauterization. He received REGEN-COV, and over the next two days his platelet count dropped from 153 to < 1 × 10⁹/L. A diagnosis of drug-induced thrombocytopenia due to REGEN-COV was made and despite platelet transfusions, intravenous immunoglobulin 2 g/kg, and dexamethasone 40 mg daily, his platelet count stayed at < 1 or 1 × 10⁹/L. Since REGEN-COV has a half-life of three weeks or more, plasma exchange was considered as a means of removing the drug. Plasma exchange daily, with plasma replacement was started on the ninth hospital day and continued for four days. The platelet count sequentially increased daily and was within the normal range by day 14. The hematuria cleared by day 11. The patient was treated for SARS-CoV-2 by other means and discharged on day 22. Plasma exchange should be considered when rapid removal of therapeutic monoclonal antibody is warranted due to life-threatening side effects.

01 Feb 2026·JOURNAL OF THEORETICAL BIOLOGY

Antibody escape of SARS-CoV-2 variants of concern on receptor-binding domain: A computational approach

Article

Author: Tuong, Lam-Truong ; Tran, Van-Thanh ; Le, Minh-Tri ; Thai, Khac-Minh ; Nguyen, Dac-Nhan ; Tran, Viet-Hung ; Hoai Huynh, Phuong Nguyen ; Dang, Thoai-My ; Tran-Thi, Phuong-Uyen ; Nguyen, Quoc-Thai

The receptor-binding domain (RBD) of the spike protein is a critical functional component responsible for binding between the SARS-CoV-2 and the ACE2 receptor, as well as monoclonal antibodies. This research focuses on evaluating the ability of SARS-CoV-2 variants to reduce or evade neutralizing antibody responses. The RBD structures of wild type, Delta, and Omicron structures along with nine RBD-directed antibodies downloaded from the Protein Data Bank were subjected to docking simulations via the HADDOCK 2.4 server to calculate Haddock score, binding affinity (ΔG) and dissociation constant (K_d). The resulting complexes underwent molecular dynamics simulations for 100 ns using GROMACS, and the binding free energy was calculated using gmx_MMPBSA. The findings indicated that the L452R and T478K mutations in Delta, as well as the K417N, E484A, S477N, and Q493R mutations in Omicron, were predicted to be pivotal factors in the interaction with antibodies. Omicron exhibited a greater potential for immune evasion compared to Delta. Notably, the Sotrovimab antibody demonstrated robust interactions with both variants. Etesevimab exhibited strong binding with Delta but displayed a weaker connection with Omicron. Therefore, Sotrovimab and Etesevimab remain promising candidates for in vitro and in vivo testing against SARS-CoV-2 variants.

31 Dec 2025·Emerging Microbes & Infections

Discovery of a pan anti-SARS-CoV-2 monoclonal antibody with highly efficient infected cell killing capacity for novel immunotherapeutic approaches

Article

Author: Roux-Portalez, Vincent ; Simonelli, Luca ; Varani, Luca ; Calderon, Hugo ; Gros, Nathalie ; Chentouf, Myriam ; Tamagnini, Elia ; Pugnière, Martine ; Vazquez, Mario ; Naranjo-Gomez, Mar ; Souchard, Manon ; Marsile-Medun, Soledad ; Juan, Manel ; Lyonnais, Sebastien ; Dinter, Heiko ; Pedotti, Mattia ; Pelegrin, Mireia ; Martineau, Pierre ; Ngo, Giang ; Abba Moussa, Daouda ; Chable-Bessia, Christine

Unlocking the potential of broadly reactive coronavirus monoclonal antibodies (mAbs) and their derivatives offers a transformative therapeutic avenue against severe COVID-19, especially crucial for safeguarding high-risk populations. Novel mAb-based immunotherapies may help address the reduced efficacy of current vaccines and neutralizing mAbs caused by the emergence of variants of concern (VOCs). Using phage display technology, we discovered a pan-SARS-CoV-2 mAb (C10) that targets a conserved region within the receptor-binding domain (RBD) of the virus. Noteworthy, C10 demonstrates exceptional efficacy in recognizing all assessed VOCs, including recent Omicron variants. While C10 lacks direct neutralization capacity, it efficiently binds to infected lung epithelial cells and induces their lysis via natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC). Building upon this pan-SARS-CoV-2 mAb, we engineered C10-based, Chimeric Antigen Receptor (CAR)-T cells endowed with efficient killing capacity against SARS-CoV-2-infected lung epithelial cells. Notably, NK and CAR-T-cell mediated killing of lung infected cells effectively reduces viral titers. These findings highlight the potential of non-neutralizing mAbs in providing immune protection against emerging infectious diseases. Our work reveals a pan-SARS-CoV-2 mAb effective in targeting infected cells and demonstrates the proof-of-concept for the potential application of CAR-T cell therapy in combating SARS-CoV-2 infections. Furthermore, it holds promise for the development of innovative antibody-based and cell-based therapeutic strategies against severe COVID-19 by expanding the array of therapeutic options available for high-risk populations.Trial registration: ClinicalTrials.gov identifier: NCT04093596.

179

News (Medical) associated with Etesevimab

15 Apr 2026

·adimab.com

Adimab Collaborator GSK Receives Additional Marketing Approval for Depemokimab

Lebanon, New Hampshire – April 15, 2026 – Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, congratulates GSK plc for recently receiving approvals by the European Commission (EC) and China’s National Medical Products Administration (NMPA) for depemokimab. This adds to recent marketing approvals in the United States, Japan, and the United Kingdom. Depemokimab is the first ultra-long-acting biologic product approved for use in its indicated conditions and was developed internally by GSK with an extended half-life and engineered high binding affinity to enable twice-yearly dosing, as demonstrated in GSK’s pivotal trials. To support in the engineering of the molecule, GSK internalized Adimab’s proprietary yeast-based technology, enabling in-house antibody discovery, optimization, production, and characterization on any target of GSK’s choosing. GSK’s research team used the Adimab Platform for depemokimab, a product tailored to meet GSK’s target product profile, including low picomolar affinity. GSK continues to use the Adimab platform to support other internal programs. “Depemokimab is the first approved product to emerge from our Platform Transfer collaborations, further validating this portion of our business model. Fittingly, GSK was our first Platform Transfer collaborator, and we congratulate them on this tremendous success,” said Philip T. Chase, Chief Executive Officer of Adimab. “Depemokimab is just one example of GSK’s adoption of the Adimab technology to pursue innovative therapeutic products,” added Eric Krauland, President and Chief Scientific Officer of Adimab. “GSK’s use of the platform, exemplified through ongoing investment in the Adimab team’s expertise and the use of Adimab's technological advances such as new library diversities, has translated into other GSK clinical programs that aim to make a real difference for patients.” Adimab’s other Platform Transfer collaborators include Biogen, Lilly, Merck, Novo Nordisk, and Takeda. Each Platform Transfer collaborator has been enabled, through training at Adimab and their own site, to operate Adimab’s proprietary platform independently. Further, each Platform Transfer collaborator has their own unique diversity, ensuring non-overlapping outputs. The Adimab technology can be used on any biologic target, in any format, and in any therapeutic area, allowing flexibility from discovery through engineering and generation of multispecifics. Support is always available, including access to Adimab scientists, biannual technology summits, and regular updates to strains, libraries, and in silico tools. Other commercial products containing molecules from Adimab include: Innovent’s TYVYT® (sintilimab injection), a PD1 program approved in China for the treatment of multiple cancers. Innovent’s SINTBILO® (tafolecimab injection), a PCSK9 program approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. IASO Bio’s FUCASO® (equecabtagene autoleucel), a BCMA CAR-T program approved in China for the treatment of patients with multiple myeloma. Invivyd’s PEMGARDA™ (pemivibart), a SARS-CoV-2 monoclonal antibody authorized for prophylactic emergency use in the United States to prevent COVID-19 infection. Sun Pharma’s UNLOXCYT™ (cosibelimab), a PD-L1 program approved in the United States for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma. There are numerous additional Adimab-associated programs that are currently in Phase II or Phase III (pivotal) trials. The total number of Adimab-associated clinical programs initiated by our collaborators has now reached 90. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. Our suite of technologies includes naïve discovery from synthetic libraries in yeast or B cells (mice, llamas, and humans), antibody engineering and optimization, bi- and multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies with complementary heterodimerization mutations that are licensed non-exclusively for bi- and multispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 140 pharmaceutical and biotechnology companies, generating more than 650 therapeutic programs, 90 clinical programs, and 6 approved products. The Adimab technology has been transferred and implemented at GSK, Biogen, Novo Nordisk, Merck, Lilly, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Innovent, Novartis, Regeneron, Vertex and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint Therapeutics, Santa Ana Bio, Tizona, Kelonia, and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Scholar Rock, and others. Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com.

Drug ApprovalPhase 3Phase 2

13 Mar 2026

·www.biospace.com

Junshi Biosciences Announces 2025 Full Year Financial Results and Provides Corporate Updates

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

Drug ApprovalPhase 3ImmunotherapyFinancial StatementAccelerated Approval

25 Feb 2026

·www.biospace.com

Junshi Biosciences Announces Strategic Collaboration with Antengene to Evaluate Combination Therapy with JS207 (PD-1/VEGF BsAb) and ATG-037 (Oral CD73 Inhibitor)

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

Phase 2Clinical ResultImmunotherapyPhase 1License out/in

100 Deals associated with Etesevimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11944	-	-	DB15897

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	United States	Eli Lilly & Co.	09 Feb 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post Acute COVID 19 Syndrome	Phase 3	United States	Eli Lilly & Co.	17 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04790786 (OPTIMISE-C19, CTgov)	Phase 4	COVID-19	4,571	Lilly Bamlanivimab (Lilly Bamlanivimab)	ejoyiwlync(pmcspnitmq) = ihntdityyw zvqmwgybks (hixkizxqbt, cfojjadvzl - hzuuojznzk) View more	-	15 Jun 2023
				Casirivimab+Imdevimab (Regeneron Casirivimab + Imdevimab)	ejoyiwlync(pmcspnitmq) = atowkydlku zvqmwgybks (hixkizxqbt, dycccefnwp - ejtibpsnek) View more
NCT04931238 (Pubmed \| Antimicrob Agents Chemother) Manual	Phase 2/3	COVID-19	197	standard care+Etesevimab	fctkvqfbnl(asgnxomtcg) = acwidnoigt jjdkwjbtos (zuombcpsry )	Negative	22 Feb 2022
				standard care	fctkvqfbnl(asgnxomtcg) = ijnmppecbk jjdkwjbtos (zuombcpsry )
NCT04497987 (BLAZE-2, CTgov)	Phase 3	COVID-19	1,180	Placebo (Placebo)	jshxcnirkr = myhqlyeors ryzpuadjju (ynyluvsuab, pljehbsdbl - nfkkrpskcw) View more	-	04 Feb 2022
				Bamlanivimab (4200mg Bamlanivimab)	jshxcnirkr = tdufngezvs ryzpuadjju (ynyluvsuab, tbrcjtfpap - rylsutzckz) View more
NCT04441931 (CTgov)	Phase 1	-	26	Placebo (Pooled Placebo)	zcktotwnke = lxrsjhvbyf fjjfpbgjho (msanadzllv, yfrotmgvfd - jkmneqhqns)	-	06 Dec 2021
				LY3832479 (700 mg LY3832479 IV)	zcktotwnke = nldeveamdr fjjfpbgjho (msanadzllv, jsjjnfsarm - jfzoikxlya) View more
NCT04611789 (CTgov)	Phase 1	-	18	LY3832479 (350 mg LY3832479)	rdibiktqcv(frsnsyytaf) = uaxjemydmk binhowstuc (qcpyyhjnai, 80) View more	-	06 Dec 2021
				LY3832479 (1000 mg LY3832479)	rdibiktqcv(frsnsyytaf) = whdgmzkusb binhowstuc (qcpyyhjnai, 31) View more
NCT04427501 (BLAZE-1, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 2/3	COVID-19	1,035	bamlanivimab+etesevimab	yahidfmcer(tbldgeyukb) = nubplafgml hricmsqqsv (uyweqjscsz ) View more	Positive	07 Oct 2021
				Placebo	yahidfmcer(tbldgeyukb) = gjkijubmwi hricmsqqsv (uyweqjscsz ) View more
NCT04441918 (Pubmed) Manual	Phase 1	COVID-19	40	Etesevimab	-	Positive	16 Jul 2021
				Placebo
NCT04634409 (BLAZE-4, FDA) Manual	Phase 2	COVID-19	483	Bamlanivimab 700mg+Etesevimab 1400mg	evuwrhdmpk(wdhnocvrsi) = aroiiytrfp tfvrmvhkal (uzszgbczbl )	Positive	09 Feb 2021
				Bamlanivimab 2800mg+Etesevimab 2800mg	evuwrhdmpk(wdhnocvrsi) = qpltxrbexg tfvrmvhkal (uzszgbczbl )
NCT04427501 (BLAZE-1, FDA) Manual	Phase 3	COVID-19	1,035	Bamlanivimab 2800mg+Etesevimab 2800mg	dooyjycfft(oxomhvzwyi) = atmdxdpmvq gfaqgzuzdy (qlfekdbdkc ) View more	Positive	09 Feb 2021
				Placebo	dooyjycfft(oxomhvzwyi) = vqpkzxzeqy gfaqgzuzdy (qlfekdbdkc ) View more
NCT04427501 (BLAZE-1, FDA) Manual	Phase 2	COVID-19	369	Bamlanivimab 2800mg+Etesevimab 2800mg	hhayijdhhh(uoxhsasjny) = Most subjects, including those receiving placebo, effectively cleared virus by Day 11. kpviccywql (atcdwecdxj ) View more	Positive	09 Feb 2021
				Bamlanivimab 700 mg

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