RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Molecular FormulaC29H31N7O3

InChIKeyXIIOFHFUYBLOLW-UHFFFAOYSA-N

CAS Registry2152628-33-4

Clinical Trials associated with Selpercatinib

NCT06532149

/ RecruitingNot ApplicableIIT

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)

Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.
The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC

Start Date05 Aug 2024

Sponsor / Collaborator-

NCT06458036

/ RecruitingPhase 2

Selpercatinib to Enhance RAI Avidity in Children, Adolescents, and Young Adults With Newly Diagnosed Differentiated Thyroid Cancers Harboring RET Fusions

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

Start Date29 Jul 2024

Sponsor / Collaborator

The Children's Hospital of Philadelphia

[+2]

CTR20233072

/ RecruitingNot Applicable

一项评价塞普替尼胶囊（Selpercatinib Capsules）治疗晚期或转移性RET基因融合阳性甲状腺癌（成人和儿童）患者有效性和安全性的（前瞻性、非干预性、）上市后观察性研究

[Translation] A prospective, non-interventional, post-marketing observational study to evaluate the efficacy and safety of selpercatinib capsules in the treatment of advanced or metastatic RET gene fusion-positive thyroid cancer (adults and children)

主要目的：通过评估中国晚期或转移性RET基因融合阳性甲状腺癌患者的rwORR，评价塞普替尼的有效性。次要目的：通过评估中国晚期或转移性RET基因融合阳性甲状腺癌患者的rwPFS、rwDoR和rwDCR，评价塞普替尼的有效性。探索性目的：描述塞普替尼的安全性特征。考察塞普替尼在真实世界诊疗常规中的治疗模式

[Translation]

Primary objective: To evaluate the efficacy of seraceptinib by evaluating the rwORR in Chinese patients with advanced or metastatic RET gene fusion-positive thyroid cancer. Secondary objective: To evaluate the efficacy of seraceptinib by evaluating the rwPFS, rwDoR and rwDCR in Chinese patients with advanced or metastatic RET gene fusion-positive thyroid cancer. Exploratory objective: To describe the safety profile of seraceptinib. To investigate the treatment pattern of seraceptinib in real-world diagnosis and treatment routine

Start Date25 Dec 2023

Sponsor / Collaborator

Eli Lilly & Co.

[+2]

100 Clinical Results associated with Selpercatinib

100 Translational Medicine associated with Selpercatinib

100 Patents (Medical) associated with Selpercatinib

475

Literatures (Medical) associated with Selpercatinib

01 Jul 2025·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

Identification and investigation of hits targeting the N-methyl-D-aspartate receptor via drug repurposing: A plausible approach for anti-Alzheimer drug discovery

Article

Author: Al-Dosari, Mohammed S ; Tyagi, Yogita ; Dwivedi, Ashish Ranjan ; Babu, M Arockia ; Yadav, Umesh ; Ali, Nemat ; Bansal, Nisha ; Parvez, Mohammad Khalid ; Singh, Thakur Gurjeet ; Dadwal, Ankita

The effective treatment of neurological diseases, particularly Alzheimer's disease (AD), is a significant source of frustration for drug discovery scientists. The lengthy process of drug discovery further makes this task exceedingly challenging. To enable a rapid stride in drug discovery, we focused on the drug repurposing strategy to identify new N-methyl-D-aspartate receptor (NMDAR) inhibitors from the pool of 1827 approved USFDA drugs. The high throughput virtual screening (HTVS) followed by molecular docking and molecular mechanics studies enabled us to identify two drugs, Ertugliflozin (Dock Score: -9.43 kcal/mol, MMGBSA: -104.50 kcal/mol) and Selpercatinib (Dock Score: 8.11 kcal/mol, MMGBSA: 83.62 kcal/mol), with a high affinity towards the NMDAR. The molecular dynamics analysis on these identified drugs led us to choose Ertugliflozin for its better stability as a lead for further studies. The corroboration of in silico findings led us to deduce that Ertugliflozin can inhibit NMDAR with an IC₅₀ of 613.19 nM. These results were confirmed by the anti-NMDAR ELISA-based analysis, which was further deduced via western blotting. The work is further supported by strong literature evidence that concludes the impact of antidiabetic molecules on AD progression, along with the evidence that Ertugliflozin possesses efficacy against AD with unequivocal evidence on the biological target and the mechanism. Further work, however, is required to establish this association in the in vivo or suitable model that could mimic the AD microenvironment as a part of future research.

01 Jun 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Separation, characterization and cytotoxicity of unknown forced degradation impurity of selpercatinib using Prep-LC, HRMS and NMR

Article

Author: Wu, Wenyi ; Sun, Rongwei ; Wang, Qin ; Cai, Liangliang

Selpercatinib (LOXO-292) is a newly marketed oral selective receptor tyrosine kinase inhibitor targeting rearranged during transfection (RET), demonstrating precise therapeutic effects against RET-positive non-small cell lung cancer and thyroid cancer. In this study, an unknown acid forced degradation impurity of selpercatinib, designated sel-1, was isolated and purified using semi-preparative liquid chromatography (semi-Prep-LC). The purified sel-1 showed a chromatographic purity of 99.1 % as determined by high-performance liquid chromatography (HPLC). It appeared as a white amorphous powder, with a maximum absorption peak at 235 nm and a chemical formula of C₂₈H₂₉N₇O₃. Its molecular structure was elucidated using high-resolution mass spectrometry (HRMS) and nuclear magnetic resonance (NMR). sel-1 was identified as 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-oxo-1,6-dihydropyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile. In vitro MTT assays revealed that sel-1 exhibited significant antitumor activity, particularly against HepaRG and MKN-1 cell lines, with stronger inhibition than selpercatinib. The study contributes to enhancing the quality control standards for selpercatinib and suggests that sel-1 holds potential for further drug development.

03 Apr 2025·JOURNAL OF CHEMOTHERAPY

Prior immune checkpoint inhibitors may enhance severe hypersensitivity related to selpercatinib in RET fusion gene-positive lung cancer

Article

Author: Imai, Hisao ; Hashimoto, Kosuke ; Shiono, Ayako ; Kaira, Kyoichi ; Kagamu, Hiroshi

Selpercatinib, a tyrosine kinase inhibitor approved for RET-fusion gene-positive lung cancer, can induce hypersensitivity, potentially exacerbated by prior immune checkpoint inhibitor (ICI) therapy. We present a case of severe toxicity following selpercatinib treatment in a 58-year-old female with lung adenocarcinoma, refractory to previous treatments including pembrolizumab. Symptoms included fever, rash, and multiorgan failure indicative of grade 4 hypersensitivity. Treatment involved platelet transfusion, heparin therapy, and prednisolone, leading to improvement upon selpercatinib cessation. This case highlights the importance of monitoring for hypersensitivity reactions in patients treated with selpercatinib, especially following prior ICI therapy.

200

News (Medical) associated with Selpercatinib

06 May 2025

·www.prnewswire.com

Innovent Announces Oral Presentation of Full Phase 2 Clinical Data for Efdamrofusp Alfa (IBI302), First-in-class anti-VEGF/complement Bispecific Fusion Protein at ARVO 2025

SAN FRANCISCO and SUZHOU, China, May 5, 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, metabolic, autoimmune and other major diseases, announces that the latest 1-year results from its Phase 2 clinical trial of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, in Chinese subjects with neovascular age-related macular degeneration (nAMD) were presented orally at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The ARVO Annual Meeting 2025 is the premiere gathering of researchers and physicians in vision and ophthalmology to share the latest research findings and collaborate on innovative solutions, to be held from May 4 - 8 in Salt Lake City, Utah, U.S.. Title: Intravitreal High-dose Efdamrofusp Alfa (IBI302) in Patients with Neovascular Age-related Macular Degeneration: A Randomized, Double-masked, Active-controlled, Phase 2 Study Presentation Number: 443 Presentation Format: Speech/Mini Oral Presentation Time: May 4, 2:15pm-2:30pm Presenter : Prof. Xiaodong Sun, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine The data were from the Phase 2 clinical study of high-dose IBI302 (NCT05403749) to evaluate the efficacy, safety and dosing intervals in patients with nAMD over a one-year treatment period. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group. After the loading therapy, IBI302 groups were administrated at personal treatment interval of Q12W or Q8W based on the disease activity assessed at Week 20. Subjects in Aflibercept 2.0 mg group were dosed Q8W after the loading therapy. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40 and the study lasts 52 weeks. The results showed 6.4 mg/ 8.0 mg IBI302 competitive efficacy and safety profiles: Potential for extended dosing interval regiment: Throughout the trial period, over 80% of participants in IBI302 groups maintained visual benefits with a 12-week dosing interval. Comparable BCVA gains versus 2.0mg Aflibercept ： The trial met the primary endpoint, BCVA gains in 6.4mg/8.0mg IBI302 were noninferior to Aflibercept at week 40 ，the mean change from baseline +10.5[SD 9.6], +11.0[11.4], and +9.8[8.7] ETDRS letters, respectively. This improvement was sustained through week 52 with +10.8 [10.2], +11.3 [10.3], and +10.0 [9.0] letters compared to baseline. Anatomical efficacy improvement versus 2.0mg Aflibercept: At week 52, the mean change of central subfield thickness (CST) reductions from baseline was 154.58 [149.17] μm for the IBI302 6.4 mg group, 174.69 [147.04] μm for the IBI302 8.0 mg group, and 131.18 [102.91] μm reduction for the Aflibercept 2.0 mg group, respectively. Potential to inhibit macular atrophy: Data from pooled analyses of two Phase 2 clinical trials (CIBI302A201 and CIBI302A202) suggested that IBI302 treatment may reduce the incidence of MA at Week 52 by nearly 40% compared to aflibercept (4.9% in IBI302 groups vs. 8.3% in Aflibercept group) . The incidences of adverse events in IBI302 groups were similar to Aflibercept. No retinal vasculitis occurred in this trial. No new safety signals were identified. Professor Xiaodong Sun, Principal Investigator of the Study, Deputy director, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, stated: "It is my privilege to present the latest research findings on IBI302 to the global ophthalmic community at the ARVO meeting as the principal investigator. While anti-VEGF drugs remain the first-line therapy for nAMD, the frequency of intravitreal injections and follow-up visits can significantly impact patient compliance. Current drug development focuses on multi-target strategies and extended dosing intervals to reduce the treatment burden by decreasing injection frequency. Notably, IBI302—a novel global first-in-class bispecific molecule (anti-VEGF/anti-complement) —recently reported Phase 2 data showing that its high-dose cohorts met the primary endpoint. The treatment group achieved approximately 10-letters improvement in visual acuity from baseline at one year, with over 80% subjects demonstrating potential for at least 12-weeks extended dosing intervals. Additionally, preliminary observations in IBI302 group suggest potential efficacy in inhibition of macular atrophy. We anticipate this innovative therapy will successfully complete the Phase 3 registration trial, providing nAMD patients with more effective, patient-friendly options." Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated: "We are honored to present the latest progress of IBI302 in its second Phase 2 clinical trial at the ARVO annual meeting. High dose IBI302 demonstrates positive efficacy in visual acuity and anatomical improvements, while extend dosing intervals and potential anti-macular atrophy effects. Additionally, no new safety signals were observed during the trial, further validating the favorable safety and tolerability profile of this agent. These encouraging results establish a robust foundation for subsequent development. We will continue collaborating with clinical experts to expedite the Phase 3 clinical trial program, and accelerate the availability of this innovative therapy for patients with nAMD." About Efdamrofusp Alfa (IBI302) IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N- terminal is a VEGF domain that can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and improve vasopermeability and reduce leakage. The C- terminal of IBI302 is the complement binding domain that can inhibit the activation of the classic pathway and alternative pathway of complement through the specific binding of C3b and C4b, and reduce the inflammatory response mediated by the complement. IBI302 may exert its therapeutic effect by inhibiting both VEGF-mediated angiogenesis and complement activation pathways. 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 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. Forward-looking statement 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 is otherwise inaccurate. 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

Phase 2Clinical ResultPhase 1

26 Apr 2025

·www.prnewswire.com

Innovent Announces NMPA Approval of Limertinib, a Third-generation EGFR TKI Collaborated with ASK Pharma, for the First-line Treatment of Lung Cancer

SAN FRANCISCO and SUZHOU,China, April 25, 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 oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations. Innovent and ASK Pharm entered into a commercial collaboration agreement for limertinib in Mainland China in 2024. The approval of this new indication is supported by positive results from a randomized, double-blind, positive-controlled Phase 3 clinical trial. A total of 337 treatment-naïve patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC were enrolled and randomized 1:1 to receive either limertinib or gefitinib. The primary endpoint was progression-free survival (PFS), as assed by an independent review committee (IRC). The data showed that limertinib significantly prolonged median PFS compared to gefitinib (20.7 months vs. 9.7 months), representing a 56% risk reduction in disease progression or death (hazard ratio [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). In patients with central nervous system (CNS) lesions at baseline, median CNS PFS was also significantly longer with limertinib (20.7 months vs. 7.1 months), corresponding to a 72% risk reduction for CNS progression or death (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), underscoring its robust intracranial activity and clinical utility in such population with high-unmet-needs. The safety profile of limertinib was consistent with that of known EGFR-targeted therapies. Adverse events were predominantly mild to moderate and well-tolerated, with no new safety signals identified during the clinical trial. Full data and analysis from this pivotal Phase 3 study will be published in academic journals. "Limertinib has demonstrated exceptional efficacy and safety as first-line therapy in patients with EGFR-muted locally advanced or metastatic NSCLC, including notable efficacy in those with brain metastases. The approval of this first-line indication introduces a new treatment option for Chinese patients, addressing a critical clinical need in this population." said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 3 Clinical Study. Dr. Hui Zhou, Senior Vice President of Innovent, stated："We are delighted that both the first-line and second-line indications for limertinib have been successively approved. As a next-generation EGFR TKI, limertinib is poised to significantly improve survival outcomes for mutation-positive patients. Innovent has built a rich portfolio of precision therapies for lung cancer—including limertinib, Retsevmo®(selpercatinib), Dupert®(fulzerasib) and DOVBLERON® (taletrectinib)—with ongoing efforts to enhance their synergistic value. We will continue to work closely with Ask Pharm to ensure that limertinib brings a new hope to the broad population of patients with EGFR-mutated NSCLC." Mr. Jingfei Ma, CEO of ASK Pharm, stated: "Within a few months, limertinib has obtained approvals for both second-line and first-line indications. The approval of the first-line indication further expands its clinical applicability. Meanwhile, ASK Pharm is advancing a clinical trial of limertinib in combination with the cMET inhibitor ASKC202 for patients with NSCLC resistant to third-generation EGFR-TKIs. We look forward to working with our partner Innovent to accelerate the accessibility of limertinib for more patients in need." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer remains one of the deadliest and most common cancers globally[1], with NSCLC accounting for approximately 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic stages that are not amenable to surgical resection. EGFR mutations are particularly prevalent among Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended standard of care in the first-line setting, with third-generation EGFR-TKIs offering the broadest treatment applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights. It has been approved by the China's NMPA for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China. 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 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. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's 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 [1] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751. 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

Phase 3License out/inDrug ApprovalClinical ResultNDA

23 Apr 2025

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Seven Oral Presentations: Innovent to Present Breakthrough Clinical Data of IBI363（PD-1/IL-2α-bias）and Other Novel Drug Candidates at the 2025 ASCO Annual Meeting

SAN FRANCISCO and SUZHOU,China, April 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 clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S. Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO, further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options." Details on the abstracts are listed below: Oral Presentation 1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma Abstract Number: 2502 Session Type: Oral Abstract Session Title: Developmental Therapeutics-Immunotherapy Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT Presenter: Jun Guo, MD, Beijing Cancer Hospital 2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer Abstract Number: 104 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot" Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC) Abstract Number: 8509 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine 4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343 Abstract Number: 4017 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center 5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21) Abstract Number: 7007 Session Type: Oral Abstract Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences 6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01) Abstract Number: 3519 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer-Colorectal and Anal Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT Presenter：Changqing Jing, MD, Shandong Provincial Hospital 7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in n as opharyngeal carcinoma: The EP-STAR trial Abstract Number: 6010 Session Type: Oral Abstract Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center Poster Presentation 1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress Abstract Number: TPS9594 Session Type: Poster Session Title: Melanoma/Skin Cancers Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute 2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial Abstract Number: 5565 Session Type: Poster Session Title: Gynecologic Cancer Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Jin Shu, MD, Chongqing University Cancer Hospital 3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study Abstract Number: 1029 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research 4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study Abstract Number: 1102 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Fan Wu, MD, Fujian Cancer Hospital 5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress Abstract Number: TPS4201 Session Type: Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Lin Shen, MD, Beijing Cancer Hospital 6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases. Abstract Number: 4050 Session Type: Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Dan Sha, MD, Shandong Provincial Hospital *Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007. 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 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. Forward-looking statement 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 materialise 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

Phase 1ASCOImmunotherapyClinical ResultPhase 2

100 Deals associated with Selpercatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11713	Selpercatinib	L01XE	DB15685

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
RET fusion-positive Solid Tumors	United States	Eli Lilly & Co.	10 Apr 2024
metastatic non-small cell lung cancer	United States	Eli Lilly & Co.	21 Sep 2022
Metastatic Solid Tumor	United States	Eli Lilly & Co.	21 Sep 2022
Thyroid Cancer, Medullary	United States	Eli Lilly & Co.	21 Sep 2022
RET fusion-positive Non-Small Cell Lung Cancer	European Union	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	Iceland	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	Liechtenstein	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	Norway	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	European Union	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	Iceland	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	Liechtenstein	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	Norway	Eli Lilly Nederland BV	11 Feb 2021
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	08 May 2020
RET Mutation-Positive Medullary Thyroid Cancer	United States	Eli Lilly & Co.	08 May 2020
Thyroid Cancer	United States	Eli Lilly & Co.	08 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
RET fusion-positive Adenocarcinoma of Lung	Phase 3	United States	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	China	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Japan	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Australia	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Austria	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Belgium	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Brazil	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Canada	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Czechia	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Denmark	Eli Lilly & Co.	20 Dec 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05630287 (CTgov)	Phase 1	-	12	Selpercatinib+[14C]-	cfhfmjqnwm(ibodskaaxj) = qcvolqkrtl lbknuoggdq (mraogfqeue, 26.6) View more	-	23 Apr 2025
NCT05436912 (CTgov)	Phase 1	Liver Injury	36	Selpercatinib (160 mg Selpercatinib: Mild Hepatic Impairment)	cdxaahuwdx(itoigtmgqc) = hmhfsfbjfp bzfsubornk (tznlouxwyt, 78.0) View more	-	13 Apr 2025
				Selpercatinib (160 mg Selpercatinib: Moderate Hepatic Impairment)	cdxaahuwdx(itoigtmgqc) = ptbtfwbagq bzfsubornk (tznlouxwyt, 185.6) View more
NCT05324124 (CTgov)	Phase 1	-	46	Selpercatinib (Selpercatinib Fasted (Reference))	josjowbwmn(wpbbcivepu) = ldxgkxyjnj somqabiehc (ovcchczvcw, 32) View more	-	21 Mar 2025
				Selpercatinib (Selpercatinib Fed (Test))	josjowbwmn(wpbbcivepu) = lagouguhbw somqabiehc (ovcchczvcw, 44) View more
NCT05136404 (CTgov)	Phase 1	-	42	Selpercatinib	fiatwljxbu(odqonthysb) = ryluwsssyn hjpcsfzohs (vkdhgykfpm, iucvnblsmm - drpueodyrc) View more	-	17 Mar 2025
NCT05089019 (CTgov)	Phase 1	-	224	Selpercatinib (160 mg Selpercatinib (Reference))	lnrnfcxxpi(fjpdvxdhfe) = fnisfgfyau klnpsatwox (qvajdlhirp, 61) View more	-	17 Mar 2025
				Selpercatinib (160 mg Selpercatinib (Test))	lnrnfcxxpi(fjpdvxdhfe) = jeiltmgpmw klnpsatwox (qvajdlhirp, 91) View more
NCT04280081 (LIBRETTO-321, Pubmed \| Ther Adv Med Oncol) Manual	Phase 2	RET fusion-positive Non-Small Cell Lung Cancer RET Positive	47	Selpercatinib	rsawfazimz(ibkmbtpmrk) = bsksjqfwmv jljyotrlsw (fxljssedeg, 57.4 - 84.4) View more	Positive	01 Jan 2025
				Selpercatinib (treatment-naïve)	rsawfazimz(ibkmbtpmrk) = jmmrdhrlqp jljyotrlsw (fxljssedeg, 71.5 - 100.0) View more
NCT05338502 (CTgov)	Phase 1	-	20	Selpercatinib+Ranitidine (150 mg Ranitidine Dosed With 160 mg Selpercatinib)	fwknotyhuv(uaibkvpihw) = stpkfntdoz iucniscdfd (jvebdslfni, 31.9) View more	-	30 Oct 2024
				Selpercatinib+Omeprazole (40 mg Omeprazole Dosed With 160 mg Selpercatinib)	fwknotyhuv(uaibkvpihw) = qamtrgyjre iucniscdfd (jvebdslfni, 27.4) View more
NCT03157128 (LIBRETTO-001, ESMO2024)	Phase 1/2	Non-Small Cell Lung Cancer \| Thyroid Cancer, Medullary	115	Selpercatinib	kxyarsgfla(rigxxlneei) = nldggjsqnv oybfsojwzh (wpxaffvtuv, 4 - 40)	Positive	14 Sep 2024
				Placebo	kxyarsgfla(rigxxlneei) = ctecdprfre oybfsojwzh (wpxaffvtuv )
NCT04194944 \| NCT03157128 (LIBRETTO-431, WCLC2024) Manual	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET+	415	Selpercatinib (KIF5B-RET)	tditimzhyf(hzmkchbluo) = mltgpsbqra kbvbwemtqh (mvqjphpeil, 59.6 - 70.7) View more	Positive	08 Sep 2024
				Selpercatinib (KIF5B-RET + Prior Treatment)	tditimzhyf(hzmkchbluo) = hekpjeqxzr kbvbwemtqh (mvqjphpeil, 46.0 - 61.1)
WCLC2024	Not Applicable	Non-Small Cell Lung Cancer First line RET fusion-positive	504	Selpercatinib 160 mg twice daily	fqnsxyhmnk(balvobhuwv) = Aspartate and alanine aminotransferase elevation were the most common adverse events leading to dose adjustments tkwhbthcin (gtivxwuvuk ) View more	Positive	08 Sep 2024

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