On June 21, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first patient has been dosed in the Chinese pivotal Phase 3 clinical trial (TriadicMM-1) of its self-developed innovative anti-GPRC5D, BCMA and CD3 tri-specific antibody IBI3003 for the second to fifth-line treatment of patients with relapsed or refractory multiple myeloma (R/R MM). IBI3003 is China’s first self-developed anti-GPRC5D/BCMA/CD3 tri-specific antibody to enter the pivotal registrational Phase III clinical trial, aiming to bring a promising next-generation immunotherapy option for Chinese R/R MM patients.
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TriadicMM-1 (NCT07623798) is a multicenter, randomized, controlled, open-label Phase 3 clinical trial designed to evaluate the efficacy and safety of IBI3003 versus investigator’s choice of regimen (pomalidomide, bortezomib and dexamethasone [PVd] or daratumumab, pomalidomide and dexamethasone [DPd]). The primary endpoint of the study is progression-free survival (PFS) assessed by the Independent Review Committee (IRC).
Clinical data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 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).
(Press release, Innovent Biologics, JUN 21, 2026, View Source [SID1234668815])