Request Demo

Last update 27 Oct 2026

Tafolecimab

Last update 27 Oct 2026

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

Action

inhibitors

Mechanism

PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

DyslipidemiasComplex dyslipidemiaPrimary hypercholesterolemia+ [1]

Inactive Indication

Heterozygous familial hypercholesterolemiaHomozygous familial hypercholesterolemiaHypercholesterolemia, Familial

Originator Organization

Innovent Biologics (Suzhou) Co. Ltd.

Active Organization

Innovent Biologics (Suzhou) Co. Ltd.

Innovent Biologics, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (15 Aug 2023),

Complex dyslipidemiaPrimary hypercholesterolemia

Regulation-

Structure/Sequence

Sequence Code 432618126L

Source: *****

Sequence Code 432618132H

Source: *****

Clinical Trials associated with Tafolecimab

NCT07686796

/ Not yet recruitingPhase 3IIT

Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial

This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab alone in patients with pMMR/MSS locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, including the pathological complete response (pCR) rate in patients who undergo surgery after neoadjuvant therapy, and the clinical complete response (cCR) rate in patients managed with a watch-and-wait strategy. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), downstaging rate, R0 resection rate, tumor regression grade, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), and safety.

Start Date01 Jan 2027

Sponsor / Collaborator

Guangdong General Hospital

[+13]

NCT07341958

/ Not yet recruitingNot ApplicableIIT

INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)：A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) [Lp(a)] levels and the risk of stroke recurrence within 90 days in patients with ischemic stroke or high-risk TIA (ABCD² ≥ 4) accompanied by elevated lipoprotein(a) levels (≥30 mg/dL).

Start Date08 Sep 2026

Sponsor / Collaborator

Beijing Tiantan Hospital

NCT07712042

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Tafolecimab With Different Dosing Intervals in Patients With Hyperlipidemia

This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization. The aim is to evaluate the real-world effectiveness and safety of the two dosing regimens.This study aims to systematically evaluate the lipid-lowering efficacy and safety of two dosing regimens of Tafolecimab 150 mg-administered every two weeks (Q2W) versus every three weeks (Q3W)-over a 12-week period in patients with hyperlipidemia whose LDL-C remains above the target after 4 weeks of treatment with moderate-intensity statins with or without cholesterol absorption inhibitors. The primary efficacy endpoint is the percent change in LDL-C from baseline at week 12 of the initial treatment.

Start Date01 Aug 2026

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

100 Clinical Results associated with Tafolecimab

100 Translational Medicine associated with Tafolecimab

100 Patents (Medical) associated with Tafolecimab

Literatures (Medical) associated with Tafolecimab

19 Jun 2026·MEDICINE

Bezafibrate-associated rhabdomyolysis in a patient with diabetic kidney disease: A case report and successful transition to tafolecimab

Article

Author: Wang, Jinrong ; Gu, Wei ; Zhang, Yiping ; Xie, Xiaohong

Rationale::

Fibrates like bezafibrate are renally excreted and can cause rhabdomyolysis in chronic kidney disease (CKD). This report describes bezafibrate-associated rhabdomyolysis in a patient with diabetic kidney disease and successful transition to tafolecimab.

Patient concerns::

Ten days after self-initiating bezafibrate (0.2 g thrice daily), a 71-year-old female patient with diabetes, hypertension, CKD, and dyslipidemia complained of fatigue, sweating, and myalgia. Tests revealed hypokalemia, renal failure (creatinine 329.3 μmol/L), and increased creatine kinase (4865 U/L).

Diagnoses::

After ruling out other causes, a peak creatine kinase of 6419 U/L (38× upper normal limit) and myalgia were used to diagnose bezafibrate-associated rhabdomyolysis.

Interventions::

The use of bezafibrate was stopped. Hepatoprotection, renal protection, bicarbonate, potassium correction, and eventually a switch to subcutaneous tafolecimab 150 mg every 2 weeks were all part of the supportive care.

Outcomes::

Myalgia went away in 6 days, and by the time of discharge, creatine kinase had returned to normal from 6419 to 54 U/L. Following tafolecimab, low-density lipoprotein cholesterol (4.18 to 2.93 mmol/L) was lower, and muscle enzymes were normal.

Lessons::

Bezafibrate may result in severe rhabdomyolysis in diabetic CKD, particularly when combined with nifedipine (a CYP3A4 inhibitor) and reduced renal clearance. Tafolecimab’s nonrenal metabolism and low myotoxicity make it a safe and efficient substitute.

01 Sep 2025·Annals of Medicine and Surgery

Efficacy and safety of tafolecimab in Chinese patients with familial hypercholesterolemia: a systematic review and meta-analysis of randomized controlled trials

Article

Author: Aziz, Hina ; Reddy Gangavarapu, Ravindra ; Mehta, Shubh ; Ramadan, Alaa ; Sinha, Akshat ; Kengo, Nathan Ezie

Background::

Familial hypercholesterolemia (FH) is a prevalent inherited disorder marked by elevated low-density lipoprotein cholesterol (LDL-C) levels, predisposing individuals to premature cardiovascular disease and related morbidities. Traditional treatments often fail to achieve target LDL-C levels in many patients, necessitating novel therapies. Tafolecimab, a monoclonal antibody targeting PCSK9, shows promise in managing HeFH by enhancing LDL receptor recycling and LDL-C clearance.

Objective::

To evaluate the efficacy and safety of tafolecimab in Chinese patients with FH through a systematic review and meta-analysis.

Methods::

This meta-analysis followed PRISMA guidelines and was registered in Prospective Register of Systematic Reviews. A comprehensive search was conducted across PubMed/MEDLINE, Web of Science, Scopus, and Embase databases. Inclusion criteria focused on randomized controlled trials (RCTs) involving patients aged 18–75 with hypercholesterolemia and high cardiovascular risk. Data extraction and quality assessment were performed independently by two reviewers. Statistical analyses were conducted using random-effects models.

Results::

Four RCTs involving 841 Chinese patients were included. Tafolecimab significantly reduced LDL-C (mean difference [MD]: −2.05; 95% CI: −2.19 to −1.90), apolipoprotein levels (MD: −0.53; 95% CI: −0.56 to −0.50), non-HDL-C (MD: −2.19; 95% CI: −2.32 to −2.06), and lipoprotein(a) levels (MD: −0.09; 95% CI: −0.11 to −0.07). The incidence of adverse events was higher in the tafolecimab group (risk ratio: 0.68; 95% CI: 0.61, 0.75), but no significant differences were found in serious adverse events, treatment discontinuation due to adverse events, deaths, hypersensitivity, muscle-related problems, upper respiratory issues, or liver damage compared to placebo.

Conclusion::

Tafolecimab effectively reduces various lipid parameters, suggesting its potential in managing hypercholesterolemia and reducing cardiovascular risk. Although adverse events were more frequent, their severity did not significantly differ from placebo. The generalizability of these findings is limited to Chinese populations, highlighting the need for further research in diverse cohorts.

01 Jul 2025·American Journal of Cardiovascular Drugs

Cost-Effectiveness and Price Threshold Analysis of Tafolecimab in Chinese Patients with Elevated LDL Cholesterol Despite Statin Therapy

Article

Author: Wan, Yuansheng ; Zhan, Xiaolian ; Zhang, Yu ; You, Ruxu ; Liu, Jinyu

BACKGROUND:

Tafolecimab is a novel PCSK9 inhibitor developed in China. In recently published phase III clinical trials, tafolecimab demonstrated long-term safety and efficacy in Chinese patients with hypercholesterolemia despite statin therapy. However, pharmacoeconomic studies of tafolecimab have yet to be published. This study aimed to explore the maximum cost-effective price of tafolecimab compared with statins alone for Chinese patients with hypercholesterolemia at various willingness-to-pay (WTP) thresholds.

METHODS:

A Markov cohort state-transition model was employed to assess the cost-effectiveness of tafolecimab from the perspective of the Chinese healthcare system. The low-density lipoprotein cholesterol (LDL-C) lowering effect of tafolecimab was observed in the CREDIT-4 trial. The baseline and subsequent incidence and transfer probability of cardiovascular events were based on prospective observational data in China and meta-analyses from the Cholesterol Treatment Trialists Study. Cost and utility values were obtained from the China Health Statistics Yearbook, health insurance, and published articles in China. The study also performed subgroup, sensitivity, and scenario analyses.

RESULTS:

The annual price thresholds for tafolecimab as an adjunctive therapy to statins were Chinese yuan (CNY) 3304 and CNY 7022 at WTP thresholds of CNY 89,358 and CNY 268,074 per quality-adjusted life year (QALY), respectively. The corresponding annual price thresholds for patients with hypercholesterolemia with acute myocardial infarction were CNY 10,355 and CNY 21,793 per year. Sensitivity analyses showed that the time horizon significantly impacted price thresholds, with a several-fold difference.

CONCLUSIONS:

From the perspective of the Chinese healthcare system, the cost-effective annual price threshold for tafolecimab for patients with hypercholesterolemia was CNY 7022, at a threshold of CNY 268,074 per QALY.

News (Medical) associated with Tafolecimab

25 Aug 2026

·www.prnewswire.com

Innovent Announces 2026 Interim Results and Business Updates

Transforming from Regional Leader to Global Premier: A Clear Strategic Path for Growth and Globalization SAN FRANCISCO and SUZHOU, China, Aug. 25, 2026 /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 its 2026 interim results and 2030 strategic vision. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "Looking back over the past fifteen years, Innovent has completed two key transformations: from 2016 to 2020, we transformed from an R&D-driven biotech company into a biopharmaceutical company with full-value-chain capabilities spanning R&D, manufacturing, and commercialization; from 2021 to 2025, we progressed from a long-term investment phase into a biopharmaceutical company that achieved revenue over RMB 10 billion and full-scale profitability. 2026 marks Innovent's best strategic window to date, and it is against this backdrop that we have set forth our new strategic goals for 2030. We have both the resolve and the confidence to drive our third critical transformation: evolving from a regional leading biopharmaceutical company into a global premier biopharma with global business operational capabilities. In the first half of 2026, Innovent delivered strong growth in both revenue and profit, further reinforcing our leading position in China's biopharmaceutical industry and highlighting our scarce value in both certainty and growth potential. At the same time, over the past ten months, we have reached multiple strategic collaborations with global multinational pharmaceutical leaders including Takeda, Eli Lilly, and Pfizer, while also partnering with biotechs such as Ollin and Spero to advance the global development of our differentiated pipeline. Our partnered pipeline now spans more than 20 assets, including 5 co-development and co-commercialization ("Co-Co") programs, with an aggregate deal value reaching USD 34 billion, representing more than 30% of the total out-licensing value among Chinese pharmaceutical companies over the same period1. Innovent stands at the most favorable strategic window in its development. We will continue to pursue high-quality growth in revenue and profit, guided by clear strategy and disciplined execution — strengthening and amplifying our 'dual-engine' advantage across oncology and general biomedicine, accelerating our global expansion, and advancing toward our 2030 strategic goals, so as to continue creating long-term value for our shareholders and society." A Visible Growth Path: Scale and Profitability Advancing in Parallel In the first half of 2026, Innovent reached RMB 8.6 billion in total revenue, representing 45% year-over-year growth, while product revenue reached RMB 8.2 billion, up 57% year over year. Building on the RMB 10 billion-plus revenue scale, Innovent maintained strong growth momentum, with its dual-engine strategy of oncology and general biomedicine continuing to deliver. Rapid revenue growth, coupled with continued improvements in operational efficiency, further drove improvements in profitability. IFRS net profit for the first half of the year was approximately RMB 1.3 billion, representing approximately 50% year-over-year growth, while Non-IFRS net profit reached RMB 1.7 billion, up 41% year over year. Innovent has entered a new stage characterized by simultaneous expansion in scale and improvement in earnings quality, setting a new paradigm for high-quality growth among biopharmaceutical companies. As of July 31, 2026, Innovent held RMB 30.2 billion in cash reserves, equivalent to approximately US$4.5 billion. In addition, we continued to generate positive cash flow, providing a strong financial foundation for long-term growth. Vision 2030: From China Leader to Global Premier Biopharma Building on high-quality growth and systematic portfolio development, the Company has underpinned its 2030 development goals. Revenue Scale: By 2030, we target to achieve total revenue of RMB 35–40 billion, largely driven by organic expansion from the existing business and pipeline. Sustainable Profitability: By 2030, we aim to benchmark our profit margin to top-tier pharmaceutical companies, through continued revenue expansion and efficiency improvements. Global Innovation: By 2030, we aim to advance at least five molecules into global MRCT Phase 3 development, achieve product launches in key markets, i.e. U.S. and Europe with international revenue emerging. Globalization: building global infrastructure and business operating capabilities, truly transforming into a global premier biopharmaceutical company. From "Product-led Growth" to "Portfolio-Driven Growth," with Dual Growth Engines Unleashing New Momentum China's Leading Oncology Franchise: Strengthening Core Oncology Leadership While Expanding Strategically into Key Growth Areas In oncology, Innovent has established a strong product portfolio and brand presence across core indications including lung cancer, gastrointestinal cancers and hematological malignancies. Focusing on the next-generation "IO + ADC" innovation strategy, the Company is advancing next-generation assets including IBI363 (PD-1/IL-2α-biased), IBI343 (CLDN18.2 ADC), and IBI3003 (GPRC5D/BCMA/CD3) into late-stage clinical development, establishing long-term growth drivers and competitive advantages across multiple strategic areas. Meanwhile, through its collaboration with Lilly on Verzenio® (abemaciclib) in breast cancer, we have strategically gained an important entry point into this major high-incidence tumor type. This asset lays the foundation for upcoming in-house pipeline programs such as IBI354(HER2 ADC) and IBI3014(PD-L1/TROP2 ADC), and paves the way for a more systematic presence in breast cancer. General Biomedicine Franchise Emerged as a New Growth Engine In general biomedicine, Innovent has established a clear framework across four major chronic disease areas—metabolic, cardiovascular, ophthalmology and autoimmune—and this franchise has become another core pillar of Innovent. SYCUME® (Teprotumumab, IGF-1R antibody), China's first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world's first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO® (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE® (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025. At the same time, our next‑generation metabolic and obesity pipeline – including IBI3032 (once‑daily oral GLP‑1), IBI3042 (once‑weekly oral GLP‑1), IBI3040 (Amylin), IBI3046 (INHBE siRNA) and IBI3030 (monthly PCSK9‑GGG) – provides deep, long‑term growth reserves in global obesity and metabolic disease. In cardiovascular & metabolism, autoimmune and ophthalmology, we are following a "flagship products life cycle management + next‑generation innovation" strategy to build focused product clusters and durable competitive positions in each area. Three Late-Stage Global Assets Unlocking More Than US$60 Billion Total Addressable Market (TAM), and 20+ Partnered Programs Accelerating Global Innovation Innovent is advancing global development of its core assets through multiple collaboration models. Three key assets have entered, or are about to enter, global multi-regional Phase 3 trials, with a combined addressable market estimated at over US$60 billion, and are expected to be major value drivers in the coming years: IBI363 (PD-1/IL-2α-biased, Takeda R&D Code: TAK-928): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications, global co-development with Takeda A global multi-regional Phase 3 study (MarsLight-11) in IO-resistant squamous non-small cell lung cancer (NSCLC) is ongoing, and with expansion into IO-resistant non-squamous NSCLC in preparation. A pivotal Phase 2 study of IBI363 in melanoma in China is expected to read out in the second half of 2026, potentially supporting the first NDA submission for IBI363. IBI363 has demonstrated preliminary positive PoC results in first-line NSCLC. PoC studies in first-line NSCLC and first-line colorectal cancer are ongoing, with additional PoC studies being advanced across other tumor types, further supporting its potential as a next-generation IO backbone therapy. Arcotatug Tavetecan (CLDN18.2 ADC, Innovent/Takeda R&D Code: IBI343/TAK-921): Globally First NDA stage Next-Generation Fc-Silenced CLDN18.2 ADC, potential TAM over US$8 billion The China-Japan multicenter Phase 3 study completed its first interim analysis and achieved primary endpoint. The NDA submission has been accepted by NMPA for the treatment of CLDN18.2-positive advanced gastric cancer in later-line settings. A Phase 3 study in first-line pancreatic cancer is planned to initiate in China. International multicenter Phase 1 and PoC studies in first-line pancreatic cancer and first-line gastric cancer are ongoing. IBI324 (VEGF/ANG2, Ollin R&D Code: OLN324): Potential best-in-disease retinal therapy, potential TAM US$15 billion Our partner Ollin Biosciences reported positive results from the Phase 1b JADE head-to-head study against faricimab in nAMD and DME patients in the U.S. Ollin plans to initiate global multi-regional Phase 3 studies in DME and nAMD in the second half of 2026, and through collaboration with Innovent, to conduct patient enrollment in China and South Korea. Diversified Partnerships to Accelerate Global Innovation Over the past 10 months, Innovent has entered into strategic multi-product collaborations with global multi-national pharmaceutical companies including Takeda, Lilly and Pfizer, while partnering with biotech companies such as Ollin and Spero to rapidly validate differentiated pipeline programs in selected disease areas. The aggregate deal value reaching US$34 billion, covering more than 20 pipeline programs, among which five are "Co-Co" assets. Leveraging diversified partnership models, the Company will progressively build overseas R&D and commercialization capabilities and evolve into a truly world-class biopharmaceutical company with global business operating capabilities. High-Quality Manufacturing Standards Innovent operates advanced manufacturing facilities built to international standards and our Suzhou manufacturing site has recently undergone and successfully passed a Good Manufacturing Practice (GMP) inspection conducted by the European Medicines Agency (EMA), and has obtained the corresponding GMP certificate. Total operational capacity of 140,000 liters, accounting for 20% of China's total biologic manufacturing capacity. Suzhou site houses 60,000 liters of antibody capacity and ADC commercial lines; Hangzhou site has 80,000 liters of antibody capacity, supporting global supply and CDMO services. Sustainable Development and ESG Commitment 9,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou. Over 3,000 new cancer patients initiate Innovent therapies daily; more than 10 million patients have benefited to date. Maintained MSCI ESG AAA rating, leading China's biopharmaceutical industry. First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status). Launched community health initiatives including the MV 'Weight Management Made Easy' and documentary 'Down in Weight, Up in Life' to promote science-based healthy weight management. Published patient education materials on thyroid eye disease and weight management to enhance public health awareness. Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 4 billion. Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise". Created over 2,700 jobs for new graduates. Cumulative taxes and contributions exceeding RMB 9 billion. Note: Data source: Next Pharma database. 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 20 products in the market. It has 1 asset in NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Takeda, Pfizer, Roche, Sanofi, Incyte, 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), Pirtobrutinib (Jaypirca) and abemaciclib (Verzenios) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements of Innovent Biologics This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 1Clinical ResultPhase 3Drug ApprovalPhase 2

15 Apr 2026

·adimab.com

Adimab Collaborator GSK Receives Additional Marketing Approval for Depemokimab

Lebanon, New Hampshire – April 15, 2026 – Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, congratulates GSK plc for recently receiving approvals by the European Commission (EC) and China’s National Medical Products Administration (NMPA) for depemokimab. This adds to recent marketing approvals in the United States, Japan, and the United Kingdom. Depemokimab is the first ultra-long-acting biologic product approved for use in its indicated conditions and was developed internally by GSK with an extended half-life and engineered high binding affinity to enable twice-yearly dosing, as demonstrated in GSK’s pivotal trials. To support in the engineering of the molecule, GSK internalized Adimab’s proprietary yeast-based technology, enabling in-house antibody discovery, optimization, production, and characterization on any target of GSK’s choosing. GSK’s research team used the Adimab Platform for depemokimab, a product tailored to meet GSK’s target product profile, including low picomolar affinity. GSK continues to use the Adimab platform to support other internal programs. “Depemokimab is the first approved product to emerge from our Platform Transfer collaborations, further validating this portion of our business model. Fittingly, GSK was our first Platform Transfer collaborator, and we congratulate them on this tremendous success,” said Philip T. Chase, Chief Executive Officer of Adimab. “Depemokimab is just one example of GSK’s adoption of the Adimab technology to pursue innovative therapeutic products,” added Eric Krauland, President and Chief Scientific Officer of Adimab. “GSK’s use of the platform, exemplified through ongoing investment in the Adimab team’s expertise and the use of Adimab's technological advances such as new library diversities, has translated into other GSK clinical programs that aim to make a real difference for patients.” Adimab’s other Platform Transfer collaborators include Biogen, Lilly, Merck, Novo Nordisk, and Takeda. Each Platform Transfer collaborator has been enabled, through training at Adimab and their own site, to operate Adimab’s proprietary platform independently. Further, each Platform Transfer collaborator has their own unique diversity, ensuring non-overlapping outputs. The Adimab technology can be used on any biologic target, in any format, and in any therapeutic area, allowing flexibility from discovery through engineering and generation of multispecifics. Support is always available, including access to Adimab scientists, biannual technology summits, and regular updates to strains, libraries, and in silico tools. Other commercial products containing molecules from Adimab include: Innovent’s TYVYT® (sintilimab injection), a PD1 program approved in China for the treatment of multiple cancers. Innovent’s SINTBILO® (tafolecimab injection), a PCSK9 program approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. IASO Bio’s FUCASO® (equecabtagene autoleucel), a BCMA CAR-T program approved in China for the treatment of patients with multiple myeloma. Invivyd’s PEMGARDA™ (pemivibart), a SARS-CoV-2 monoclonal antibody authorized for prophylactic emergency use in the United States to prevent COVID-19 infection. Sun Pharma’s UNLOXCYT™ (cosibelimab), a PD-L1 program approved in the United States for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma. There are numerous additional Adimab-associated programs that are currently in Phase II or Phase III (pivotal) trials. The total number of Adimab-associated clinical programs initiated by our collaborators has now reached 90. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. Our suite of technologies includes naïve discovery from synthetic libraries in yeast or B cells (mice, llamas, and humans), antibody engineering and optimization, bi- and multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies with complementary heterodimerization mutations that are licensed non-exclusively for bi- and multispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 140 pharmaceutical and biotechnology companies, generating more than 650 therapeutic programs, 90 clinical programs, and 6 approved products. The Adimab technology has been transferred and implemented at GSK, Biogen, Novo Nordisk, Merck, Lilly, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Innovent, Novartis, Regeneron, Vertex and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint Therapeutics, Santa Ana Bio, Tizona, Kelonia, and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Scholar Rock, and others. Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com.

Drug ApprovalPhase 3Phase 2

26 Mar 2026

·www.prnewswire.com

Innovent Announces 2025 Annual Results and Business Updates

From China Leadership to Global Premier: Revenue Surpasses RMB 10 Billion, Entering the Era of Profitability and Globalization SAN FRANCISCO and SUZHOU, China, March 26, 2026 /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 its 2025 annual results and long-term strategic blueprint. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "2025 marks the most successful year in Innovent's history. We achieved historic breakthroughs across three areas: business scale, financial strength, and global innovation. We successfully upgraded our strategy from an oncology-focused leader to a 'dual-engine growth model' driven by oncology and general biomedicine portfolio. Encouragingly, we delivered our first full year of net profit, marking a formal entry into an era of sustainable profitability. Our robust cash reserves and positive operating cash flow will provide strong support for strategic growth. On the innovation front, three global high-potential assets advanced into or near global registrational clinical development, targeting a combined addressable market value of over US$60 billion. Meanwhile, we accelerated the global value realization of our pipeline through multiple landmark strategic collaborations, laying a solid foundation for global expansion. Total deal value reached over US$22 billion in the past year, accounting for more than 10% of China's innovative pharmaceutical sector outbound licensing value in 2025[1]. These achievements not only validate the foresight of our strategy but also highlight our uniqueness of strong growth and high certainty within China's biopharma industry. Guided by our Vision 2030 to become a global premier biopharmaceutical company, we will continue to drive progress across four core pillars: revenue, profitability, innovative pipeline and organizational capabilities, creating sustainable value for patients, shareholders and society." Revenue Set New Height, Achieved Full-Year Profitability with Strong Cash Position Total revenue reached RMB 13.0 billion, representing a year-on-year increase of 38.4%. Product revenue amounted to RMB 11.9 billion, up 44.6% year-on-year. From the commercial launch of its first product in 2019 to 18 approved products and surpassing RMB 10 billion revenue milestone, Innovent accomplished this in only 7 years, setting a new growth benchmark for China's innovative biopharmaceutical industry. The Company achieved its first full year of net profit. IFRS net profit reached RMB 814 million, and Non-IFRS net profit rose to RMB 1.72 billion, marking a structural inflection in profitability and entry into a sustainable earnings era. Operating efficiency continued to improve. Gross margin improved 2.3 percentage points to 87.2%. Selling and administrative expense ratio declined 2.9 percentage points to 48.0%. EBITDA surged to RMB 1.99 billion (2024: RMB 412 million). As of December 31, 2025, cash reserves totaled RMB 24.3 billion (~US$3.5 billion). Additionally, the Company also generated positive operating cash flow, providing strong financial support for long-term development. [2] Dual-Engine Strategy Fully Implemented, Commercial Foundation Strengthened China Leading Oncology Brand with Synergistic Value of Innovative Portfolio Innovent has established a leading oncology brand in China. Cornerstone products including TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and HALPRYZA® (rituximab injection) have benefited millions of Chinese cancer patients. In addition, five small-molecule targeted oncology drugs—Limertinib (EGFR TKI), DOVBLERON® (Taletrectinib, ROS1i), Dupert® (fulzerasib, KRAS G12Ci), JAYPIRCA® (Pirtobrutinib, BTKi), and Retsevmo® (selpercatinib, RETi) — were successfully included in the 2025 National Reimbursement Drug List (NRDL), further strengthening the competitiveness and commercial performance of Innovent's oncology portfolio. General Biomedicine Franchise Emerged as a New Growth Engine Benefiting from forward-looking strategic layout, Innovent's general biomedicine portfolio delivered strong momentum in 2025. SYCUME® (Teprotumumab, IGF-1R antibody), China's first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world's first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO® (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE® (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025. Within a single year, the general biomedicine portfolio has become a second core engine driving high-speed growth. Today, Innovent possesses one of the highest-quality commercial portfolio and pipeline in the industry, supported by a fully established commercial network, reinforcing its solid commercial foundation. Year of Globalization: Pipeline Value Unlocked, Growth Potential Expanded 2025 marked a breakthrough year for the Company's globalization strategy, unlocking substantial long-term growth potential. Innovent successfully advanced three core assets into or near global Phase 3 clinical trials. According to its partner estimates, these late-stage assets target a combined total addressable market (TAM) of over US$60 billion, including: IBI363 (PD-1/IL-2α-bias): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications In collaboration with Takeda, IBI363 is being advanced globally. The first global MRCT Phase 3 in IO-resistant squamous NSCLC has been initiated. PoC in IO-resistant non-squamous NSCLC is completed, with a new global Phase 3 planned subject to the PoC results and regulatory communications. A Phase 3 trial in 3L colorectal cancer (CRC) in China is planned for 2026. A Phase 2 trial in IO-naïve mucosal/acral melanoma is underway in China. PoC studies in 1L NSCLC and 1L CRC are ongoing. IBI343 (CLDN18.2 ADC): Cornerstone for gastrointestinal cancers, potential TAM over US$8 billion Interim analysis from the China-Japan Phase 3 clinical trial in 3L gastric cancer is expected in 2026. Phase 3 in 3L pancreatic cancer in China was initiated in 2025. PoC studies in 1L gastric and 1L pancreatic cancer are ongoing. IBI324 (VEGF/ANG2): Potential best-in-class retinaltherapy, potential TAM US$15 billion Our partner Ollin Biosciences reported positive top-line results from the Phase 1b JADE head-to-head study against faricimab in wAMD and DME patients in the US. Innovent is working closely with Ollin to engage global regulators in 2026 and advance IBI324 into global Phase 3 trials. Diversified Partnerships to Accelerate Global Innovation Total deal value from Innovent's global collaborations reached over US$22 billion in 2025, representing over 10% of China's innovative pharma outbound licensing value. These partnerships not only accelerate global pipeline development but also help build core capabilities for Innovent to become a truly world-class biopharma. With Takeda: Landmark "IO + ADC" collaboration under a co-development and co-commercialization ("Co-Co") model for IBI363 to build its global R&D and commercialization capabilities. With Eli Lilly: Seventh partnership with an end-to-end innovation model to jointly develop novel oncology and immunology molecules, enhancing full lifecycle R&D frameworks and decision-making from a multinational perspective. With Roche: Leveraging global oncology resources to advance IBI3009 (DLL3 ADC) worldwide. With Ollin: Utilizing global ophthalmology expertise to accelerate IBI324's clinical development and market positioning. High-Quality Manufacturing Standards Total operational capacity of 140,000 liters, accounting for 20% of China's total biologic manufacturing capacity. Site 1 houses 60,000 liters of antibody capacity and ADC commercial lines; Site 2 has 80,000 liters of antibody capacity, supporting global supply and CDMO services. Sustainable Development and ESG Commitment 8,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou. Over 3,000 new cancer patients initiate Innovent therapies daily; more than 6 million patients have benefited to date. Maintained MSCI ESG AAA rating, leading China's biopharmaceutical industry. First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status). Launched community health initiatives including the MV 'Weight Management Made Easy' and documentary 'Down in Weight, Up in Life' to promote science-based healthy weight management. Published patient education materials on thyroid eye disease and weight management to enhance public health awareness. Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 3.6 billion. Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise". Created over 2,200 jobs for new graduates. Cumulative taxes and contributions exceeding RMB 6 billion. Vision 2030: From China Leader to Global Premier Biopharma Entering 2026, Innovent celebrates its 15th anniversary. Building on its strong foundation, the Company reaffirms Vision 2030: to evolve into a global premier biopharmaceutical company. Revenue: Target RMB 20 billion by 2027 with continued expansion thereafter. International revenue will become a new growth driver in the future. Profitability: Maintain high-quality growth while steadily improving profit margins benchmarking industry-leading levels. Pipeline: Focus on advancing high-value assets including IBI363, IBI343 and IBI324. Push next-generation oncology and general biomedicine molecules into global early-stage and PoC studies. Target at least 5 molecules in global MRCT Phase 3 by 2030. Organization: Established a US R&D and operating team of nearly 100 people. Through deep partnerships with Takeda, Lilly, Ollin, Roche and others, Innovent is rapidly building global R&D, regulatory and commercial capabilities. These growing global competencies will further support independent development, enabling Innovent to leap forward into a fully independent, world-class biopharmaceutical enterprise. 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 18 products in the market. It has 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 1Drug ApprovalFinancial StatementPhase 3Clinical Result

100 Deals associated with Tafolecimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16336

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dyslipidemias	Macao	Innovent Biologics, Inc.	09 Jun 2025
Complex dyslipidemia	China	Innovent Biologics (Suzhou) Co. Ltd.	15 Aug 2023
Primary hypercholesterolemia	China	Innovent Biologics (Suzhou) Co. Ltd.	15 Aug 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mixed hyperlipidemia	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	04 Mar 2026
Hypercholesterolemia, Familial	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	29 Apr 2020
Heterozygous familial hypercholesterolemia	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	17 Dec 2019
Homozygous familial hypercholesterolemia	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	29 Sep 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CREDIT-1 (ESC2025)	Phase 3	-	734	Tafolecimab 450 mg Q4W	biuiikoatk(jkifvcivbg) = fidkkahklx gdjngxjrfu (htnmjrzmgl ) View more	Positive	29 Aug 2025
				Placebo Q4W	biuiikoatk(jkifvcivbg) = etqbcyydfw gdjngxjrfu (htnmjrzmgl ) View more
NCT04289285 \| NCT04709536 \| NCT04179669 (CREDIT-2, NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Hypercholesterolemia	255	托莱西单抗	zomlybjemm(zcazutxcin) = pjrvrfidjq sxbdjexylw (gqgcognzqx ) View more	Positive	09 Apr 2025
				Placebo	zomlybjemm(zcazutxcin) = rjblxvfkpr sxbdjexylw (gqgcognzqx ) View more
NCT04289285 (CREDIT-1, Pubmed \| Lancet Reg Health West Pac) Manual	Phase 3	Hypercholesterolemia	614	Tafolecimab 450 mg Q4W	qquhvxsslo(cjzobwjnla) = qtmtrhtgna loktmvvilo (dtmsxpzxmu )	Positive	01 Dec 2023
				Tafolecimab 600 mg Q6W	qquhvxsslo(cjzobwjnla) = ymilcofnkt loktmvvilo (dtmsxpzxmu )
NCT04709536 (CREDIT-4, Pubmed)	Phase 3	Hypercholesterolemia	303	Tafolecimab	qqdsvxgwiy(nshzyxdxha) = cnekuyvvlu qukuulnanm (hxbdbwcyrd, SE 1.4%)	Positive	01 Aug 2023
				Placebo	qqdsvxgwiy(nshzyxdxha) = wqftfspxto qukuulnanm (hxbdbwcyrd, SE 1.8%)
NCT04709536 (CREDIT-4, Literature) Manual	Phase 3	Hypercholesterolemia	303	tafolecimab	orxyniqgrk(jhhlrdpttm) = rszqffmaij ewawzvsudb (lyhxcfixdb, 1.4)	Positive	11 Jul 2023
				placebo	orxyniqgrk(jhhlrdpttm) = vntcxlszyi ewawzvsudb (lyhxcfixdb, 1.8)
NCT04179669 (CREDIT-2, Literature \| Pubmed \| BMC Med) Manual	Phase 3	Heterozygous familial hypercholesterolemia	148	tafolecimab 150 mg Q2W	imxekcjozk(iospisvfeq): −57.4 (97.5% CI, −69.2 - −45.5), P-Value = <0.0001 View more	Positive	28 Feb 2023
				placebo 150 mg Q2W
NCT04289285 (CREDIT-1, AHA2022) Manual	Phase 3	Hypercholesterolemia, Familial	568	tafolecimab 450 mg Q4W	izbuufqbuy(wqsiogfkiz): -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 \| Hypercholesterolemia, Familial	-	IBI306	ppohrcrshe(zelejjecjm) = jvcafvhezd sxaigpvmdi (ddaqdxtmyi, -66.48 to -59.56)	Positive	17 Feb 2022
				placebo	-
NCT03366688 (Literature) Manual	Phase 1	Hypercholesterolemia	48	Tafolecimab	qrstvndkze(qiyukyjygd) = either mild or moderate aborbpchfk (adhtokyoiv )	Positive	01 Dec 2021
				Placebo
NCT03815812 (Literature) Manual	Phase 1	Hypercholesterolemia	60	Tafolecimab	rcwkknathr(uhxlbtzurd) = Adverse events in both studies were either mild or moderate. vffzbjuujp (gqlwgmkrra )	Positive	01 Dec 2021
				Placebo

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis