Request Demo
Last update 17 Jan 2026
IBI-3003
Last update 17 Jan 2026
Overview
Basic Info
Drug Type Trispecific T-cell engager (TriTE) |
Synonyms IBI 3003, IBI3003 |
Target |
Action inhibitors, stimulants |
Mechanism BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 1/2 |
First Approval Date- |
Regulation- |
Login to view timeline
Related
2
Clinical Trials associated with IBI-3003NCT07336472
A Phase I/II, Multicenter, Open-label Study of IBI3003 in Participants With Relapsed or Refractory Multiple Myeloma
This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 54
360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma
360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma
Start Date01 Apr 2026 |
Sponsor / Collaborator |
NCT06083207
A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 23
116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.
116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.
Start Date29 Jul 2024 |
Sponsor / Collaborator |
100 Clinical Results associated with IBI-3003
Login to view more data
100 Translational Medicine associated with IBI-3003
Login to view more data
100 Patents (Medical) associated with IBI-3003
Login to view more data
4
News (Medical) associated with IBI-300308 Dec 2025
SAN FRANCISCO and SUZHOU, China, Dec. 7, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced the initial data of the first-in-human trial of IBI3003, a novel trispecific antibody targeting G protein-coupled receptor C5D (GPRC5D), B-cell maturation antigen (BCMA), and CD3 for the treatment of relapsed or refractory multiple myeloma (R/R MM), in an oral presentation at the 2025 American Society of Hematology (ASH) Annual Meeting. IBI3003 demonstrated favorable tolerability and a manageable safety profile. Despite the relatively short follow-up duration, IBI3003 has shown encouraging efficacy signals, particularly in high-risk patients with extramedullary disease (EMD) or those who have previously received anti-BCMA and/or anti-GPRC5D targeted therapies.
IBI3003 is a novel trispecific antibody targeting GPRC5D, BCMA and CD3 simultaneously. Its dual-targeting design against BCMA and GPRC5 aims to overcome single antigen escape in multiple myeloma (MM). In preclinical studies, IBI3003 exhibited superior in vivo anti-tumor activity over marketed benchmark bispecific antibodies in mouse models, with particularly prominent tumor-killing efficacy in in vitro cell models with low expression of BCMA and GPRC5D. Currently, Innovent is conducting a Phase 1/2 clinical trial (NCT06083207) of IBI3003 in China and Australia to evaluate its safety, tolerability, and efficacy in patients with R/R MM.
The first phase of the study enrolled eligible R/R MM patients who had failed ≥2 lines of previous anti-myeloma therapies that included at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 mAb; and must be relapsed or refractory to their last anti-myeloma regimen. Prior BCMA- or GPRC5D-targeting therapy was allowed.
IBI3003 was administered subcutaneously once weekly (QW). For patients who have received continuous treatment for ≥6 months and achieved partial response (PR) or better for ≥2 months could switch to Q2W as maintenance. To reduce the risk of cytokine release syndrome (CRS), 1 to 3 priming doses were included in the study design.
A total of 39 patients were enrolled in this phase in China and Australia, with a dose range of 0.1 μg/kg to 800 μg/kg. The median age of patients was 62 years (range: 40-79), 64.1% of whom were classified as high-risk per mSMART criteria, and 46.2% had ≥1 EMD. The median number of prior lines of therapy was 4 (range: 1-10). All patients had received at least three classes of drugs (PI, IMiD, and anti-CD38 antibody), 51.3% had received at least five classes of drugs (at least 2 PIs, 2 IMiDs, and 1 anti-CD38 antibody), 41% had previously received anti-BCMA and/or anti-GPRC5D therapies, and 76.9% were refractory to the last treatment. As of the data cutoff date, November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4-7.4), and the median treatment duration was 12.14 weeks (range: 1.0-33.0).
Manageable Safety Profile of IBI3003 in R/R MM Patients
Dose-limiting toxicity (DLT) only occurred in 2 patients, both of whom experienced Grade 4 platelet count decreased and recovered.
97.4% of patients experienced treatment-emergent adverse events (TEAEs). Common TEAEs included CRS, neutrophil count decrease, anemia, lymphocyte count decrease, white blood cell count decrease, and platelet count decrease.
Hematological disorders were the most common Grade ≥3 TEAEs that mainly occurred during step-up dosing and were manageable and recoverable.
The incidences of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were 64.1% and 6.1%, respectively, all of which were Grade 1-2 and resolved with treatment. Prophylactic use of tocilizumab may reduce incidence, severity, and duration CRS.
The incidence of all-grade infections was 48.7%, with Grade ≥3 infections reported in 28.2% of patients.
For GPRC5D target-related TEAEs involving the oral cavity, skin, and nails, no Grade ≥3 oral TEAEs were observed. Most skin and nail TEAEs were Grade 1-2, with only 2 patients experiencing Grade 3 rash.
Encouraging Efficacy and Depth of Response Observed with IBI3003 at Doses ≥120 μg/kg
Encouraging efficacy was observed with a median follow-up of 3.25 months: Among patients treated with ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 cases of stringent complete response (sCR), 7 cases of very good partial response (VGPR), and 9 cases of partial response (PR).
Among patients treated with ≥120 μg/kg, the ORR was 80% in 10 patients with EMD and 77.8% in 9 patients who had previously received anti-BCMA and/or anti-GPRC5D therapies.
Among patients who achieved CR or better as assessed by central laboratory next-generation sequencing (NGS) testing, the minimal residual disease (MRD) negativity rate was 100% (n=4).
Potent and Sustained Pharmacodynamic Responses Observed with IBI3003 in R/R MM Patients
Biomarker analysis showed that baseline soluble BCMA (sBCMA) levels were high and variable in R/R MM patients (median level: 198 ng/mL, range: 10-3010 ng/mL).
A profound and durable decline in serum sBCMA across 120, 360 and 540 μg/kg groups was observed, demonstrating a strong pharmacodynamic response.
IBI3003 has demonstrated favorable tolerability and a manageable safety profile in R/R MM patients, with encouraging efficacy signals observed at doses ≥120 μg/kg. Efficacy responses were also observed in high-risk patients, including those with EMD or prior anti-BCMA and/or anti-GPRC5D therapies. Current follow-up remains relatively short, and deeper anti-tumor responses are expected with continued treatment and observation. Dose optimization for IBI3003 is ongoing in the Phase 1 study.
Professor Peng Liu, Zhongshan Hospital Affiliated to Fudan University, stated, "Patients with R/R MM have a poor prognosis after failing standard treatments, including PI, IMiD, and anti-CD38 therapies, with an ORR of only 29.8%, a median progression-free survival of 4.6 months, and a median overall survival of 12.4 months[1]. Therefore, there is an urgent unmet clinical need for these patients, particularly those with high-risk features such as EMD or prior anti-BCMA and/or anti-GPRC5D therapies. The dual-target coverage of BCMA and GPRC5D by IBI3003 addresses the issues of antigen expression heterogeneity and treatment resistance associated with single-target drugs, reducing tumor escape. Meanwhile, its optimized CD3 affinity enables precise T-cell activation for tumor killing while also improving safety. In the disclosed Phase 1 study results, IBI3003 showed a manageable safety profile and impressive efficacy data at doses ≥120 μg/kg, with an ORR of 83.3%. It also demonstrated significant efficacy in high-risk patients with EMD or prior anti-BCMA and/or anti-GPRC5D therapies, fully reflecting its potential in overcoming R/R MM. We look forward to the long-term follow-up survival data with continuous IBI3003 treatment."
About IBI3003 (Anti-GPRC5D/BCMA/CD3 Trispecific Antibody)
IBI3003 is a tri-specific TCE developed using Innovent's proprietary Sanbody platform to target both GPRC5D and BCMA. Designed to overcome drug resistance driven by single-antigen tumor escape, IBI3003 has exhibited superior in vivo antitumor activity in preclinical studies compared with marketed benchmark TCEs, especially in cell models with low BCMA and GPRC5D expression. Innovent is currently conducting a Phase 1/2 clinical trial (NCT06083207) of IBI3003 in China and Australia to evaluate its safety, tolerability, and efficacy in patients with R/R MM.
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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 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:
(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] Mateos M , Weisel K , Stefano V D ,et al.LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma[J].Leukemia, 2022, 36:1371 - 1376.DOI:10.1038/s41375-022-01531-2.
SOURCE Innovent Biologics
21%
more press release views with
Request a Demo
Clinical ResultPhase 1ASHAACR
27 Aug 2025
Robust revenue growth and substantial profit improvement
Continued exceptional executions under a clear roadmap of dual-driven growth and global innovation
SAN FRANCISCO and SUZHOU, China, Aug. 27, 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 cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2025 interim results and major business updates.
Continue Reading
Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum.
On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent's innovation capabilities and lays a solid foundation for globalization.
We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent's growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company."
Dual-driven revenue growth with execution excellence
Robust revenue growth and substantial profit improvement[1]
Total revenue: RMB 5.95 billion, up 50.6% year-on-year
Product revenue: RMB 5.23 billion, up 37.3% year-on-year
Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion
Gross margin: 86.8%, up 2.7 percentage points year-on-year
Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year
R&D investment: RMB 903 million
Cash on hand: approximately USD 2 billion[2]
Dual-engine growth supported by comprehensive and diversified product portfolio
Expansion of oncology product portfolio with three new launches
Dovbleron® (taletrectinib) : Potentially best-in-class ROS1 inhibitor
Limertinib
: Third-generation EGFR TKI
Jaypirca®(pirtobrutinib) : First non-covalent BTK inhibitor
Strengthening general biomedicine portfolio with innovative pipeline
SINTBILO® (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025
SYCUME
® (
teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China
Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review
Innovative commercial strategy with multi-channel coverage
Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management
Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence
Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients
Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence
Enhancing brand strength through the establishment of a lifecycle management system
TYVYT
®
: NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway
SYCUME
® (
teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED
Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc.
Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics
Emerging value from globalization strategy, prioritizing novel pipeline's global R&D
Flagship pipeline showcased at top-tier conferences, entering global registration studies
IBI363 (PD-1/IL-2
α
-bias
): Unleashing potential as a next-generation IO therapy with global first-in-class design
Three oral presentations at ASCO highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits
Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate
Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more
BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC
First MRCT Phase 3 study of GC has been initiated in China and Japan
First Phase 3 study of PDAC has been initiated
Global MRCT of PDAC is in plan
NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted
Over 10 next-generation programs advancing into global development
Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc
CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc
A
uto
immune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc
Hybrid models to accelerate innovation
IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide
Enhance global presence with broader market access
Six products (TYVYT®, BYVASDA®, Pemazyre®, Dupert®, SINTBILO®, SYCUME®) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia
More launches planned Brazil, Mexico, Columbia, India, etc
Research innovation showcased at medical conferences
Oncology pipeline: AACR, ASCO, Nature Medicine
General biomedicine pipeline: ADA, NEJM
Facilities and manufacturing capacity adhering to high-quality standards
7,500 employees globally
Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou
To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China's total biopharmaceutical production capacity
First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply
Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations
Committed to responsible business practices and enhancing ESG management practices
Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent's innovative drugs
Innovent has been
graded 'AAA' rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry
We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion
Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise"
Provided over 2,200 job opportunities for recent graduates
To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees
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 16 products in the market. It has 2 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, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn.
Statement:
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and 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
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
440k+
Newsrooms &
Influencers
9k+
Digital Media
Outlets
270k+
Journalists
Opted In
GET STARTED
Drug ApprovalBreakthrough TherapyPhase 3Phase 2Fast Track
28 Aug 2024
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
100 Deals associated with IBI-3003
Login to view more data
R&D Status
10 top R&D records. to view more data
Login
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Refractory Multiple Myeloma | Phase 2 | - | 01 Apr 2026 | |
| Multiple Myeloma | Phase 2 | China | 29 Jul 2024 | |
| Multiple Myeloma | Phase 2 | Australia | 29 Jul 2024 | |
| Relapse multiple myeloma | IND Application | China | 14 May 2024 |
Login to view more data
Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
NCT06083207 (ASH2025) Manual  | Phase 1 | 28 | (40 μg/kg) | hichrshtwq(ijobgtdotv) = Most commonly being CRS (71.4%, all G1-G2), anemia (64.3%, G3+: 25.0%), platelet count decreased (57.1%, G3+: 28.6%), lymphocyte count decreased (53.6%, G3+: 50.0%) and neutrophil count decreased (53.6%, G3+: 39.3%). Infections occurred in 11 (46.4%, G3+: 14.3%) patients. nefckukqwn (loevmrzcnv ) View more | Positive | 09 Dec 2025 | |
(≥120 μg/kg) | |||||||
Company_Website Manual | Phase 1 | 39 | dxjqdkunbh(zoffarmirw) = 血液系统毒性是最常见的≥3级TEAEs，主要发生在剂量递增阶段，程度可控且可恢复。CRS、免疫效应细胞相关神经毒性综合征（ICANS）发生率分别为64.1%、6.1%，均为1-2级，经治疗后已恢复；预防性使用托珠单抗可降低CRS的发生风险。感染发生率为48.7%，其中≥3级感染占28.2%。对于GPRC5D靶点相关的口腔、皮肤、指甲相关TEAE，未观察到3级以上的口腔TEAE，大多数皮肤、指甲TEAE为1-2级，仅有2例患者出现3级皮疹。 nbewthycit (wauvevzxok ) | Positive | 08 Dec 2025 | ||
IBI3003≥120ug/kg |
Login to view more data
Translational Medicine
Boost your research with our translational medicine data.
login
or
Deal
Boost your decision using our deal data.
login
or
Core Patent
Boost your research with our Core Patent data.
login
or
Clinical Trial
Identify the latest clinical trials across global registries.
login
or
Approval
Accelerate your research with the latest regulatory approval information.
login
or
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.
login
or
Regulation
Understand key drug designations in just a few clicks with Synapse.
login
or
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
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.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free