Last update 04 Nov 2024

Tafolecimab

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-PCSK-9 Antibody (Innovent Biologics), Immunoglobulin igg2, anti-(human proprotein convertase subtilisin/kexin type 9) (human monoclonal ibi306 .gamma.2-chain), disulfide with human monoclonal ibi306 .kappa.-chain, dimer, Protein convertase subtilisin/kexin type 9 human monoclonal antibody(Innovent Biologics)

+ [6]

Target

PCSK9

Mechanism

PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)

Therapeutic Areas

Endocrinology and Metabolic DiseaseCardiovascular Diseases

Active Indication

Complex dyslipidemiaPrimary hypercholesterolemiaNon ST segment elevation acute coronary syndrome

Inactive Indication

Heterozygous familial hypercholesterolemiaHomozygous familial hypercholesterolemiaHyperlipoproteinemia Type II

Originator Organization

Innovent Biologics (Suzhou) Co. Ltd.

Active Organization

Innovent Biologics (Suzhou) Co. Ltd.

Innovent Biologics, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (15 Aug 2023),

Complex dyslipidemiaPrimary hypercholesterolemia

Regulation-

Gene Sequence

Sequence Code 432618126L

Source: *****

Sequence Code 432618132H

Source: *****

Clinical Trials associated with Tafolecimab

NCT06096909 / Not yet recruitingNot ApplicableIIT

Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population (EMPACT): A Randomized Controlled Trial

For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.

Start Date01 Nov 2023

Sponsor / Collaborator

National Center for Cardiovascular Diseases

[+1]

NCT05792917 / CompletedPhase 1

Bioequivalence Study of Tafolecimab Injections Manufactured by Two Different Processes in Chinese Healthy Male Volunteers

This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with different manufacturing process

Start Date06 Mar 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20230556 / CompletedPhase 1

在中国健康男性受试者中评估工艺变更前后的重组全人源抗前蛋白转化酶枯草溶菌素9（PCSK-9）单克隆抗体注射液（托莱西单抗）的PK相似性I期研究

[Translation] A Phase I study to evaluate the PK similarity of a recombinant fully human anti-proprotein convertase subtilisin/kexin type 9 (PCSK-9) monoclonal antibody injection (tolesimumab) before and after a process change in healthy Chinese male subjects

评价中国健康男性受试者单剂量皮下注射托莱西单抗（变更后）和托莱西单抗（变更前）的生物相似性

[Translation]

Evaluation of the biosimilarity of a single subcutaneous dose of tolcizumab (after the change) and tolcizumab (before the change) in healthy Chinese male subjects

Start Date06 Mar 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Tafolecimab

100 Translational Medicine associated with Tafolecimab

100 Patents (Medical) associated with Tafolecimab

Literatures (Medical) associated with Tafolecimab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Oct 2024·Cardiovascular drugs and therapy

The Impact of Convertase Subtilisin/Kexin Type 9 Monoclonal Antibodies with and without Apheresis on Platelet Aggregation in Familial Hypercholesterolemia

Article

Author: Karlíčková, Jana ; Carazo, Alejandro ; Konečný, Lukáš ; Krčmová, Lenka Kujovská ; Javorská, Lenka ; Blaha, Vladimír ; Hrubša, Marcel ; Matoušová, Kateřina ; Bláha, Milan ; Mladěnka, Přemysl

Background and aims:

It is well known that elevated cholesterol is associated with enhanced platelet aggregation and patients suffering from familial hypercholesterolemia (FH) have a high risk of thrombotic cardiovascular events. Although decreasing cholesterol level is associated with attenuation of platelet hyperactivity, there are currently no data on the effect of convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9ab) on platelet reactivity in FH. The aim of the study was to analyse the impact of different therapies including PCSK9ab on platelet aggregation in FH.

Methods:

This study enrolled all 15 patients treated in the University Hospital Hradec Králové for FH. PCSK9ab have been administered in 12 of 15 patients while 8 patients were also undergoing lipid apheresis. Blood samples from all patients including pre- and post-apheresis period were tested for platelet aggregation triggered by 7 inducers, and the effect of 3 clinically used drugs (acetylsalicylic acid, ticagrelor and vorapaxar) was compared as well.

Results:

Although apheresis decreased the reactivity of platelets in general, platelet responses were not different between non-apheresis patients treated with PCSK9ab and apheresis patients (post-apheresis values) with the exception of ristocetin. However, when compared to age-matched healthy population, FH patients had significantly lower platelet aggregation responses to 4 out of 7 used inducers and higher profit from 2 out of 3 used antiplatelet drugs even after exclusion of FH patients regularly receiving conventional antiplatelet treatment.

Conclusion:

This study showed for the first time the suitability of PCSK9ab treatment for reduction of platelet reactivity in FH patients.

24 Jun 2024·American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Optimal follow-up schedule for patients taking PCSK9 monoclonal antibodies in a health system: Analysis of specialty pharmacy clinical interventions

Article

Author: Pilat, Stephanie ; Trawinski, Allison ; Reindel, Kristin ; Avlasevich, Viktoriya ; Rightmier, Elizabeth ; Manou, Katherine

Abstract:

Purpose:

The objective of this study was to determine if and when it is clinically appropriate to consider a reduction in the frequency of health-system specialty pharmacy (HSSP) clinical pharmacist assessments for patients taking a proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody (mAb) after they are deemed clinically stable on therapy.

Methods:

A single-center, retrospective, observational study of adult patients on PCSK9 mAb therapy enrolled in the University of Rochester Specialty Pharmacy Cardiology Patient Management Program was performed between October 24, 2016, and April 30, 2022. The primary outcome was the number of clinical pharmacist interventions per interval within the baseline 12 months compared to 12-month intervals for up to 72 months after initiation of PCSK9 mAb therapy.

Results:

A total of 368 patients on PCSK9 mAb therapy were included in the study. A significantly lower percentage of patients had more than 2 interventions during the 12- to 24-month interval (24.3%) as compared to the baseline 12-month interval (80.2%) (P < 0.001); this represented a 70% reduction in the chance of a patient requiring more than 2 interventions (relative risk, 0.30; 95% CI, 0.24-0.38). A similar trend was demonstrated in the 24- to 36-month and 36- to 48-month intervals when compared to the first year of therapy. The most commonly documented clinical pharmacist interventions were in the categories of safety (29.2%), effectiveness (28.4%), and adherence (19.9%).

Conclusion:

Patients beyond 1 year of PCSK9 mAb therapy required less clinical pharmacist interventions. Therefore, stable patients receiving a PCSK9 mAb may be considered for less frequent clinical assessments to allow for HSSP growth to nontraditional clinical areas.

News (Medical) associated with Tafolecimab

28 Aug 2024

·www.prnewswire.com

Innovent Announces 2024 Interim Results and Business Updates

Strong commercial performance and significant pipeline milestones support sustained growth and innovation SAN FRANSISCO and SUZHOU, China, Aug. 28, 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 cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2024 interim results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "For the first half of 2024, our company's strategy of sustainable growth and global innovation continue executing very well: we achieved strong revenue growth, improved operational efficiency in all areas, and reached significant milestones in our late-stage pipeline to support our sustained growth. We also reported promising data readouts from early-stage assets, reinforcing our confidence in achieving global innovation and contributing to new long-term opportunities. The successful first half of 2024 has laid a solid foundation for achieving our full-year's growth. With strong commercial and financial execution, a high-value late-stage pipeline, and disciplined investments in next-generation innovation, we are well-positioned to deliver long-term value for patients, employees, shareholders and society." Enhanced operational efficiency and strong financial performance S trong revenue growth momentum: total revenue was RMB3,952.3 million in the first half of 2024, with a strong year-over-year growth of 46.3%, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Significantly improved financial performance: EBITDA Loss was significantly reduced, driven by strong revenue growth, enhanced operational efficiency and notable financial improvement. The gross profit margin of total revenue was 84.1%, a year-over-year increase of 1.8 percentage points The selling and marketing expenses of product revenue was 48.6%, a year-over-year decrease of 5.9 percentage points The administration and expenses of total revenue was 5.2%, a year-over-year decrease of 4.9 percentage points R&D expenses were RMB1,293.9 million; cash and short-term financial assets were RMB10,112.3 million, or approximately over USD1.4 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB160.8 million, a notable year-over-year decrease of 39.9% Strong product revenue growth; preparing for CVM commercialization Product sales revenue reached RMB3 ,811.4 million in the first half of 2024, a strong year-over-year growth of 55.1%. Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage [1] , [2] and patient access: Eleven approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® , SINTBILO® and DUPERT® (new product, KRAS G12C inhibitor) . TYVYT® and PEMAZYRE® were newly approved in the Macau market. TYVYT® and BYVASDA® were included in the NRDL for the treatment of EGFR-mutated NSCLC. Solidify oncology leadership; in active preparation for new commercial opportunities in general biomedicine. Oncology: we strengthened our leadership with a robust product portfolio, including TYVYT® (sintilimab injection), and expanded out oncology business with a 10th product, a ROS1 inhibitor, set for approval in the second half of 2024. General biomedicines: Following the approval of the first CVM product SINTBILO® (tafolecimab injection) in 2023, we have successfully submitted three new drug applications (NDA)—two for mazdutide, targeting obesity/overweight population and T2D, and one for IBI311 (IGF-1R) for thyroid eye disease (TED). As a key strategic priority, we are steadily building our commercialization capabilities in the CVM field with systematic approaches, aiming to unlock substantial commercial opportunities and drive sustainable growth. Material innovation delivery supports strategic goals 7 new assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early-phase clinical studies Substantial milestones delivered for key late-stage assets Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): submitted an NDA for its eighth indication, 2L endometrial cancer (EMC). New registrational clinical trials for neoadjuvant therapy in colon cancer and perioperative therapy in NSCLC have been initiated. Additionally, we are exploring the potential of combination therapies through multiple collaborations with novel modalities. IBI310 (CTLA-4 )：initiated a Phase 3 clinical trial for IBI310 in combination with sintilimab as neoadjuvant therapy in treating colon cancer. IBI343 (CLDN18.2 ADC)：Phase 1b positive data readout in GC and a Phase 3 trial is in preparation. Accelerating new launch momentum in general biomedicine to unlock significant opportunities Mazdutide (GLP-1R/GCGR) : first NDA for weight management in obese or overweight populations and second NDA for T2D treatment, both under NMPA review. We plan to develop new indications, including adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), obstructive sleep apnea (OSA), and heart failure with preserved ejection fraction (HFpEF). Teprotumumab (IGF-1R) : the NDA for TED is under NMPA review. With a longstanding lack of innovative TED treatments in China, Teprotumumab is set to be a transformative therapy for this significant unmet need once approved. Picankibart (IL-23p19) : the only IL-23p19 that reported over 80% subjects achieving ≥90% improvement in Psoriasis and Severity Index (PASI90) in 16 weeks of treatment, along with strong long-term skin clearance maintenance and quarterly dosing interval advantage. We plan to submit an NDA in the second half of 2024. IBI128 (XOI) : potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is currently undergoing overseas Phase 3 clinical trials overseas with our partner LG Chem, and we have completed patient enrollment for a Phase 2 clinical trial in China. IBI302 (VEGF/C) : Phase 3 study initiated for the treatment of nAMD, following stable and robust visual benefit observed with an extended dosing interval and potential macular atrophy inhibition in two Phase 2 studies. Abundant early-stage pipeline to support long-term growth and global ambition Encouraging data readouts from multiple oncology assets in Phase 1 studies, eyeing most difficult-to-treat cancers IBI363 (PD-1/IL-2 α -bias ) : preliminary positive signals in multiple IO-failed/cold tumor types; further investigations across different rumor types are ongoing; a Phase 2 clinical trial in the U.S. has been initiated. IBI343 (CLDN18.2 ADC) : encouraging positive signal in pancreatic cancer, with FDA fast track designation granted. Plans are underway for a clinical trial in the U.S. IBI389 (CLDN18.2/CD3) : encouraging and differentiated signals in GC and PDAC in Phase 1 studies; Phase 1b study is continuing. Multiple programs ongoing including IBI3003 (GPRC5D/BCMA/CD3), IBI115 (DLL3/CD3); IBI3004 (DR5/CEA); IBI3001 (EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) Develop next-generation general biomedicine programs to improve chronic disease treatment IBI3016 （ AGT siRNA ） : a new-generation siRNA drug candidate, entered into a Phase 1 clinical trial for hypertension. IBI355 (CD40L), IBI356 (OX40L) and IBI3002 (IL-4R α / TSLP) : innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Research innovation published in high-impact scientific journals and medical conferences, such as: AACR, ASCO, ESMO GI and ESMO plenary for oncology pipeline innovation, including 10+ oral presentations ADA, APAO, ICE, CSE for general biomedicine pipeline material progress, such as mazdutide and teprotumumab Facilitates and Manufacturing capacity adhering to high-standard quality: Shanghai R&D center (medical) is newly operational in August 2024 First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Second manufacturing site: first phase of 80,000L completed construction to secure CDMO business Devoted to responsible business practices and enhancing ESG management practices We remain committed to sustainable development, corporate responsibility and ethical business practices. We newly launched our ESG website to enhance our efforts in sustainability, corporate responsibility and ethical business conduct. The new platform highlights our initiatives, policies and performance in key ESG areas, including "Excellent Governance", "Enjoying Good Health", "Ensuring High-Quality Products", "Empowering Employees", and "Embracing Ecology". Innovent is graded 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. 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 treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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 Biologics ("Innovent"), 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 is otherwise inaccurate. SOURCE Innovent Biologics

Phase 1Phase 3Financial StatementPhase 2Fast Track

28 Jun 2024

·www.prnewswire.com

Innovent Provides Interpretation and Updates on Clinical Data from Mazdutide GLORY-1 Study and General Biomedicine Pipeline

SAN FRANCISCO and SUZHOU, China, June 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, provided interpretation and updates on clinical data from Mazdutide's GLORY-1 study and its general biomedicine pipeline at an investor conference call on June 25. Continue Reading At the 2024 American Diabetes Association (ADA) Scientific Meeting, the company reported the results of its first Phase 3 clinical study (GLORY-1) on the GLP-1R/GCGR dual agonist mazdutide (Innovent R&D code: IBI362) in overweight or obese adults in China, along with the exploratory analysis results on liver fat content. During the June 25 conference call, leadership offered an in-depth interpretation of the clinical data. Innovent's Chief Financial Officer Rachel You and General Biomedicine Vice President of Clinical Development Lei Qian attended the meeting and made reports. Professor Linong Ji, MD, the principal investigator of the GLORY-1 study and Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital, also provided commentary. GLORY-1 is the first Phase 3 clinical study worldwide evaluating a GLP-1R/GCGR dual agonist for weight loss. The findings demonstrate significant weight reduction, robust safety, unique liver fat reduction and comprehensive improvement in metabolic indicators, confirming the distinctive advantages of mazdutide as a dual agonist targeting GLP-1R and GCGR. At the same time, Innovent is actively pursuing new development pathways, including innovative molecules that extend beyond T2D and weight management, with the aim to deliver transformative treatments in metabolic health. Mazdutide is an analogue of oxyntomodulin (OXM), a natural peptide hormone existing in humans that activates both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), to scientifically and effectively reduce weight, increase energy expenditure, burn fat and improve liver fat metabolism. It can also achieve comprehensive metabolic benefits and improve physical health. The findings from GLORY-1 underscore mazdutide's impressive weight loss effects, safety and tolerability, and further highlight its ability to significantly reduce liver fat content and improve multiple cardiovascular metabolic risk factors. These results reaffirm the distinct advantages of new-generation of GLP-1R/GCGR dual agonists. Excellent weight loss efficacy The GLORY-1 study demonstrated mazdutide's remarkable weight loss efficacy. After 48 weeks of treatment, the mazdutide 6mg group experienced an average weight reduction of 14.3% compared to baseline. Additionally, mazdutide showed significant reductions in waist circumference, hip circumference, and neck circumference, indicating its potential in reducing body fat. Unprecedented liver benefits In addition to its exceptional weight management capabilities, mazdutide also demonstrated an 80.2% reduction in liver fat content in the GLORY-1 study, indicating improvements to liver health. Acting directly on the liver as a GLP-1R/GCGR dual agonist, mazdutide shows promise in treating metabolic-associated fatty liver disease (MAFLD) and metabolic-associated steatohepatitis (MASH), enhancing liver metabolic function and mitigating factors contributing to liver metabolic dysfunction. Significant reduction in multiple cardiovascular metabolic risk indicators The data at week 48 showed that mazdutide outperformed placebo in reducing waist circumference, systolic blood pressure, triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT levels compared to baseline. Furthermore, mazdutide significantly normalized blood sugar level for participants with HbA1C≥5.7%. These findings highlight mazdutide's potential to mitigate cardiovascular metabolic risk factors and improve blood sugar management. Well tolerated and favorable safety profile Mazdutide showed excellent safety and tolerability in the GLORY-1 study, establishing itself as a safe treatment choice. Most gastrointestinal symptoms observed in the treatment group, such as nausea, vomiting, and diarrhea, were mild or moderate, with no signals indicating increased cardiovascular risk. These findings underscore mazdutide's effectiveness in weight loss and improving metabolic conditions, while also highlighting its promising safety profile, positioning it as a potential best-in-class treatment option. The marketing application for mazdutide's first weight loss indication is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). If approved, mazdutide is positioned to be a safe, effective, and comprehensive solution for chronic weight management among obese and overweight individuals in China, and could aid them to improve liver fat metabolism and address obesity-related comorbidities. Moving forward, Innovent plans to explore additional indications for mazdutide, advance the research and development of next-generation GLP-1 products, and contribute to improving the quality of life for patients with chronic diseases. Additionally, Innovent discussed its products in the cardiovascular and metabolic (CVM) field targeting various clinical needs currently in development. SINTBILO® (PCSK9) is the first and only Chinese-developed PCSK9 monoclonal antibody approved for treating hyperlipidemia. IBI128 (a new xanthine oxidase inhibitor) represents a next-generation candidate for managing gout and hyperuricemia, with ongoing Phase 3 clinical trials overseas and planned Phase 1/2 studies in China starting in 2024. IBI3016 (AGT siRNA) is an innovative siRNA therapy for hypertension, with a Phase 1 clinical trial scheduled to commence in 2024. Furthermore, several early-stage projects are poised to enter the IND stage, bolstering Innovent's strategic positioning and competitive edge in CVM. Metabolic diseases significantly affect quality of life and overall well-being. Innovent is accelerating innovation in this crucial area, dedicated to addressing unmet clinical needs and delivering safer, more effective treatments to patients. Over the next five years, Innovent plans to introduce 5-6 new metabolic products targeting diabetes, weight loss, cardiovascular conditions and other indications, aiming to establish itself as a leading research and development company in the field of cardiovascular metabolic diseases in China. Autoimmune: addressing global unmet clinical needs In the field of autoimmune, Innovent has successfully launched SULINNO® (adalimumab injection), which is approved for eight indications including rheumatoid arthritis and psoriasis and is covered under the National Reimbursement Drug List. Picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, successfully met primary and key secondary endpoints in its Phase 3 clinical study (CLEAR-1) for moderate to severe plaque psoriasis in China. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients, and Innovent is preparing for a NDA submission to the CDE of NMPA. Innovent continues to explore unmet clinical needs in autoimmune diseases globally with advancements like IBI355 (CD40L), IBI356 (OX40L), IBI3002 (IL-4Rα/TSLP) and other innovative First-in-class/Best-in-class molecules targeting indications including primary Sjögren's syndrome, systemic lupus erythematosus, atopic dermatitis, asthma, and other diseases. Ophthalmology: advancing treatment standards In the field of ophthalmology, Innovent's new drug application for IBI311 Injection (recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, R&D) has been accepted for the treatment of thyroid eye disease (TED). This biologic with an innovative mechanism of action is poised to address a 60-year gap in domestic TED treatment, meeting significant clinical needs and offering effective, safe, and accessible treatment options for Chinese TED patients. In addition, Phase 3 clinical trials for IBI302 (VEGF/C) have commenced to address neovascular age-related maculopathy, with long-interval administration expected to achieve significant efficacy and potentially enhance management of geographic atrophy. Furthermore, IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are currently in Phase 1 clinical trials to explore their differentiated clinical value. 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 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 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 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 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. SOURCE Innovent Biologics

Clinical ResultPhase 3Phase 1Drug ApprovalPhase 2

03 Apr 2024

·www.pharmaceutical-technology.com

China accepts Innovent-HUTCHMED’s endometrial cancer therapy NDA

The companies sought approval for sintilimab and fruquintinib to treat advanced endometrial cancer. Credit: Fancy Studio / Shutterstock.com. The China National Medical Products Administration (NMPA) has granted priority review for Innovent Biologics and Hutchmed ’s new drug application (NDA) for the combination of sintilimab and fruquintinib for advanced endometrial cancer. The NDA seeks a new therapeutic regimen for people with proficient mismatch repair or non-microsatellite instability-high tumours who have exhausted previous systemic therapies and are not eligible for curative surgical procedures or radiation. Sintilimab is a programmed cell death protein 1 immunoglobulin G4 monoclonal antibody, marketed in China as TYVYT (sintilimab injection). It has been developed through a collaboration between Innovent and Eli Lilly. The application is based on the data from the FRUSICA-1 study, a Phase II multicentre, open-label trial. The primary measure of success was the objective response rate as assessed by an independent review committee. See Also: FDA accepts AstraZeneca-Daiichi Sankyo’s Datopotamab deruxtecan BLA MASH revival with over $2.5bn for innovator drug partnership deals in 2024 Disease control rate, duration of response, progression-free survival, overall survival and pharmacokinetic assessments were the secondary endpoints. In July 2023, the NMPA recognised the potential of the combination therapy, granting it a breakthrough designation. This status is reserved for treatments that offer a significant advancement over existing options for serious ailments lacking effective therapies, and where clinical evidence indicates substantial benefits. Innovent senior vice-president Dr Hui Zhou stated: “TYVYT (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China. “We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYTin China.” In August 2023, the company received approval from China NMPA for SINTBILO (tafolecimab injection) for primary hypercholesterolemia and mixed dyslipidemia .

Phase 2Priority ReviewNDADrug ApprovalBreakthrough Therapy

100 Deals associated with Tafolecimab

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Complex dyslipidemia	CN	Innovent Biologics (Suzhou) Co. Ltd.	15 Aug 2023
Primary hypercholesterolemia	CN	Innovent Biologics (Suzhou) Co. Ltd.	15 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipoproteinemia Type II	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	26 Apr 2020
Heterozygous familial hypercholesterolemia	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	17 Dec 2019
Homozygous familial hypercholesterolemia	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	29 Sep 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04709536 (CREDIT-4, Literature) Manual	Phase 3	Hypercholesterolemia	303	tafolecimab	rugbwvwhcy(tndgnbgdup) = smtjxatrio ooogxteocg (xzdtyvnago, 1.4)	Positive	11 Jul 2023
				placebo	rugbwvwhcy(tndgnbgdup) = cbfqzelxct ooogxteocg (xzdtyvnago, 1.8)
NCT04179669 (CREDIT-2, Literature) Manual	Phase 3	Heterozygous familial hypercholesterolemia	148	tafolecimab 150 mg Q2W	tjzjnvntim(asgwkohjwv): −57.4 (97.5% CI, −69.2 - −45.5), P-Value = <0.0001 View more	Positive	28 Feb 2023
				placebo 150 mg Q2W
NCT04179669 (CREDIT-2, Pubmed)	Phase 3	Heterozygous familial hypercholesterolemia	149	Tafolecimab 150 mg Q2W	qwpxmwlmfm(otfibiyfui) = jexdnlqeko vcficsatyh (hnfhvfdtlk, -69.2 to -45.5)	-	28 Feb 2023
				Tafolecimab 450 mg Q4W	qwpxmwlmfm(otfibiyfui) = habanszlro vcficsatyh (hnfhvfdtlk, -73.4 to -50.4)
NCT04289285 (CREDIT-1, AHA2022) Manual	Phase 3	Hyperlipoproteinemia Type II	568	tafolecimab 450 mg Q4W	mvdwseyisn(jjdvawsgeq): -65.04 (97.5% CI, -70.22 to -59.86), P-Value = <0.0001 View more	Positive	08 Nov 2022
				placebo Q4W
NCT04709536 (CREDIT-4, NEWS) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Hyperlipoproteinemia Type II	-	IBI306	yxhycadohf(nwjpgvnjvd) = jmpqrtzzcf eksmhwbjmg (hlwzakxzgh, -66.48 to -59.56)	Positive	17 Feb 2022
				placebo	-
NCT03815812 (Literature) Manual	Phase 1	Hypercholesterolemia	60	Tafolecimab	amzzouicuw(mvqxzkcxlg) = Adverse events in both studies were either mild or moderate. klsvzrqvsj (athnpeztmd )	Positive	01 Dec 2021
				Placebo
NCT03366688 (Literature) Manual	Phase 1	Hypercholesterolemia	48	Tafolecimab	avhafxwitd(usrdpqzvhp) = either mild or moderate aigxypcnvx (hwizjvsdzl )	Positive	01 Dec 2021
				Placebo
NCT03815812 \| NCT03366688 (IBI306B101 \| IBI306A101, Biospace) Manual	Phase 1/2	Hypercholesterolemia	-	Tafolecimab	kglknoqmed(hqvcykobxn) = The incidence of adverse events was comparable between the Tafolecimab and placebo groups goliuwichp (iwvmlmpofp )	Positive	31 Aug 2020
				Placebo
ESC2020	Phase 1/2	Hypercholesterolemia	-	Tafolecimab	tlfwvqflhx(ovjxzvmjqs) = There were no serious TEAEs or events leading to death or treatment discontinuation in both SAD and MAD srwaduylny (xrtdaehtkp ) View more	-	28 Aug 2020

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