San Francisco, USA and Suzhou, ChinaMay 11, 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 and cardiovascular, and ophthalmology, announced that its first-in-class PD-1/IL-2α-bias bispecific fusion protein, IBI363, has received a third Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. This designation is for IBI363 in combination with bevacizumab for the treatment of advanced microsatellite stable or mismatch repair proficient (MSS/pMMR) colorectal cancer in patients who have failed ≥2 prior lines of standard therapy. A Phase III clinical trial for this indication is planned to be initiated in China in the near future.
Previously, IBI363 had received two Breakthrough Therapy Designations from the NMPA CDE in China and two Fast Track Designations (FTD) from the U.S. FDA, covering indications for non-small cell lung cancer and melanoma. This new BTD marks further progress for IBI363 in addressing unmet clinical needs such as immune resistance and cold tumors. Early clinical data for IBI363 in the treatment of advanced MSS/pMMR colorectal cancer were presented at the 2025 ASCO Annual Meeting (link), showing encouraging efficacy of IBI363 in combination with bevacizumab in patients who had failed multiple prior lines of standard therapy.
Dr. Hui Zhou, Senior Vice President of Oncology R&D at Innovent Biologics, stated: “IBI363 is a highly promising next-generation immunotherapy drug that reshapes the tumor immune microenvironment through a dual mechanism of PD-1 blockade and IL-2-driven expansion of tumor-specific T cell populations. This new regulatory milestone underscores its clinical value in addressing unmet medical needs. We are working closely with our partner Takeda to accelerate the global development of IBI363 across multiple tumor types, bringing this innovative therapy at the forefront of immunotherapy to patients worldwide.”
Breakthrough Therapy Designation is designed to expedite the development of new drugs for serious conditions that have demonstrated preliminary clinical evidence of significant improvement in efficacy or safety over existing therapies. Receiving BTD allows for close communication and guidance from the CDE during the R&D process, thereby accelerating drug approval and addressing unmet clinical needs of patients in China more quickly.
About MSS/pMMR Colorectal Cancer
Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR type accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed prior standard therapy, there remains a significant and urgent unmet clinical need, with limited treatment options and poor prognosis.
About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)
IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein independently developed by Innovent Biologics. It possesses dual functions of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 has been engineered to retain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby lowering toxicity. The PD-1 binding arm enables simultaneous PD-1 blockade and selective IL-2 delivery. This differentiated strategy allows for more precise and effective targeting and activation of tumor-specific T cell subsets.
Currently, IBI363 is undergoing a series of clinical trials globally, including a global multi-regional Phase III trial for immune-resistant squamous non-small cell lung cancer and a pivotal Phase II study in China for untreated acral and mucosal melanoma. Additionally, multiple Phase Ib/II trials are ongoing to evaluate IBI363 for non-small cell lung cancer and colorectal cancer (including first-line and later-line treatments), as well as other tumor types. To date, IBI363 has received three Breakthrough Therapy Designations (BTD) from the NMPA in China and two Fast Track Designations (FTD) from the U.S. FDA.
In October 2025, Innovent Biologics entered into a strategic collaboration with Takeda. The two parties will jointly develop IBI363 (Takeda development code: TAK-928) globally and co-commercialize it in the United States. Additionally, Innovent has granted Takeda commercialization rights for IBI363 in regions outside of Greater China and the United States.
About Innovent Biologics
“Start with Integrity, Succeed through Action” – Innovent’s mission and goal is to develop high-quality biologics that are affordable for the people. 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, ensuring our work benefits 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®), tafasitamab injection (Monjuvi®), fluoxetinib tablets (Dabote®), pirtobrutinib tablets (Jaypirca®), taletrectinib capsules (Dabole®), lietinib tablets (Aoyixin®), teplizumab injection (Tzield®), mazdutide injection (Xinerme®), piconivimab injection (Xinmeiyue®), and ipilimumab injection (Yervoy®). Currently, 5 new drug candidates are in Phase III or pivotal clinical studies, and another 14 new drug candidates have entered clinical research.
The company has established over 30 strategic collaborations with international partners such as Eli Lilly, Roche, Takeda, 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, adhered to a “patient-centered” approach, 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 to afford and access high-quality biologics. 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 with everyone to improve the development level of China’s biopharmaceutical industry, to meet the accessibility of medications for the people and the pursuit of a healthy life.
For more information, please visit the company’s website: www.innoventbio.com or the company’s LinkedIn account www.linkedin.com/company/innovent-biologics/
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Disclaimer: 1. Innovent does not recommend the use of unapproved drugs/indications. |
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2. Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) are developed by Eli Lilly. |
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