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

Structure/Sequence

Molecular FormulaC29H31N7O3

InChIKeyXIIOFHFUYBLOLW-UHFFFAOYSA-N

CAS Registry2152628-33-4

Clinical Trials associated with Selpercatinib

NCT06532149

/ RecruitingNot ApplicableIIT

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

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

Start Date05 Aug 2024

Sponsor / Collaborator-

NCT06458036

/ RecruitingPhase 2

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

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

Start Date29 Jul 2024

Sponsor / Collaborator

The Children's Hospital of Philadelphia

[+2]

CTR20233072

/ RecruitingNot Applicable

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

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

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

[Translation]

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

Start Date25 Dec 2023

Sponsor / Collaborator

Eli Lilly & Co.

[+2]

100 Clinical Results associated with Selpercatinib

100 Translational Medicine associated with Selpercatinib

100 Patents (Medical) associated with Selpercatinib

481

Literatures (Medical) associated with Selpercatinib

01 Jul 2025·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

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

Article

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

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

01 Jul 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Potent and highly selective inhibition of selpercatinib towards UDP-glucuronosyltransferase 1A4 (UGT1A4) isoform

Article

Author: Liu, Yueyi ; Jiang, Lili ; Yin, Hang ; Lv, Xin

Selpercatinib is a potent and highly selective Rearranged during Transfection (RET) kinase inhibitor for patients with RET fusion-positive thyroid cancer and non-small-cell lung cancer. The present study aims to investigate the inhibitory effects of selpercatinib towards human UDP-glucuronosyltransferases (UGTs), and assess its risk for drug-drug interactions (DDIs) via UGT inhibition. The inhibition of selpercatinib towards 12 recombinant human UGT isoforms were measured. Our data demonstrated that selpercatinib exhibited highly selective inhibition towards UGT1A4. Enzyme kinetic study indicated that selpercatinib competitively inhibited the activity of UGT1A4, with a K_i value of 1.57 ± 0.14 μM. The quantitative prediction of DDIs risk indicated that the co-administration of selpercatinib with UGT1A4 substrate might trigger clinically significant DDIs. Additional caution should be taken to avoid unexpected DDIs when selpercatinib and other UGT1A4 substrates are combined.

01 Jun 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

Article

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

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

206

News (Medical) associated with Selpercatinib

19 May 2025

·www.prnewswire.com

Innovent Released 2024 ESG Report, Underscoring Commitment to Sustainable Development and Global Innovation

SAN FRANCISCO and SUZHOU, China, May 18, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the release of its "2024 Environmental, Social and Governance (ESG) Report", highlighting the Company's strategies, actions, and achievements in sustainable development across five pillars, which include "Excellent Governance", "Enjoying Good Health", "High Quality as Key", "People First" and "Embracing Ecology". Continue Reading MSCI ESG RATING Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "As China's leading biopharmaceutical company, Innovent consistently navigates the pulse of the times with strategic foresight, forging a closed-loop system for value creation through synergistic integration of global innovation-driven strategies and sustainable development practices. We achieved an MSCI ESG rating of AAA, as the only biotech in China and one of just three globally to receive this rating. Throughout the year of 2024, we remained committed to our mission, 'to empower patients worldwide with affordable, high-quality biopharmaceuticals,' and stayed true to our original aspiration, 'Start with Integrity, Succeed through Action.' We deeply integrated social responsibility into our business practices, actively responded to the United Nations Sustainable Development Goals (SDGs), strengthened our governance structure, improved operational efficiency, advanced high-quality innovation, promoted diversity and empowerment among employees, and strived for low-carbon development. These initiatives firmly honored our commitment to sustainable growth. We have embedded ESG principles into the fabric of our organization, which enables us to continuously create multidimensional value for shareholders, employees, patients, and society." Building Enduring Excellence through Lean Governance Robust governance is the cornerstone of sustainable business development. In 2024, Innovent further refined its ESG governance framework to ensure agility in responding to global changes while maintaining steady, compliant operations. We strengthened compliance management through continuous improvement of risk management systems and the upholding of rigorous business ethics standards. Looking ahead, we are committed to building a stable and sustainable business ecosystem in collaboration with our partners. Board Diversity: added one female Executive Director, with every Board Committee now including at least one female chair or member. Compliance, anti-corruption, and business ethics training: 100% participation among Directors and employees. Supplier business ethics: 100% of suppliers signed the "Commitment to Compliance". Official ESG website: launched in 2024, underscoring the company's firm commitment to sustainable development. ESG recognition: achieved an MSCI ESG rating of AAA, the only biotech in China and one of just three globally to receive this rating. Driving Inclusive Healthcare through Innovation Bridging geographic and economic gaps through innovative therapies remains Innovent's unwavering goal. Guided by our company strategy, "To discover new medicines through innovation and deliver them through our global platforms", Innovent has solidified its oncology leadership in China, achieved multiple groundbreaking advancements in chronic disease therapies, and expanded our global impact. Out dedication to scientific progress is grounded in a strong sense of social responsibility, which extends to improving drug accessibility and affordability for patients worldwide, rural education, volunteer activities, and broader community support initiatives. Improving drug accessibility through an innovative pipeline: 15 commercialized products have benefited 5 million patients cumulatively. 3 New Drug Applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 molecules in early clinical development. Oncology and general biomedicine have become the Company's two growth engines. 6 drugs or assets granted 13 orphan drug designations, with 2 drug candidates for rare diseases in preclinical and clinical stages. SYCUME® (teprotumumab N01 injection) was launched as China's first IGF-1R antibody for the treatment of thyroid eye disease, ending a 70-year absence of treatment options and transforming care for this rare condition. Enhancing drug affordability by supporting medical insurance coverage with 6 medicines (TYVYT®, BYVASDA®, HALPRYZA®, SULINNO®, Olverembatinib, and SINTBILO®) included in China's National Reimbursement Drug List (NRDL) and 8 medicines (Pemazyre®, Cyramza®, Retsevmo®, FUCASO®, TYVYT®, DOVBLERON®, Jaypirca® and DUPERT®) included in the Catalog of Specific Drug Reimbursements under Huimin Insurance Programs. SINTBILO® became China's first domestically developed PCSK9 inhibitor included in the NRDL. Patient assistance programs have benefited over 200,000 patients, with donated medicines valued at more than RMB 3.6 Billion. Health education and public welfare programs benefited over 240,000 patients. Ongoing efforts in supporting rural education have cumulatively benefited nearly 4,000 teachers and students. Innovent volunteer teams contributed a total of 2,754 hours of community service, reflecting our long-term commitment to social responsibility. Delivering Life-Changing Quality High-quality is a foundational principle at Innovent that underpins our mission to deliver safer, more effective therapies to patients. Patient-centricity drives our adherence to internationally recognized quality standards across the entire product lifecycle, from development and manufacturing to distribution. Even in the face of complex external environments, we actively collaborate with industry partners to elevate sector-wide benchmarks and maintain a resilient, sustainable dual-sourcing supply chain. Our responsible marketing practices further prioritize transparency and the protection of patient rights. Innovent Biologics currently operates 140,000 L of total production capacity, comprising 60,000L of antibody production capacity at Suzhou manufacturing site and 80,000L of antibody and ADC production capacity at Hangzhou manufacturing site. With an additional 90,000L of capacity in plan at the Hangzhou site, the total production capacity will reach 230,000L upon full completion. All commercially operational production facilities are 100% GMP-certified. Reached 100% batch success rate in drug substance manufacturing. Maintained 100% pass rate in audits conducted by regulatory authorities and strategic partners. Established dual-source supply chains for raw materials used in self-manufactured commercial products. Conducted 122 quality audits of suppliers; delivered capacity-building training to approximately 170 suppliers; deployed over 400 personnel to provide on-site quality supervision, guidance, and training at 10 key supplier sites. Empowering Talent and Igniting Potential A thriving talent ecosystem fuels our innovation. At Innovent, we view our employees as the foundation of long-term success and are deeply committed to cultivating a fair, inclusive, and empowering workplace. We offer diverse career development pathways and a multi-tiered professional development training system tailored to different career stages. Our comprehensive compensation and benefits framework is designed to strengthen employees' sense of belonging, while enhancing our ability to attract, retain, and develop top talent. Committed to making Innovent a learning institution, we support employees in achieving both personal and professional growth. Women represent 51% of total employees and hold 44.2% of management positions. Key talent retention rate reached 96.8%. Employee satisfaction rate exceeded 98%. The "Innovent Beginning" Campus Recruitment Program offered over 2,100 job opportunities to new graduates from nearly 20 provinces. All operational production facilities are 100% ISO 45001 occupational health and safety (OH&S) certified. Safeguarding the Green Future with a Commitment to Sustainability Green development underpins Innovent's high-quality growth strategy. We are committed to eco-friendly practices that protect natural resources and ecosystems while actively contributing to global climate action. Through comprehensive climate risk assessments, we evaluate the potential operational impacts of climate change and implement measures to reduce our business activities' climate impacts. By integrating green, low-carbon principles across all aspects of our production and operations, we continue to set clear targets that drive continuous improvement in our environmental performance and contribute to a more sustainable future. 100% of operational production facilities are certified under the ISO 14001 Environmental Management System. Successfully completed one internal and one external environmental management audit to ensure ongoing compliance and system integrity. 29% reduction in energy consumption (per unit of production) compared to the previous year. Reduced fresh water use by 22% (per unit of production) compared to the previous year. Recycled a total of 51,100 tons of water, reflecting out commitment to resource conservation. Innovent Shanghai Global R&D Center was awarded LEED Gold certification by the U.S. Green Building Council (USGBC). Innovent remains firmly committed to sustainable development and global innovation. We will continue strategically consolidating our business momentum while pursuing breakthrough innovations in science. By harmonizing business success with long-term social value, Innovent is steadily progressing toward its vision of becoming a premier global biopharmaceutical company. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. 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. 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

Orphan Drug

16 May 2025

·www.prnewswire.com

Second Head-to-head Phase 3 Study of Mazdutide versus Semaglutide Completes First Participant Dosing in Adults in China with Overweight or Obesity Accompanied Fatty Liver Disease (GLORY-3)

SAN FRANCISCO and SUZHOU, China, May 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 oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in GLORY-3, a Phase 3 clinical study of mazdutide (Innovent R&D Code: IBI362), a dual glucagon (GCG) and glucagon-like peptide 1 receptor (GLP-1) receptor agonist. The study targets adults in China with overweight or obesity accompanied metabolic dysfunction-associated fatty liver disease (MAFLD). GLORY-3 is a multicenter, randomized, open-label Phase 3 clinical study (NCT06884293) comparing the efficacy and safety of mazdutide versus semaglutide in Chinese adults with overweight or obesity accompanied MAFLD. This study plans to enroll approximately 470 participants with overweight or obesity (BMI ≥ 27 kg/m2) accompanied MAFLD, who will be randomized 1:1 to receive mazdutide 9 mg or semaglutide 2.4 mg. The primary endpoints are the percentage change in liver fat content (LFC) as measured by magnetic resonance proton density fat fraction (MRI-PDFF) and the percentage change in body weight from baseline to week 48. A Phase 2 study conducted in Chinese adults with obesity (BMI ≥ 30 kg/m2, NCT04904913) showed that after 48 weeks of treatment, mazdutide 9 mg achieved an 18.6% (17.8kg) placebo-adjusted mean percent reduction in body weight. Meanwhile, 51.2% and 34.9% of the subjects in the mazdutide 9 mg group achieved 15% or more and 20% or more weight loss from baseline, respectively. Among participants with baseline LFC≥ 5% (measured by MRI-PDFF), the percent change in LFC from baseline to week 24 was reduced by 73.3% in the mazdutide 9 mg group. This decrease was sustained during the 48-week extended treatment period, suggesting that mazdutide can effectively reduce body weight and liver fat in participants with overweight or obesity. Professor Lixin Guo, the Principal Investigator of the Study, Peking University People's Hospital, stated, "MAFLD is now the most common chronic liver disease in the world and has surpassed viral hepatitis as the leading chronic liver disease in China. Obesity is a key risk factor, with MAFLD affecting up to 81.8% people with obesity in China[1]. The latest Chinese guidelines recommended GLP-1 agents such as semaglutide for treating obesity and MAFLD ('Guideline for chronic weight management and clinical practice of anti-obesity medications'). As a dual GCG/GLP-1 receptor agonist, mazdutide 9 mg has shown strong weight loss effects and notable improvements in liver fat and enzyme levels, thanks to its additional GCG activity. GLORY-3 is the first clinical trial comparing a dual GCG/GLP-1 receptor agonist with a GLP-1R-only drug in Chinese adults with obesity. It will compare the efficacy and safety of mazdutide 9 mg versus semaglutide 2.4 mg in participants with overweight or obesity accompanied MAFLD. Together with our investigator team, I am committed to conducting this study to the highest standards and to delivering a better treatment option for the Chinese population with overweight or obesity accompanied MAFLD." Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, stated, "Mazdutide, as a dual GCG/GLP-1 receptor agonist, enhances lipolysis and fatty acid oxidation by stimulating the GCG receptor, offering a series of comprehensive metabolic benefits compared to GLP-1 single receptor agonist drugs. In our Phase 2 study conducted in Chinese adults with obesity, participants with baseline LFC ≥ 5% had a 73.3% reduction in liver fat content after 24 weeks of treatment with mazdutide 9 mg, which preliminarily demonstrated the efficacy of mazdutide in reducing liver fat content. I am very confident that mazdutide will continue to show strong clinical efficacy in the GLORY-3 study, including in weight loss and liver metabolism, and provide a better treatment option for Chinese patients with overweight or obesity accompanied MAFLD." About Obesity China has the world's largest population of people with overweight or obesity[2], with the obesity rate likely to rise. Obesity contributes to multiple comorbidities, reducing life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths related from chronic non-communicable diseases in China, a significant increase from 5.7% in 1990[3]. As obesity is a chronic disease, it requires long-term management, and China faces a lack of long-term effective and safe treatments. Despite lifestyle interventions being the first-line treatment, many patients fail to achieve their desired weight loss goals, underscoring the need for more effective and safer pharmacological interventions. About MAFLD MAFLD is the most common chronic liver disease worldwide, with a global prevalence estimated around 32.4% and increasing. Obesity is one of the risk factors for MAFLD, and the prevalence of MAFLD in those with obesity worldwide has reached 75.3%. In China, MAFLD has overtaken viral hepatitis as the leading chronic liver condition, affecting 81.8% of obese individuals[1]. China also has the world's highest incidence of MAFLD in both normal and obese populations. Treatment goals include reducing body weight and waist circumference, improving insulin resistance, preventing and treating metabolic-related syndromes, and reversing fibrosis. For patients with MAFLD and overweight or obesity, combining lifestyle and pharmacological interventions is considered the most effective strategy to improve health outcomes and quality of life. About Mazdutide (IBI362) Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight—by also activating the glucagon receptor to increase energy expenditure and improve hepatic fat metabolism. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Mazdutide currently has two NDAs accepted for review by NMPA, including: For chronic weight management in adults with overweight of obesity; For glycemia control in adults with type 2 diabetes. Mazdutide is currently being evaluated in six Phase 3 clinical studies, including: GLORY-1: A Phase 3 trial in Chinese participants with overweight or obesity. GLORY-2: A Phase 3 trial in Chinese participants with moderate-to-severe obesity. GLORY-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). DREAMS-1: A Phase 3 trial in treatment-naïve Chinese patients with T2D. DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D patients with inadequate glycemic control on oral antidiabetic drugs. DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese patients with T2D and obesity. Among these, GLORY-1, DREAMS-1 and DREAMS-2 studies have all met their endpoints. In addition, several new clinical studies of mazdutide are planned, including: A Phase 3 trial in adolescents with obesity. A Phase 3 trial in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity. New studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References [1] Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Nov;25(11):3390-3399. [2] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92. [3] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. (accessed Jan 10, 2021). 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 2Phase 3Clinical ResultLicense out/in

06 May 2025

·pipelinereview.com

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

SAN FRANCISCO, CA, USA and SUZHOU, China I May 5, 2025 I Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announces that the latest 1-year results from its Phase 2 clinical trial of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, in Chinese subjects with neovascular age-related macular degeneration (nAMD) were presented orally at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The ARVO Annual Meeting 2025 is the premiere gathering of researchers and physicians in vision and ophthalmology to share the latest research findings and collaborate on innovative solutions, to be held from May 4 – 8 in Salt Lake City, Utah, U.S.. Title: Intravitreal High-dose Efdamrofusp Alfa (IBI302) in Patients with Neovascular Age-related Macular Degeneration: A Randomized, Double-masked, Active-controlled, Phase 2 Study Presentation Number: 443 Presentation Format: Speech/Mini Oral Presentation Time: May 4, 2:15pm-2:30pm Presenter: Prof. Xiaodong Sun, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine The data were from the Phase 2 clinical study of high-dose IBI302 (NCT05403749) to evaluate the efficacy, safety and dosing intervals in patients with nAMD over a one-year treatment period. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group. After the loading therapy, IBI302 groups were administrated at personal treatment interval of Q12W or Q8W based on the disease activity assessed at Week 20. Subjects in Aflibercept 2.0 mg group were dosed Q8W after the loading therapy. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40 and the study lasts 52 weeks. The results showed 6.4 mg/ 8.0 mg IBI302 competitive efficacy and safety profiles : Professor Xiaodong Sun, Principal Investigator of the Study, Deputy director, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine , stated: “It is my privilege to present the latest research findings on IBI302 to the global ophthalmic community at the ARVO meeting as the principal investigator. While anti-VEGF drugs remain the first-line therapy for nAMD, the frequency of intravitreal injections and follow-up visits can significantly impact patient compliance. Current drug development focuses on multi-target strategies and extended dosing intervals to reduce the treatment burden by decreasing injection frequency. Notably, IBI302—a novel global first-in-class bispecific molecule (anti-VEGF/anti-complement) —recently reported Phase 2 data showing that its high-dose cohorts met the primary endpoint. The treatment group achieved approximately 10-letters improvement in visual acuity from baseline at one year, with over 80% subjects demonstrating potential for at least 12-weeks extended dosing intervals. Additionally, preliminary observations in IBI302 group suggest potential efficacy in inhibition of macular atrophy. We anticipate this innovative therapy will successfully complete the Phase 3 registration trial, providing nAMD patients with more effective, patient-friendly options.” Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent , stated: “We are honored to present the latest progress of IBI302 in its second Phase 2 clinical trial at the ARVO annual meeting. High dose IBI302 demonstrates positive efficacy in visual acuity and anatomical improvements, while extend dosing intervals and potential anti-macular atrophy effects. Additionally, no new safety signals were observed during the trial, further validating the favorable safety and tolerability profile of this agent. These encouraging results establish a robust foundation for subsequent development. We will continue collaborating with clinical experts to expedite the Phase 3 clinical trial program, and accelerate the availability of this innovative therapy for patients with nAMD.” About Efdamrofusp Alfa (IBI302) IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N- terminal is a VEGF domain that can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and improve vasopermeability and reduce leakage. The C- terminal of IBI302 is the complement binding domain that can inhibit the activation of the classic pathway and alternative pathway of complement through the specific binding of C3b and C4b, and reduce the inflammatory response mediated by the complement. IBI302 may exert its therapeutic effect by inhibiting both VEGF-mediated angiogenesis and complement activation pathways. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com , or follow Innovent on Facebook and LinkedIn. Statement: （ 1 ） Innovent does not recommend the use of any unapproved drug (s)/indication (s). （ 2 ） Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. SOURCE: Innovent Biologics

Phase 2Clinical ResultPhase 1

100 Deals associated with Selpercatinib

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KEGG	Wiki	ATC	Drug Bank
D11713	Selpercatinib	L01XE	DB15685

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Approved

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

Developing

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05338515 (CTgov)	Phase 1	-	18	Selpercatinib (320 mg Selpercatinib)	dmnliemqyg = dcklkbfzkw huoewbgczk (tshfypdosn, jkgbiefevl - fdboiwgrzf) View more	-	18 May 2025
				Selpercatinib (640 mg Selpercatinib)	dmnliemqyg = xwdevlrrdh huoewbgczk (tshfypdosn, gkvysasyhe - iulblioocp) View more
NCT05630287 (CTgov)	Phase 1	-	12	Selpercatinib	vsmqjsspyj(twqknarhua) = klysnnzyuo oxqutcqttg (kqirptmfaw, 26.6) View more	-	23 Apr 2025
NCT05436912 (CTgov)	Phase 1	Liver Injury	36	Selpercatinib (160 mg Selpercatinib: Mild Hepatic Impairment)	nmapleuxcw(yyvymgalac) = aqeoxikrir swewqpwmoa (nblkquymrj, 78.0) View more	-	13 Apr 2025
				Selpercatinib (160 mg Selpercatinib: Moderate Hepatic Impairment)	nmapleuxcw(yyvymgalac) = nuvdigzjkr swewqpwmoa (nblkquymrj, 185.6) View more
NCT05324124 (CTgov)	Phase 1	-	46	Selpercatinib (Selpercatinib Fasted (Reference))	wjlpgvbgqa(dypcivmqso) = tsxwpllmfi yvrbfvinpt (xsgyvrdvkv, 32) View more	-	21 Mar 2025
				Selpercatinib (Selpercatinib Fed (Test))	wjlpgvbgqa(dypcivmqso) = jrxypuelme yvrbfvinpt (xsgyvrdvkv, 44) View more
NCT05089019 (CTgov)	Phase 1	-	224	Selpercatinib (160 mg Selpercatinib (Reference))	sxizromjhj(idoecoydcf) = cmvosherpl eahpyvtlbu (codguddihp, 61) View more	-	17 Mar 2025
				Selpercatinib (160 mg Selpercatinib (Test))	sxizromjhj(idoecoydcf) = mnwakamhqr eahpyvtlbu (codguddihp, 91) View more
NCT05136404 (CTgov)	Phase 1	-	42	Selpercatinib	hdqzbzxqfe(mfauowflvf) = mujutpewri svsbbfjeou (iiwomnlxqs, ysespuzwbx - curxqyfubb) View more	-	17 Mar 2025
NCT04280081 (LIBRETTO-321, Pubmed \| Ther Adv Med Oncol) Manual	Phase 2	RET fusion-positive Non-Small Cell Lung Cancer RET Positive	47	Selpercatinib	xomxiehjxb(akajsmiktn) = jieuzhenog umnphqcsvm (vgutvkioxb, 57.4 - 84.4) View more	Positive	01 Jan 2025
				Selpercatinib (treatment-naïve)	xomxiehjxb(akajsmiktn) = vqbxnuqogr umnphqcsvm (vgutvkioxb, 71.5 - 100.0) View more
NCT05338502 (CTgov)	Phase 1	-	20	Selpercatinib+Ranitidine (150 mg Ranitidine Dosed With 160 mg Selpercatinib)	ukzusujndx(qhczmilgvq) = aossbzbili dutwvfikrv (gtrnpfhiwj, 31.9) View more	-	30 Oct 2024
				Selpercatinib+Omeprazole (40 mg Omeprazole Dosed With 160 mg Selpercatinib)	ukzusujndx(qhczmilgvq) = nkbzwkhgck dutwvfikrv (gtrnpfhiwj, 27.4) View more
NCT03157128 (LIBRETTO-001, ESMO2024)	Phase 1/2	Non-Small Cell Lung Cancer \| Thyroid Cancer, Medullary	115	Selpercatinib	bpidodbyda(sjgyoernin) = wdokaizjoz egrxsucwej (yaazllpbau, 4 - 40)	Positive	14 Sep 2024
				Placebo	bpidodbyda(sjgyoernin) = pddstsuobh egrxsucwej (yaazllpbau )
NCT04194944 \| NCT03157128 (LIBRETTO-431, WCLC2024) Manual	Not Applicable	RET fusion-positive Non-Small Cell Lung Cancer RET+	415	Selpercatinib (KIF5B-RET)	rrwrdfrxms(avujoqfaav) = poheokqesp jnsoumjhzp (myffqqxbsi, 59.6 - 70.7) View more	Positive	08 Sep 2024
				Selpercatinib (KIF5B-RET + Prior Treatment)	rrwrdfrxms(avujoqfaav) = myioxvtfeg jnsoumjhzp (myffqqxbsi, 46.0 - 61.1)

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