RegulationAccelerated Approval (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (AU), Breakthrough Therapy (US), Orphan Drug (US)

Structure

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 2IIT

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

305

Literatures (Medical) associated with Selpercatinib

31 Dec 2024·Journal of medical economics

Integrated budget impact model to estimate the impact of introducing selpercatinib as a tumor-agnostic treatment option for patients with RET -altered solid tumors in the US

Article

Author: Myers, Julie ; Ale-Ali, Amine ; Gilligan, Adrienne M. ; Bhandari, Naleen Raj ; Smolen, Lee

OBJECTIVE:

To estimate the potential budget impact on US third party payers (commercial or Medicare) associated with addition of selpercatinib as a tumor-agnostic treatment for patients with Rearranged during Transfection (RET)-altered solid tumors.

METHODS:

An integrated budget impact model (iBIM) with 3-year (Y) time horizon was developed for 19 RET-altered tumors. It is referred to as an integrated model because it is a single model that integrated results across multiple tumor types (as opposed to tumor-specific models developed traditionally). The model estimated eligible patient populations and included tumor-specific comparator treatments for each tumor type. Estimated annual total costs (2022USD, $) included costs of drug, administration, supportive care, and toxicity. For a one-million-member plan, the number of patients with RET-altered tumors eligible for treatment, incremental total costs, and incremental per-member per-month (PMPM) costs associated with introduction of selpercatinib treatment were estimated. Uncertainty associated with model parameters was assessed using various sensitivity analyses.

RESULTS:

Commercial perspective estimated 11.68 patients/million with RET-altered tumors as treatment-eligible annually, of which 7.59 (Y1), 8.17 (Y2), and 8.76 (Y3) patients would be selpercatinib-treated (based on forecasted market share). The associated incremental total and PMPM costs (commercial) were estimated to be: $873,099 and $0.073 (Y1), $2,160,525 and $0.180 (Y2), and $2,561,281 and $0.213 (Y3), respectively. The Medicare perspective estimated 55.82 patients/million with RET-altered tumors as treatment-eligible annually, of which 36.29 (Y1), 39.08 (Y2), and 41.87 (Y3) patients would be selpercatinib-treated. The associated incremental total and PMPM costs (Medicare) were estimated to be: $4,447,832 and $0.371 (Y1), $11,076,422 and $0.923 (Y2), and $12,637,458 and $1.053 (Y3), respectively. One-way sensitivity analyses across both perspectives identified drug costs, selpercatinib market share, incidence of RET, and treatment duration as significant drivers of incremental costs.

CONCLUSIONS:

Three-year incremental PMPM cost estimates suggest a modest impact on payer-budgets associated with introduction of tumor-agnostic selpercatinib treatment.

06 Dec 2024·ONCOLOGIST

Long-term safety of selpercatinib for Rearranged during transfection (RET)-activated advanced solid tumors in LIBRETTO-001: differing patterns of adverse events over time

Article

Author: Raez, Luis E ; Barker, Scott S ; Peterson, Patrick M ; Pennell, Nathan A ; Liming, Katherine ; Massey, Ashish C

Abstract:

Background:

Selpercatinib is a selective RET inhibitor approved for treatment of RET-activated cancers. Adverse events (AEs) are manageable with dose modifications. This post hoc analysis characterized selpercatinib’s clinical safety profile after long-term follow-up in the safety population of LIBRETTO-001.

Patients and Methods:

LIBRETTO-001 is an ongoing phase I/II, single-arm, open-label trial (NCT03157128). Eligible patients were ≥18 years old with diagnosis of advanced/metastatic RET fusion-positive solid tumor, RET-mutant medullary thyroid cancer, or other RET-activated tumors. In phase I, patients received selpercatinib 20 mg QD or 20-240 mg BID; patients in phase II received 160 mg BID. The analyzed population comprised all patients who received ≥1 selpercatinib dose and were followed up until data cutoff (January 13, 2023).

Results:

For the 837 patients, median follow-up was 45.4 months (95% CI, 44.5-46.6); median time on treatment was 30.1 months (range 0.1-66.8). Grade ≥3 treatment-emergent AEs (TEAEs) were reported in 76.2% of patients; most common events were hypertension (19.7%), ALT increased (11.8%), and hyponatremia (9.2%). Serious TEAEs were reported in 51.4% of patients. Most frequently reported any-grade AEs at <6 months of treatment were fatigue (36.6%), dry mouth (32.8%), and ALT increased (30.5%); at ≥24 months of treatment, these were edema (63.2%), diarrhea (60.7%), and fatigue (53.0%). Selpercatinib-related TEAEs leading to reduced dosage were reported in 39.3%, those leading to treatment interruption were reported in 47.1%, and those leading to discontinuation were reported in 4.3% of patients.

Conclusion:

Long-term treatment with selpercatinib is feasible. AEs are manageable with dose modifications, allowing most patients to continue safely on therapy.

01 Dec 2024·BULLETIN DU CANCER

Letter

Author: Bardet, Stéphane ; Dolfi, Mathieu

166

News (Medical) associated with Selpercatinib

17 Dec 2024

·www.echemi.com

Eli Lilly’s Pirtobrutinib Joins the Race as BTK Competition Heats Up

On December 16, Innovent Biologics and Eli Lilly announced a collaboration agreement for the non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, pirtobrutinib, in mainland China. Under this agreement, Innovent Biologics will handle the import, sales, promotion, and distribution, while Eli Lilly will manage R&D and post-market medical affairs. On October 29, Eli Lilly’s pirtobrutinib received approval from the National Medical Products Administration (NMPA) for treating relapsed or refractory mantle cell lymphoma (MCL) in adults who have previously received BTK inhibitor treatments. Currently, the domestic market has five approved BTK inhibitors, including ibrutinib, zanubrutinib, ocatabrutinib, and acabrutinib. Sanofi’s Tolebrutinib and Rilzabrutinib are in Phase III clinical trials, while CT-1530 from Shouyao Holdings is in Phase II. The robust development of BTK inhibitors indicates potential market changes. BTK inhibitors work by targeting the BCR signaling pathway, binding to BTK, inhibiting its phosphorylation, and inducing apoptosis, effectively managing B-cell malignancies. Before BTK inhibitors, lymphoma treatments were limited to chemotherapy, anti-CD20 antibodies, and radiotherapy. Ibrutinib, the first BTK inhibitor, revolutionized B-cell cancer treatment since its 2013 debut and was approved in China in 2017. However, sales of ibrutinib have slowed due to competition from similar drugs. Zanubrutinib, developed by BeiGene, reached $1.297 billion in global sales in 2023, marking the first domestic drug to achieve such success, but it now faces increasing competition. Pirtobrutinib, as the first and only non-covalent BTK inhibitor, intensifies competition in this niche market. It shows potential to overcome resistance to covalent BTK inhibitors and offers a new option for relapsed/refractory MCL patients. To highlight its efficacy, Eli Lilly conducted a head-to-head study in the BRUIN MCL-321 trial. By 2030, pirtobrutinib is projected to capture 60% of the chronic lymphocytic leukemia market, equating to $3 billion in annual sales. With advancing technology and new drug development, the BTK market is expanding rapidly. According to Frost & Sullivan, the global BTK market could reach $20 billion by 2025 and $26.1 billion by 2030. In China, the market size is expected to reach RMB 13.1 billion by 2025 and RMB 22.5 billion by 2030. The growing BTK market has attracted numerous pharmaceutical companies. At least 20 BTK inhibitors are in clinical trials domestically, with Shouyao Holdings, Hengrui Medicine, and Hezheng Pharmaceutical leading the way. Ibrutinib’s core patent will expire on December 28, 2026, and at least 10 companies are preparing generics. This will lead to fierce competition among original drugs, domestic innovations, and generics. BeiGene’s zanubrutinib remains a key product, but new competitors like pirtobrutinib pose challenges. The success of pirtobrutinib in China’s market is worth monitoring. Originally developed by Redx Pharma and acquired by Loxo Oncology, pirtobrutinib was purchased by Eli Lilly for $8 billion in 2019. In March 2022, Innovent Biologics secured Chinese commercialization rights for pirtobrutinib with an initial payment of $45 million. The partnership between Innovent Biologics and Eli Lilly began in 2015 and has expanded through multiple projects. Despite setbacks like sintilimab’s rejection by the U.S. FDA in 2022, their collaboration continues with other initiatives. Their 2019 cooperation on IBI362, a dual GLP-1R and GCGR agonist, is in Phase II/III trials for Type 2 diabetes and weight loss. In March 2022, Eli Lilly’s ramucirumab was approved in China, granting Innovent Biologics exclusive commercialization rights. Additionally, they collaborate on selpercatinib, a RET inhibitor for gene fusion tumors. The cooperation and competition between domestic and multinational pharmaceutical companies are becoming a norm. This model offers a win-win strategy for navigating the global market.

Drug ApprovalAcquisitionPhase 3Phase 2License out/in

15 Dec 2024

·www.prnewswire.com

Innovent and Lilly Expand Collaboration Through Agreement on Commercialization Rights for Jaypirca® (pirtobrutinib) in Mainland China

SAN FRANCISCO and SUZHOU, China, Dec. 15, 2024 /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, and Eli Lilly and Company (NYSE: LLY) today jointly announced a Distribution and Promotion Agreement in Mainland China regarding Lilly's non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets). The agreement highlights the following aspects: Innovent will be responsible for the importation, marketing, distribution and promotion of Jaypirca®; Lilly will be responsible for the R&D and post-market medical affairs of Jaypirca®. Jaypirca®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma (MCL) patients previously treated with a covalent BTK inhibitor (approved including ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) and extend the benefit of targeting the BTK pathway, thus effectively addressing the unmet clinical needs for these patients. Approved by the U.S. FDA in January 2023, Jaypirca® (pirtobrutinib) became the first and only approved non-covalent (reversible) BTK inhibitor. In October 2024, Jaypirca® (pirtobrutinib) received approval from China's National Medical Products Administration (NMPA) as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two types of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor (Link). Lilly is conducting comprehensive global Phase 3 development programs (including in China), in first-line and relapse or refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and BTK inhibitor-naïve relapse or refractory MCL, to explore monotherapy or combination therapy. Under the agreement, Innovent holds the sole commercialization rights for Jaypirca® in Mainland China, overseeing importation, marketing, distribution and promotion. Lilly will be responsible for R&D and post-market medical affairs. Leveraging Innovent's established hematology oncology commercial team and Lilly's deep expertise in drug development and scientific insights in the therapeutic area, the partnership is committed to broadening access to innovative treatments and improving outcomes for cancer patients in Mainland China. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Building on our long-term strategic collaboration with Lilly, we are proud to expand our collaboration through this agreement. Jaypirca®, the world's first and only approved non-covalent (reversible) BTK inhibitor, represents a breakthrough treatment option for patients who have previously received BTK inhibitors. Innovent has built a robust and leading portfolio in the hematological malignancy field, consisting of TYVYT® (sintilimab injection), HALPRYZA® (rituximab injection), olverembatinib, FUCASO® (Equecabtagene Autoleucel Injection), and Jaypirca®. By fully leveraging our commercialization capabilities and extensive coverage in this field, we aim to bring forward innovative medicines to benefit cancer patients and further enhance our leading position in oncology. We remain steadfast in our commitment to advancing the biopharmaceutical industry through collaborative efforts so that first-rate pharmaceutical drugs can become widely accessible." Huzur Devletsah, President and General Manager of Lilly China, states, "Lilly is thrilled to appoint Innovent for the distribution and promotion of Jaypirca® marking a pivotal moment in hematologic cancer treatment for Lilly. This agreement allows to rapidly increase patient access in Mainland China by drawing on Innovent's robust market presence and our extensive R&D expertise. Together, we are poised to deliver innovative therapies and support the 'Healthy China 2030' initiative, continuing our commitment: 'In China, For China." About Jaypirca® (pirtobrutinib) Jaypirca® (pirtobrutinib, formerly known as LOXO-305) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[i] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.[ii],[iii] About Innovent's strategic cooperation with Lilly Innovent and Lilly have established a comprehensive level of cooperation, setting an example of partnership between a Chinese innovative pharmaceutical company and a global leading medicine company in the field of R&D, CMC, clinical development and commercialization, aiming to accelerate the access of innovative medicines to benefit more patients worldwide. In March 2015, Innovent entered into a strategic partnership with Lilly focused on biological medicine. Under the initial agreement, Lilly and Innovent co-developed and co-commercialized oncology medicines, including Tyvyt® (sintilimab injection) in China. In October 2015, the two parties announced the extension of collaboration to include the co-development of three additional antibodies in oncology. In August 2019, the cooperation extended with a licensing agreement for the development and commercialization of a potentially global best-in-class investigational GCG/GLP-1 medicine in China. In August 2020, Innovent and Lilly announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened their engagement in oncology, granting Innovent sole commercialization rights for Cyramza® (ramucirumab) and Retsevmo® (selpercatinib), and a right of first negotiation for potential future commercialization of Jaypirca® (pirtobrutinib) in Mainland China. In December 2024, the agreement of the commercialization of Jaypirca® (pirtobrutinib) in Mainland China officially achieved. 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 12 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza), Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. About Eli Lilly and Company Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit . Forward-Looking Statements 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 Biologics, Inc. ("Innovent" or "Company"), 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 turn out to be incorrect. References 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

License out/inDrug ApprovalPhase 3Biosimilar

04 Dec 2024

·www.prnewswire.com

Innovent and HUTCHMED Jointly Announce NMPA Conditional Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Advanced Endometrial Cancer

SAN FRANCISCO, U.S. and SUZHOU, China, Dec. 3, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13)，jointly announce that the New Drug Application (NDA) for the combination of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been granted conditional approval in China 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 approval follows the priority review status and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China and marks the eighth approved indication for TYVYT® (sintilimab injection). The conditional approval by the NMPA was supported by registration stage data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who have experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy. Results from FRUSICA-1 were presented at the American Society of Clinical Oncology annual meeting in June 2024.[i] The study results showed that IRC-assessed ORR and DCR was 35.6% and 88.5% respectively; the combination treatment showed rapid on-set efficacy, with a median time to tumor response (mTTR) of only 1.6 months. The median PFS and OS reached 9.5 months and 21.3 months, respectively. Adverse events are consistent with those reported for similar immunotherapy and antiangiogenic agents combination treatments. Additional details can be found at clinicaltrials.gov, using identifier NCT03903705. A Phase 3 confirmatory study of the sintilimab and fruquintinib combination in this setting has been planned (NCT06584032). "This approval of sintilimab plus fruquintinib could represent a paradigm shift in managing this challenging disease. This innovative combination not only leverages the synergistic effects of targeted therapy and immunotherapy, but also addresses a critical gap in treatments available for patients with limited responses to traditional therapies," said Prof. Xiaohua Wu, Director of the Department of Gynecologic Oncology at Fudan University Affiliated Cancer Hospital and Principal Investigator of the FRUSICA-1 study. "With the promising efficacy and manageable safety profile observed in clinical trials, we are eager to have this treatment option available to patients. It brings us closer to our goal of improving survival and enhancing quality of life for patients living with advanced endometrial cancer." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The approval of sintilimab and fruquintinib combination therapy marks a meaningful advancement in the treatment landscape for advanced endometrial cancer. Together with HUTCHMED, we aim to provide a novel treatment option that improves survival rates and quality of life for patients facing limited treatment options against this aggressive cancer. TYVYT® (sintilimab injection), as a cornerstone in immuno-therapy, continues to be evaluated in clinical trials in combination with novel modalities. We remain steadfast in our commitment to reinforcing the leadership position of TYVYT® (sintilimab injection) in immuno-therapy and driving forward treatment solutions through innovation and cooperation." "This NMPA approval of fruquintinib in combination with sintilimab represents a significant advancement for patients with advanced endometrial cancer who have long awaited more effective treatments. It underscores the potential of fruquintinib to be used with other therapeutic agents to improve patient outcomes," said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "It is also a testament to our ongoing efforts to extend the clinical benefit of fruquintinib to a broader patient population. We are eager to make this innovative treatment available to advanced endometrial cancer patients as soon as we can and will continue to explore further opportunities to bring hope to more patients battling cancer." About Endometrial Cancer Endometrial cancer originates in the uterus and remains a significant global health challenge. In 2020, approximately 417,000 people worldwide were diagnosed with endometrial cancer, resulting in around 97,000 deaths.[ii] Іn China alone, an estimated 82,000 new cases and 17,000 deaths were reported that year.[iii] While early-stage cases can often be surgically resected, recurrent and/or metastatic endometrial cancer remains an area of high unmet need with poor outcomes and limited treatment options.[iv],[v],[vi] About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[vii] In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was approved by the NMPA in December 2024. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor ("VEGF") receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy. Fruquintinib is approved for marketing for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor ("EGFR") therapy (RAS wild-type) in China, where it is co-developed and co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List ("NRDL") in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. In December 2024, fruquintinib was approved by NMPA in combination with sintilimab for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. 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 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) were developed by Eli Lilly and Company. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit: ‑med.com or follow us on LinkedIn. 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. 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 2Drug ApprovalPhase 3Clinical ResultImmunotherapy

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	US	Loxo Oncology, Inc.	10 Apr 2024
metastatic non-small cell lung cancer	US	Loxo Oncology, Inc.	21 Sep 2022
Metastatic Solid Tumor	US	Loxo Oncology, Inc.	21 Sep 2022
Thyroid Cancer, Medullary	US	Loxo Oncology, Inc.	21 Sep 2022
RET fusion-positive Non-Small Cell Lung Cancer	EU	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	IS	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	LI	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	NO	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	EU	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	IS	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	LI	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	NO	Eli Lilly Nederland BV	11 Feb 2021
Non-Small Cell Lung Cancer	US	Loxo Oncology, Inc.	08 May 2020
RET Mutation-Positive Medullary Thyroid Cancer	US	Loxo Oncology, Inc.	08 May 2020
Thyroid Cancer	US	Loxo Oncology, Inc.	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	US	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	CN	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	JP	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	AU	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	AT	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	BE	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	BR	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	CA	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	CZ	Eli Lilly & Co.	20 Dec 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	DK	Eli Lilly & Co.	20 Dec 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05338502 (CTgov)	Phase 1	-	20	Selpercatinib+Ranitidine (150 mg Ranitidine Dosed With 160 mg Selpercatinib)	pykzskcaqi(mhvapgbyzf) = zdmszhdgyw zhtssvxfjc (cebqupmffh, hhxxrpdhul - rxwyagiday) View more	-	30 Oct 2024
				Selpercatinib+Omeprazole (40 mg Omeprazole Dosed With 160 mg Selpercatinib)	pykzskcaqi(mhvapgbyzf) = dydfnfuufj zhtssvxfjc (cebqupmffh, ndatkmoomt - zokhpbyxlh) View more
NCT03157128 (LIBRETTO-001, ESMO2024)	Phase 1/2	Non-Small Cell Lung Cancer \| Thyroid Cancer, Medullary	115	Selpercatinib	oahfrluxce(nsfvmxcrld) = qayvgmsrey lhavxvzqqf (euxtvbmbhm, 4 - 40)	Positive	14 Sep 2024
				Placebo	oahfrluxce(nsfvmxcrld) = ywdcpienzw lhavxvzqqf (euxtvbmbhm )
NCT04194944 \| NCT03157128 (LIBRETTO-431, WCLC2024) Manual	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET+	415	Selpercatinib (KIF5B-RET)	yopgihghva(uhjhouwroj) = vmlariybrj aljnuuvnva (akvwmnvgzu, 59.6 - 70.7) View more	Positive	08 Sep 2024
				Selpercatinib (KIF5B-RET + Prior Treatment)	yopgihghva(uhjhouwroj) = fsfjcaeklb aljnuuvnva (akvwmnvgzu, 46.0 - 61.1)
WCLC2024	Not Applicable	Non-Small Cell Lung Cancer First line RET fusion-positive	504	Selpercatinib 160 mg twice daily	upyvidnkvd(wkcfzhyyjz) = Aspartate and alanine aminotransferase elevation were the most common adverse events leading to dose adjustments zescvyoqyk (cgkngbione ) View more	Positive	08 Sep 2024
NCT03157128 (LIBRETTO-001, Pubmed) Manual	Phase 1/2	RET fusion-positive Thyroid Cancer \| RET Mutation-Positive Medullary Thyroid Cancer RET Fusion \| RET Mutation	390	Selpercatinib (medullary thyroid cancer + cabozantinib/vandetanib-naïve)	nchkfezpdm(yfjjmccmhk) = wmqvtvmzlf fuwevejnqq (jcjmkssqdm ) View more	Positive	02 Aug 2024
				Selpercatinib (thyroid cancer + treatment-naïve)	nchkfezpdm(yfjjmccmhk) = klzvakkfqb fuwevejnqq (jcjmkssqdm ) View more
NCT03899792 (LIBRETTO-121, FDA) Manual	Phase 1/2	Thyroid cancer metastatic \| Solid tumor \| Thyroid Cancer RET Fusion \| RET Mutation	25	Selpercatinib 92 mg/m2	mkwjvadudo(ghmemmmvst) = apoceklzky yzjvfkkykz (czfiqwhnme, 28 - 69) View more	Positive	29 Jun 2024
				Selpercatinib 92 mg/m2 (MTC)	mkwjvadudo(ghmemmmvst) = tgybzzmifv yzjvfkkykz (czfiqwhnme, 18 - 71) View more
NCT04194944 (phase 3 \| LIBRETTO-431, CTgov)	Phase 3	RET fusion-positive Non-Small Cell Lung Cancer	261	Selpercatinib (TRT A) (Selpercatinib (TRT A))	wcbatobksg(focztxdtvt) = cgahqjreen csurmmvsjp (whomtxpbrz, xkscdccvoc - vybnihmila) View more	-	20 Jun 2024
				Platinum+Pembrolizumab+Pemetrexed (Pemetrexed and Platinum With Pembrolizumab (TRT B))	wcbatobksg(focztxdtvt) = sljkgggkqa csurmmvsjp (whomtxpbrz, zncalwiuuk - cfwufjqewg) View more
NCT04211337 (LIBRETTO-531, CTgov)	Phase 3	RET Mutation-Positive Medullary Thyroid Cancer	291	Selpercatinib (Selpercatinib - Treatment A (TRT A))	jkrsukdpbk(fspmiyrwju) = nransljqwm qgcamvwklr (tftxbkwkkf, uypitptsqx - oncvohbeqc) View more	-	13 Jun 2024
				Vandetanib+Cabozantinib (Cabozantinib or Vandetanib - Treatment B (TRT B))	jkrsukdpbk(fspmiyrwju) = xzgthmizgd qgcamvwklr (tftxbkwkkf, qgabtbcxbb - vxgvndownc) View more
ENDO2024	Not Applicable	Thyroid Cancer, Medullary RET mutation	-	Selpercatinib	hkmfqskpsk(zgwipoccjy) = txpyrtvucx aemxprkhun (sfnocfrayu ) View more	Positive	01 Jun 2024
NCT03899792 (LIBRETTO-121, ASCO2024) Manual	Phase 1/2	RET mutation Solid Tumors	27	selpercatinib	jnhznmhfux(abpeptfjch) = kzhbipotvk vgsomrunax (jdvebtmeyv ) View more	Positive	24 May 2024
				selpercatinib (MTC)	sxogvusbbp(ckpphhvfks) = vvnuwqakfh vbroirucbg (qliuzfoyfn ) View more

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