Innovent's IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Receives Second NMPA Breakthrough Therapy Designation for Immuno-resistant Squamous Non-Small Cell Lung Cancer

Rhea-AI Summary

Innovent Biologics (IVBIY) has received a second Breakthrough Therapy Designation (BTD) from China's NMPA for IBI363, its PD-1/IL-2α-bias bispecific antibody fusion protein, targeting immunotherapy-resistant squamous non-small cell lung cancer (sqNSCLC). The drug has already received BTDs from China's NMPA and Fast Track Designations from the U.S. FDA for both sqNSCLC and melanoma indications. Phase 1 clinical study data presented at ASCO 2025 showed manageable safety profiles and encouraging efficacy in immunotherapy-resistant patients. IBI363 combines PD-1 blockade with IL-2-driven tumor-specific T-cell expansion mechanisms. The company is advancing global development with a registrational study in melanoma and plans for additional trials in lung and colorectal cancer.

Positive

• Received second Breakthrough Therapy Designation from China's NMPA for sqNSCLC indication
• Obtained Fast Track Designations from U.S. FDA for both sqNSCLC and melanoma indications
• Phase 1 clinical study showed promising safety and efficacy results in multiple cancer types
• First registrational study already initiated for acral and mucosal melanoma

Negative

• Still in early clinical development phases for most indications
• Requires additional registrational trials for lung cancer and colorectal cancer
• Faces competition from established immunotherapy treatments

SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. To date, IBI363 has received BTDs from China's NMPA CDE and Fast Track Designations (FTDs) from the U.S. FDA for two indications—sqNSCLC and melanoma. The latest BTD further advances IBI363's potential in addressing immunotherapy resistance and cold tumor challenges.

The latest data from the Phase 1 clinical study of IBI363 in subjects with squamous non-small cell lung cancer (sqNSCLC) who previously received immunotherapy were reported in an oral presentation at the 2025 ASCO Annual Meeting. Manageable safety, encouraging efficacy, and long-term survival benefits were observed in both immunotherapy-resistant squamous non-small cell lung cancer and wild-type lung adenocarcinoma, offering new therapeutic hope for immunotherapy-resistant patients. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention.

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "IBI363 could potentially be a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshape the tumor microenvironment. Recent regulatory milestones, including multiple FTDs and BTDs, underscore its clinical value in addressing unmet needs. We are accelerating IBI363's global development across multiple tumor types: the first registrational study in acral and mucosal melanoma, a head-to-head trial against pembrolizumab, has already been initiated. We will communicate with regulatory authorities about additional registrational clinical trials for lung cancer and colorectal cancer, bringing innovation therapies at the forefront of immunotherapy to benefit global patients."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.

About Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Lung cancer is the most common and deadliest malignancy worldwide, including in China^[1], posing a significant public health challenge. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases^[2], with squamous cell carcinoma being one of its two major subtypes^[2]. In recent years, immune checkpoint inhibitors have transformed the treatment landscape for NSCLC. However, for patients with NSCLC who have failed immunotherapy and lack driver gene mutations, there remains a significant and urgent unmet need for effective treatment options. The standard second- or third-line treatment, docetaxel, offers limited efficacy, with a median progression-free survival (PFS) of less than four months^[3],[4]. While antibody-drug conjugates (ADCs) have shown promise, two large Phase 3 studies in squamous NSCLC have yet to demonstrate satisfactory efficacy^[3],[4].

About IBI363 (First-in-class PD-1/IL-2^α-bias bispecific antibody fusion protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models.

At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention.

In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.

IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively.

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 15 products in the market. It has 3 new drug applications (NDA) under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli 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.

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.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

References: 1 Globocan 2022 (version 1.1) - 08.02.2024 2 NCCN guidelines (NSCLC, version 3.2025) 3 J Clin Oncol . 2025 Jan 20;43(3):260-272. doi: 10.1200/JCO-24-01544. 4 J Clin Oncol . 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733.

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SOURCE Innovent Biologics

FAQ

What is IBI363 and how does it work?

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein that combines PD-1 blockade with IL-2-driven tumor-specific T-cell expansion to treat various cancers.

What designations has IVBIY's IBI363 received from regulatory authorities?

IBI363 has received two Breakthrough Therapy Designations from China's NMPA and Fast Track Designations from the U.S. FDA for both sqNSCLC and melanoma indications.

What were the results of IBI363's Phase 1 clinical trial?

The Phase 1 trial showed manageable safety profiles, encouraging efficacy, and long-term survival benefits in immunotherapy-resistant squamous non-small cell lung cancer and wild-type lung adenocarcinoma.

What types of cancer is IBI363 being developed to treat?

IBI363 is being developed for multiple cancer types including squamous non-small cell lung cancer, melanoma, and colorectal cancer, particularly focusing on immunotherapy-resistant cases.

What is the current development status of IBI363?

IBI363 has initiated its first registrational study in acral and mucosal melanoma, with plans for additional registrational trials in lung cancer and colorectal cancer.