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Last update 29 Sep 2025

Sintilimab

Last update 29 Sep 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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Innovent Biologics (Suzhou) Co. Ltd.

Eli Lilly & Co.

+ [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: *****

773

Clinical Trials associated with Sintilimab

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]

ChiCTR2500109899

/ Not yet recruitingPhase 4IIT

Clinical Study on Efficacy Differences of Regorafenib Combined with Sintilimab in Left- vs. Right-Sided Metastatic Colorectal Cancer

Start Date08 Oct 2025

Sponsor / Collaborator

Chongqing University Cancer Hospital

[+1]

NCT07018063

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Neoadjuvant Nab-Paclitaxel Combined With Oxaliplatin, S-1, and Sintilimab in Patients With Locally Advanced Resectable Early-onset Gastric Cancer: A Phase II, Single-Arm, Open-Label Clinical Trial

This study aims to evaluate the effectiveness and safety of a preoperative treatment (called neoadjuvant therapy) combining four drugs-nab-paclitaxel, oxaliplatin, S-1, and sintilimab-for patients with locally advanced, resectable early-onset gastric cancer (diagnosed at age 45 or younger).
All participants will receive this drug combination before undergoing surgery to remove the tumor. The goal is to shrink the tumor, increase the chance of complete surgical removal, and improve long-term outcomes.
This is a single-arm, open-label, phase II clinical trial, meaning all participants will receive the same treatment, and both doctors and patients will know what drugs are being used. The study is being conducted at Peking University People's Hospital.

Start Date01 Oct 2025

Sponsor / Collaborator

Peking University People's Hospital

100 Clinical Results associated with Sintilimab

100 Translational Medicine associated with Sintilimab

100 Patents (Medical) associated with Sintilimab

844

Literatures (Medical) associated with Sintilimab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Hedgehog pathway inhibitors (HHI) combined with radiotherapy and immunotherapy for advanced basal cell carcinoma: a case report

Article

Author: Yao, Zhijian ; Wei, Gao ; Li, Longshan ; Zhao, Chen ; Li, Xianghui ; Ruan, Zhuren

PURPOSE:

Basal cell carcinoma (BCC) is one of the most common skin cancers. Most BCCs can be treated with surgery excision. For advanced BCC unsuitable for curative surgery, the combination of radiotherapy and Hedgehog pathway inhibitors (HHI) are effective systemic treatment options. However, there is a scarcity of evidence-based guidelines for the management of patients with advanced or metastatic BCC, particularly those who develop resistance to HHI therapy.

MATERIALS AND METHODS:

We report the case of a patient with advanced BCC of the head and neck, which originated from a nevus sebaceous.

RESULTS:

The patient initially responded well to sonidegib, an HHI, but resistance emerged within a month. We then modified the systemic therapy to include a combination of radiotherapy and the anti-PD-1 agent sintilimab.

CONCLUSIONS:

This adjusted treatment regimen led to effective long-term clinical responses without significant adverse events.

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.

265

News (Medical) associated with Sintilimab

27 Aug 2025

·www.prnewswire.com

Innovent Announces 2025 Interim Results and Business Updates

Robust revenue growth and substantial profit improvement Continued exceptional executions under a clear roadmap of dual-driven growth and global innovation SAN FRANCISCO and SUZHOU, China, Aug. 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2025 interim results and major business updates. Continue Reading Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum. On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent's innovation capabilities and lays a solid foundation for globalization. We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent's growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company." Dual-driven revenue growth with execution excellence Robust revenue growth and substantial profit improvement[1] Total revenue: RMB 5.95 billion, up 50.6% year-on-year Product revenue: RMB 5.23 billion, up 37.3% year-on-year Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion Gross margin: 86.8%, up 2.7 percentage points year-on-year Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year R&D investment: RMB 903 million Cash on hand: approximately USD 2 billion[2] Dual-engine growth supported by comprehensive and diversified product portfolio Expansion of oncology product portfolio with three new launches Dovbleron® (taletrectinib) : Potentially best-in-class ROS1 inhibitor Limertinib : Third-generation EGFR TKI Jaypirca®(pirtobrutinib) : First non-covalent BTK inhibitor Strengthening general biomedicine portfolio with innovative pipeline SINTBILO® (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025 SYCUME ® ( teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review Innovative commercial strategy with multi-channel coverage Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence Enhancing brand strength through the establishment of a lifecycle management system TYVYT ® : NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway SYCUME ® ( teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc. Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics Emerging value from globalization strategy, prioritizing novel pipeline's global R&D Flagship pipeline showcased at top-tier conferences, entering global registration studies IBI363 (PD-1/IL-2 α -bias ): Unleashing potential as a next-generation IO therapy with global first-in-class design Three oral presentations at ASCO highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC First MRCT Phase 3 study of GC has been initiated in China and Japan First Phase 3 study of PDAC has been initiated Global MRCT of PDAC is in plan NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted Over 10 next-generation programs advancing into global development Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc A uto immune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc Hybrid models to accelerate innovation IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide Enhance global presence with broader market access Six products (TYVYT®, BYVASDA®, Pemazyre®, Dupert®, SINTBILO®, SYCUME®) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia More launches planned Brazil, Mexico, Columbia, India, etc Research innovation showcased at medical conferences Oncology pipeline: AACR, ASCO, Nature Medicine General biomedicine pipeline: ADA, NEJM Facilities and manufacturing capacity adhering to high-quality standards 7,500 employees globally Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China's total biopharmaceutical production capacity First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations Committed to responsible business practices and enhancing ESG management practices Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent's innovative drugs Innovent has been graded 'AAA' rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise" Provided over 2,200 job opportunities for recent graduates To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBreakthrough TherapyPhase 3Phase 2Fast Track

11 Jun 2025

·www.biospace.com

Biopharma Right of First Negotiation Not a Golden Ticket to M&A, Jefferies Finds

iStock, Anastasiia_New Looking at licensing deals struck in the past 10 years, Jefferies found that many Big Pharmas do not ultimately follow through with M&A after earning a right of first negotiation. Sanofi, on the other hand, almost always does, as it did with Vigil recently. For biotech, a right of first negotiation to a buyout is not always a ticket to M&A, a new report from Jefferies suggests. But Sanofi’s $470 million acquisition of Vigil Neuroscience—which indeed stemmed from such a clause in a previous licensing deal—has reinvigorated interest in the idea of ROFNs. Jefferies took a look at 50 ROFN agreements that have occurred across biopharma in the past 10 or so years. These agreements are sometimes included in licensing agreements between two companies with varying terms such as providing a first shot at deal talks if the smaller company decides to sell. They can also pertain to single assets or for future drug development or commercialization opt-ins. Many Big Pharmas do not ultimately follow through despite including a ROFN in a licensing deal, Jefferies found. But somehave led to business development collaborations instead, such as AbbVie’s partnership with Aldeyra Therapeutics and GSK’s pact with Liquidia Corporation. Sanofi is a particularly big fan of including ROFNs in its licensing deals. Vigil is the most recent example, but Jefferies flagged three more outstanding from the pharma: with Ventyx Biosciences, Zucara and MeiraGTx. In the case of Vigil, Sanofi provided $40 million in capital back in July 2024, securing the ROFN for Alzheimer’s disease asset VG-3927. Eleven months later, Sanofi apparently saw all it needed to and executed on an acquisition of the entire company, save for one asset that was to be returned to Amgen . Other companies with ROFNs still on the books include Pfizer and Axsome Therapeutics, Gilead and Nektar Therapeutics, and Catalyst Pharmaceuticals and Santhera Pharmaceuticals. Below, BioSpace looks at five ROFN agreements across biopharma that are still chugging along—or not. Ventyx Rises as Sanofi Buys Out Peer Of Sanofi’s multiple deals including a ROFN is its $27 million investment in Ventyx Biosciences. Struck last year, the contract gave Sanofi an exclusive right to have the first say in the prospects of VTX3232, a central nervous system-penetrant NLRP3 inhibitor in Phase II development. Ventyx is expecting multiple major readouts for VTX3232 this year, including in Parkinson’s disease and in subjects with obesity and additional cardiometabolic risk factors. Ventyx’s shares climbed when Sanofi acquired Vigil, given the similar focus on CNS diseases. Through the ROFN, Sanofi has gained the right to an exclusive period of time to negotiate a potential deal, but the clause does not stop another pharma from putting in an offer. Jefferies suggested that Eli Lilly or AbbVie could be interested , as Ventyx’s work crosses between immunology and CNS. The cardiometabolic data could also be a nice boost to Ventyx’s fortunes; Jefferies referred to this as a “wild card” that could be an add on for for GLP-1 therapies. AbbVie Gets First Eye on Aldeyra’s Ophthalmology Work AbbVie zeroed in on Aldeyra’s dry eye disease therapy reproxalap in November 2023, inking a deal worth up to $400 million. AbbVie snagged a 60%-40% profit split with Aldeyra for sales in the U.S., while the latter would receive royalties on ex-U.S. sales. Since then, the regulatory process for reproxalap has not gone smoothly . Aldeyra has received two FDA rejections of the drug’s application for dry eye disease. Most recently, the FDA issued a complete response letter in April stating that reproxalap “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes.” The agency asked for another trial with a positive effect on the ocular symptoms of dry eye. AbbVie has an option agreement on reproxalap that requires a decision 10 days after an FDA approval is achieved, if any, meaning it remains open. The original AbbVie-Aldeyra deal also included a ROFN for AbbVie on “compounds that are owned or otherwise controlled by Aldeyra” in ophthalmology, particularly therapies for treating conditions of the ocular surface. AbbVie also negotiated the right to review data for any of these compounds in ophthalmology as well as immunology before anyone else gets a look. Aldeyra’s other pipeline meds include the retinitis pigmentosa injection ADX-2191 and ADX-248 for atopic dermatitis, which is in Phase I. AstraZeneca and Conduit’s Convoluted Deal Licensing deals typically involve a bigger company taking on a smaller biotech’s assets for development, but this deal gets strange as you dig deeper. Conduit Pharma and AstraZeneca partnered in August 2024, with the U.K.-pharma providing Conduit with exclusive licensing rights to the HK-4 glucokinase activators AZD1656 and AZD5658, as well as the myeloperoxidase inhibitor AZD5904. Conduit’s structure is unique. The company acquires and funds development of Phase II-ready assets, then fuels them toward Phase II before selling the rights to a third party if all goes well. AZD1656, AZD5658 and AZD5904 are originally AstraZeneca’s drugs—so a ROFN clause fits in nicely as AstraZeneca clearly didn’t want to let them go fully as Conduit tested some of them in new indications. AZD1656, which is being tested in lupus, was originally developed by AstraZeneca for diabetes, meaning Coinduit is essentially handling the mid-phase lifecycle of the drug’s development in the new indication. The drug had already been tested in thousands of patients and more than a dozen trials before Conduit began its work, so the safety record was firmly established by AstraZeneca allowing for quick advancement. Conduit developed a new formulation to improve on the physicochemical properties of the drug and is currently working on Phase II trials. Besides the ROFN, AstraZeneca took ownership of common stock in Conduit as part of the deal, though the details were not disclosed. As of March, Conduit was working on initiating the Phase II trials with results expected in the second half of this year. AZD1656 is also being tested for ANCA vasculitis, while AZD5658 is earmarked for autoimmune disorders and AZD5904 is in trials for idiopathic male infertility. Lilly Dealt With Innovent in China Before It Was Cool Partnerships with Chinese biotechs have been all the rage lately , but Eli Lilly saw the light at least a decade ago when it signed a partnership with Innovent Biologics. The deal initially focused on three therapies , one of which would become the approved PD-1 inhibitor Tyvyt. Innovent received $56 million upfront plus up to $400 million in milestones. Over the years, the deal has been revamped and renegotiated, with Innovent nabbing in-China rights to some of Lilly’s medicines. In 2022, the Chinese biotech took on the rights to Cyramza and Retsevmo, and earned a ROFN on future commercialization of the Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca in China. The ROFN was achieved in December 2024, with Innovent officially achieving commercialization of Jaypirca in mainland China. Biogen Scales Back Denali Work This one has been rocky. Biogen and Denali Therapeutics originally tied up in August 2020, agreeing to work on neurodegenerative diseases including Parkinson’s. Denali received $560 million upfront, plus $465 million in equity from Biogen and the possibility of milestones down the line. The original focus was on Denali’s small molecule LRRK2 inhibitor program, but Biogen also received an exclusive option on two programs that utilized the biotech’s platform technology for crossing the blood-brain barrier (BBB). These two programs included a ROFN. Biogen exercised its rights to one of the two neurodegenerative programs in April 2023 for Alzheimer’s disease. On one part of the Parkinson’s program, however, progress turned out to be too slow for Biogen, which cut a trial for BIIB122 that wasn’t expected to read out until 2031, according to a June 2023 release . Then in August 2024, Biogen ended the Alzheimer’s work too, leaving Denali to pick up the pieces. The partners continue to advance the LRRK2, called BIIB122/DNL151, in a Phase IIb trial. The BBB-crossing tech program is still in investigational new drug application pre-clinical testing. The Biogen trouble has been just one aspect of Denali’s rocky few years. The company’s Sanofi-partnered multiple sclerosis program was canned in October 2024 after failing a Phase II trial. The same drug also failed a test in amyotrophic lateral sclerosis (ALS) earlier the same year. And in January, Denali suffered another ALS failure as part of the HEALEY ALS platform study .

Phase 2License out/inPhase 1Acquisition

05 Jun 2025

·www.prnewswire.com

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Renal Cell Carcinoma

SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the New Drug Application (NDA) for the combination of sintilimab and fruquintinib for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). The NDA is supported by data from FRUSICA-2, 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. The study has met its primary endpoint of progression free survival (PFS), as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. The combination also demonstrated improvements in secondary endpoints including objective response rate (ORR) and duration of response (DoR). The safety profile was tolerable and no new safety signals were observed. Data from FRUSICA-2 will be submitted for presentation at an upcoming scientific conference. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231. Dr Hui Zhou, Senior Vice President of Innovent, stated: "The second NDA acceptance of sintilimab and fruquintinib combination represents a significant step toward providing a more effective treatment option for patients with second line advanced renal cell carcinoma in China . Our PD-1 inhibitor, sintilimab (TYVYT®), has solidified its position as a cornerstone of immuno-oncology (IO) therapy with this NDA as its 10th indication, marking a meaningful milestone in lifecycle management and clinical value optimization." Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated: "Kidney cancer continues to pose significant challenges in China, with limited treatment options for patients who fail first-line therapies. Submitting this NDA for the fruquintinib and sintilimab combination for advanced renal cell carcinoma marks an important step in our efforts to address this unmet need. We are dedicated to making this combination therapy available to patients with renal cell carcinoma. At the same time, through ongoing research, we remain focused on exploring the full potential of this combination, as well as advancing our broader pipeline across multiple cancer types, to provide more patients with new and effective treatment options." In December 2024, the combination of sintilimab and fruquintinib received conditional approval from the China NMPA for the treatment of patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705). About Kidney Cancer and Renal Cell Carcinoma It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[ii] Approximately 90% of kidney tumors are RCC. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed and co-commercialized by Innovent and Eli Lilly and Company, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[iii] In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. Two NDAs for sintilimab are currently under the NMPA review, including: In combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation; In combination with fruquintinib for the treatment of patients with locally advanced or metastatic renal cell carcinoma who failed prior treatment with one TKI. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 clinical study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 clinical study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. About Fruquintinib Fruquintinib 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 have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.[iv] About Fruquintinib Approvals 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. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. The combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has 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®. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US, Europe, Japan and many other countries around the world. The safety and efficacy of fruquintinib for the following investigational uses 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 Fruquintinib for Second-line Treatment of RCC Single-agent targeted therapy continues to be one of the primary choices for first-line treatment of advanced RCC in China. Notably, advanced RCC patients who have experienced failure with single-agent targeted therapy previously still indicate an unmet medical need. Results from a proof-of-concept Phase Ib/II study of fruquintinib plus sintilimab were published in Targeted Oncology in January 2025. The combination demonstrated promising efficacy and a tolerable safety profile in this setting. At the data cutoff of October 9, 2024, all 20 enrolled previously treated patients were evaluable for efficacy, with a median follow-up duration of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and median PFS was 15.9 months. Overall survival (OS) was not reached, and the 36-month OS rate was 58.3%.[v] About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception, HUTCHMED 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 ‑med.com or follow us on LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3License out/inDrug ApprovalPhase 2

100 Deals associated with Sintilimab

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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


NCT04691388 (Pubmed \| Cancer Med)	Phase 2	metastatic non-small cell lung cancer Second line	29	Sintilimab plus Anlotinib	jqbnbkkqiz(fgxxcziogf) = ybllhgtxui oyfzlknryu (gchabdhoer ) View more	Positive	01 Sep 2025
NCT05484024 (STELLAR II, Pubmed \| Med)	Phase 2/3	Locally Advanced Rectal Carcinoma Neoadjuvant pMMR \| MSS	218	SCRT+capecitabine and oxaliplatin or leucovorin, oxaliplatin, and fluorouracil	wjpxcjubdb(bnutymuqpv) = hwjzzungsk jaglvdqpsv (iqvbwhwoks ) View more	Positive	01 Aug 2025
				SCRT+capecitabine and oxaliplatin or leucovorin, oxaliplatin, and fluorouracil+sintilimab	wjpxcjubdb(bnutymuqpv) = crsjmurbmb jaglvdqpsv (iqvbwhwoks ) View more
NCT06121505 (IHC002, Pubmed \| BMJ Open)	Phase 2	First line	114	SBRT and LDRT + Sintilimab and Chemotherapy	ezfnbraaad(rlceznrqde): P-Value = 0.2	Positive	01 Aug 2025
				Sintilimab + Chemotherapy
ChiCTR2100052288 (SPRING-01, Pubmed \| NEWS \| Lancet Oncol) Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant	98	sintilimab + capecitabine+oxaliplatin	llykyizhki(cvcytsjlcg) = vusihmouhm hsutclbpma (lfnxwxnroz, 45.4 - 72.9) View more	Positive	08 Jul 2025
				capecitabine+oxaliplatin	llykyizhki(cvcytsjlcg) = juzjgzqsca hsutclbpma (lfnxwxnroz, 19·5 - 45·8) View more
NCT04300959 (SAGC, Pubmed \| Nat Commun)	Phase 2	Advanced biliary tract cancer AKT \| YAP	80	Sintilimab, Anlotinib, Gemcitabine, Cisplatin (SAGC)	gmieuabmoa(wnzgilcood) = kyjokqirfl bophotptjy (virtogbuny ) View more	Positive	01 Jul 2025
				Chemotherapy alone (GC)	gmieuabmoa(wnzgilcood) = yjgljpopzl bophotptjy (virtogbuny ) View more
NCT04877821 (NeoSACT, Pubmed \| Cell Rep Med)	Phase 2	Triple Negative Breast Cancer Neoadjuvant programmed death-ligand 1 (PD-L1)-negative	29	Anlotinib	vjyaomiazf(rciurnduvn) = vxuzshjigl jmtsfqqptq (jlcqzodfox, 49.0% - 85.0)	Positive	01 Jul 2025
NCT04994210 (SCENT-2, ASCO2025) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma \| T-Cell Lymphoma First line	47	Sintilimab + Chidamide (part A)	qttblibckc(clrfauxxkh) = kdnlngnnxd uduxjhnkgi (szmnzhoxot ) View more	Positive	30 May 2025
				Sintilimab + Chidamide + P-GemOx (part A+part B)	qttblibckc(clrfauxxkh) = dlqstavfcz uduxjhnkgi (szmnzhoxot ) View more
ASCO2025	Not Applicable	Recurrent Childhood Acute Lymphoblastic Leukemia	75	Sintilimab	wrpynsaood(tbiivmtymy) = 39.7% (29/73) experienced Grade 3-4 hematological TRAEs, mainly including granulocytopenia and anemia wyrrcawhef (agwwdlksgs ) View more	Positive	30 May 2025
				Pembrolizumab
NCT05519410 (ASCO2025)	Phase 2	Hepatocellular Carcinoma Neoadjuvant	40	Sintilimab 200 mg Q3W and Lenvatinib 8 mg QD	uzdyqfnxgm(vayhyxtwsl) = aruhkchwsd itlwqnmpel (wuhvebzmax )	-	30 May 2025
				Sintilimab (HAIC-FOLFOX)	iwsmnagzki(tbvwwgfnsl) = ttrtfhedkj zfitwuknst (egdfgjxryj, 5.3% - 21.1%)
NCT06013618 (ASCO2025)	Phase 2	Refractory Neuroblastoma MYCN-amplified NB	34	Naxitamab+GM-CSF+Sintilimab	svhmaaeodu(zyyrpvgrvz): PFS = 76.9, P-Value = 0.059 View more	Positive	30 May 2025
				Naxitamab+GM-CSF

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