RegulationOrphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Conditional marketing approval (CN)

Structure/Sequence

Sequence Code 13029014H

Source: *****

Sequence Code 13029039L

Source: *****

650

Clinical Trials associated with Sintilimab

NCT06688656

/ Not yet recruitingPhase 2IIT

A Phase II Single-Center Exploratory Study on the Efficacy and Safety of Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant Stage II-IIIB Non-Squamous Non-Small Cell Lung Cancer Patients

This study is a prospective, single-arm, single-center Phase II trial, aiming to investigate efficacy and safety of neoadjuvant chemotherapy sequentially combined with sintilimab in resectable EGFR-mutant stage II-IIIB non-squamous NSCLC patients

Start Date31 Mar 2025

Sponsor / Collaborator

Shanghai Chest Hospital

NCT05562297

/ Not yet recruitingPhase 2IIT

A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined with Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients with Resectable and Borderline Resectable Pancreatic Cancer

The purpose of this research is to investigate the activity and safety of the combination of gemcitabine plus nab-paclitaxel and sintilimab as neoadjuvant therapy in treating patients with resectable and borderline resectable pancreatic cancer.
The drugs involved in this study are:
* Sintilimab
* Nab-paclitaxel
* Gemcitabine

Start Date20 Mar 2025

Sponsor / Collaborator

Zhongshan Hospital Fudan University

[+1]

ChiCTR2500097205

/ SuspendedPhase 2IIT

Sequential Paclitaxel and Oxaliplatin HIPEC Followed by XELOX plus Sintilimab in HER2-Negative Peritoneal Metastatic Gastric Cancer (S-HIPEC): A Multicenter, Open-Label, Randomized Trial

Start Date01 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Sintilimab

100 Translational Medicine associated with Sintilimab

100 Patents (Medical) associated with Sintilimab

1,431

Literatures (Medical) associated with Sintilimab

01 Mar 2025·DRUG RESISTANCE UPDATES

N6-methyladenosine modification of 3'tRF-AlaAGC impairs PD-1 blockade efficacy by promoting lactic acid accumulation in the tumor microenvironment of gastric carcinoma

Article

Author: Jiang, Yu ; Wang, Xiao ; Zhou, Bin ; Mo, Dongping ; Zheng, Junyu ; Li, Gang ; Li, Jie ; Ma, Jingjing ; Nian, Yong ; Wang, Ping ; Miao, Yinxing ; Ma, Yuyan ; Yan, Feng ; Wu, Jun ; Xu, Weiguo

The balance between CD8⁺ T cells and regulatory T (Treg) cells in the tumor microenvironment (TME) plays a crucial role in the immune checkpoint inhibition (ICI) therapy in gastric carcinoma (GC). However, related factors leading to the disturbance of TME and resistance to ICI therapy remain unknown. In this study, we applied N6-methyladenosine (m6A) small RNA Epitranscriptomic Microarray and screened out 3'tRF-AlaAGC based on its highest differential expression level and lowest inter-group variance. N6-methyladenosine modification significantly enhanced the stability of 3'tRF-AlaAGC, which strengthened glycolysis and lactic acid (LA) production in GC cells by binding to PTBP1 (Polypyrimidine Tract Binding Protein 1). In the peritoneal GC implantation model established in huPBMC-NCG mice, 3'tRF-AlaAGC significantly increased the proportion of PD1⁺ Treg cells. Furthermore, in high-LA environments driven by glucose consumption of GC cells, Treg cells actively uptake LA through MCT1, facilitating NFAT1 translocation into the nucleus and enhancing PD1 expression, whereas PD1 expression by effector T cell is diminished. Meanwhile, T cell suppression assays were performed under low-LA or high-LA conditions, and the proliferation of CD8⁺ T cells was dampened by adding Sintilimab in a high-LA but not in a low-LA environment, suggesting the preferential activation of PD1⁺ Treg cell. These findings deciphered the complexities of the immune microenvironment in GC, providing prospects for identifying robust biomarkers that could improve the evaluation of therapeutic effectiveness and prognosis in immune therapy for GC.

01 Mar 2025·PHYTOMEDICINE

SQYC formula improves the efficacy of PD-1 monoclonal antibodies in MSS colorectal cancer by regulating dendritic cell mitophagy via the PINK1-Parkin pathway

Article

Author: Chen, Yan ; Liu, Yu Ping ; Huang, Chu Yue ; Yang, Lin ; Ji, Yi ; Deng, Shan ; Ye, Xie Tao ; Sun, Ye Yang ; Che, Xiao Yu ; Qin, Xiao Ying ; Wang, Hong

BACKGROUND:

Microsatellite stable (MSS) colorectal carcinomas (CRCs) exhibit poor responsiveness to immunotherapy such as immune checkpoint inhibitors (ICIs). In the realm of clinical cancer treatment, traditional Chinese medicines (TCMs) are extensively utilized for their immunomodulatory properties. Shen Qi Yi Chang (SQYC), a clinical prescription for CRC treatment, improve the life quality of CRC patients and enhance their immune function.

PURPOSE:

This study was to reveal the effect and mechanism of SQYC in improving the effect of PD-1 inhibitors in the treatment of MSS-type CRC.

METHODS:

CT26-luc in situ CRC tumor model and human CRC organoid model was established to evaluate the anti-tumor efficacy of SQYC combined with PD-1 inhibitor. Flow cytometry analysis was utilized to investigate the effect of SQYC on the infiltration and immune function of TILs and DCs in the immune microenvironment. Following this, RNA sequencing analysis, seahorse, TEM and immunofluorescence were performed to regulation of SQYC on mitophagy in DCs cells. UPLC-Q-TOF/MS and molecular docking were used to reveal the key blood-entering components of SQYC-regulated PINK1-parkin pathway.

RESULTS:

The SQYC-containing serum improved the efficacy of sintilimab in MSS CRC organoid model. After combined administration of 11.4 g/kg/day SQYC extract and 5 mg/kg α-PD-1, it was observed that SQYC enhanced the efficacy of PD-1 inhibitor against MSS CRC. Flow cytometry and immunofluorescence analysis revealed an augmented infiltration of tumor-infiltrating lymphocytes (TILs) and an improved antigen presentation function of dendritic cells (DCs). Notably, RNA sequencing analysis demonstrated an evident correlation with mitochondrial function related pathways following SQYC treatment. Mechanistically, SQYC promoted mitophagy in DCs via the PINK1-Parkin pathway, thereby improving mitochondrial quality, energy metabolism, and mitochondrial dynamics. Evaluation of the blood components of SQYC coupled with molecular docking, demonstrated good binding affinity with PINK1/PARKIN/LC3.

CONCLUSION:

Our findings highlight SQYC as a promising candidate for improving immunotherapy in MSS CRC, suggesting that targeting PINK1-Parkin in DCs could represent a novel strategy for improving the efficacy of ICIs. Furthermore, it provides new theoretical and scientific underpinnings to enhance the clinical efficacy of immunosuppressants.

07 Feb 2025·MEDICINE

Sintilimab-induced photodistributed bullous pemphigoid: A case report

Article

Author: Shen, Xiaowei ; Cui, Wenjuan ; Wang, Su ; Hu, Murong ; Xu, Junzhu

Rationale::

Immune-checkpoint inhibitors have emerged as a frontline treatment for a growing list of malignancies. Immunotherapy-induced bullous pemphigoid (BP) is a rare dermatological immune-related adverse event of immune-checkpoint inhibitor therapy immune-checkpoint inhibitor therapy. We report a case of immunotherapy-associated BP, with lesions presenting in a photodistribution. This case report aims to emphasize the early recognition of rare clinical manifestations induced by immunotherapy to improve patient prognosis.

Patient concerns::

The patient was a 77-year-old man with a history of right upper lung squamous cell carcinoma on sintilimab (anti-programmed cell death protein-1 [PD-1]) for over a year. After 12 months of initiation of PD-1 inhibitors, nonspecific cutaneous eruption appeared on his head, face, and extremities, mostly pruritic eczematous dermatitis with papules and plaques. The time to development of bullae after medication initiation was 16 months.

Diagnoses::

Sintilimab-induced BP.

Intervention::

Oral prednisone was gradually tapered to discontinuation following intravenous methylprednisolone; the skin lesions have basically recovered.

Outcomes::

Follow-up for 19 months showed no recurrence of the skin lesions.

Lessons::

This case report emphasizes that the clinical manifestations of BP induced by PD-1/programmed death ligand-1 inhibitors can be diverse. Dermatologists need to increase their awareness of BP caused by PD-1/programmed death ligand-1 inhibitors.

228

News (Medical) associated with Sintilimab

23 Feb 2025

·www.prnewswire.com

NMPA Accepts NDA and Grants Priority Review Designation to Innovent's Ipilimumab Injection, China's First Domestic CTLA-4 Inhibitor, in Combination with Sintilimab as Neoadjuvant Treatment for Colon Cancer

SAN FRANCISCO and SUZHOU, China, Feb. 23, 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, announces that the New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and granted Priority Review designation[1] in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. This is China's first NDA for a domestic CTLA-4 inhibitor and another milestone strengthening sintilimab's leadership position in cancer immunotherapy. Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed oncology treatment, ipilimumab with sintilimab as a neoadjuvant treatment could increase R0 resection rate, achieve pathological complete response, and relieve the majority of patients from adjuvant chemotherapy burdens. This novel treatment is also expected to reduce recurrence rate and improve long-term prognosis, anticipated to benefit MSI-H/dMMR colon cancer patients upon NDA approval. The NDA acceptance and Priority Review designation are based on results from a randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742) which evaluated the safety and efficacy of ipilimumab combined with sintilimab as neoadjuvant therapy and as compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) showed that the NeoShot trial has met its primary endpoint. Detailed results will be presented at future academic conferences or published in academic journals. Previously, the results of a randomized controlled Phase 1b trial evaluating ipilimumab in combination with sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were presented orally at the 2024 American Society of Clinical Oncology (ASCO) Annual Meetingi. Based on promising Phase 1b results, the CDE has granted Breakthrough Therapy Designation (BTD) for ipilimumab. As of February 4, 2024, 101 patients were enrolled and randomized to receive ipilimumab plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pCR rate in the ipilimumab-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm（80.0% vs 47.7%, p=0.0007）. All patients in both treatment arms had R0 resection. With median follow-up of 5.65 months, no patient had disease recurrence. At postoperative pathological evaluation, 3.9% of patients with ipilimumab plus sintilimab and 15.9% of patients with sintilimab alone were stage N+. The majority of patients could be relieved from adjuvant treatment according to clinical guidelines. Ipilimumab -plus-sintilimab increased neither safety risk compared to sintilimab alone nor risk for subsequent surgery delay or cancellation. The Principal Investigator of the NeoShot study, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "At present, R0 resection for certain locally advanced colon cancer patients remains a significant challenge, along with risks of extensive trauma and poor prognosis. The results of the FOxTROT study suggested that neoadjuvant chemotherapy is not effective in MSI-H/dMMR colon cancer, and the pCR rate is only around 5%ii. The NeoShot trial is the first randomized, controlled, Phase 3 clinical trial to show promising efficacy of dual checkpoint inhibition as neoadjuvant therapy in MSI-H/dMMR colon cancer. Results from the phase 1b study suggest that ipilimumab with sintilimab as short-term neoadjuvant treatment could increase R0 resection rate, achieve pathological complete response, and relieve patients from adjuvant chemotherapy burdens. This novel treatment is also expected to lower recurrence rate and improve long-term prognosis i.As this dual immunotherapy regimen has the potential to change clinical practice, we look forward to the NDA approval of this novel drug to benefit more MSI-H/dMMR colon cancer patients soon. " Dr. Hui Zhou, Senior Vice President of Innovent, stated: "There is a huge unmet clinical need for neoadjuvant therapy of resectable MSI-H/dMMR colon cancer in China. Interim analysis showed that the NeoShot trial has met its primary endpoint. With Innovent's highly efficient and high-quality clinical development, ipilimumab has become China's first domestic CTLA-4 inhibitor to submit an NDA. We will actively cooperate with regulatory authorities to accelerate approval, and provide a new treatment option for patients with resectable MSI-H/dMMR colon cancer in China." About Ipilimumab Ipilimumab (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab can specifically bind cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4 mediated T cell inhibition, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. iii The NDA for ipilimumab in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer is under the NMPA review and has been granted Priority Review designation. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, 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.iv 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. And the NDA for sintilimab 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 addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. 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 14 products in the market. It has 4 new drug applications under regulatory review, 2 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, 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) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. 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. Reference: 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 3Breakthrough TherapyASCOImmunotherapy

14 Jan 2025

·www.businesswire.com

Adimab Provides Update on Pipeline

LEBANON, N.H.--( BUSINESS WIRE )--Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that five therapeutic products containing molecules discovered or optimized by Adimab have been approved for commercial sale. Adimab’s first partnered program to receive approval was Innovent’s TYVYT ® (sintilimab injection), which is currently marketed by Innovent and Lilly in China for seven cancer indications. Other commercial products containing molecules from Adimab include: Innovent’s SINTBILO ® (tafolecimab injection), a PCSK9 program approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. IASO Bio’s FUCASO ® (equecabtagene autoleucel), a BCMA CAR-T program approved in China for the treatment of patients with multiple myeloma. Invivyd’s PEMGARDA™ (pemivibart), a SARS-CoV-2 monoclonal antibody approved for prophylactic emergency use to prevent COVID-19 infection in the United States. Checkpoint Therapeutic’s UNLOXCYT™ (cosibelimab) received BLA approval December 2024 in the United States for multiple myeloma. There are 11 additional Adimab-associated programs that are currently in Phase II or Phase III (pivotal) trials. The total number of Adimab-associated clinical programs initiated by our partners has now reached 78. "Helping our partners get new therapies on the market to treat patients has been our goal from day one," explained Ryan McGovern, Chief Financial Officer of Adimab. “Given our high number of currently-approved and late-stage programs, we made the decision in 2024 to move royalty rights on our more advanced assets into a separate business unit called Adimab Royalty Company (ARC), which provides a unique opportunity for investors interested in an advancing, diversified portfolio of royalty-bearing assets. The rapid clinical and commercial advancement of so many exciting therapies is driving the value of ARC in addition to validating our core business at Adimab, which remains focused on generating new therapeutic candidates for our partners.” “Therapeutic product development has many challenges, and it is truly meaningful when programs are approved and reach patients. Over time, we have succeeded in building a valuable, sustainable business because of our relentless focus on high-quality execution for our partners without the distraction and conflict of an internal development pipeline. Also critical to our success are our continuous investment in improving the Adimab platform, our discipline on the expense side, our highly talented and committed employees, and our supportive investor base,” said Philip T. Chase, Chief Executive Officer of Adimab. “We have been a reliable collaborator since 2009 and those looking to discover protein-based therapeutics know that we will continue to be a dependable resource for years to come.” Adimab partners have exercised more than 115 commercial licenses to option rights to advance programs into clinical development. In 2024, 11 partners exercised commercial options including BMS, NextPoint, Regeneron, REGiMMUNE, SixPeaks Bio, Santa Ana Bio, Triveni Bio, and Werewolf, among others. Technologies Antibody Discovery: Adimab discovers therapeutic antibodies in IgG and VHH formats through our proprietary yeast-based technology. Adimab can utilize its fully human synthetic diversity as well as additional diversities from in vivo sources. Antibodies from Adimab have exquisite specificity and are utilized in a variety of modalities, including monoclonal and multispecific formats, CAR-Ts, ADCs, etc. Engineering: Adimab has developed and refined its engineering capabilities over thousands of lead antibody optimization efforts. The process starts with one or more partner-selected lead antibodies with the goal of optimizing potency, specificity, and/or developability. In addition to Adimab-discovered antibodies, engineered antibodies can originate from outside sources, typically to fix undesirable properties of antibodies from in vivo and phage-based technologies. Adimab also applies its engineering expertise to cytokines, TCRs, and other proteins. Multispecifics: Adimab has extensive bispecific and multispecific know-how and capabilities, including proprietary solutions for both Fc (HC:HC) and Fab (HC:LC) heterodimerization, to allow for the generation of numerous bispecific and multispecific product designs with excellent developability properties. Additionally, Adimab can perform common light chain and fragment-based discovery and engineering necessary for certain partner-desired formats. T Cell Engagers: Adimab has a highly characterized suite of functional and diverse CD3 (both IgG and VHH binders) and CD28 antibodies to generate bi- and multi-specific T cell engagers. Adimab has partnered this program non-exclusively with more than 25 partners, to date. Complex Targets: Certain membrane-obligate proteins (e.g., GPCRs and ion channels) are often poorly behaved outside their native membrane environment. For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that rely solely on the target being expressed in its native membrane and without the need for antigen mimetics. The company has employed these workflows numerous times to generate robust panels of functional and specific antibodies to these classically difficult targets, which are then further extensively engineered with our yeast platform. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. This includes naïve discovery from synthetic libraries in yeast or B cells (mice and humans), antibody engineering and optimization, multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies licensed non-exclusively for bispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 130 pharmaceutical and biotechnology companies, generating more than 600 therapeutic programs, over 75 clinical programs, and multiple approved products. The Adimab technology has been transferred and implemented at Biogen, GSK, Lilly, Merck, Novo Nordisk, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Novartis, Regeneron, Vertex and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint, Santa Ana Bio, Tizona, TRex Bio and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Innovent, iTeos, Mersana, Scholar Rock, and others. Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com .

Drug ApprovalPhase 3

02 Jan 2025

·www.pharmaceutical-technology.com

Innovent and Roche link on lung cancer therapy development

The partnership involves the development of an ADC for the treatment of individuals with advanced small cell lung cancer. Credit: Jo Panuwat D/Shutterstock. Innovent Biologics and Roche have entered a partnership and exclusive licence agreement to accelerate the development of a delta-like ligand 3 (DLL3)-targeted antibody-drug conjugate (ADC) candidate, IBI3009, for the treatment of individuals with advanced small cell lung cancer. Roche will gain exclusive worldwide rights to develop, manufacture and commercialise the antibody. The partnership will initially focus on the ADC’s early-stage development, after which Roche will assume full responsibility for its development. Innovent will obtain an $80m upfront payment and could earn up to $1bn in development and commercial milestones, as well as tiered royalties on net product sales. Roche corporate business development head Boris Zaïtra stated: “We are excited to enter this partnership with the Innovent team to further develop this promising investigational treatment for patients with small cell lung cancer. “This partnership builds on Roche’s long history of innovation in the area of ADCs, to address the unmet needs of patients with solid tumours with transformational medicines.” Developed using the topoisomerase 1 inhibitor platform of Innovent, the therapy has demonstrated a safety profile described as favourable, and “encouraging” anti-tumour activity in preclinical studies. DLL3 is an antigen overexpressed in certain cancers, and IBI3009 is designed to target this while maintaining low expression in normal tissues. The antibody has already received investigational new drug approvals in the US, China and Australia. The first subject was dosed in December 2024 in a Phase I study. Innovent Biologics chief business officer Dr Samuel Zhang stated: “By combining Roche’s scientific expertise and global development capabilities with our innovative approach, we are taking a significant step forward in our mission — to empower patients worldwide with affordable, high-quality biopharmaceuticals.” The partnership with Roche builds on Innovent’s history of strategic collaborations, such as the expanded agreement with Eli Lilly in August 2020 for the joint development of Tyvyt (sintilimab injection) in China.

ADCLicense out/inPhase 1

100 Deals associated with Sintilimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Sintilimab	L01XC	DB15765

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mismatch repair-deficient Colonic Cancer	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2025
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022
Esophageal Carcinoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	22 Sep 2021
Endometrial Carcinoma	Phase 3	CN	HUTCHMED (China) Ltd.	12 Dec 2024
Colorectal Cancer	Phase 3	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	27 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	15 Mar 2024
Resectable Lung Non-Small Cell Carcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	15 Mar 2024
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Advanced Renal Cell Carcinoma	Phase 3	CN	HUTCHMED (China) Ltd.	27 Oct 2022
Liver Cancer	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04745130 (Pubmed) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma	-	Regorafenib plus Sintilimab	hyutqvoson(pzenawndhd) = edpruyrrub cfbdzaxves (yokpulatza, 10.5 - 17.7) View more	Positive	10 Feb 2025
NCT04745130 (Pubmed) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma	-	Regorafenib plus Sintilimab (RAS/RAF wild-type)	hyutqvoson(pzenawndhd) = fqmqaaqrtg cfbdzaxves (yokpulatza, 10.0 - 36.6)	Positive	10 Feb 2025
NCT04722718 (NeoSAC, Signal Transduct Target Ther) Manual	Phase 2	Triple Negative Breast Cancer Neoadjuvant HER2 Negative \| PR Negative \| ER Negative	34	Apatinib + sintilimab + nab-paclitaxel + carboplatin	fxvgjepmie(yngwknnsdp) = nsliebqqpb lfikaimftf (gxbzjdpota, 53.0 - 85.3) View more	Positive	07 Feb 2025
NCT05244798 (SCIENCE, ASCO_GI2025) Manual	Phase 3	Esophageal Squamous Cell Carcinoma Neoadjuvant	146	Sintilimab combined with nCT (nab-paclitaxel plus carboplatin) for two cycles	ctfyftbfto(losrmvxtfu) = mliwdykomw ktkkmbofgx (lmohyzwogl ) Met View more	Positive	27 Jan 2025
NCT05244798 (SCIENCE, ASCO_GI2025) Manual	Phase 3	Esophageal Squamous Cell Carcinoma Neoadjuvant	146	Sintilimab combined with concurrent nCRT (nab-paclitaxel plus carboplatin chemotherapy and radiotherapy using IMRT/IGRT totaling 41.4 Gy)	ctfyftbfto(losrmvxtfu) = hysuzkecmm ktkkmbofgx (lmohyzwogl ) Met View more	Positive	27 Jan 2025
NCT05024968 (ASCO_GI2025) Manual	Phase 2	Unknown Primary Neoplasms	10	Sintilimab 200 mg IV every 3 weeks	spprucyygw(tqepmcaexe) = bimrgfkigk omjfbedfsx (epkyelrwds, 12.2 - 73.8) View more	Positive	23 Jan 2025
NCT04271813 (ESMO_ASIA2024) Manual	Phase 2	Colorectal Cancer First line	29	Sintilimab plus Anlotinib	ktoqlbayly(hlkoakqkyb) = mvnhmalfgx knizzgplkg (xogqqawidu, 28.3–65.7) View more	Positive	07 Dec 2024
ESMO_ASIA2024 Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Anlotinib + Sintilimab	groorhtmyi(nmvenzlzib) = pxywcnrwbu svndrgikco (dojjrawnxf ) View more	Positive	07 Dec 2024
ESMO_ASIA2024 Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Chemotherapy + Immunotherapy	groorhtmyi(nmvenzlzib) = kpixpqpavu svndrgikco (dojjrawnxf ) View more	Positive	07 Dec 2024
NCT05017103 (CTgov)	Phase 2	Malignant Fibrous Histiocytoma	6	sintilimab	ykfrilrbir(ezrlboxptc) = igxiuscjol ckyrschdxm (xmohrbbeif, gunytnacgd - eotqjjcmwy) View more	-	12 Nov 2024
NCT05400070 (TD-NeoFOUR, Pubmed) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	45	Sintilimab+Anlotinib+Chemotherapy (ITT)	uomjiuzgtx(onvaraeqpb) = jdjgdufqwh ygvnlxkgye (kytrusywxk ) View more	Positive	28 Oct 2024
NCT05400070 (TD-NeoFOUR, Pubmed) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	45	Sintilimab+Anlotinib+Chemotherapy (per-protocol set)	uomjiuzgtx(onvaraeqpb) = bdktfauata ygvnlxkgye (kytrusywxk ) View more	Positive	28 Oct 2024
NEWS Manual	Phase 2	Primary Central Nervous System Lymphoma	27	信迪利单抗+甲氨蝶呤+替莫唑胺+利妥昔单抗	xibuuwpofh(iuhujmztws) = rbminoltzf mbyecgdfju (ktjliehzve ) View more	Positive	19 Sep 2024
NCT05753163 (ESMO2024) Manual	Phase 2	colon cancer liver metastasis Adjuvant	35	sintilimabterial Infusion Chemotherapy (HAIC) - FOLFOX	iuqkdumayb(rgljhszoya) = hllbioykkd atjdulcwrw (lrtsqouewl ) View more	Positive	16 Sep 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Sintilimab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation