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

Structure/Sequence

Molecular FormulaC29H31N7O3

InChIKeyXIIOFHFUYBLOLW-UHFFFAOYSA-N

CAS Registry2152628-33-4

Clinical Trials associated with Selpercatinib

NCT06532149

/ RecruitingNot ApplicableIIT

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

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

Start Date05 Aug 2024

Sponsor / Collaborator-

NCT06458036

/ RecruitingPhase 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

450

Literatures (Medical) associated with Selpercatinib

01 Mar 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design, synthesis and evaluation of (E)-1-(4-(2-(1H-pyrazol-5-yl)vinyl)phenyl) derivatives as next generation selective RET inhibitors overcoming RET solvent front mutations (G810C/R)

Article

Author: He, Jiahuan ; Zhang, Shuyao ; Yang, Gangpeng ; Ma, Haowen ; Xu, Mingjin ; He, Rui ; Tan, Li ; Wu, Kaifu ; Peng, Lijie ; Zhang, Zhang ; Cai, Qian

RET is a well-recognized drug target for cancer treatment. Despite the promising efficacy of selective second-generation RET inhibitors Selpercatinib and Pralsetinib, the clinical benefits have been compromised due to the quickly developed resistance to these drugs. RET G810 mutations at the solvent front site have been identified as the major on-target mutations contributing to resistance against Selpercatinib and Pralsetinib. Therefore, there is an urgent need for the development of next-generation RET inhibitors to overcome acquired solvent-front resistance mutations. In this study, a series of (E)-1-(4-(2-(1H-pyrazol-5-yl)vinyl)phenyl) derivatives have been identified as selective next-generation RET inhibitors. The representative compound, CQ1373 exhibits potent cellular potency with IC₅₀ values of 13.0, 25.7 and 28.4 nM against BaF3 cells expressing CCDC6-RET, CCDC6-RET-G810C and CCDC6-RET-G810R, respectively. A comprehensive selectivity profile across 89 kinases reveals that CQ1373 demonstrates good selectivity toward wild-type RET and solvent front mutants G810C/R with IC₅₀ values of 4.2, 7.1 and 32.4 nM, respectively. Furthermore, western blot analysis reveals that CQ1373 effectively inhibits RET phosphorylation and downstream signaling through SHC. It also induces apoptosis and cell cycle arrest in a dose-dependent manner in BaF3 cells harboring CCDC6-RET, CCDC6-RET-G810C and CCDC6-RET-G810R fusions. More significantly, CQ1373 exhibits promising in vivo anti-tumor efficacy in a CCDC6-RET-G810R mice xenograft model, highlighting its potentials for RET-driven cancers treatment.

01 Feb 2025·CANCER LETTERS

Selpercatinib mitigates cancer cachexia independent of anti-tumor activity in the HT1080 tumor model

Article

Author: Khatri, Ujjwol ; Subbiah, Vivek ; Li, Min ; Hu, Xueqing ; Shen, Tao ; Chauhan, Neeraj K ; Huang, Suming ; Pandey, Shriya ; Wu, Jie ; Gouda, Mohamed A

Anorexia is a major cause of cancer cachexia and is induced by growth differentiation factor-15 (GDF15), which activates the rearranged during transfection (RET) protein tyrosine kinase in the hindbrain through GDF family receptor α-like (GFRAL), raising the possibility of targeting RET for cancer cachexia treatment. RET-altered cancer patients treated with RET-selective kinase inhibitors gain weight, however, it is unclear whether this results from tumor regression that improves the overall health of patients. Thus, the potential of using a RET inhibitor to address cancer cachexia remains unknown. Using a RET-negative tumor model, we evaluated the activity of the RET-selective inhibitor selpercatinib (LOXO-292) against cancer cachexia. In tumor-bearing animals, selpercatinib significantly increased food consumption, skeletal muscle mass and strength, adipose tissues, and body temperature, as well as reducing body weight loss, without significantly affecting tumor growth. Transcriptomes of skeletal muscle from mock-treated tumor-bearing mice were enriched in starvation and muscle atrophy genes, whereas those from selpercatinib-treated mice were enriched in myoblast proliferation, gluconeogenesis, and insulin receptor signaling genes. In parallel, retrospective analysis of weight gain in selpercatinib-treated patients showed that weight gain was not correlated with tumor response to selpercatinib. Our data demonstrate that selpercatinib could alleviate anorexia and cancer cachexia in an animal model and that weight gain in selpercatinib-treated patients is not dependent on tumor regression. These results identify a RET inhibitor as the first protein tyrosine kinase inhibitor for mitigating cancer cachexia.

01 Feb 2025·JOURNAL OF NUCLEAR MEDICINE

Redifferentiation of a RET-Fusion, Radioiodine-Refractory, Differentiated Thyroid Cancer with Selpercatinib: Flip-Flop Between [¹⁸F]FDG PET/CT and¹³¹I Posttreatment Scanning

Article

Author: Jannin, Arnaud ; Chevalier, Benjamin ; Boury, Samuel ; Baillet, Clio ; Do Cao, Christine ; Lion, Georges ; Beron, Amandine ; Marciniak, Camille ; Barbry, Floriane

167

News (Medical) associated with Selpercatinib

16 Jan 2025

·www.prnewswire.com

Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

SAN FRANCISCO and SUZHOU, China, Jan. 15, 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, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment. The BTD for IBI343 was granted based on data from an ongoing Phase 1 study conducted in China, Australia and the U.S. (NCT05458219), which demonstrated favorable safety and tolerability, as well as promising antitumor activity of IBI343 monotherapy in advanced PDAC patients. Data from the study's dose-expansion cohort were presented orally at the 2024 ESMO Asia Congress: A total of 43 patients with CLDN18.2-positive advanced PDAC (≥60% tumor cells with membranous staining intensity ≥1+ by IHC) received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least one line of prior therapy, and 60.5% had received two or more lines of anticancer treatment. The confirmed overall objective response rate (ORR) was 23.3%, and progression-free survival (PFS) events occurred in 26 patients, with a median progression-free survival (mPFS) of 5.3 months (4.1-7.4) as of the data cutoff date. (link) Previously, in May 2024, the CDE has granted IBI343 its first BTD for monotherapy in the treatment of CLDN18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least two lines of prior systematic treatments. In addition, in June 2024, IBI343 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, unresectable or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy. The first patient in the U.S. Phase 1 study of IBI343 was successfully dosed in December 2024. Dr. Hui Zhou, Senior Vice President of Innovent, said, "Pancreatic cancer is an aggressive and difficult-to-diagnose malignancy. At present, treatment for advanced pancreatic cancer relies primarily on systemic chemotherapy, with particularly limited options for second-line treatment. This results in poor patient outcomes and underscores an urgent unmet clinical need. As the world's first CLDN18.2 ADC to receive BTD in this difficult-to-treat cancer, IBI343 monotherapy has shown encouraging efficacy and tolerable safety in late-line treatment of patients with advanced pancreatic cancer. Subject to PoC data readout, we plan to initiate pivotal MRCT studies to further confirm its efficacy and safety in this indication. Additionally, we will also explore the potential of IBI343 in combination therapy for pancreatic cancer and other solid tumors, including gastric cancer." NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly. About Pancreatic Ductal Adenocarcinoma Pancreatic cancer is one of the most aggressive malignances of the digestive system, with a 5-year survival rate of about 10%[i]. Despite rising incidence rates in recent years, early detection remains low, seriously endangering human life and health. Current treatment for advanced pancreatic cancer is primarily based on systemic chemotherapy, with first-line treatment options typically including fluorouracil (5-FU) or gemcitabine-based chemotherapy. However, second-line treatment options are limited, offering a chemotherapy response rate of only 6-16%, a median progression free survival of 2 to 5 months, and a median overall survival of approximately 6 to 9 months[ii]. These statistics highlight the urgent need for new therapeutic approaches. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally confined to the gastric mucosa. The development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[iii]. CLDN18.2 is present in 50% to 70% of pancreatic cancer cases, making it a highly targeted biomarker for therapeutic development[iv]. About IBI343 (CLDN18.2 ADC) IBI343 is an antibody-drug conjugate composed of an anti-CLDN18.2 antibody, and a cytotoxic drug exatecan. Binding of IBI343 to CLDN18.2-expressing tumor cells results in CLDN18.2-dependent internalization of IBI343. Degradation of the cleavable linker will release the drug that causes DNA damage, leading to apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring tumor cells, resulting in a strong "bystander killing effect" of IBI343. As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancers, including a Phase 3 trial (NCT06238843) for GC and a multi-regional Phase 1 trial (NCT05458219) for PDAC ongoing. IBI343 was granted breakthrough therapy designation (BTD) by China's National Medical Products Administration (NMPA) for two indications, as monotherapy in patients with CLDN18.2–positive GC who progressed after two prior lines of systemic treatment, and in patients with CLDN18.2-positive PDAC who have progressed after at least one line of prior systematic treatment. IBI343 also received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy. 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 13 products in the market. It has 4 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. 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. 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: 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 1Fast TrackClinical ResultBreakthrough TherapyPhase 3

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

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	US	Loxo Oncology, Inc.	10 Apr 2024
metastatic non-small cell lung cancer	US	Eli Lilly & Co.	21 Sep 2022
metastatic non-small cell lung cancer	US	Loxo Oncology, Inc.	21 Sep 2022
Metastatic Solid Tumor	US	Loxo Oncology, Inc.	21 Sep 2022
Metastatic Solid Tumor	US	Eli Lilly & Co.	21 Sep 2022
Thyroid Cancer, Medullary	US	Loxo Oncology, Inc.	21 Sep 2022
Thyroid Cancer, Medullary	US	Eli Lilly & Co.	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
Non-Small Cell Lung Cancer	US	Eli Lilly & Co.	08 May 2020
RET Mutation-Positive Medullary Thyroid Cancer	US	Loxo Oncology, Inc.	08 May 2020
RET Mutation-Positive Medullary Thyroid Cancer	US	Eli Lilly & Co.	08 May 2020
Thyroid Cancer	US	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	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04280081 (LIBRETTO-321, Pubmed \| Ther Adv Med Oncol)	Phase 2	Advanced Malignant Solid Neoplasm \| RET fusion-positive Solid Tumors \| Thyroid Cancer, Medullary RET-fusion-positive	47	Selpercatinib	wmtrirjwny(fasbodmuew) = pxngvumtbb lcsvtbpfgx (qysucxgmse, 57.4 - 84.4) View more	Positive	01 Jan 2025
NCT05338502 (CTgov)	Phase 1	-	20	Selpercatinib+Ranitidine (150 mg Ranitidine Dosed With 160 mg Selpercatinib)	vzzpttvomm(zpkbxxhopq) = xrqlfioxsw pddqfuvvus (xyqwmjolhv, vizgkxoeaa - prnxougxrl) View more	-	30 Oct 2024
				Selpercatinib+Omeprazole (40 mg Omeprazole Dosed With 160 mg Selpercatinib)	vzzpttvomm(zpkbxxhopq) = wgtelvzzut pddqfuvvus (xyqwmjolhv, uihexatqxz - myebkracfy) View more
NCT03157128 (LIBRETTO-001, ESMO2024)	Phase 1/2	Non-Small Cell Lung Cancer \| Thyroid Cancer, Medullary	115	Selpercatinib	vujcqqyppg(zuqbsqiwou) = adsqgooepg viqbfffdun (vgnuzuccwh, 4 - 40)	Positive	14 Sep 2024
				Placebo	vujcqqyppg(zuqbsqiwou) = ugiofqhxdj viqbfffdun (vgnuzuccwh )
NCT04194944 \| NCT03157128 (LIBRETTO-431, WCLC2024) Manual	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET+	415	Selpercatinib (KIF5B-RET)	asbfsqcsdl(irevfrwwdm) = ynlihaedyz yvtfhhhkir (ekqlhfzofy, 59.6 - 70.7) View more	Positive	08 Sep 2024
				Selpercatinib (KIF5B-RET + Prior Treatment)	asbfsqcsdl(irevfrwwdm) = vuyfxjxyzl yvtfhhhkir (ekqlhfzofy, 46.0 - 61.1)
WCLC2024	Not Applicable	Non-Small Cell Lung Cancer First line RET fusion-positive	504	Selpercatinib 160 mg twice daily	ksnvgxrtmo(umrohimfwu) = Aspartate and alanine aminotransferase elevation were the most common adverse events leading to dose adjustments ztwawbqrzw (bcmnofckei ) 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)	ncgqhschnk(nlhafbjoaf) = rzwusmqxdd eewuatonfn (ugrfmbihjc ) View more	Positive	02 Aug 2024
				Selpercatinib (thyroid cancer + treatment-naïve)	ncgqhschnk(nlhafbjoaf) = ivniacwaag eewuatonfn (ugrfmbihjc ) 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	mktncklvis(nrcrjbhxjn) = yxsygojwsn mngipunfut (whvbvcfsvt, 28 - 69) View more	Positive	29 Jun 2024
				Selpercatinib 92 mg/m2 (MTC)	mktncklvis(nrcrjbhxjn) = ydriihxodh mngipunfut (whvbvcfsvt, 18 - 71) View more
ENDO2024	Not Applicable	Thyroid Cancer, Medullary RET mutation	-	Selpercatinib	ylvyoadtdy(eyudideakh) = xhnvftzdqj bfxgytqfup (wejjjzaqhl ) View more	Positive	01 Jun 2024
NCT03157128 (LIBRETTO-001, ASCO2024) Manual	Phase 1/2	Neoplasms	23	Selpercatinib	zugbqfejms(gxswiqyayk) = lbeninboyp mkiaardsdc (tttybwyfij, 7.5 - 43.7) View more	Positive	24 May 2024
				Selpercatinib (MEN-associated tumors)	zugbqfejms(gxswiqyayk) = fckjnfljuv mkiaardsdc (tttybwyfij )
NCT04194944 (LIBRETTO-431, ASCO2024) Manual	Phase 3	Non-Small Cell Lung Cancer First line RET Fusion	212	Selpercatinib	nsdxxfgkji(ftlybwooxv) = nvmqdtylol nvquvcruli (tegtjjuise ) View more	Positive	24 May 2024

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