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

Structure/Sequence

Molecular FormulaC22H21F4N5O3

InChIKeyFWZAWAUZXYCBKZ-NSHDSACASA-N

CAS Registry2101700-15-4

Clinical Trials associated with Pirtobrutinib

NCT06967610

/ Not yet recruitingPhase 2IIT

Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Start Date30 Oct 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06948786

/ Not yet recruitingPhase 2IIT

PROMOTE-FL: Pirtobrutinib and Mosunetuzumab to Enhance Treatment Efficacy for Patients With Relapsed/Refractory Follicular Lymphoma

This phase II trial tests how well pirtobrutinib and mosunetuzumab work in treating patients with grade 1-3a follicular lymphoma (FL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pirtobrutinib, a type of tyrosine kinase inhibitor, works by blocking the action of the Bruton tyrosine kinase (BTK) protein. The BTK protein signals cancer cells to multiply, and blocking it may help keep cancer cells from growing. It could also improve T cell fitness and decrease inflammation, therefore, may improve the efficacy and safety of T cell-based therapies, such as mosunetuzumab. Mosunetuzumab is a bispecific antibody that binds both T cells and the lymphoma cancer cells and harnesses T cells to interfere with the ability of cancer cells to grow and spread. Giving pirtobrutinib and mosunetuzumab together may kill more tumor cells in patients with relapsed or refractory grade 1-3a FL and potentially decreases some side effects of mosunetuzumab which are related to T cells being activated (e.g., cytokine release syndrome).

Start Date01 Oct 2025

Sponsor / Collaborator

University of Washington

[+1]

NCT06839872

/ Not yet recruitingPhase 2

BOSS: BTK Inhibitor Optimal Sequencing Study Phase II Open-label Single Arm Trial of Pirtobrutinib in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma After First-line Acalabrutinib Progression

To assess the efficacy and safety of pirtobrutinib in participants with CLL/SLL who have progressed on first-line treatment with acalabrutinib.

Start Date30 Jun 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Pirtobrutinib

100 Translational Medicine associated with Pirtobrutinib

100 Patents (Medical) associated with Pirtobrutinib

164

Literatures (Medical) associated with Pirtobrutinib

01 Jun 2025·INTERNATIONAL JOURNAL OF CANCER

Pirtobrutinib in Chinese patients with relapsed or refractory B‐cell malignancies: A single‐arm, open‐label, phase 2, multicenter trial

Article

Author: Zhang, Liling ; Song, Yuqin ; Guo, Ye ; Qian, Yijiao ; Zhu, Jiankun ; Yang, Haiyan ; Yi, Shuhua ; Zhu, Jun ; Lin, Ningjing ; Zhang, Qingyuan ; Huang, Huiqiang ; Feng, Ru ; Liu, Yanyan ; Zhang, Huilai

Abstract:

Pirtobrutinib, a highly selective, noncovalent (reversible) Bruton tyrosine kinase inhibitor (BTKi), demonstrated clinically meaningful antitumor responses in covalent BTKi pretreated mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in the global phase 1/2 BRUIN study. In this multi‐center, open‐label, phase 2 trial, we investigated the efficacy and safety of pirtobrutinib in Chinese patients with BTKi pretreated relapsed/refractory (R/R) MCL, CLL/SLL, or other B‐cell malignancies. All patients received pirtobrutinib once daily in continuous 28‐day cycles. The primary endpoint was the overall response rate (ORR). Efficacy was assessed in patients with MCL and CLL/SLL with prior BTKi treatment and safety in all enrolled patients who received at least one dose of pirtobrutinib. Among 35 patients with covalent BTKis (cBTKi) pretreated MCL, the ORR was 62.9% (95% CI: 44.9, 78.5), the median duration of response (DOR) was not reached, and the 12‐month DOR rate was 59.7% (95% CI: 35.3, 77.5). Among 11 patients with cBTKi pretreated CLL/SLL, the ORR was 63.6% (95% CI: 30.8, 89.1), and the 12‐month DOR rate was 83.3% (95% CI: 27.3, 97.5). The most common adverse events in the safety population (n = 87) were anemia (32.2%) and neutrophil count decreased (31.0%). Grade ≥3 hemorrhage occurred in 2.3% of patients and there were no cases of atrial fibrillation/flutter. Pirtobrutinib demonstrated clinically meaningful efficacy in Chinese patients with cBTKi pretreated R/R MCL, preliminary antitumor activity in Chinese patients with cBTKi pretreated R/R CLL/SLL and was generally well‐tolerated with no new safety signals observed.

01 Jun 2025·AMERICAN JOURNAL OF HEMATOLOGY

Waldenström Macroglobulinemia: 2025 Update on Diagnosis, Risk Stratification, and Management

Review

Author: Gertz, Morie A.

ABSTRACT:

Disease Overview:

Waldenström macroglobulinemia (WM) is a lymphoplasmacytic lymphoma with immunoglobulin M (IgM) monoclonal protein. Clinical features include anemia, thrombocytopenia, hepatosplenomegaly, lymphadenopathy, and rarely hyperviscosity.

Diagnosis:

The presence of IgM monoclonal protein associated with ≥ 10% clonal lymphoplasmacytic cells in bone marrow confirms the diagnosis. The L265P mutation in MYD88 is detectable in more than 90% of patients and is found in most IgM MGUS patients. MYD88 is not required for the diagnosis.

Risk Stratification:

Age, albumin, hemoglobin level, platelet count, β2 microglobulin, Lactate dehydrogenase (LDH), and monoclonal IgM concentrations are characteristics that are predictive of outcomes.

Risk‐Adapted Therapy:

Not all patients who fulfill WM criteria require therapy; these patients can be observed until symptoms develop. Rituximab‐monotherapy is inferior to combination regimens. Recommended first‐line therapy can be chemoimmunotherapy or a covalent Bruton tyrosine kinase inhibitor. The preferred Mayo Clinic induction is either rituximab and bendamustine (without rituximab maintenance) or zanubrutinib.

Management of Refractory Disease:

Bortezomib, cyclophosphamide, fludarabine, thalidomide, everolimus, pirtobrutinib, carfilzomib, lenalidomide, bendamustine, and venetoclax have all been shown to have activity in relapsed WM. Given WM's natural history, the reduction of therapy toxicity is an important part of treatment selection. Most patients succumb to causes unrelated to macroglobulinemia.

01 May 2025·BIOMEDICAL CHROMATOGRAPHY

High‐Performance Liquid Chromatography–Ultraviolet Assay for the Determination of Pirtobrutinib Levels in a Patient With Mantle Cell Lymphoma

Article

Author: Yasu, Takeo ; Tukada, Masao ; Gando, Yoshito ; Shimoda, Mari

ABSTRACT:

Pirtobrutinib is a Bruton's tyrosine kinase inhibitor used to treat mantle cell lymphoma and chronic lymphocytic leukemia. Pirtobrutinib has a steady‐state trough concentration of > 825 ng/mL, corresponding to a 90% inhibitory concentration of Bruton's tyrosine kinase. Therefore, maintaining stable trough concentrations of pirtobrutinib is clinically important; however, no methods of monitoring pirtobrutinib levels have been developed. In this study, our aim was to develop a method to determine pirtobrutinib levels in human plasma and validate it for therapeutic drug monitoring. Pirtobrutinib and ibrutinib (internal standard) were separated on a reversed‐phase column using a mobile phase comprising 0.5% KH2PO4 (pH 4.5) and acetonitrile (52:48, v/v) at a flow rate of 1.0 mL/min. Ultraviolet detection was performed at 234 nm. Calibration curves for pirtobrutinib were linear (r2 = 0.9998) in the range of 0.25–10 μg/mL. The intraday and interday validation coefficients were 0.72%–2.86% and 1.29%–3.22%, respectively. This study is the first one to develop and validate a method for quantifying pirtobrutinib in human plasma. These findings may support the widespread application of therapeutic drug monitoring for pirtobrutinib.

145

News (Medical) associated with Pirtobrutinib

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 Pirtobrutinib

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Indication	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	United States	Loxo Oncology, Inc.	01 Dec 2023
Small Lymphocytic Lymphoma	United States	Loxo Oncology, Inc.	01 Dec 2023
Mantle-Cell Lymphoma	European Union	Eli Lilly Nederland BV	30 Oct 2023
Mantle-Cell Lymphoma	Iceland	Eli Lilly Nederland BV	30 Oct 2023
Mantle-Cell Lymphoma	Liechtenstein	Eli Lilly Nederland BV	30 Oct 2023
Mantle-Cell Lymphoma	Norway	Eli Lilly Nederland BV	30 Oct 2023
Mantle cell lymphoma recurrent	United States	Loxo Oncology, Inc.	27 Jan 2023
Mantle cell lymphoma refractory	United States	Loxo Oncology, Inc.	27 Jan 2023

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Lymphoma	NDA/BLA	Canada	Eli Lilly Canada, Inc.	01 Mar 2025
Chronic lymphocytic leukaemia refractory	NDA/BLA	European Union	Eli Lilly Nederland BV	27 Feb 2025
Recurrent Chronic Lymphoid Leukemia	NDA/BLA	European Union	Eli Lilly Nederland BV	27 Feb 2025
Recurrent Follicular Lymphoma	Phase 2	United States	Eli Lilly & Co.	01 Oct 2025
Refractory Follicular Lymphoma	Phase 2	United States	Eli Lilly & Co.	01 Oct 2025
Purpura, Thrombocytopenic, Idiopathic	Phase 2	United States	Eli Lilly & Co.	01 May 2025
Multiple sclerosis relapse	Phase 2	United States	Eli Lilly & Co.	01 May 2024
Multiple sclerosis relapse	Phase 2	Puerto Rico	Eli Lilly & Co.	01 May 2024
Chronic leukemia	Phase 2	China	Eli Lilly & Co.	14 May 2021
Diffuse Large B-Cell Lymphoma	Phase 2	China	Eli Lilly & Co.	14 May 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04849416 (Pubmed \| Int J Cancer) Manual	Phase 2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma ... View more	87	Pirtobrutinib	-	Positive	01 Jun 2025
				Pirtobrutinib (patients with covalent BTKis pretreated MCL)	drslqfaycz(delhciifdh) = dlbkcoktuf waryptzbxu (qvtbprawwr, 44.9 - 78.5) View more
NCT06165146 (CTgov)	Phase 1	-	16	Repaglinide (Period 1: 0.5 mg Repaglinide)	fgrrpcfvzc(wqcrnqnqxv) = goyxhpvqcd bilfnmxeur (bhgtkcaeeo, 36.9) View more	-	17 Mar 2025
				Repaglinide+Pirtobrutinib (Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide)	fgrrpcfvzc(wqcrnqnqxv) = jafnytjncn bilfnmxeur (bhgtkcaeeo, 56.1) View more
NCT06215430 (CTgov)	Phase 1	-	16	Warfarin tablet+Omeprazole capsule+Caffeine Tablet (Period 1: Probe Drug Cocktail)	swlhpvyzch(vxqxvqhcuz) = kaafrcmjma lilcimmdpm (oqpvycuwws, 31.8) View more	-	10 Mar 2025
				Warfarin tablet+Omeprazole capsule+Pirtobrutinib+Caffeine Tablet (Period 2: Pirtobrutinib + Probe Drug Cocktail)	swlhpvyzch(vxqxvqhcuz) = isdyqylztc lilcimmdpm (oqpvycuwws, 31.8) View more
NCT04666038 (BRUIN CLL-321, CTgov)	Phase 3	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	238	Pirtobrutinib (Arm A - Pirtobrutinib)	cszzwigkcz(jcuzrxrlxe) = undrpowiil yjodjvkrbn (scssdbpjit, prldvlrqys - vkbupxguil) View more	-	07 Mar 2025
				bendamustine+Idelalisib+Rituximab (Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab)	cszzwigkcz(jcuzrxrlxe) = mlztmrolnz yjodjvkrbn (scssdbpjit, racjkguzew - sipskokwvk) View more
NCT06215521 (CTgov)	Phase 1	-	31	Pirtobrutinib (Treatment A: 900 mg Pirtobrutinib)	bmoqedevpp(nwuzinvlxq) = tglzlkpkli mbbogkhitb (thynzliupk, paixzmqdcy - thbzyldixe) View more	-	24 Feb 2025
				Placebo+Pirtobrutinib (Treatment B: 900 mg Pirtobrutinib Matched Placebo)	oovaivqkth(enqkuqvogm) = hmoeelrklg igiaxifxwn (yqppklgvar, vjmpujxgum - rfdecjfeny) View more
NCT06194214 (CTgov)	Phase 1	-	16	Digoxin+Pirtobrutinib	trcetrqapx(rdkupcrvmn) = bwlpigfwks xrvdbkhdje (bomxpvzhkm, 21.1) View more	-	21 Feb 2025
NCT06181006 (CTgov)	Phase 1	-	24	Pirtobrutinib (Cohort 1: 300 mg Pirtobrutinib)	humjglhfnm = klmyiinfcw uuwsxmbzuw (bvtmerbbbt, bawiuuxizl - qkhlaraqrt) View more	-	14 Jan 2025
				Pirtobrutinib (Cohort 2: 600 mg Pirtobrutinib)	humjglhfnm = zmggpcmjgv uuwsxmbzuw (bvtmerbbbt, vthqynkhku - grkztsutah) View more
NCT06180954 (CTgov)	Phase 1	-	9	[14C]-LOXO-305 (Part 1: [14C]-LOXO-305 Oral Solution)	vlomxsiswh(jsvpkdgiho) = rklvoldhgt cajbsazoja (ltlcjbdzhg, 14.8) View more	-	13 Jan 2025
				LOXO-305 (Part 2: LOXO-305 Oral Tablet + [14C]-LOXO-305 IV Solution)	helftgdxtt(xmotovmtrm) = jghjoveshj iwrhcychmk (jwwmdukhul, 28.1) View more

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