San Francisco, USA and Suzhou, ChinaJune 22, 2026 /PRNewswire/ — Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, cardiovascular, and ophthalmology, announced that the first patient has been dosed in its pivotal Phase III clinical study (TriadicMM-1) in China for IBI3003, a novel anti-GPRC5D/BCMA/CD3 trispecific antibody independently developed by the company, for the treatment of relapsed/refractory multiple myeloma (R/R MM) in second to fifth-line settings. IBI3003 is the first domestically developed trispecific antibody to enter a pivotal registrational Phase III clinical trial in China, offering a promising next-generation immunotherapy option for Chinese patients with R/R MM in second to fifth-line settings.
Clinical data for IBI3003 were presented orally at the 2025 American Society of Hematology (ASH) Annual Meeting, demonstrating encouraging safety and efficacy signals in eligible R/R MM patients who had failed at least two prior lines of therapy [link].
- Among 24 patients treated with doses ≥120 μg/kg, 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 10 patients with extramedullary disease (EMD), the ORR was 80%, and in 9 patients previously treated with anti-BCMA and/or anti-GPRC5D therapies, the ORR was 77.8%. Among patients achieving complete response (CR) or better as assessed by central laboratory next-generation sequencing (NGS) (n=4), the minimal residual disease (MRD) negativity rate was 100%.
- Cytokine release syndrome (CRS) events were all Grade 1-2, with only 2 cases of Grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). GPRC5D target-related treatment-emergent adverse events (TEAEs) involving the oral cavity, skin, and nails were mostly Grade 1-2, with only 2 cases of Grade 3 rash.
- Results from dose optimization studies related to this Phase I/II clinical trial, including the determination of the recommended Phase II dose (RP2D), are planned for presentation at future academic conferences.
- Additionally, IBI3003 received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) earlier this year for the treatment of R/R MM in patients who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. A Phase I/II clinical trial in the U.S. is ongoing.
Professor Peng Liu, Principal Investigator of this study at Zhongshan Hospital, Fudan University, stated: “We are pleased that the first patient has been enrolled in the TriadicMM-1 clinical study at our hospital. This is the first domestically developed trispecific antibody with independent intellectual property rights to enter a pivotal Phase III clinical trial for R/R MM. IBI3003 is also the second trispecific antibody globally to advance into a pivotal Phase III clinical trial for R/R MM. Although multiple treatment options exist for multiple myeloma, the disease remains highly recurrent and incurable. With each relapse, symptoms recur, quality of life deteriorates, and the likelihood and duration of treatment response typically decrease. Therefore, there remains a significant and urgent unmet need for novel therapeutic approaches with 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 look forward to the Phase III TriadicMM-1 clinical study validating the potential of IBI3003 and advancing it as a new standard of care for multiple myeloma.”
Dr. Hui Zhou, Chief Medical Officer (Oncology) at Innovent Biologics, stated: “The successful first dosing of the first patient in the pivotal Phase III TriadicMM-1 study in China marks a significant milestone for IBI3003, our first trispecific antibody pipeline candidate, in its transition toward clinical value. IBI3003 was developed using Innovent’s proprietary Sanbody® platform, and its preliminary studies have demonstrated excellent efficacy data and a manageable safety profile, positioning it as a promising next-generation immunotherapy for multiple myeloma. Looking ahead, Innovent will continue to deepen innovation in both ADC and immunotherapy upgrades, committed to bringing innovative therapies to patients worldwide.”
About Multiple Myeloma
Multiple myeloma is a malignant clonal hematologic tumor originating from plasma cells in the bone marrow. The abnormal proliferation of plasma cells accumulates within the bone marrow, disrupting normal hematopoiesis and secreting abnormal monoclonal immunoglobulins (M proteins), leading to a range of severe clinical symptoms such as bone destruction, anemia, renal impairment, and hypercalcemia. With the aging population, the incidence of multiple myeloma is rising globally. Although recent advances in innovative therapies, including targeted drugs, immunomodulators, and proteasome inhibitors, have significantly improved patient outcomes, multiple myeloma remains considered an incurable disease. The vast majority of patients inevitably experience a cycle of relapse and drug resistance after achieving remission from initial treatment. Particularly for patients with relapsed/refractory multiple myeloma who have received 1-4 prior lines of therapy, treatment options become increasingly limited with each subsequent line, response durations shorten progressively, and prognosis is extremely poor. Therefore, there is an urgent clinical need for more effective, safer, and mechanistically innovative treatment regimens to overcome drug resistance, extend patient survival, and improve quality of life.
About IBI3003 (Anti-GPRC5D/BCMA/CD3 Trispecific Antibody)
IBI3003, developed using Innovent’s proprietary Sanbody® platform, is a novel trispecific antibody targeting G protein-coupled receptor class C group 5 member D (GPRC5D), B-cell maturation antigen (BCMA), and CD3. This molecular design aims to overcome single tumor antigen escape. It demonstrated superior in vivo anti-tumor activity in preclinical mouse models compared to benchmark bispecific antibodies, and notably showed enhanced tumor-killing potency in in vitro cell models with low BCMA and GPRC5D expression.
About Innovent Biologics
“Start with integrity, succeed through action” – developing high-quality biologics that are affordable to the public is the mission and goal of Innovent Biologics. Founded in 2011, Innovent is dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmology, aiming to benefit more lives. The company has 18 approved products: sintilimab injection (Tyvyt®), bevacizumab injection (Byvasda®), adalimumab injection (Sulinno®), rituximab injection (Dabohua®), pemigatinib tablets (Pemazyre®), olverembatinib tablets (Nerlynx®), ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), equecabtagene autoleucel injection (Fucaso®), tafolecimab injection (Xinbile®), fulzerasib tablets (Dabote®), pirtobrutinib tablets (Jaypirca®), taletrectinib capsules (Dabole®), lietinib tablets (Aoyixin®), and teprotumumab N01 injection (Xinbimin®), mazdutide injection (Xinermei®), picankibart injection (Xinmeiyue®), and ipilimumab N01 injection (Daboxin®). Currently, one product is under NMPA review, four new drug molecules have entered Phase III or pivotal clinical studies, and 14 additional new drug candidates have entered clinical trials.
The company has established over 30 strategic collaborations with international partners including Eli Lilly, Roche, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously innovating and developing its own drugs and pursuing growth, Innovent adheres to a people-centered development philosophy in economic construction. Over the years, it has always upheld scientific goodwill, remained patient-centered, cared for patients and their families, and actively fulfilled social responsibilities. The company has initiated and participated in multiple drug assistance programs, enabling more patients to benefit from advances in life sciences and access high-quality biologics affordably. To date, Innovent’s patient assistance programs have benefited over 200,000 ordinary patients, with a total drug donation value of RMB 4 billion. Innovent hopes to work together to improve the development level of China’s biopharmaceutical industry, meeting the accessibility of medications for the public and the pursuit of people’s life and health aspirations.
For more information, please visit the company’s website: www.innoventbio.com or LinkedIn account: www.linkedin.com/company/innovent-biologics/.
|
Disclaimer: 1. Innovent does not recommend the use of unapproved drugs/indications. |
|
2. Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) are developed by Eli Lilly. |
Forward-Looking Statements
The information released in this press release may contain certain forward-looking statements. These statements are inherently subject to significant risks and uncertainties. When using terms such as “expect,” “believe,” “predict,” “anticipate,” “intend,” and other similar expressions, when related to the company, they are intended to identify forward-looking statements. The company undertakes no obligation to continuously update these forward-looking statements.
These forward-looking statements are based on the current views, assumptions, expectations, estimates, projections, and understanding of the company’s management regarding future events at the time the statements are made. These statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the company’s control and difficult to predict. Therefore, actual results may differ materially from the information contained in the forward-looking statements due to future changes and developments in our business, competitive environment, political, economic, legal, and social conditions.
References