Innovent Biologics Announces First Patient Dosed in a Phase 3 Clinical Trial of IBI3003(GPRC5D/BCMA/CD3 Tri-specific Antibody) for the Treatment of Multiple Myeloma

Clinical data presented at the American Society of Hematology (ASH) Annual Meeting on December 7, 2025 [Link], demonstrated a tolerable safety profile and promising efficacy signals for IBI3003 in patients who had failed ≥2 prior lines of myeloma therapy:

• Thirty-nine patients with R/R MM who had previously received at least a PI, an IMiD, and an anti-CD38 monoclonal antibody were treated with IBI3003 at dose levels ranging from 0.1 μg/kg to 800 μg/kg and underwent at least one tumor assessment after baseline. As of the data cutoff date of 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).
• Among patients treated at doses ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR). In this cohort, the ORR was 80% among 10 patients with extramedullary disease (EMD) and 77.8% among 9 patients previously treated with BCMA- and/or GPRC5D-directed therapies. Among patients who achieved complete response or better, the minimal residual disease (MRD) negativity rate was 100% (n=4), as assessed by validated next-generation sequencing, with a threshold of 10^-5, performed at a central laboratory.
• All cases of cytokine release syndrome (CRS) were Grade 1-2, with only 2 cases of Grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS) reported. Most treatment-emergent adverse events (TEAEs) related to GPRC5D targeting, including those affecting the oral cavity, skin, and nails, were Grade 1–2, with two patients experiencing Grade 3 rash.
• Relevant dose optimization data (including RP2D selection) from this Phase 1/2 study will be presented at future academic conferences.
• In addition, IBI3003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) earlier this year. This designation applies to the treatment of R/R MM in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. The Phase I/II clinical trial in the United States is currently underway.

Professor Peng Liu from Zhongshan Hospital Affiliated to Fudan University, the Principal Investigator of the TriadicMM-1 Study, stated: "We are delighted that the first patient has been enrolled in TriadicMM-1 at our hospital. This is the first domestic pivotal Phase 3 clinical trial of a tri-specific antibody with independent intellectual property rights for the treatment of R/R/MM in China. Furthermore, IBI3003 is also the second tri-specific antibody globally to have advanced into pivotal Phase III clinical development in the R/R MM setting. Although multiple myeloma has multiple treatment options, the disease still recurs most frequently and is incurable. With each recurrence, symptoms reappear, quality of life declines, and both the likelihood and duration of treatment response typically decrease. Therefore, there remains a significant and urgent unmet medical need for novel therapeutic agents targeting alternative mechanisms of action to better control the disease, achieve deeper and more durable responses, and improve long-term outcomes including maintaining health-related quality of life. We highly anticipate that the Phase III study TriadicMM-1 will validate the potential of IBI3003 and establish IBI3003 as a new standard of care for 2-5 line R/R MM."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent Biologics, stated: "The successful completion of the first patient's first dose in the Chinese pivotal Phase III study TriadicMM-1 of IBI3003 is an important milestone for Innovent in advancing its first tri-specific antibody program into the registrational stage. IBI3003 is built on Innovent's proprietary Sanbody^® platform. The promising efficacy data and manageable safety profile observed in preclinical and clinical studies are expected to bring a promising next-generation immunotherapy option for patients with multiple myeloma. Looking ahead, Innovent will deepen its dual innovation in ADC and immunotherapy, and is committed to delivering cutting-edge therapies to patients worldwide."

About Multiple Myeloma

Multiple Myeloma is a malignant hematological malignancy originating from plasma cells in the bone marrow, ranking as the second most common blood cancer globally. Abnormal, clonal expansion of these malignant plasma cells crowding the bone marrow disrupts normal hematopoiesis and secretes abnormal monoclonal immunoglobulins (M protein). This process leads to a series of severe clinical complications, classically characterized by bone destruction, anemia, renal impairment, and hypercalcemia.

Driven by an aging global population, the incidence of multiple myeloma is continuously rising. Although the introduction of innovative therapies—such as proteasome inhibitors, immunomodulatory drugs, and targeted agents—has significantly improved patient prognosis over the past decades, multiple myeloma remains largely incurable. The vast majority of patients who initially achieve remission will inevitably experience a relentless cycle of relapse and drug resistance.

For patients with relapsed/refractory multiple myeloma who have already progressed through 1-4 lines of therapy, subsequent treatment options become severely limited. With each successive line of therapy, the duration of remission shortens, and the prognosis worsens drastically. Consequently, there is a critical and unmet medical need for novel therapeutic regimens with superior efficacy, manageable safety profiles, and distinct mechanisms of action to overcome resistance, prolong overall survival, and preserve patient quality of life.

About IBI3003

IBI3003, constructed on Innovent's proprietary Sanbody^® platform, is a novel trispecific antibody targeting G protein–coupled receptor, family C, group 5, member D (GPRC5D), B-cell maturation antigen (BCMA) and CD3. This molecular design aims to overcome single tumor antigen escape. Its antitumor activity in preclinical mouse models is superior to that of marketed bispecific antibody benchmarks, and it exhibits particularly potent tumor killing efficacy in in vitro cell models with low expression of BCMA and GPRC5D.

Currently, a Phase I/II clinical trial of IBI3003 is underway in China, Australia and U.S. (NCT06083207) to explore the safety, tolerability and efficacy of IBI3003 in subjects with R/R MM. In China, the program has advanced into pivotal registration stage with TriadicMM‑1 (NCT07623798), a randomized, controlled, open‑label Phase III study comparing IBI3003 to investigator's choice of regimens (DPd or PVd). The primary endpoint is progression‑free survival (PFS) assessed by an independent review committee (IRC).

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 18 products in the market. It has 1 asset in NMPA NDA review, 4 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 www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement:

1) Innovent does not recommend the use of any unapproved drug (s)/indication (s).

2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.

Disclaimer: Innovent does not recommend any off-label usage.

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.

Reference：

1. Rajkumar SV, et al. Multiple myeloma: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Aug;97(8):1086-1107.
2. Kumar SK, et al. International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149-57.
3. Zhuge L, et al. Global, regional and national epidemiological trends of multiple myeloma from 1990 to 2021: a systematic analysis of the Global Burden of Disease study 2021. Front Public Health. 2025 Jan 27;13:1527198.

View original content:https://www.prnewswire.com/news-releases/innovent-biologics-announces-first-patient-dosed-in-a-phase-3-clinical-trial-of-ibi3003gprc5dbcmacd3-tri-specific-antibody-for-the-treatment-of-multiple-myeloma-302805881.html

SOURCE Innovent Biologics