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Last update 14 Nov 2025

Sintilimab

Last update 14 Nov 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Sintilimab injection, Tyvyt, IBI-308

+ [2]

Target

PD-1

Action

inhibitors

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [5]

Active Indication

Advanced Endometrial CarcinomaClassical Hodgkin's LymphomaNon-Small Cell Lung Cancer+ [40]

Inactive Indication

Acral Lentiginous Malignant MelanomaAdvanced biliary tract cancerAdvanced Gastric Adenocarcinoma+ [33]

Originator Organization

Eli Lilly & Co.

Innovent Biologics (Suzhou) Co. Ltd.

Active Organization

Innovent Biologics (Suzhou) Co. Ltd.

RemeGen Co., Ltd.

Innovent Biologics, Inc.

+ [6]

Inactive Organization

CSPC Pharmaceutical Group Ltd.

License Organization

Xuanzhu Biopharmaceutical Co., Ltd.

Eli Lilly & Co.

Mankind Pharma Ltd.

+ [10]

Drug Highest PhaseApproved

First Approval Date

China (24 Dec 2018),

Hodgkin's Lymphoma

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 13029014H

Source: *****

Sequence Code 13029039L

Source: *****

790

Clinical Trials associated with Sintilimab

ChiCTR2500111980

/ Not yet recruitingPhase 4IIT

Sintilimab Combined with Sacituzumab tirumotecan in Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer: A Single-Arm, Single-Center, Phase II Clinical Study

Start Date15 Nov 2025

Sponsor / Collaborator

Self Finance, Inc.

ChiCTR2500111957

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Multi-mode Thermal Therapy Combined with Paclitaxel plus Gemcitabine (AG Regimen) as First-Line Treatment for Pancreatic Cancer with Liver Metastases: A Prospective Single-Arm Study

Start Date10 Nov 2025

Sponsor / Collaborator

The Affiliated Hospital of Qingdao University

[+1]

ChiCTR2500109605

/ Not yet recruitingPhase 4IIT

Prospective multicenter clinical study of the combination of remifentanil and autologous hematopoietic stem cell transplantation, obetinib, and sintilimab in the treatment of primary first-line/relapsed refractory diffuse large B-cell lymphoma of the central nervous system

Start Date31 Oct 2025

Sponsor / Collaborator

The First Affiliated Hospital of Zhengzhou University

[+1]

100 Clinical Results associated with Sintilimab

100 Translational Medicine associated with Sintilimab

100 Patents (Medical) associated with Sintilimab

820

Literatures (Medical) associated with Sintilimab

31 Dec 2025·Hematology

Sintilimab for treating progressive multifocal leukoencephalopathy caused by human polyomavirus 2 virus infection following allogeneic hematopoietic cell transplantation: a case report

Article

Author: Zhong, Xushu ; Liu, Qinyu ; Jin, Xuelian ; Chen, Xinchuan

BACKGROUND:

Progressive multifocal leukoencephalopathy (PML) is characterized by demyelination in the central nervous system. It is caused by infection with human polyomavirus 2 and has a poor prognosis. Therapeutic strategies involve restoring immune function and/or discontinuing immunosuppressive treatment. Immune checkpoint inhibitors such as those targeting programmed death receptor-1 (PD-1) can alleviate PML by restoring T cell function. There are no case reports on the use of the PD-1 inhibitor, Sintilimab, for treating PML. Here, we report a case of successful treatment of PML with sintilimab following allogeneic hematopoietic stem cell transplantation.

CASE PRESENTATION:

A 35-year-old woman with high-risk acute myeloid leukemia underwent allogeneic hematopoietic stem cell transplantation after induced remission and developed PML 12 months after transplantation. She received five courses of 100 mg every 4 weeks with monitoring by magnetic resonance imaging (MRI) and viral load in the cerebrospinal fluid, showing clinical improvement, resolution of neurological symptoms, and reduced viral load. MRI showed initial exacerbation of lesions but significant improvement after five courses of treatment. No graft-versus-host disease occurred, but manageable immune reconstitution inflammatory syndrome was observed.

CONCLUSION:

Sintilimab, a PD-1 inhibitor, might be used to treat PML in patients with hematologic malignancies undergoing allo-HSCT, which needs further investigation.

31 Dec 2025·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

Author: Xu, Kai ; Zhang, Lingli ; Yu, Man ; Lin, Yingtao ; Su, Dan ; Li, Xin ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

31 Dec 2025·Future Science OA

Chemo-immunotherapy sequential with radiotherapy in advanced or metastatic esophageal squamous cell carcinoma

Article

Author: Xu, Xiajuan ; Zhang, Ling ; Guo, Xiuhui ; Niu, Yuchao ; Zhao, Zhimei ; Nie, Keke ; Han, Xiang ; Ji, Youxin ; Zhang, Zhongfa ; Hou, Qiuyu ; You, Yunhong

BACKGROUND:

To evaluate the efficacy and safety of chemo-immunotherapy combined with residual lesions irradiation of advanced stage esophageal squamous cell carcinoma.

METHODS:

Treatment-naïve patients with radiologically and histologically confirmed advanced or metastatic squamous-cell esophageal carcinoma were enrolled. Participants received four cycles of the TP regimen combined with the PD-1 inhibitor sintilimab. Patients who completed four cycles of chemo-immunotherapy with stable disease (SD) or partial response (PR) subsequently received 50 Gy of radiation in 25 fractions for residual tumors. Maintenance sintilimab therapy was administered every 21 days for up to 31 cycles or until disease progression or intolerable toxicity occurred.

RESULTS:

A total of 39 patients were enrolled in this study, of whom 30 were evaluable for efficacy and toxicity. The complete response (CR) rate was 6.7% (2/30), the partial response (PR) rate was 53.3% (16/30). The median depth of response (DpR) was 34.5% for chemo-immunotherapy and increased to 64.0% after radiotherapy. The progression-free survival (PFS) was 16.4 months, while overall survival (OS) has not yet been reached.

CONCLUSIONS:

Chemo-immunotherapy followed by radiotherapy for residual tumors and maintenance sintilimab, demonstrated high response rates, prolonged PFS, and tolerable toxicity as a first-line treatment for patients with advanced or metastatic esophageal squamous-cell carcinoma.

269

News (Medical) associated with Sintilimab

03 Nov 2025

·www.globenewswire.com

HUTCHMED Highlights Pipeline and Business Progress at R&D Updates Event

— HUTCHMED unveils its innovative ATTC platform, potentially providing precision oncology with synergistic dual-mechanism of action — — Lead candidate HMPL-A251 harnesses a selective PI3K/PIKK inhibitor payload, demonstrating promising preclinical efficacy and safety — — Progress in global and China trials, including FRUSICA-2, SANOVO, surufatinib’s PDAC and fanregratinib’s IHCC studies, advances HUTCHMED’s late-stage pipeline — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) announced key research and development (R&D) and business updates presented during its R&D Updates event held on October 31, 2025. The event highlighted HUTCHMED’s progress in advancing innovative cancer and immunology treatments, including the introduction of its next-generation Antibody-Targeted Therapy Conjugate (“ATTC”) platform, alongside updates on late-stage pipeline candidates. "Our commitment to advancing innovative therapies drives HUTCHMED’s mission to address critical unmet needs in oncology and immunology," said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "The ATTC platform’s potential to redefine precision oncology, combined with our robust pipeline and partnership strategy, positions us to deliver potentially transformative cancer and immunology treatments to patients around the world." Breakthrough ATTC Platform and Lead Candidate HMPL-A251 The ATTC platform represents potentially a groundbreaking approach to precision oncology, integrating monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. The ATTC platform integrates monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. In contrast to traditional cytotoxin-based antibody-drug conjugates (“ADC”), ATTCs leverage targeted therapies to achieve synergistic anti-tumor activity and durable responses, as demonstrated in preclinical models. These conjugates have shown superior efficacy and safety profiles compared to standalone antibody or small molecule inhibitor components. Overcoming Cancer Challenges with PAM-Targeting Payload: The first wave of ATTC candidates focuses on payloads targeting the PI3K/AKT/mTOR (“PAM”) signaling pathway. The PAM pathway is a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant limitations, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery. The ATTC strategy tries to address these challenges by enhancing targeted delivery of PAM inhibitors directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure. HUTCHMED's Lead ATTC Candidate, HMPL-A251: HMPL-A251 is a PAM-HER2 ATTC consisting of a highly selective and potent PI3K/PIKK inhibitor payload conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker. Preclinical data for HMPL-A251 was recently presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In vitro, the PI3K/PIKK inhibitor payload exhibited high selectivity, potency, and robust anti-tumor activity across a diverse panel of tumor cell lines. HMPL-A251 demonstrated HER2-dependent antitumor activity, with potent inhibition of HER2-positive tumor cell growth regardless of PAM pathway alterations, and moderately reduced activity in HER2-low, PAM-altered lines. Notably, HMPL-A251 exhibited a strong bystander effect, impacting HER2-null cells when co-cultured with HER2-positive cells. In vivo evaluations showed superior anti-tumor efficacy and tolerability compared to the naked antibody and payload administered separately. When benchmarked against trastuzumab deruxtecan (T-DXd), a leading HER2-directed ADC, HMPL-A251 achieved comparable or superior efficacy at equivalent doses in most models tested. Furthermore, payload-related toxicities are anticipated to be improved, with plasma exposure of the free payload being significantly lower than that of HMPL-A251. Encouraged by these promising preclinical results in both HER2-positive and HER2-low models, with or without PAM alterations, HUTCHMED plans to advance HMPL-A251 into clinical development starting in late 2025 using a data-driven strategy. Initial studies will evaluate the candidate across various cancer types with diverse HER2 and PAM alteration statuses. Adaptable Payload and Antibody Design Unlocks Versatile Mechanisms: Beyond HER2-targeted antibodies, HUTCHMED aims to explore a broader range of antibody selections that synergize with the payload’s signaling pathways, leveraging the antibody as a delivery vehicle to enhance combination effects. Payload options are also adaptive, targeting a wide array of signaling pathways, positioning ATTCs as a versatile tool in overcoming resistance and improving treatment outcomes. Additionally, ATTC shows potential for combination with chemotherapy-based frontline standard-of-care treatments or as a chemotherapy-free adjuvant for long-term use, enhancing its possible application as combination therapy in early-line settings. Successful development of multiple ATTC molecules is expected to lead to collaboration and licensing opportunities in the future. Initial responses from potential partners are very positive. Significant Progress from Late-stage Programs In addition to the ATTC platform, the R&D Updates featured updates on some of the late-stage programs: Fruquintinib FRUSICA-2 Study: Data from the Phase III trial of fruquintinib in combination with sintilimab for second-line renal cell carcinoma was presented at ESMO Congress 2025. The combination achieved a progression-free survival (PFS) of 22.2 months versus 6.9 months with standard-of-care axitinib or everolimus (hazard ratio [HR]: 0.37; p<0.0001). The objective response rate more than doubled to 60.5% versus 24.3%, with a median duration of response of 23.7 months compared to 11.3 months.Savolitinib Registration Studies: Recruitment has been completed for the SANOVO China Phase III study in first-line EGFR-mutated non-small cell lung cancer (“NSCLC”) with MET overexpression. Recruitment for the SAFFRON global Phase III study for second-line EGFR-mutated NSCLC patients with MET amplification or overexpression is progressing well, with enrollment completion expected in late 2025.Surufatinib for Pancreatic Cancer: The Phase II/III study of surufatinib combined with Hengrui's camrelizumab (a PD-1 antibody), nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) remains on track. Results from the Phase II portion will be presented at an upcoming scientific conference.Sovleplenib for ITP and wAIHA: Preparations for the resubmission of the new drug application for second-line immune thrombocytopenia (ITP) are progressing as outlined in the 2025 interim report, with resubmission planned for the second quarter of 2026. The ESLIM-02 study in second-line warm autoimmune hemolytic anemia (wAIHA) has completed enrollment, with topline results expected in early 2026.Fanregratinib in China: Recruitment for the registrational Phase II study in patients with advanced intrahepatic cholangiocarcinoma (IHCC) in China has been completed, with new drug application submission preparation underway for the first half of 2026. For more information on the R&D updates presentation, please visit www.hutch-med.com/event/. 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 three 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: www.hutch-med.com 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 HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib, the further clinical development for HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib , its expectations as to whether any studies on HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib 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 HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib, 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 HMPL-A251 or other drug candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. 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. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

Phase 3ImmunotherapyPhase 2Clinical ResultAACR

21 Oct 2025

·www.fiercebiotech.com

‘We need to pick a lane’: Lilly oncology president weighs in on FDA cancer drug policies

Eli Lilly’s oncology chief, Jake Van Naarden, suggested that the FDA\'s proposed policies on clinical trial crossover and high U.S. enrollment are not compatible.\n While most of what the FDA laid out in a recent draft guidance on the assessment of overall survival in oncology clinical trials was expected, the document still raised one concern for Eli Lilly’s oncology chief, Jake Van Naarden, and other experts.In the draft guidance, released in August, the FDA suggested that “in general,” the use of crossovers in oncology clinical trials “should be limited.”Crossovers allow patients in the control arm to receive the drug used in the experimental arm upon disease progression. Doing so may mask the drug’s efficacy in the tested disease setting, sometimes leading to unfavorable overall survival data. As the FDA duly noted, “[c]rossover can impact the interpretation of overall survival results because it can confound treatment effect estimates.”The overall theme of the guidance is to emphasize the importance of the evaluation of overall survival as a key trial endpoint.Simultaneously, the FDA is pushing for more U.S. patient representation in oncology trials.“Unfortunately, if you take a look at all the oncology trials that come to us, only about 20% of the population is derived from the United States,” Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, said during an advisory committee meeting in May. “We’d like to see robust increased enrollment in the United States.”To Van Naarden, these two policies are not compatible with each other.“I don’t think you can have both of those,” Van Naarden said in a recent interview with Fierce. “We need to pick a lane here as a country. Which one do we care more about? Proving survival, which means no crossover; or getting U.S. participation, where crossover is a pretty important incentive.”Lilly’s chief medical officer, David Hyman, M.D., echoed that tension.“We struggle every day to accrue our patients from the U.S., and it’s a major focus of the organization, and this just makes it that much harder, unfortunately,” he said in the joint interview, calling crossover and its impact on trial enrollment the main topic Lilly had in its discussions of the draft guidance.The FDA acknowledged in its draft guidance, too, that “[i]nclusion of crossover in clinical trials can improve enrollment and help with retention of enrolled participants.” Lilly has been caught by both policies in the past. In a high-profile case in 2022, the FDA declined to approve Innovent Biologics’ then Lilly-partnered PD-1 inhibitor Tyvyt because the phase 3 trial supporting the application was conducted in China without U.S. participation and featured a weak comparator arm. Lilly later terminated its collaboration with Innovent on the drug in countries outside of China.Then last year, the phase 3 Bruin CLL-32 trial of Lilly’s novel BTK inhibitor Jaypirca in second-line chronic lymphocytic leukemia or small lymphocytic lymphoma missed its OS endpoint after a high, 76% crossover rate.More recently, Lilly’s partner Lantheus called it quits on their PSMA-directed radioligand candidate PNT2002 after an 85% crossover rate confounded the phase 3 Splash trial’s overall survival readout in metastatic castration-resistant prostate cancer. After the trial reached the prespecified number of deaths for a final analysis, the OS results did not turn in favor of PNT2002.With the OS readout, Lantheus has decided not to pursue an approval with the FDA because the agency has not been lenient with trial results that suggest any hint of potential detriment to patients’ survival. While OS data from a crossover design could scupper—or cause major delays, such as in the case of Novartis’ rival PSMA radiotherapeutic Pluvicto—a phase 3 readout, it can also sometimes put one trial’s data at a disadvantage compared with a rival study that doesn’t feature crossovers.At the 2025 European Society for Medical Oncology (ESMO) Congress this past weekend, AstraZeneca and Daiichi Sankyo’s Datroway showed in the Tropion-Breast02 trial that it can reduce the risk of death versus chemotherapy by 21% in first-line triple-negative breast cancer patients who are not candidates for immunotherapy.At the same time, Gilead Sciences’ rival TROP2 antibody-drug conjugate Trodelvy is not yet able to show a survival benefit against chemo in the same disease setting, with a mere 2% trend in favor of the drug, albeit from a shorter follow-up time compared with the AZ/Daiichi trial, according to results published at ESMO 2025.Because Trodelvy is FDA-approved as a later-line therapy for triple-negative breast cancer (TNBC), Gilead’s ASCENT-03 trial allowed crossover; among control-arm patients who initiated subsequent therapy, 82% received Trodelvy. In contrast, only about 30% of patients in the Datroway trial received any ADC in subsequent treatments. Datroway is not approved as a later-line TNBC treatment, and its Tropion-Breast02 trial does not feature a crossover design.The Lilly execs aren’t the only ones finding the FDA’s crossover policy problematic. In an article published last week in The Lancet Oncology, three oncologists led by Bishal Gyawali from Queen’s University in Canada argued that the FDA should generally “encourage, rather than discourage, crossover in all trials testing an already approved drug.”In cases where a drug has already been shown to improve OS in later lines, crossover should be mandated in an earlier-line study involving the drug, “because patients in the control group should receive the best proven therapy at progression,” the experts wrote in the article.In a 2023 Nature Reviews Clinical Oncology article, Gyawali argued that even for new “me-too” drugs following the approval of an agent in the same drug class, crossover should also be mandatory. Such was the case with Lantheus’ PNT2002 trial, but not AZ and Daiichi’s Datroway study.The FDA appeared to agree with the scenarios Gyawali proposed, although such strong words as “mandatory” were not used.Writing in an article published last fall in the journal Clinical Cancer Research, FDA staffers, including Pazdur, suggested that while crossover may complicate OS analysis, it “may be appropriate under certain circumstances.” These include “the investigational therapy is approved for a later line of therapy; drugs similar to the investigational therapy are available off-study,” and “challenging patient recruitment is expected without crossover,” among others.In that article, the FDA also recognized that a crossover design “may appeal to potential trial participants by increasing their chances of receiving the investigational therapy,” but also said it reflects “the unproven assumption that an investigational therapy is superior to [standard of care].”In the current draft guidance, the FDA only said that crossover “would be most appropriate” in disease settings that “have no other or very limited therapeutic options.”Comments on the draft guidance closed yesterday, Oct. 20. The U.S. government’s website shows the document received 33 comments. In one of five comment documents displayed, three doctors from Italy, Kenya and Morocco recommended that the FDA expand the discussion on crossover “to better reflect real-world complexities.”In addition to raising the same scenario where a later-line approval already exists, the doctors argued that even if such an approval isn’t already in place in a particular country, offering ex-protocol access to experimental drugs is also important where regional disparities in access exist. This would create a quasi-crossover effect even if crossover is not part of the trial’s protocol.“Ensuring equitable post-protocol treatment access, especially when the investigational drug is already available and manufactured by the sponsor, reflects not only sound scientific design but also ethical imperatives,” the doctors wrote.FDA guidance documents are not binding, yet they outline important development pathways for drugmakers.“We can agree or disagree on the finer points,” Lilly’s Hyman said. “But at least if these things are in guidances […] the roads are very clear and written, and I think that’s a step in the right direction.”

Phase 3Clinical ResultImmunotherapy

13 Oct 2025

·www.globenewswire.com

HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress

The fruquintinib and sintilimab combination demonstrated significant PFS improvements in advanced renal cell carcinoma patients after progression on first-line therapiesHONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 13, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) announces results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma. Results of the Phase III part of the study will be presented on Friday, October 17, 2025 during the European Society for Medical Oncology (“ESMO”) Congress in Berlin, Germany. FRUSICA-2 is a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma (NCT05522231). A total of 234 patients were randomized into a group that received fruquintinib plus sintilimab combination therapy, or into a group that received axitinib or everolimus monotherapy. As of the progression free survival (“PFS”) final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months. The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response (DoR) was 23.7 vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria. The safety profile of the fruquintinib and sintilimab combination was tolerable and consistent with the known profiles of each individual treatment. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 71.4% of patients in the fruquintinib plus sintilimab group compared to 58.8% for patients in the axitinib/everolimus group. “The FRUSICA-2 trial results provide compelling evidence that fruquintinib and sintilimab may offer a valuable new treatment option for patients with advanced renal cell carcinoma,” said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study. “These findings show the combination’s potential to address a critical unmet need for this patient population, delivering consistent benefits across varied patient profiles and prognostic risk groups.” “The FRUSICA-2 study suggests that fruquintinib and sintilimab could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma,” said Professor Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study. “These results point to the combination’s potential to enhance clinical outcomes, providing a new option for managing this challenging disease.” Supported by data from FRUSICA-2, a New Drug Application (NDA) for the combination of fruquintinib and sintilimab in patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment has been accepted for review by the China National Medical Products Administration (NMPA). About Kidney Cancer and Renal Cell CarcinomaIt is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.1 In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.2 Approximately 90% of kidney tumors are renal cell carcinoma. The safety and efficacy of fruquintinib for the investigational uses discussed above have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated. About FruquintinibFruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to limit off-target kinase activity and improve drug exposure to achieve sustained target inhibition.3 Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. The combination of fruquintinib and sintilimab has received conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation. 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 HUTCHMEDHUTCHMED (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 three 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: www.hutch-med.com or follow us on LinkedIn. Forward-Looking StatementsThis 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, the further clinical development for fruquintinib, its expectations as to whether any studies on fruquintinib 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, 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 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 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 InformationThis 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.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000 ____________________________1 The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf. Accessed February 19, 2025.2 The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed February 19, 2025.3 Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther. 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087.

Clinical ResultPhase 3License out/inImmunotherapyDrug Approval

100 Deals associated with Sintilimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Sintilimab	L01XC	DB15765

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Dec 2024
Classical Hodgkin's Lymphoma	Macao	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
Non-Small Cell Lung Cancer	Macao	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
EGFR positive Non-squamous non-small cell lung cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	06 May 2023
Gastroesophageal junction adenocarcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	23 Jun 2022
Stomach Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	23 Jun 2022
Esophageal Squamous Cell Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	16 Jun 2022
Hepatocellular Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Jun 2021
Non-squamous non-small cell lung cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	03 Feb 2021
Hodgkin's Lymphoma	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Dec 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Renal Cell Carcinoma	NDA/BLA	China	Innovent Biologics, Inc.	05 Jun 2025
Metastatic Renal Cell Carcinoma	NDA/BLA	China	Innovent Biologics, Inc.	05 Jun 2025
Mismatch repair-deficient Colonic Cancer	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2025
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022
Esophageal Carcinoma	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Sep 2021
Unresectable Colorectal Carcinoma	Phase 3	China	Shenzhen Chipscreen Biosciences Co., Ltd.	27 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	15 Mar 2024
Resectable Lung Non-Small Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	15 Mar 2024
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Advanced Renal Cell Carcinoma	Phase 3	China	HUTCHMED (China) Ltd.	27 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2200067045 (ESMO2025) Manual	Phase 2	Anaplastic Thyroid Carcinoma BRAF Gene Mutation Negative	19	SintilimabAnlotinib + SintilimabAnlotinibb	jdtawbnore(nylfijrkim) = qvlnlqmemx lajrbzkzol (jvbmhhuxjh ) View more	Positive	17 Oct 2025
ChiCTR2000035072 (ESMO2025) Manual	Phase 2	Platinum-Resistant Epithelial Ovarian Carcinoma	17	Sintilimab + PaclitaxeAnlotinibinib	qooaapfgin(goareejdfg) = lzpkslwaux kfofhniobl (ucvlgbcbub, 3.5 - NR) View more	Positive	17 Oct 2025
NCT05522231 (FRUSICA-2, ESMO2025) Manual	Phase 3	Locally Advanced Renal Cell Carcinoma Second line	234	Fruquintinib + Sintilimab	bomiqobgkf(feozixmqiz) = fsyvqqcola iocajewphf (qwruwurbrc ) View more	Superior	17 Oct 2025
NCT05522231 (FRUSICA-2, ESMO2025) Manual	Phase 3	Locally Advanced Renal Cell Carcinoma Second line	234	Axitinib / Everolimus	bomiqobgkf(feozixmqiz) = tliwksvswy iocajewphf (qwruwurbrc ) View more	Superior	17 Oct 2025
ChiCTR2400093087 (ESMO2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-sensitive mutations \| PD-L1≥50%	27	Sintilimab plus platinum doublet chemotherapy	heqozcbmrx(vjyasoftjn) = rozvlhrjtd rdscbrajgn (jzwmtnpavc, NA) View more	Positive	17 Oct 2025
ChiCTR2400093087 (ESMO2025)	Phase 2		27	Osimertinib	heqozcbmrx(vjyasoftjn) = btzcxxtmaq rdscbrajgn (jzwmtnpavc, 1.80 - 7.20) View more	Positive	17 Oct 2025
ESMO2025	Phase 2	Renal Cell Carcinoma	26	SintilimabAxitinibab + SintilimabAxitinib (Stereotactic Radiotherapy (SBRT))	jqtlzsvdtw(orimdbkmmv) = wztzrbovor lsmxgzmuvb (pwofezbumx ) View more	Positive	17 Oct 2025
NCT04982939 (PERSIST, ESMO2025)	Phase 2	Gastrooesophageal junction cancer \| Stomach Cancer	264	Sintilimab + SOX	isjynqupan(bftbveomkm) = rffiqxpwqj irzcndlvxj (wodcdfaqwo ) View more	Positive	17 Oct 2025
NCT04982939 (PERSIST, ESMO2025)	Phase 2	Gastrooesophageal junction cancer \| Stomach Cancer	264	SOX	isjynqupan(bftbveomkm) = yodfiikqec irzcndlvxj (wodcdfaqwo ) View more	Positive	17 Oct 2025
ChiCTR2300071203 (ESMO2025)	Phase 2	Esophageal Squamous Cell Carcinoma First line	50	Sintilimab + chemotherapy + radiotherapy	ioydkxgbft(zpzuyrumdx) = jqjvusvhky kxaukkzvkj (jxarjvlsiw, 12.03 - NE) View more	Positive	17 Oct 2025
NCT05640609 (ESMO2025)	Phase 1/2	Advanced Gastroesophageal Junction Adenocarcinoma First line HER2-negative	56	Sintilimab + Bevacizumab biosimilar IBI305 + Chemotherapy	dkycgczyny(qzqasgvcrf) = zkewitycby bduxqverff (iqjmqnpwqt, 75 - 95) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Advanced Lung Non-Small Cell Carcinoma First line	153	Sintilimab+Bevacizumab+Cis/Carboplatin+Taxane (wild-type non-squamous NSCLC)	hbngfoadnd(farcgpuyna) = mikdifvpbn daaindaznb (ydddhpgvmw ) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Advanced Lung Non-Small Cell Carcinoma First line	153	Sintilimab+Bevacizumab+Cis/Carboplatin+Pemetrexed (wild-type non-squamous NSCLC)	hbngfoadnd(farcgpuyna) = xzvdoqspai daaindaznb (ydddhpgvmw ) View more	Positive	17 Oct 2025
NCT05225116 (ESMO2025)	Phase 1	Hepatocellular Carcinoma Neoadjuvant	13	Radiotherapy + Lenvatinib + Sintilimab	kdwwnuneap(ojwacfvjfl) = yldtcyplsy stwmnymzmu (kuwqwasooq ) View more	Positive	17 Oct 2025

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