Innovent Biologics and IASO Biopharma Announce Breakthrough Therapy Designation by China’s NMPA for Fully Human BCMA-Targeted CAR-T Therapy IBI326/CT103A in Relapsed/Refractory Multiple Myeloma

SAN FRANCISCO, USA and SUZHOU, China, Feb. 23, 2021 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases, today jointly announced with IASO Bio that their collaboratively developed fully human BCMA chimeric antigen receptor (CAR) autologous T-cell injection (Innovent’s development code: IBI326; IASO Bio’s development code: CT103A) has passed the public notice period of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) and has been included in the “Breakthrough Therapy Drug” list, with the proposed indication being relapsed/refractory multiple myeloma (R/R MM). The breakthrough therapy designation enables close communication and guidance from the CDE during the drug’s development process, thereby accelerating its market approval and addressing the unmet clinical needs of patients in China at an earlier stage. The breakthrough therapy designation for IBI326 is based on results observed in an ongoing Phase 1/2 study (ChiCTR1800018137) conducted in China for the treatment of R/R MM.

IBI326 is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), which uses lentiviral vectors to transduce autologous T cells. The CAR comprises a fully human scFv, CD8a hinge and transmembrane domains, 4-1BB co-stimulatory domain, andCD3ζActivation Domain. Based on rigorous screening and comprehensive in vitro and in vivo functional evaluations, IBI326 demonstrates potent, rapid, and durable efficacy.

At the 61st American Society of Hematology (ASH) Annual Meeting held in 2019, IASO Bio and Innovent Bio jointly presented an oral report on clinical study data for their co-developed fully human BCMA CAR-T therapy for the treatment of relapsed/refractory multiple myeloma (Abstract #582). The data demonstrated that IBI326 exhibited favorable safety, efficacy, and durability of response. Notably, the study included four patients who had relapsed after prior treatment with murine-derived anti-BCMA CAR-T therapy; their overall outcomes indicated that IBI326 may provide an effective therapeutic option for patients who relapse after murine-derived CAR-T therapy.

In January 2021, the latest clinical research findings of this innovative drug received further international authoritative recognition—the latest results of the study on “Efficacy and Safety of Fully Human BCMA CAR-T in the Treatment of Relapsed/Refractory Multiple Myeloma,” conducted by IASO Bio in collaboration with Professor Zhou Jianfeng’s team from the Department of Hematology at Tongji Hospital Affiliated to Huazhong University of Science and Technology, were published in Blood, a prestigious academic journal in hematology. (“A Phase 1 Study of a Novel Fully Human BCMA-targeting CAR (IBI326) in Patients with Relapsed/Refractory Multiple Myeloma.”）

Dr. Zhou Hui, Vice President of Medical Science and Strategic Oncology at Innovent Bio, stated: “The inclusion of IBI326 in the CDE’s Breakthrough Therapy Designation program underscores its significant potential in treating relapsed/refractory multiple myeloma. We hope this drug will be approved for market access soon to benefit more patients.”

Zhang Jinhua, Founder and CEO of IASO Bio, stated, “The inclusion of the CT103A clinical trial in the CDE’s Breakthrough Therapy Designation program is expected to accelerate the development and approval process of this drug in China, enabling it to benefit more patients at an earlier stage.”

About IBI326

IBI326 is an innovative product jointly developed by Innovent Bio and IASO Bio. This product uses a lentiviral vector to transduce autologous T cells. The CAR comprises a fully human scFv, CD8α hinge and transmembrane domains, 4-1BB co-stimulatory domain, andCD3ζActivation Domain. Based on rigorous screening and comprehensive in vitro and in vivo functional evaluations, the IBI326 CAR-T product demonstrates potent and rapid efficacy, along with outstanding durability.

About Multiple Myeloma

Multiple myeloma is one of the most common hematologic malignancies, characterized by the clonal proliferation of abnormal plasma cells. For newly diagnosed patients, first-line therapies commonly include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While these standard regimens stabilize disease for 3–5 years in the majority of patients, a small subset exhibits primary resistance at initial treatment, resulting in inadequate disease control. Furthermore, most initially responsive patients will inevitably progress to relapsed or refractory stages after a period of disease stability. Consequently, there remains an unmet medical need for patients with relapsed/refractory multiple myeloma.

# On the Breakthrough Therapy Drug Program

In recent years, China has established an expedited review and approval pathway for drugs to encourage innovation and address urgent clinical needs. The Breakthrough Therapy Designation is designed to accelerate the development of new drugs targeting serious diseases that have demonstrated significant advantages in efficacy or safety over existing treatments in early-stage clinical trials. Obtaining Breakthrough Therapy Designation enables close communication with and guidance from the Center for Drug Evaluation (CDE) during the research and development process, thereby accelerating market approval and addressing unmet clinical needs of patients in China at an earlier stage.

About Innovent Bio

“Rooted in Trust, Realized through Action.” Innovent Bio’s vision and goal is to develop high-quality biologics that are affordable to the general public. Founded in 2011, Innovent Bio is dedicated to the development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases, including cancer, autoimmune disorders, and metabolic diseases. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies with its innovative achievements and internationalized operational model. It has established a product pipeline comprising 23 new drug candidates, covering multiple therapeutic areas including oncology, metabolic diseases, and autoimmune disorders. Among these, six candidates have been selected for the National “Major New Drug Creation” Special Project, and four products (Sintilimab Injection, brand name: Tyvyt^®, English trademark: TYVYT^®; Bevacizumab biosimilar, brand name: Byvasda^®, English trademark: BYVASDA^®; Adalimumab biosimilar, brand name: Sulixin^®, English trademark: SULINNO^®; Rituximab biosimilar, brand name: Tyvyt^®, English trademark: HALPRYZA^®) received NMPA approval for market launch, four products entered Phase III or pivotal clinical studies, and an additional 15 products have entered clinical studies. Sintilimab was successfully included in the National Reimbursement Drug List (NRDL) in November 2019, becoming the first and only PD-1 inhibitor to be included in the NRDL that year.

Innovent Bio has assembled a high-caliber team of professionals in the development and industrialization of biopharmaceuticals, featuring international advanced expertise and numerous overseas-returning experts. The company has established strategic collaborations with international partners, including Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical. Innovent Bio is committed to working collectively to elevate the development level of China’s biopharmaceutical industry, thereby enhancing drug accessibility for the public and fulfilling people’s aspirations for better health and well-being. For more details, please visit the company’s website:www.innoventbio.com。

About IASO Bio

IASO Bio is an innovative biopharmaceutical company focused on the development and industrialization of oncology cell immunotherapy drugs, dedicated to bringing new hope to patients in China and around the world. Founded in 2017, the company has assembled an international management team with extensive experience in new drug development, clinical research, and commercialization, currently employing 360 staff members. With the development of hematologic malignancy cell therapies and antibody drugs as its innovation foundation, IASO Bio is expanding into solid tumors and autoimmune diseases, and currently possesses more than ten competitive innovative pipeline products. The company’s core product—fully human BCMA CAR-T (CT103A)—has entered confirmatory clinical trials, while several other pipeline products are undergoing investigator-initiated clinical trials.

Driven by a highly execution-oriented management team, a robust product pipeline, and distinctive innovation in R&D and business models, IASO Bio aspires to become the most influential innovative pharmaceutical company in the industry. We are committed to advancing truly competitive innovative drugs that address critical unmet clinical needs from development through to market launch, thereby paving new therapeutic pathways and bringing new hope to patients. For more information, please visit our company website.http://www.iasobio.com。