Last updated: February 19, 2026
This report analyzes Chinese patent CN111465413, titled "An anti-PD-1 antibody and its application." The patent, filed on April 23, 2018, and published on August 21, 2020, claims a specific anti-PD-1 antibody, related pharmaceutical compositions, and their use in treating cancers. Key elements include the antibody's sequence, its binding characteristics, and therapeutic applications, particularly in conjunction with other treatments.
What is the claimed antibody?
The core of CN111465413 is a humanized anti-PD-1 antibody. The patent specifies the antibody's light chain variable region and heavy chain variable region by their amino acid sequences. These sequences are critical for defining the antibody's unique structure and binding properties.
Antibody Sequence Details
- Light Chain Variable Region (SEQ ID NO: 1): The patent provides the precise amino acid sequence for the light chain variable region of the claimed antibody.
- Heavy Chain Variable Region (SEQ ID NO: 2): Similarly, the patent provides the precise amino acid sequence for the heavy chain variable region of the claimed antibody.
These specific sequences are designed to confer high affinity and specificity for the programmed cell death protein 1 (PD-1) receptor.
What are the binding characteristics of the antibody?
The patent asserts that the claimed anti-PD-1 antibody exhibits specific binding properties essential for its therapeutic function. These properties are quantified through various binding assays.
Binding Affinity and Kinetics
- Binding to PD-1: The antibody is designed to bind to human PD-1. The patent provides data on the equilibrium dissociation constant (KD) of the antibody for PD-1, which is stated to be in the picomolar (pM) range. A lower KD indicates a stronger and more stable binding interaction.
- Blocking PD-1/PD-L1 Interaction: A key functional characteristic is the antibody's ability to block the interaction between PD-1 and its ligand, PD-L1. This blockade is crucial for reactivating T-cells that have been suppressed by the PD-1/PD-L1 pathway, thereby enabling an anti-tumor immune response.
What pharmaceutical compositions are claimed?
CN111465413 claims pharmaceutical compositions comprising the anti-PD-1 antibody. These compositions are formulated for therapeutic administration.
Compositional Elements
- Active Ingredient: The primary active ingredient is the anti-PD-1 antibody as described by its variable region sequences.
- Excipients: The compositions include pharmaceutically acceptable carriers, diluents, stabilizers, and other excipients. These are standard components in drug formulations to ensure stability, solubility, and effective delivery. Examples of excipients may include buffers, salts, and sugars.
What are the claimed therapeutic applications?
The patent outlines the use of the anti-PD-1 antibody and its pharmaceutical compositions for treating various types of cancer. The therapeutic efficacy is attributed to the antibody's ability to restore anti-tumor immunity.
Cancer Treatment Applications
- Monotherapy: The antibody can be used as a standalone treatment for cancers that are responsive to PD-1 pathway blockade.
- Combination Therapy: The patent emphasizes the use of the antibody in combination with other therapeutic agents. This dual approach aims to enhance treatment outcomes.
Specific Combination Therapies Mentioned
- Chemotherapy: The antibody can be administered alongside chemotherapeutic drugs.
- Radiotherapy: The combination with radiation therapy is also claimed.
- Other Immunotherapies: The patent suggests combining the anti-PD-1 antibody with other immune-modulating agents, such as anti-CTLA-4 antibodies or cytokines.
- Targeted Therapy: Combinations with small molecule inhibitors targeting specific cancer pathways are also included.
The patent lists specific cancer types for which these treatments are indicated, including but not limited to:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma
- Bladder cancer
- Head and neck squamous cell carcinoma
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
What is the patent landscape for anti-PD-1 antibodies in China?
The patenting of anti-PD-1 antibodies in China is a competitive and active area, with numerous domestic and international entities filing for protection. CN111465413 is part of this broader landscape.
Key Players and Filing Trends
- Domestic Companies: Chinese pharmaceutical companies have significantly increased their R&D in immuno-oncology, leading to a surge in patent filings for novel antibodies and related therapies.
- International Companies: Global biopharmaceutical giants also actively protect their innovations in the Chinese market.
- Focus Areas: Patent filings typically cover antibody sequences, therapeutic uses, combination therapies, and manufacturing processes.
Overlap and Differentiation
Patents in this space often claim antibodies with specific amino acid sequences, CDR regions, or therapeutic indications. Differentiation is achieved through:
- Novel Epitope Binding: Claiming antibodies that bind to different or overlapping epitopes on PD-1.
- Improved Affinity/Potency: Demonstrating superior binding kinetics or functional activity compared to existing therapies.
- Unique Combination Regimens: Patenting specific combinations of anti-PD-1 antibodies with other drugs for particular cancer types.
- Proprietary Formulations: Developing and patenting novel drug delivery systems or formulations.
The existence of CN111465413 highlights the ongoing innovation and patent activity aimed at securing intellectual property rights for anti-PD-1 therapies in China. Companies operating in this space must conduct thorough freedom-to-operate analyses to navigate existing patents and identify opportunities for innovation.
Key Takeaways
- CN111465413 claims a specific humanized anti-PD-1 antibody defined by its light and heavy chain variable region amino acid sequences.
- The antibody exhibits high affinity for PD-1 (pM KD) and blocks PD-1/PD-L1 interactions.
- The patent covers pharmaceutical compositions containing the antibody and their use in treating various cancers, including monotherapy and combination therapies with chemotherapy, radiotherapy, other immunotherapies, and targeted agents.
- The patent landscape for anti-PD-1 antibodies in China is highly active, with significant competition from both domestic and international entities.
Frequently Asked Questions
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What is the exact sequence of the claimed anti-PD-1 antibody?
The patent provides SEQ ID NO: 1 for the light chain variable region and SEQ ID NO: 2 for the heavy chain variable region, specifying the amino acid sequences.
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Does the patent claim specific dosages or administration routes for the antibody?
While the patent claims pharmaceutical compositions and their therapeutic applications, it does not typically detail specific dosages or administration routes, which are often determined through clinical trials and are not always fully disclosed in foundational patents.
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Can this antibody be used against PD-L1?
The patent claims an anti-PD-1 antibody, meaning it targets the PD-1 receptor, not its ligand PD-L1. Its efficacy stems from blocking the PD-1/PD-L1 interaction.
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Are there any approved drugs in China with similar patent claims?
The patent landscape is dynamic. While CN111465413 is a specific patent, several anti-PD-1 antibodies have received marketing authorization in China, such as those developed by domestic companies like Junshi Biosciences and Hengrui Medicine, and international entities. A freedom-to-operate analysis would be required to determine if this specific patent blocks any approved products.
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What is the expiration date of CN111465413?
The patent was filed on April 23, 2018. In China, utility patents typically have a term of 20 years from the filing date. Therefore, CN111465413 is expected to expire around April 23, 2038, barring any extensions or invalidations.
Citations
[1] An anti-PD-1 antibody and its application. (2020). CN111465413. China National Intellectual Property Administration.
