RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC29H31N7O3

InChIKeyXIIOFHFUYBLOLW-UHFFFAOYSA-N

CAS Registry2152628-33-4

Clinical Trials associated with Selpercatinib

NCT07146893

/ Not yet recruitingEarly Phase 1IIT

Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia

The purpose of this study is to assess the effects of selpercatinib on cachexia and anorexia in patients diagnosed with NSCLC, colorectal cancer, or pancreatic cancer.

Start Date26 Feb 2026

Sponsor / Collaborator

University of Oklahoma

[+1]

NCT07010393

/ Not yet recruitingPhase 4IIT

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.

Start Date01 Jul 2025

Sponsor / Collaborator

Fujian Medical University

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-

100 Clinical Results associated with Selpercatinib

100 Translational Medicine associated with Selpercatinib

100 Patents (Medical) associated with Selpercatinib

423

Literatures (Medical) associated with Selpercatinib

02 Jan 2026·JOURNAL OF CHEMOTHERAPY

An acquired CCDC6:: RET gene fusion as resistance mechanism for Osimertinib in exon 21 EGFR(L858R) -mutated non-small cell lung cancer and its successful management with Osimertinib and Selpercatinib: a case report and review of literature

Review

Author: Van Haecke, Peter ; Demedts, Ingel ; Lormans, Maud

Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) are the recommended front-line therapy for treatment-naïve patients with advanced stage EGFR mutated Non-Small Cell Lung Cancer (NSCLC), with better tolerance and outcomes compared to chemotherapy. However, patients inevitably develop resistance to EGFR-TKI. The extent of progression free survival depends on intrinsic or acquired on-target/off-target mechanisms of EGFR-TKI resistance. Overcoming these acquired rearrangements remains challenging in modern precision medicine. In case of disease progression during treatment with an EGFR-TKI, rebiopsy is recommended to search for a potential resistance mechanism. However, the therapeutic potential of these resistance mechanisms represents an unmet need in thoracic oncology. Case Presentation: We present a case of a 78-year-old woman with stage IVB EGFR-mutated NSCLC in whom an acquired RET Gene Fusion was identified as the EGFR-independent resistance mechanism. Additionally, a combined therapy of Osimertinib and Selpercatinib showed a durable oncological response with 14 months of progression free survival in the absence of adverse events. Conclusion: Addition of Selpercatinib to Osimertinib in an EGFR-mutated NSCLC patient with an acquired RET fusion was well tolerated and created a clinical benefit. Further prospective investigation into these novel combination strategies is needed as resistance mechanisms could serve as possible targets for new therapy approaches.

01 Jan 2026·BIOMEDICAL CHROMATOGRAPHY

Stress‐Induced Structural Divergence of Selpercatinib, a RET Inhibitor: Application of HRMS and NMR for the Discovery of Unique Degradation Products

Article

Author: Kollu, Sai Ram Prasad ; Swain, Debasish ; Jithender Reddy, G. ; Mohanta, Tarzan ; Vuyyala, Bhuvaneshwari

ABSTRACT:

Selpercatinib (SPB) is a selective RET kinase inhibitor used to treat non–small cell lung cancer and thyroid cancer. Separation and identification of impurities formed during the manufacturing or storage of drug substances play a key role in determining their stability under various conditions during the life cycle of the drug. Hence, in the present study, SPB was exposed to different stress conditions like hydrolytic (acid, base and neutral), oxidative, thermal and photolytic stress conditions. A total of five degradation products were formed under the specified conditions. A UHPLC‐PDA method employing Agilent Zorbax Extend C18 RRHD (100 × 2.1 mm, 1.8 μm) column with mobile phases of 0.1% formic acid in H 2 O (A) and 0.1% formic acid in MeOH: ACN (70:30 v/v) (B) in gradient elution at a flow rate of 0.3 mL/min was developed to separate the potential degradation products. LC‐QToF‐MS/MS was used for the structural characterisation of the impurities. One of the degradation products (DP‐2) was isolated and characterised through 1D and 2D NMR experiments. The developed method was validated as per ICH Q2 (R2) guidelines and provides valuable information about the stability of SPB, which can offer a strong foundation for its formulation development, quality control and regulatory compliance in bulk drug and dosage forms.

01 Jan 2026·INTERNAL MEDICINE

Selpercatinib-induced Acalculous Cholecystitis in an Elderly Patient with RET Fusion-positive Non-small Cell Lung Cancer: A Case Report

Article

Author: Fujiwara, Keiichi ; Sasano, Yuto ; Shibayama, Takuo ; Watanabe, Hiromi ; Takigawa, Yuki ; Kudo, Kenichiro ; Matsuoka, Suzuka ; Sato, Akiko ; Matsumoto, Shoichiro ; Sato, Ken ; Ichikawa, Takeru

The effectiveness of selpercatinib against RET-fusion-positive non-small cell lung cancer (NSCLC) in geriatric patients is underreported. We report the case of an 84-year-old woman in whom reduced-dose selpercatinib elicited a significant tumor response in KIF5B-RET fusion-positive NSCLC. However, she developed acalculous cholecystitis, which led to the discontinuation of the drug. This is the first reported case of selpercatinib-induced acalculous cholecystitis in a patient. The report highlighted the potential efficacy of selpercatinib in elderly patients while underscoring the risk of severe adverse events and emphasizing monitoring and personalized dose management.

217

News (Medical) associated with Selpercatinib

20 Jan 2026

·www.prnewswire.com

Illumina secures CMS reimbursement for TruSight™ Oncology Comprehensive, expanding access to precision oncology

The FDA-approved comprehensive genomic profiling test will be reimbursed at a rate of $2,989.55 per test, helping to advance adoption in the US healthcare system SAN DIEGO, Jan. 20, 2026 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN) today announced that reimbursement has been granted for its FDA-approved in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test. The reimbursement decision from the Centers for Medicare and Medicaid Services (CMS) will expand access to comprehensive genomic profiling (CGP) and the growing role of personalized genomics in oncology care. Continue Reading Illumina TruSight™ Oncology Comprehensive is now reimbursed through the Centers for Medicare and Medicaid Services; enabling broader access to precision oncology solutions for patients with advanced cancer. "This decision helps removes barriers that have limited adoption of comprehensive genomic profiling for patients, empowering more healthcare providers to deliver precision oncology insights that will improve outcomes," said John Fox, MD, senior director, Market Access and Government Affairs at Illumina. TSO Comprehensive gives clinicians the ability to simultaneously assess hundreds of genes—including relevant cancer biomarkers—to inform treatment decisions. With reimbursement now in place, more laboratories will be able to bring CGP in-house and deliver clinically actionable results to their patients, closer to the point of care. TSO Comprehensive enables laboratories of all sizes to deliver FDA-approved, clinically valuable genomic insights that are easy to access and implement. This promotes broader access to precision oncology diagnostics across academic medical centers, healthcare networks, hospitals, and regional reference laboratories. Effective January 1, 2026, TSO Comprehensive is reimbursed under the Clinical Laboratory Fee Schedule at a rate of $2,989.55 using Proprietary Laboratory Analysis (PLA) code 0543U, which establishes a clear and predictable reimbursement pathway for all Medicare beneficiaries. Advancing clinical genomics across the healthcare ecosystem Clinical demand for genomic testing is growing at every level of the health care ecosystem. With that demand comes opportunity for better health care and improved quality of life by advancing access to and adoption of tests like TSO Comprehensive . Earlier this month, Illumina reported preliminary unaudited financials for the fourth quarter and fiscal year 2025, which highlighted clinical markets as a key driver of growth. Roughly 60% of the company's sequencing consumables revenue was driven by clinical customers last year. About TruSight Oncology Comprehensive TruSight Oncology Comprehensive is a single FDA-approved test that interrogates more than 500 genes to profile a patient's solid tumor, helping increase the likelihood of identifying immuno-oncology or other clinically actionable biomarkers that can guide targeted therapy selection or clinical trial enrollment. TSO Comprehensive is approved as a companion diagnostic (CDx) to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions and may benefit from treatment with Bayer's VITRAKVI® (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) who may benefit from treatment with Lilly's RETEVMO® (selpercatinib). Use of forward-looking statements This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) customer uptake of, and satisfaction with, new and existing products and services; and (ii) our ability to obtain or maintain regulatory approval for our products from government agencies and reimbursement from payors, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube. Investors: Illumina Investor Relations 858-291-6421 [email protected] Media: Christine Douglass [email protected] SOURCE Illumina, Inc. 21% more press release views with Request a Demo

Financial Statement

08 Dec 2025

·www.prnewswire.com

ASH 2025 Oral Presentation: Innovent Biologics Announces Initial Results of the First-in-Human Phase 1 Study of Trispecific Antibody IBI3003 in Relapsed or Refractory Multiple Myeloma

SAN FRANCISCO and SUZHOU, China, Dec. 7, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced the initial data of the first-in-human trial of IBI3003, a novel trispecific antibody targeting G protein-coupled receptor C5D (GPRC5D), B-cell maturation antigen (BCMA), and CD3 for the treatment of relapsed or refractory multiple myeloma (R/R MM), in an oral presentation at the 2025 American Society of Hematology (ASH) Annual Meeting. IBI3003 demonstrated favorable tolerability and a manageable safety profile. Despite the relatively short follow-up duration, IBI3003 has shown encouraging efficacy signals, particularly in high-risk patients with extramedullary disease (EMD) or those who have previously received anti-BCMA and/or anti-GPRC5D targeted therapies. IBI3003 is a novel trispecific antibody targeting GPRC5D, BCMA and CD3 simultaneously. Its dual-targeting design against BCMA and GPRC5 aims to overcome single antigen escape in multiple myeloma (MM). In preclinical studies, IBI3003 exhibited superior in vivo anti-tumor activity over marketed benchmark bispecific antibodies in mouse models, with particularly prominent tumor-killing efficacy in in vitro cell models with low expression of BCMA and GPRC5D. Currently, Innovent is conducting a Phase 1/2 clinical trial (NCT06083207) of IBI3003 in China and Australia to evaluate its safety, tolerability, and efficacy in patients with R/R MM. The first phase of the study enrolled eligible R/R MM patients who had failed ≥2 lines of previous anti-myeloma therapies that included at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 mAb; and must be relapsed or refractory to their last anti-myeloma regimen. Prior BCMA- or GPRC5D-targeting therapy was allowed. IBI3003 was administered subcutaneously once weekly (QW). For patients who have received continuous treatment for ≥6 months and achieved partial response (PR) or better for ≥2 months could switch to Q2W as maintenance. To reduce the risk of cytokine release syndrome (CRS), 1 to 3 priming doses were included in the study design. A total of 39 patients were enrolled in this phase in China and Australia, with a dose range of 0.1 μg/kg to 800 μg/kg. The median age of patients was 62 years (range: 40-79), 64.1% of whom were classified as high-risk per mSMART criteria, and 46.2% had ≥1 EMD. The median number of prior lines of therapy was 4 (range: 1-10). All patients had received at least three classes of drugs (PI, IMiD, and anti-CD38 antibody), 51.3% had received at least five classes of drugs (at least 2 PIs, 2 IMiDs, and 1 anti-CD38 antibody), 41% had previously received anti-BCMA and/or anti-GPRC5D therapies, and 76.9% were refractory to the last treatment. As of the data cutoff date, November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4-7.4), and the median treatment duration was 12.14 weeks (range: 1.0-33.0). Manageable Safety Profile of IBI3003 in R/R MM Patients Dose-limiting toxicity (DLT) only occurred in 2 patients, both of whom experienced Grade 4 platelet count decreased and recovered. 97.4% of patients experienced treatment-emergent adverse events (TEAEs). Common TEAEs included CRS, neutrophil count decrease, anemia, lymphocyte count decrease, white blood cell count decrease, and platelet count decrease. Hematological disorders were the most common Grade ≥3 TEAEs that mainly occurred during step-up dosing and were manageable and recoverable. The incidences of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were 64.1% and 6.1%, respectively, all of which were Grade 1-2 and resolved with treatment. Prophylactic use of tocilizumab may reduce incidence, severity, and duration CRS. The incidence of all-grade infections was 48.7%, with Grade ≥3 infections reported in 28.2% of patients. For GPRC5D target-related TEAEs involving the oral cavity, skin, and nails, no Grade ≥3 oral TEAEs were observed. Most skin and nail TEAEs were Grade 1-2, with only 2 patients experiencing Grade 3 rash. Encouraging Efficacy and Depth of Response Observed with IBI3003 at Doses ≥120 μg/kg Encouraging efficacy was observed with a median follow-up of 3.25 months: Among patients treated with ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 cases of stringent complete response (sCR), 7 cases of very good partial response (VGPR), and 9 cases of partial response (PR). Among patients treated with ≥120 μg/kg, the ORR was 80% in 10 patients with EMD and 77.8% in 9 patients who had previously received anti-BCMA and/or anti-GPRC5D therapies. Among patients who achieved CR or better as assessed by central laboratory next-generation sequencing (NGS) testing, the minimal residual disease (MRD) negativity rate was 100% (n=4). Potent and Sustained Pharmacodynamic Responses Observed with IBI3003 in R/R MM Patients Biomarker analysis showed that baseline soluble BCMA (sBCMA) levels were high and variable in R/R MM patients (median level: 198 ng/mL, range: 10-3010 ng/mL). A profound and durable decline in serum sBCMA across 120, 360 and 540 μg/kg groups was observed, demonstrating a strong pharmacodynamic response. IBI3003 has demonstrated favorable tolerability and a manageable safety profile in R/R MM patients, with encouraging efficacy signals observed at doses ≥120 μg/kg. Efficacy responses were also observed in high-risk patients, including those with EMD or prior anti-BCMA and/or anti-GPRC5D therapies. Current follow-up remains relatively short, and deeper anti-tumor responses are expected with continued treatment and observation. Dose optimization for IBI3003 is ongoing in the Phase 1 study. Professor Peng Liu, Zhongshan Hospital Affiliated to Fudan University, stated, "Patients with R/R MM have a poor prognosis after failing standard treatments, including PI, IMiD, and anti-CD38 therapies, with an ORR of only 29.8%, a median progression-free survival of 4.6 months, and a median overall survival of 12.4 months[1]. Therefore, there is an urgent unmet clinical need for these patients, particularly those with high-risk features such as EMD or prior anti-BCMA and/or anti-GPRC5D therapies. The dual-target coverage of BCMA and GPRC5D by IBI3003 addresses the issues of antigen expression heterogeneity and treatment resistance associated with single-target drugs, reducing tumor escape. Meanwhile, its optimized CD3 affinity enables precise T-cell activation for tumor killing while also improving safety. In the disclosed Phase 1 study results, IBI3003 showed a manageable safety profile and impressive efficacy data at doses ≥120 μg/kg, with an ORR of 83.3%. It also demonstrated significant efficacy in high-risk patients with EMD or prior anti-BCMA and/or anti-GPRC5D therapies, fully reflecting its potential in overcoming R/R MM. We look forward to the long-term follow-up survival data with continuous IBI3003 treatment." About IBI3003 (Anti-GPRC5D/BCMA/CD3 Trispecific Antibody) IBI3003 is a tri-specific TCE developed using Innovent's proprietary Sanbody platform to target both GPRC5D and BCMA. Designed to overcome drug resistance driven by single-antigen tumor escape, IBI3003 has exhibited superior in vivo antitumor activity in preclinical studies compared with marketed benchmark TCEs, especially in cell models with low BCMA and GPRC5D expression. Innovent is currently conducting a Phase 1/2 clinical trial (NCT06083207) of IBI3003 in China and Australia to evaluate its safety, tolerability, and efficacy in patients with R/R MM. 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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 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. 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, 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. References [1] Mateos M , Weisel K , Stefano V D ,et al.LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma[J].Leukemia, 2022, 36:1371 - 1376.DOI:10.1038/s41375-022-01531-2. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Clinical ResultPhase 1ASHAACR

07 Dec 2025

·www.prnewswire.com

Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China's National Reimbursement Drug List

SAN FRANCISCO and SUZHOU, China, Dec. 6, 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 seven of its innovative products have been included in the updated 2025 National Reimbursement Drug List (NRDL). This list features a new indication of TYVYT® (sintilimab injection), and first-time inclusions of SYCUME® (teprotumumab N01 injection, a recombinant anti-IGF-1R antibody), Limertinib (EGFR TKI), Dupert® (fulzerasib, KRAS G12C inhibitor), DOVBLERON® (taletrectinib, ROS1 inhibitor), Retsevmo® (selpercatinib, RET inhibitor), and Jaypirca® (pirtobrutinib, BTK inhibitor). The updated NRDL will be officially effective from January 1, 2026. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We are pleased with the NRDL inclusion of our seven innovative therapies this year. These therapies cover key disease areas that pose substantial public health challenges in China—particularly oncology (including lung, liver, gastric, esophageal, gynecological cancers, and hematological malignancies) as well as cardiovascular and metabolic (CVM) diseases. Their inclusion will help broaden patients' access to and enhance their affordability of these medications, ultimately benefiting more individuals and families across the country. As a company with the mission of 'empowering patients worldwide with affordable, high-quality biopharmaceuticals', Innovent continues to invest in pioneering treatments across oncology, CVM, autoimmune and ophthalmology—areas of significant societal need. We remain committed to our patient-centered approach, leveraging our innovation and product capabilities to further improve drug affordability and accessibility, so that high-quality medicines can reach and benefit more patients and their families as soon as possible. We are proud to contribute to better care for our patients." TYVYT® (sintilimab injection) TYVYT® (sintilimab injection) is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. In China, sintilimab has been approved for eight indications and two more NDAs are under review by the NMPA, including squamous non-small cell lung cancer (NSCLC), non-squamous NSCLC, liver cancer, gastric cancer, esophageal cancer, endometrial cancer and Hodgkin's lymphoma[i]. In the updated NRDL, the eighth indication of TYVYT®(sintilimab injection) is newly included, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This new indication addresses a critical gap in treatments available for advanced endometrial cancer patients with limited responses to traditional therapies. SYCUME® (teprotumumab N01 injection) SYCUME® (teprotumumab N01 injection) is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody developed by Innovent. SYCUME® blocks the activation of IGF-1R signaling pathway, consequently improving clinical manifestations such as proptosis, inflammation and diplopia, thus enhancing quality of life in patients with thyroid eye disease (TED)[ii]. In the updated NRDL, SYCUME®(teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease. SYCUME®(teprotumumab N01 injection) is China's first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China. The NRDL inclusion will bring this world-class novel treatment option to Chinese patients with thyroid eye disease and significantly enhance patient accessibility and affordability. Limertinib Limertinib is a third-generation EGFR TKI in collaboration with ASK Pharm, and Innovent holds exclusive commercialization rights in Mainland China.[iii] In the updated NRDL, limertinib is newly listed 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. Limertinib incorporates a unique naphthylamine group structure, which endows it with enhanced lipophilicity. This property ensures effective drug penetrate across the blood-brain barrier (BBB), thereby significantly reducing the risk of disease progression—specifically, the risk of disease progression in patients with brain metastases and the risk of intracranial disease progression. The NRDL inclusion of limertinib will provide a more effective treatment option for NSCLC patients with EGFR mutations. Dupert® (fulzerasib) Dupert® (fulzerasib) is a novel KRAS G12C inhibitor in collaboration with GenFleet Therapeutics, and Innovent holds exclusive development and commercialization rights in Greater China.[iv] In the updated NRDL, Dupert®(fulzerasib) is newly listed for the treatment of advanced NSCLC adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The NRDL inclusion of Dupert®(fulzerasib) will provide a novel targeted therapy benefiting NSCLC patients harboring KRAS G12C mutation. DOVBLERON® (taletrectinib) DOVBLERON® (taletrectinib) is a novel next-generation ROS1 TKI in collaboration with Nuvation Bio China, a Nuvation Bio (NYSE: NUVB) Company, and Innovent holds exclusive commercialization rights in Greater China.[v] In the updated NRDL, DOVBLERON® (taletrectinib) is newly listed for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The NRDL inclusion of DOVBLERON® (taletrectinib) will provide a potentially best-in-class therapy benefiting patients with locally advanced ROS1-positive NSCLC. Retsevmo® (selpercatinib) Retsevmo® (selpercatinib) is a selective and potent rearranged during transfection (RET) kinase inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent.[vi] In the updated NRDL, Retsevmo® (selpercatinib) is newly listed for the treatment of: 1) adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, 2) adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and 3) adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory. Retsevmo® (selpercatinib) is the first RET inhibitor approved globally and its NRDL inclusion will bring an innovative therapy for NSCLC and thyroid cancer patients with a RET alteration. Jaypirca® (pirtobrutinib) Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent. Jaypirca® (pirtobrutinib) is the first and only non-covalent (reversible) BTK inhibitor approved in the world.[vii] In the updated NRDL, Jaypirca® is newly listed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor. Its NRDL inclusion will benefit heavily-treated MCL patients that previously received the treatment of a BTK inhibitor, addressing their unmet needs and further enhancing Jaypirca's affordability for those patients. 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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, 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. Statements: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab（Cyramza）, Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) 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. 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 21% more press release views with Request a Demo

Drug ApprovalImmunotherapyBiosimilarCSCOLicense out/in

100 Deals associated with Selpercatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11713	Selpercatinib	L01XE	DB15685

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03899792 (LIBRETTO-121, CTgov)	Phase 1/2	RET mutation Solid Tumors \| Papillary thyroid cancer \| Central Nervous System Neoplasms ... View more	36	Selpercatinib	uxykhopalr(rfzkxtvohw) = jydirxmvsw epxkxluceh (lovzvcuroo, fslqhrrqui - sssbqvbrwt) View more	-	06 Jan 2026
NCT05469113 (CTgov)	Phase 1	-	16	Repaglinide (Period 1: Repaglinide)	mlaohyimgm(buwapvzjku) = agrwtknvfh fxdzqaozit (sgtdxzixzk, 57.1) View more	-	11 Dec 2025
				Selpercatinib+Repaglinide (Period 2: Selpercatinib + Repaglinide)	mlaohyimgm(buwapvzjku) = rihdmgcqex fxdzqaozit (sgtdxzixzk, 53.2) View more
NCT04320888 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Ependymoma \| Relapsed Solid Neoplasm ... View more	1	Computed Tomography+Selpercatinib	bbmptpwcou = wvsxzddsuq dszhvdzldb (debshquznx, zzsslnqzng - cmrmezedsm) View more	-	06 Nov 2025
NCT05338476 (CTgov)	Phase 1	-	16	Midazolam	mdbydgarng(pmxtlcvrat) = yvgizvgnmg vlusreceug (qpsvxtwzpm, 38.4) View more	-	20 Oct 2025
NCT05468164 (CTgov)	Phase 1	-	20	Selpercatinib (Treatment A: 160 mg Selpercatinib (Fasted))	vhnfkwwzuk(gubsqccoln) = ihbemwrbgl zmzdeikxfs (qgkkxvdgvh, 38.9) View more	-	19 Sep 2025
				Selpercatinib (Treatment B: 160 mg Selpercatinib (Fed))	vhnfkwwzuk(gubsqccoln) = phzaivcspi zmzdeikxfs (qgkkxvdgvh, 20.4) View more
NCT05338489 (CTgov)	Phase 1	-	24	Selpercatinib (Part 1 Period 1: 160 mg Selpercatinib)	mhoszycznl(iumcqxioxv) = zqgtcprrtp dqpjtytbky (vdlwhzlrup, 31.8) View more	-	19 Sep 2025
				Itraconazole+Selpercatinib (Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole)	mhoszycznl(iumcqxioxv) = msatrfvnlh dqpjtytbky (vdlwhzlrup, 41.9) View more
NCT05630274 (CTgov)	Phase 1	-	32	Selpercatinib (320 mg Selpercatinib (Treatment A))	cmmusholae(ocuatapgch) = pjvhqkdroj wuvrgieewq (rwtrpgwhai, iqldqbpiad - jonfoldmml) View more	-	18 Sep 2025
				Selpercatnib (640 mg Selpercatnib (Treatment B))	cmmusholae(ocuatapgch) = jwpvnreudi wuvrgieewq (rwtrpgwhai, ilobkzytng - sltgqzwggq) View more
NCT05469100 (CTgov)	Phase 1	Renal Insufficiency	37	Selpercatinib (Selpercatinib (Control; Normal Renal Function))	drahoneoal(iqquhxokpa) = iohkdfpeqn itjqjhrmjj (plobkfryui, 52.1) View more	-	18 Sep 2025
				Selpercatinib (Selpercatinib (Mild Renal Impairment))	drahoneoal(iqquhxokpa) = hnxfzwdsoi itjqjhrmjj (plobkfryui, 36.0) View more
NCT05906836 (CTgov)	Phase 1	-	28	Rosuvastatin+Selpercatinib	iqttqgnryi(ytavpyjbdv) = cdgaictdxb utzjaukfbo (qvtzeoyvvm, 38) View more	-	16 Sep 2025
GEMINI (ASCO2025)	Not Applicable	Non-Small Cell Lung Cancer \| Chylothorax \| Pericarditis First line RET fusion-positive	103	Selpercatinib	sepiuuqpar(eumhgwwgyv) = We identified chylous effusion as an AE following RETi exposure in 12% of pts in our cohort, including 2 cases of chylopericardium. These adverse events can occur with either selpercatinib or pralsetinib, and making a differential diagnosis, including ruling out disease progression, is crucial for effective management. hyawxajzvb (ckuinsmhki ) View more	Positive	30 May 2025
				Pralsetinib

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

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

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

Selpercatinib

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation