Tislelizumab-jsgr - Biologic Drug Details

Summary for tislelizumab-jsgr

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for tislelizumab-jsgr

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for tislelizumab-jsgr Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tislelizumab-jsgr Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tislelizumab-jsgr Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Tislelizumab-jsgr

Introduction

Tislelizumab, a monoclonal antibody and a PD-1 inhibitor, has been making significant waves in the oncology market, particularly in the treatment of various types of cancer. Developed by BeiGene, tislelizumab-jsgr (hereafter referred to as tislelizumab) is part of a broader class of immune checkpoint inhibitors that have revolutionized cancer therapy.

Market Overview of Immune Checkpoint Inhibitors

The global immune checkpoint inhibitors market is experiencing rapid growth, driven by factors such as the increasing prevalence of cancer, advancements in clinical trials, and regulatory approvals. The market was valued at USD 62.51 billion in 2024 and is projected to reach USD 189.40 billion by 2033, with a CAGR of 11.98% during the forecast period[1].

Tislelizumab: A Key Player in the PD-1 Inhibitor Market

Tislelizumab is one of the several PD-1 inhibitors that have gained significant traction in recent years. While KEYTRUDA and OPDIVO dominate the market, tislelizumab has carved out its own niche, particularly in regions like China.

Regulatory Milestones

Tislelizumab has received several regulatory approvals, including those in China and other countries. For instance, BeiGene submitted the first biologics license application (BLA) for tislelizumab in the U.S. in collaboration with Novartis for patients with advanced or metastatic esophageal squamous cell carcinoma following prior systemic therapy[3].

Clinical Development

The clinical development of tislelizumab has been robust, with multiple ongoing and completed clinical trials. These trials have demonstrated the efficacy and safety of tislelizumab in various cancer indications, which has been crucial for its market acceptance[4].

Financial Performance of Tislelizumab

The financial performance of tislelizumab has been impressive, reflecting its growing market presence.

Sales Revenue

In the fourth quarter of 2023, sales of tislelizumab reached $128.0 million, and for the full year, they totaled $536.6 million. This represents a significant increase from the prior year, where sales were $102.2 million and $422.9 million, respectively[2].

Market Penetration

Tislelizumab has shown strong market penetration, particularly in China. In the third quarter of 2021, sales of tislelizumab in China totaled $77.0 million, representing a 54% increase compared to the prior year period. This growth was driven by broader reimbursement, expansion of the sales force, and increased hospital listings[3].

Regional Market Dynamics

North America

While North America is the largest market for immune checkpoint inhibitors, tislelizumab's presence is more pronounced in other regions. However, regulatory approvals and partnerships are expected to increase its footprint in North America[1].

Asia-Pacific

The Asia-Pacific region, particularly China, has been a key growth area for tislelizumab. The region's rapid growth is driven by increasing cancer incidence, heightened awareness of advanced cancer therapies, and growing investments in healthcare infrastructure. Improving regulatory frameworks and partnerships between local and global pharmaceutical companies have also facilitated greater access to tislelizumab[1].

Competitive Landscape

The PD-1 inhibitor market is highly competitive, with KEYTRUDA and OPDIVO being the dominant players. However, tislelizumab has managed to secure a significant market share, especially in non-U.S. markets.

Key Competitors

• KEYTRUDA: Dominates the U.S. market with over 50% market share across 20 indications[4].
• OPDIVO: Leads in Japan and holds a significant share globally[4].
• LIBTAYO: Leads in non-melanoma skin cancers[4].

Future Outlook

The future outlook for tislelizumab is promising, driven by several factors:

Increasing Cancer Incidence

The global prevalence of cancer is increasing, which will drive the demand for effective cancer therapies like tislelizumab[1].

Ongoing Clinical Trials

Ongoing and planned clinical trials exploring new indications and combination therapies will further enhance the therapeutic landscape for tislelizumab[1].

Regulatory Approvals

Pending and future regulatory approvals in additional markets will expand the reach of tislelizumab, contributing to its market growth[3].

Financial Projections

Given the current trends, tislelizumab is expected to continue its strong financial performance. Here are some key financial projections:

Revenue Growth

Tislelizumab's revenue is expected to grow significantly, driven by increased market penetration and new regulatory approvals. By 2033, the overall immune checkpoint inhibitors market, which includes tislelizumab, is projected to reach USD 189.40 billion[1].

Gross Margin

BeiGene's gross margin percentage has increased due to a higher product sales mix of tislelizumab and other high-margin products. This trend is expected to continue, contributing to the financial health of the company[2].

Key Takeaways

• Market Growth: Tislelizumab is part of a rapidly growing immune checkpoint inhibitors market.
• Regulatory Approvals: Multiple regulatory approvals have been secured, with more pending.
• Financial Performance: Strong sales revenue and increasing market penetration.
• Regional Dynamics: Significant presence in the Asia-Pacific region, particularly China.
• Competitive Landscape: Competes with KEYTRUDA and OPDIVO but has a strong niche market.

FAQs

What is tislelizumab-jsgr?

Tislelizumab-jsgr, or tislelizumab, is a PD-1 inhibitor used in the treatment of various types of cancer.

Who developed tislelizumab?

Tislelizumab was developed by BeiGene.

What are the key regulatory milestones for tislelizumab?

Tislelizumab has received several regulatory approvals, including those in China, and has pending approvals in other markets such as the U.S.[3].

How has tislelizumab performed financially?

Tislelizumab has shown strong financial performance, with sales of $128.0 million in the fourth quarter of 2023 and $536.6 million for the full year 2023[2].

What is the future outlook for tislelizumab?

The future outlook is promising, driven by increasing cancer incidence, ongoing clinical trials, and pending regulatory approvals.

Sources

1. Straits Research: Immune Checkpoint Inhibitors Market Size, Global Trends, Top Players.
2. BeiGene: Fourth Quarter and Full Year 2023 Financial Results and Business Updates.
3. BeiGene: Third Quarter 2021 Financial Results.
4. PR Newswire: PD-(L)1 Inhibitors Market to Remarkable Growth at a CAGR of 5% by 2034.