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

Structure/Sequence

Molecular FormulaC29H31N7O3

InChIKeyXIIOFHFUYBLOLW-UHFFFAOYSA-N

CAS Registry2152628-33-4

Clinical Trials associated with Selpercatinib

CTIS2025-522431-34-00

/ Not yet recruitingPhase 2

TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)

Start Date01 Oct 2026

Sponsor / Collaborator

Region Hovedstadens Apotek

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

100 Clinical Results associated with Selpercatinib

100 Translational Medicine associated with Selpercatinib

100 Patents (Medical) associated with Selpercatinib

516

Literatures (Medical) associated with Selpercatinib

01 Oct 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Identification of RET PROTAC with excellent degradation efficiency against medullary thyroid carcinoma

Article

Author: Jeon, Eunhye ; Kim, Chanil ; Song, Jaewon ; Lim, Sugene ; Park, Seung Min ; Park, Jong Bae ; Sim, Taebo

Mutations and rearrangements of Rearranged during Transfection kinase (RET) are highly implicated with thyroid cancer. This study aimed to explore the therapeutic potential of a targeted protein degradation (TPD) strategy against RET-associated medullary thyroid carcinoma (MTC). The investigation of the structure-activity relationship (SAR) led to the identification of a novel RET-CRBN degrader, JW15 which possesses excellent degradation capability (DC₅₀ = 0.3 nM) and potent anti-proliferative activity (GI₅₀ = 1.2 nM) on TT cells (MTC). Mechanistic studies revealed that JW15 degrades RET kinase via the ubiquitin-proteasome system (UPS) and effectively recruits cereblon (CRBN) E3 ligase in target engagement assays. Notably, JW15 exhibited superior suppression of RET phosphorylation and downstream signaling compared with selpercatinib. In addition, JW15 demonstrated greater efficacy than selpercatinib in inducing apoptosis and suppressing colony-forming capacity on TT cells, particularly at a concentration of 1 nM. JW15 administered intravenously at 20 mg/kg twice weekly demonstrated significant antitumor efficacy, showing 70% tumor growth inhibition in RET Ba/F3 xenograft models over 13 days. Taken together, our study provides fundamental guidelines for structure-guided design and optimization for the development of RET degraders, offering a promising strategy for targeting RET-driven cancers.

01 Aug 2026·Translational Oncology

Real-world evidence of RET fusion prevalence and testing in patients with metastatic non-small cell lung cancer

Article

Author: Epskamp-Kuijpers, C C H J ; van der Wekken, A J ; de Jager, V D ; Willems, S M ; van Kempen, L C ; Garcia, B N Cajiao ; Schuuring, E

OBJECTIVES:

Rearranged during transfection (RET) fusion is a driver aberration in non-small cell lung cancer (NSCLC). Approval of RET inhibitors selpercatinib and pralsetinib prompts adequate molecular testing for RET fusions in NSCLC. The aim of this study was to determine changes in the detection of RET fusions and the effect of various testing strategies in stage IV NSCLC patients using real-world data.

MATERIALS AND METHODS:

Patients diagnosed with metastatic non-squamous NSCLC in 2017 and 2019 were selected from Netherlands Cancer Registry (NCR) database and linked to their pathology reports form the Dutch nationwide pathology databank (Palga). Based on these data, RET fusion testing rates, prevalence and laboratory variation were evaluated.

RESULTS:

A total of 3651 patients and 3934 patients were included in 2017 and 2019, respectively. The prevalence of RET fusion in non-squamous NSCLC was 1.3% and 0.7%, in 2017 and 2019, respectively. The overall RET fusion testing rate increased from 22.6% (2017) to 31.8% (2019). Between 2017 and 2019, a shift from FISH (91% to 47%) to RNA-based testing (6% to 46%) for the detection of RET fusions was observed.

CONCLUSION:

The prevalence calculated from real-world data in the Netherlands with nation-wide coverage was 1.3% in 2017 and 0.7% in 2019. The decrease in detected RET fusions between 2017 and 2019 was associated with decreased use of FISH testing The prevalence of RET fusions in non-squamous NSCLC published in the literature (1-2%) is therefore likely overestimated.

01 Aug 2026·THYROID

Targeted Therapy-Induced Erythrocytosis in Thyroid Cancers: An Underrecognized Safety Signal from a Retrospective Study

Article

Author: Spagnoletti, Andrea ; Romanò, Rebecca ; Locati, Laura Deborah ; Meschia, Lorenzo ; Demurtas, Sara ; Colombo, Elena ; Marchesi, Silvia ; Alfieri, Salvatore ; Cavalieri, Stefano ; Licitra, Lisa ; Miceli, Rosalba ; Guidetti, Anna ; De Monte, Matteo ; Sciortino, Carolina ; Ottini, Arianna ; Salvetti, Monica ; Bergamini, Cristiana ; Paolini, Biagio ; Carpenedo, Monica ; Buriolla, Silvia ; Nuzzolese, Imperia ; Barretta, Francesco

Background::

Antiangiogenic and targeted therapies represent the most effective systemic options for advanced thyroid cancers. In this setting, toxicity management is essential to ensure treatment adherence. Among hematological toxicities, erythrocytosis has been rarely investigated, and its clinical pattern and management remain unclear.

Materials and Methods::

We conducted a retrospective cohort study including patients with any advanced thyroid cancer histology treated with antiangiogenic or targeted therapies between 2012 and 2023 at two Italian referral centers. Therapies included RET inhibitors ( RET i: selpercatinib, pralsetinib), cabozantinib, the BRAF / MEK inhibitor combination dabrafenib + trametinib, lenvatinib, sorafenib, and vandetanib. Erythrocytosis, defined according to 2022 World Health Organization criteria, was assessed through serial hemoglobin and hematocrit measurements up to 36 months from treatment start. Associations with clinical variables, event-free survival (EFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and acute vascular events were assessed using Fisher’s exact and regression models, as appropriate.

Results::

Among 173 screened patients, 135 were included in the final analysis (median follow-up 68.5 months). Erythrocytosis occurred in 24 patients (17.8%), with 16/24 (66.6%) experiencing recurrent events (total: 50). Median time to onset was 1.28 months (Q1–Q3: 0.76–5.14). RET i showed the highest incidence (46.7%), followed by vandetanib (20.7%). Among 14/24 tested patients, no JAK2 V617F or exon 12 alterations were detected. Management involved temporary treatment interruption in 60.0% (30/50) of events, with 53.3% (16/30) resuming at a reduced dose; in selected cases (4/9, 44.4%), hematology-guided phlebotomy was performed without drug discontinuation. Erythrocytosis was not associated with EFS, OS, or ORR, but was associated with higher DCR ( p = 0.031). Incidence of acute vascular events was comparable among patients with (8.3%) and without (14.4%) erythrocytosis.

Conclusions::

Erythrocytosis represents an underrecognized, early, recurrent, and indolent adverse event of antiangiogenic and targeted therapies, particularly RET i, in advanced thyroid cancer. Its biological mechanisms and optimal management strategies warrant further investigation.

241

News (Medical) associated with Selpercatinib

06 Aug 2026

·www.prnewswire.com

Innovent Announces First Patient Dosed in Pivotal Registrational Study of IBI363/TAK-928 (PD-1/IL-2α-biased Bispecific Fusion Protein) in Combination with Bevacizumab in Late-Line Advanced Colorectal Cancer in China

SAN FRANCISCO and SUZHOU, China, Aug. 5, 2026 /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 diseases, announced that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, in combination with bevacizumab versus investigator's choice of therapy, in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment. This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation immuno-oncology (IO) therapies in overcoming colorectal cancer—a classic 'immune-cold' tumor. Previously initiated studies of IBI363 include a pivotal Phase 2 clinical study (NCT07217301) in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-center, Phase 3 clinical study (NCT06797297) in IO-resistant squamous non-small cell lung cancer (NSCLC) has also been initiated. As part of a license and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialize IBI363/TAK-928 in the U.S. Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China. This trial (NCT07722494) is a multicenter, randomized, open-label, Phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled. The primary endpoint of this study is overall survival (OS). This study is being conducted in China where Innovent holds development and commercialization rights for IBI363/TAK-928. At the 2025 ASCO Annual Meeting, data from a Phase 1 clinical study of IBI363 for the treatment of advanced colorectal cancer was presented as an oral presentation. IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile. [ link ] Among patients treated with IBI363 in combination with bevacizumab (n=73), the overall confirmed objective response rate (cORR) was 15.1%, and the disease control rate (DCR) was 61.6%. With a median follow-up of 9.9 months, the progression-free survival (PFS) reached 4.7 months. With a median follow-up of 9.4 months, overall survival (OS) data remained immature, with only 13 events (17.8%) observed. The overall safety profile was clinically manageable, and no new safety signals were observed. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) in the combination therapy group was 35.6%. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. Based on updated long-term follow-up data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal cancer (CRC) who have progressed on ≥ 2 lines of prior standard therapy. The updated study results are planned for presentation at a future international academic conference or publication in an international academic journal. Professor Kefeng Ding from the Second Affiliated Hospital of Zhejiang University School of Medicine, the principal investigator of this study, stated: "Colorectal cancer is a common gastrointestinal malignancy that poses a severe threat to human health. Worldwide, it ranks third in incidence and second in mortality among all malignant tumors[1]. Approximately 86% of colorectal cancers are in an immune-desert or immune-suppressed state, rendering them unresponsive to traditional immune checkpoint inhibitors (ICIs)[2]. For patients with colorectal cancer who have failed standard therapy, treatment options are limited, survival is short, and there remains a huge unmet clinical need[3-5]. As a PD-1/IL-2α-biased bispecific molecule, IBI363's dual antitumor mechanism—blocking PD-1 while stimulating tumor-specific CD8⁺ T cells (TST cells)—holds the promise of turning 'cold' tumors 'hot'. Early data for IBI363 in combination with bevacizumab in late-line treatment have demonstrated encouraging, breakthrough efficacy along with tolerable safety, showing potential to become a novel immunotherapy for colorectal cancer. I will work closely with other investigators to advance and complete this pivotal clinical study, steadily generating high-quality clinical data to provide colorectal cancer patients with a more effective treatment option." Professor Tao Zhang from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: "For patients with advanced colorectal cancer (CRC), treatment options become extremely limited after the failure of second-line or later therapies. In particular, patients with MSS CRC—who represent the vast majority of colorectal cancer cases—are largely insensitive to current immune checkpoint inhibitors. Chemotherapy or anti-angiogenic agents offer limited efficacy and fail to deliver durable disease control, leaving patients in urgent need of effective late-line treatment options. IBI363, featuring a unique PD-1/IL-2α-biased dual immuno-activation mechanism, holds the potential to overcome the immunosuppressive state of 'cold tumors.' The early clinical data for IBI363 in combination with bevacizumab are highly encouraging. As a clinician, I look forward to the initiation and progress of the Phase 3 clinical study, hoping it will soon bring meaningful treatment choices and renewed hope of survival to patients with late-line colorectal cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "IBI363 represents the evolutionary direction of next-generation immunotherapy—not only potentially improving on the survival benefits of existing IO therapies, but also striving to overcome 'cold' tumors that traditional IO treatments cannot effectively address. Early clinical data demonstrate that IBI363 in combination with bevacizumab achieves significant responses and long-term survival benefits in non-MSI-H/pMMR advanced colorectal cancer, validating its unique mechanism and broad-spectrum potential. Currently, the first batch of core indications for IBI363 has smoothly entered pivotal registration clinical trials. We look forward to offering a new choice for colorectal cancer patients and bringing hope to broader unaddressed areas in immunotherapy." About MSS/pMMR Colorectal Cancer Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor (mPFS 1.9~5.6 months, mOS 6.4~10.8 months[3-5]). About IBI363/TAK-928 (PD-1/IL-2α-biased bispecific fusion protein) IBI363 is a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein being co-developed by Innovent Biologics and Takeda (Takeda R&D code: TAK-928). It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 is being evaluated in a series of clinical trials globally, including: A pivotal Phase 2 study in China in previously untreated acral and mucosal melanoma A global, multi-center Phase 3 study in immunotherapy-resistant squamous NSCLC A pivotal Phase 3 study in China in advanced CRC refractory or intolerant to standard treatment In parallel, multiple Phase 1b/2 trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far. In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363/TAK-928 globally and co-commercialize IBI363/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 19 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Pfizer, 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products discovered and developed by Eli Lilly. 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: GLOBOCAN 2024. Huyghe N, et al. Biomarkers of Response and Resistance to Immunotherapy in Microsatellite Stable Colorectal Cancer: Toward a New Personalized Medicine. Cancers (Basel). 2022 Apr 29;14(9):2241. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Grothey, Axel et al. The Lancet, Volume 381, Issue 9863, 303 – 312. Li J, Qin S, Xu R, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486–2496. doi:10.1001/jama.2018.7855. Prager G et al. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 3Fast TrackPhase 1License out/inImmunotherapy

24 Jul 2026

·telixpharma.com

EJNMMI Research: TLX400-Tx Shows Encouraging Disease Control in Medullary Thyroid Cancer

Melbourne (Australia) and Indianapolis, IN (United States) | July 24, 2026 Telix today announces publication of long‑term clinical outcomes from an investigator‑led study evaluating TLX400‑Tx, its lead fibroblast activation protein (FAP)-targeted therapy candidate, in patients with advanced or metastatic medullary thyroid carcinoma (MTC)[1]. Published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Research, TLX400-Tx (177Lu-DOTAGA.Glu.(FAPi)2) demonstrated encouraging disease control, an acceptable safety profile, and preliminary efficacy signals in this rare, difficult‑to‑treat thyroid cancer. The peer-reviewed results further support the clinical potential of Telix’s lead FAP therapeutic candidate in solid tumors. In this retrospective analysis of data from patients treated in a real-world compassionate use setting, Dr. Sanjana Ballal and colleagues report outcomes from 17 evaluable patients with progressive, locally advanced or metastatic MTC, most of whom had received prior systemic therapies and had limited remaining treatment options[2]. Patients received a median of five cycles of TLX400-Tx, with a subset also receiving tandem 177Lu/225Ac-DOTAGA.Glu.FAPi dimer therapy[3]. The analysis demonstrated a disease control rate of 80% according to RECIST 1.1 criteria[4], with a partial response rate of 33%, and stable disease in 47% of patients. The median progression-free survival (PFS) was 26 months, and the median overall survival (OS) was 42 months. The overall hematologic and hepatic safety profile was acceptable in this advanced patient population, with no dose-limiting toxicities detected. The authors concluded that this supports the tolerability of the treatment or intervention administered during the study period. Dr. Sanjana Ballal, Senior Researcher at the All India Institute of Medical Sciences (AIIMS, New Delhi), investigator and lead author, said, “This study highlights the potential of TLX400‑Tx for patients with advanced MTC, particularly those who have exhausted standard therapies and/or have limited treatment options remaining. The favorable safety profile and encouraging preliminary efficacy signals warrant further validation in larger prospective studies.” Dr. David N. Cade, Group Chief Medical Officer, Telix, added, “These real‑world data in medullary thyroid cancer further reinforce the scientific potential and versatility of Telix’s FAP-targeting platform. TLX400-Tx continues to demonstrate a favorable safety profile and potential efficacy across multiple tumor types, supporting a broad clinical development strategy.” About medullary thyroid carcinoma (MTC) Medullary thyroid carcinoma (MTC) is a rare neuroendocrine malignancy originating from C-cells of the thyroid, accounting for approximately 1% to 5% of all thyroid cancers[5]. The 10-year-survival rate exceeds 95% for intrathyroidal disease but drops to ~40% in the presence of distant metastases. For localized MTC, complete surgical resection of the tumor and affected lymph nodes remains the cornerstone of curative treatment. However, in patients with distant metastases, therapeutic options are limited. MTC is typically resistant to chemotherapy and radiotherapy and does not take up radioiodine, making treatment challenging. Currently, first-line systemic therapies include tyrosine kinase inhibitors (TKIs) such as vandetanib and cabozantinib, and selective RET inhibitors like selpercatinib. While these agents can lead to objective tumor reduction, complete responses are rare, and off-target toxicities often impair quality of life[6]. About TLX400-Tx FAP-targeted radiopharmaceutical therapy has the potential to disrupt the tumor microenvironment and target both stromal and tumor cells. TLX400-Tx is a next generation FAP-targeting therapeutic candidate, differentiated by a novel structure that aims to drive prolonged tumor retention while minimizing off-target uptake. TLX400-Tx was designed to overcome the limitations seen with first-generation FAP compounds and has extensive pre-clinical and clinical data covering a range of tumors[7]. TLX400-Tx has not received a marketing authorization in any jurisdiction. [1] Ballal et al. EJNMMI Res. 2026. [2] Data were collected as part of a compassionate use program covered by an overarching protocol, approved by the institutional ethics board. [3] In the tandem dimer therapy regimen, treatment allocation (177Lu-only vs tandem therapy) was not protocol-driven and was influenced by availability and clinical considerations, reflecting real-world practice. [4] Response Evaluation Criteria in Solid Tumors (RECIST 1.1). [5] Kaliszewski et al. Cancers. 2022. [6] Wells et al. Thyroid. 2015; Kim et al. Endocrinol Metab. 2021. Koehler et al. Thyroid. 2021. [7] See Telix investor presentation lodged with the ASX on November 19, 2024; Ballal et al. Thyroid. 2025; Ballal et al. J Nucl Med. 2025.

Clinical Result

14 Jul 2026

·www.prnewswire.com

Innovent Biologics and Spero Therapeutics Announce Exclusive License for IBI355 (SP001), a Phase 2-Ready Third-Generation Anti-CD40L Antibody

Under the terms of the agreement, Spero will receive exclusive global rights, excluding Greater China, to develop, research, manufacture, and commercialize IBI355 (Spero R&D code: SP001) Innovent will receive an upfront payment, and is eligible to receive development, regulatory and commercial milestone payments, totaling approximately US$1.1 billion, as well as tiered royalties on net sales Spero plans to initiate a Phase 2 trial for IBI355 in Q2 2027 in IgG4-related disease (IgG4-RD), a serious, chronic fibroinflammatory condition with significant treatment burden and limited therapeutic options Innovent plans to initiate a Phase 2 trial in China by early 2027 for Sjögren's disease (SjD), a chronic autoimmune disorder with limited therapeutic options SAN FRANCISCO, CAMBRIDGE, Mass., and SUZHOU, China, July 14, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (01801.HK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced an exclusive license agreement for IBI355 (Spero R&D code: SP001), a third-generation Fc-silent anti-CD40L antibody. Spero will receive exclusive rights to develop, research, manufacture, and commercialize IBI355 worldwide, excluding Greater China, where Innovent retains rights. Spero currently expects to advance IBI355 into a Phase 2 study in IgG4-RD patients in Q2 2027; Innovent expects to initiate a Phase 2 trial in China for SjD by early 2027. IBI355 (SP001) targets CD40L, an immune signal protein that sits upstream of multiple immune pathways and has the potential to redefine treatment paradigms across a range of immune-mediated diseases. Innovent has evaluated this antibody in two healthy volunteer Phase 1 trials: a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. Innovent has also evaluated IBI355 in a Phase 1b MAD study in patients with SjD. Data from the Phase 1b SjD study were presented in a poster session at the EULAR 2026 Congress. "CD40L is an important upstream mediator of immune activation and T-cell/B-cell collaboration, both of which are relevant to IgG4-RD progression," said Dr. Arezou Khosroshahi, MD, Professor of Medicine, Emory University School of Medicine. "A non-B cell depleting approach that interrupts CD40L signaling could represent an important area for clinical evaluation in IgG4-RD, where patients need additional options that address chronic inflammation, relapse, and treatment burden." "IgG4-related disease, Sjögren's disease, and other autoimmune conditions impose significant burdens on patients worldwide, with many facing limited treatment options." said Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent Biologics. "We are pleased to partner with Spero Therapeutics on IBI355 to advance the development of this CD40L-targeted approach. By combining Innovent and Spero's immunology expertise and development commitment, we aim to accelerate the delivery of differentiated therapies to patients living with these chronic conditions. Our shared goal is to bring meaningful new options to patients in need, wherever they are." "Having successfully advanced and delivered a therapy for patients with serious infectious diseases, we are now applying the same disciplined development approach to immune-mediated diseases. This in-licensing transaction establishes the foundation of our new pipeline and positions Spero to pursue potentially transformative therapies for patients living with chronic, debilitating conditions," said Esther Rajavelu, President and Chief Executive Officer of Spero Therapeutics. "We view CD40L as a clinically validated pathway with broad applicability across several immune-mediated diseases. In IgG4-RD, we believe this approach has the potential to meaningfully address the burden patients face from a chronic, relapsing condition with limited treatment options. Beyond IgG4-RD, we see opportunities to explore the role of CD40L inhibition across multiple autoimmune and inflammatory conditions. We are delighted to partner with Innovent Biologics, whose scientific leadership, development expertise, and commitment to innovation have been instrumental in advancing this program to its current stage." Under the terms of the license agreement, Spero will receive exclusive rights to develop, research, manufacture, and commercialize IBI355 worldwide, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). Innovent will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments, bringing total value of the deal to approximately $1.1 billion. Innovent is also eligible to receive tiered royalties on net sales generated in Spero's licensed territories. About IBI355 (SP001) IBI355 (SP001) is a third-generation, humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L, an upstream immune activation signal involved in B-cell, antigen-presenting cell, and platelet biology. By blocking CD40L, IBI355 has the potential to provide a targeted non-B-cell-depleting treatment across multiple immune-mediated diseases where immune-cell interactions drive chronic inflammation, relapse, and tissue damage. IBI355 is designed to address platelet activation concerns associated with earlier anti-CD40L antibodies, while preserving key monoclonal antibody properties, including FcRn interaction that supports IgG-like half-life. About IgG4-Related Disease IgG4-related disease is a serious, chronic fibroinflammatory condition that can affect multiple organs, including the pancreas, salivary glands, lacrimal glands, kidneys, lungs, lymph nodes, and other tissues. The disease can cause immune-mediated inflammation, fibrosis, organ damage, relapse risk, and significant treatment burden. Current approaches can include steroids and B-cell-directed therapies, but additional options are needed to support durable disease control, reduce long-term treatment burden, and preserve immune function. About Sjögren's Disease (SjD) Sjögren's disease is a chronic, systemic autoimmune disorder that primarily affects the salivary and tear glands, but can also involve multiple organs in more severe cases. It is one of the most common autoantibody-driven diseases, yet no approved therapies address its underlying systemic nature, and it predominantly affects women. The disease is marked by autoantibody production, chronic inflammation, and lymphocytic infiltration, leading to symptoms such as dry eyes, dry mouth, joint pain, and fatigue. In some patients, organ involvement can include kidney or lung dysfunction, and there is an increased risk of non-Hodgkin's B-cell lymphoma. More than half of patients develop moderate-to-severe disease, with a burden comparable to other serious autoimmune conditions. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 19 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Pfizer, 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products discovered and developed by Eli Lilly. About Spero Therapeutics Spero Therapeutics is a clinical-stage biopharmaceutical company focused on advancing next-generation medicines in immunology and inflammation for patients with serious diseases and major treatment gaps. The company's lead program, SP001, is a next-generation, Fc-silent anti-CD40L monoclonal antibody being advanced first in IgG4-related disease, with broader potential for additional immune-related conditions. For more information, visit . Forward-looking statement of Innovent Biologics 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. Forward-Looking Statements of Spero Therapeutics This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, statements regarding Spero's plans, strategy, and expectations for future development; the potential benefits of SP001; the potential of CD40L blockade in IgG4-related disease and other immune-related conditions; Spero's plans to advance SP001 into clinical development; anticipated development timelines, regulatory activities, and future milestones; and the potential benefits of Spero's agreement with Innovent. In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Forward-looking statements are based on Spero's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to the completion and integration of the Innovent transaction; Spero's ability to successfully develop SP001; the timing and outcome of clinical trials and regulatory interactions; the ability to obtain and maintain regulatory approvals; potential safety, efficacy, manufacturing, supply, intellectual property, financing, competitive, and market risks; and other risks described in Spero's filings with the Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Spero undertakes no obligation to update any forward-looking statements, except as required by law. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 1License out/inImmunotherapy

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
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 Solid Tumors	Japan	日本イーライリリー株式会社	27 Sep 2021
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
Differentiated Thyroid Gland Carcinoma	Phase 2	United States	Eli Lilly & Co.	29 Jul 2024
Thyroid Cancer, Follicular	Phase 2	United States	Eli Lilly & Co.	01 Mar 2023
Central Nervous System Neoplasms	Phase 2	United States	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	Japan	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	Australia	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	Canada	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	Denmark	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	France	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	Germany	Eli Lilly & Co.	13 Jun 2019
Central Nervous System Neoplasms	Phase 2	Italy	Eli Lilly & Co.	13 Jun 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04819100 (LIBRETTO-432, Pubmed \| N Engl J Med)	Phase 3	RET fusion-positive Non-Small Cell Lung Cancer Adjuvant RET fusion-positive	151	Selpercatinib	hjyglqvpig(zmclekdebj) = wqtgkuserj wqieutxwcc (lntwzelfnb ) View more	Positive	31 May 2026
				Placebo	hjyglqvpig(zmclekdebj) = wapgpyvkoj wqieutxwcc (lntwzelfnb ) View more
NCT04819100 (LIBRETTO-432, ASCO2026)	Phase 3	RET fusion-positive Non-Small Cell Lung Cancer Adjuvant RET fusion-positive	151	Selpercatinib 160mg BID	wvnrmishuu(vtzlooticz) = owefcwimrd aleyrerxaz (qwseowdhut )	Positive	29 May 2026
				Placebo	wvnrmishuu(vtzlooticz) = ofbyovcmsw aleyrerxaz (qwseowdhut ) View more
SPRINT-RET (ESMO_ELCC2026)	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET fusion-positive	52	Selpercatinib	fjmesixyhd(dycbcmaghs) = bysnxdjrlk zpwottwflh (ispeqwqlaw ) View more	Positive	25 Mar 2026
NCT03899792 (LIBRETTO-121, CTgov)	Phase 1/2	RET mutation Solid Tumors \| Papillary thyroid cancer \| Central Nervous System Neoplasms ... View more	36	Selpercatinib	pstwwbyelw(qlkavnjwny) = xmjlhrdhtb fmdsxhrtvs (gczcrlhwhs, niesswmiqw - xbwhyacxgs) View more	-	06 Jan 2026
NCT05469113 (CTgov)	Phase 1	-	16	Repaglinide (Period 1: Repaglinide)	jqojyspbls(apqksnlpbv) = xbjyudfuml cxcrqnpwsf (sbbtukujga, 57.1) View more	-	11 Dec 2025
				Selpercatinib+Repaglinide (Period 2: Selpercatinib + Repaglinide)	jqojyspbls(apqksnlpbv) = iotapjghws cxcrqnpwsf (sbbtukujga, 53.2) View more
NCT04320888 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Ependymoma \| Relapsed Solid Neoplasm ... View more	1	Computed Tomography+Selpercatinib	rofdbphrbk = hctftiqtcg rmpbyzormx (hdpiazjrnc, gqgwmegtke - srmtxkyuet) View more	-	06 Nov 2025
NCT05338476 (CTgov)	Phase 1	-	16	Midazolam	xohfwkhoim(hkcnedijpc) = xbiagsxwdh kzybuognuz (vcupokmsni, 38.4) View more	-	20 Oct 2025
NCT05468164 (CTgov)	Phase 1	-	20	Selpercatinib (Treatment A: 160 mg Selpercatinib (Fasted))	vgpfnlznif(uauwgdlwjq) = qoiumfoses cwvjairlst (fvulbpwpte, 38.9) View more	-	19 Sep 2025
				Selpercatinib (Treatment B: 160 mg Selpercatinib (Fed))	vgpfnlznif(uauwgdlwjq) = tornrivyyt cwvjairlst (fvulbpwpte, 20.4) View more
NCT05338489 (CTgov)	Phase 1	-	24	Selpercatinib (Part 1 Period 1: 160 mg Selpercatinib)	tvmpqanxiw(klsmnzqxck) = shynxtxpwq wlwhsflari (bfsvyqgriv, 31.8) View more	-	19 Sep 2025
				Itraconazole+Selpercatinib (Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole)	tvmpqanxiw(klsmnzqxck) = rtkdhpveah wlwhsflari (bfsvyqgriv, 41.9) View more
NCT05630274 (CTgov)	Phase 1	-	32	Selpercatinib (320 mg Selpercatinib (Treatment A))	yfgbojyohb(rfyunlioda) = sgwrbzgwgk bzvlavysvq (zqwrvzlccc, iintkbmkqq - mbqfltvoan) View more	-	18 Sep 2025
				Selpercatnib (640 mg Selpercatnib (Treatment B))	yfgbojyohb(rfyunlioda) = yunulteibj bzvlavysvq (zqwrvzlccc, yghqistpgc - hmqzlaljes) View more

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