You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 20, 2025

Investigational Drug Information for Surufatinib


✉ Email this page to a colleague

« Back to Dashboard


What is the development status for investigational drug Surufatinib?

Surufatinib is an investigational drug.

There have been 68 clinical trials for Surufatinib. The most recent clinical trial was a Phase 2 trial, which was initiated on December 7th 2015.

The most common disease conditions in clinical trials are Carcinoma, Neuroendocrine Tumors, and Neoplasms. The leading clinical trial sponsors are Hutchison Medipharma Limited, Sun Yat-sen University, and Fujian Cancer Hospital.

There are two US patents protecting this investigational drug and twenty-one international patents.

Recent Clinical Trials for Surufatinib
TitleSponsorPhase
A Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard TherapyShanghai Changzheng HospitalN/A
A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine TumorsChanghai HospitalPhase 2
A Study of Surufatinib in the Treatment of Advanced Soft Tissue SarcomaFudan UniversityN/A

See all Surufatinib clinical trials

Clinical Trial Summary for Surufatinib

Top disease conditions for Surufatinib
trials0123456789101112CarcinomaNeuroendocrine TumorsNeoplasms[disabled in preview]
Top clinical trial sponsors for Surufatinib
trials0246810121416182022Hutchison Medipharma LimitedSun Yat-sen UniversityFujian Cancer Hospital[disabled in preview]

See all Surufatinib clinical trials

US Patents for Surufatinib

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
Surufatinib ⤷  Subscribe Compound, certain novel forms thereof, pharmaceutical compositions thereof and methods for preparation and use Hutchison MediPharma Limited (Shanghai, CN) ⤷  Subscribe
Surufatinib ⤷  Subscribe Compound, certain novel forms thereof, pharmaceutical compositions thereof and methods for preparation and use Hutchison Medipharma Limited (Shanghai, CN) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 2 of 2 entries

International Patents for Surufatinib

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
Surufatinib Australia AU2010321366 2029-11-23 ⤷  Subscribe
Surufatinib Brazil BR112012012138 2029-11-23 ⤷  Subscribe
Surufatinib Canada CA2781066 2029-11-23 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 3 of 3 entries

Surufatinib: A Promising Drug Candidate for Neuroendocrine Tumors

Introduction

Surufatinib, developed by HUTCHMED Limited, is a novel oncology drug candidate that has shown significant promise in the treatment of neuroendocrine tumors (NETs), particularly pancreatic and extra-pancreatic NETs. Here, we will delve into the recent development updates, clinical trial results, and market projections for this drug.

Clinical Development and Trial Results

Surufatinib has undergone extensive clinical testing, with two pivotal Phase III trials conducted in China and one study in the United States.

Phase III SANET-p Trial

The SANET-p trial, a randomized, double-blind, placebo-controlled study, demonstrated that surufatinib significantly improved progression-free survival (PFS) in patients with progressive, advanced, well-differentiated pancreatic NETs. The trial showed a hazard ratio of 0.49 (95% CI, 0.32-0.76), indicating a 51% reduction in the risk of disease progression or death compared to the placebo group[1][3].

Phase III SANET-ep Trial

The SANET-ep trial, focusing on non-pancreatic NETs, also yielded positive results, with surufatinib reducing the risk of disease progression or death across multiple subgroups of patients. These results were published in The Lancet Oncology[3].

Regulatory Submissions and Approvals

FDA Submission

HUTCHMED completed a rolling submission for the New Drug Application (NDA) for surufatinib to the U.S. FDA in 2021. This submission was based on data from the Phase III trials in China and the U.S. study. The company is eagerly awaiting FDA approval to provide this therapeutic option to NET patients in the U.S. and globally[1].

Fast Track and Orphan Drug Designations

In the U.S., surufatinib has been granted Fast Track Designations for the development in both pancreatic and non-pancreatic NETs, as well as Orphan Drug Designation for pancreatic NET. These designations highlight the drug's potential to address significant unmet medical needs[5].

Market Performance and Projections

Sales and Revenue

Surufatinib, marketed as SULANDA®, has seen significant growth in sales. In the first half of 2023, in-market sales increased by 66% (79% at constant exchange rates) to $22.6 million, reflecting its growing acceptance and demand in the market[2].

Global Expansion

While HUTCHMED has decided not to file a Japanese NDA for surufatinib based on current clinical trial data, the drug is being evaluated for regulatory interactions in the U.S., Europe, and other regions. This global approach is expected to expand its market reach and patient access[4].

Clinical Collaborations and Future Development

Collaboration with BeiGene

HUTCHMED and BeiGene have entered into a clinical collaboration to evaluate the combination of surufatinib with BeiGene’s anti-PD-1 antibody tislelizumab for various solid tumor cancers. This collaboration aims to explore multiple indications and regions, including the U.S., Europe, China, and Australia[5].

Patient Access and Expanded Programs

Expanded Access Program

An expanded access program for surufatinib is currently underway in the United States, allowing patients to access the drug before its potential FDA approval. This program underscores HUTCHMED's commitment to providing critical therapeutic options to patients in need[1].

Financial and Business Updates

Revenue Recognition

In addition to the sales growth, HUTCHMED has recognized significant revenue from various sources, including a $400 million upfront payment from Takeda for licensing agreements. This financial support is crucial for the ongoing development and commercialization of surufatinib and other drug candidates[2].

Expert Insights and Industry Impact

"Having successfully launched surufatinib in China early this year, we are now looking forward, subject to its approval, to being able to provide access to this important new therapeutic option for NET patients in the U.S. and beyond," said Marek Kania, MD, MBA, Managing Director and Chief Medical Officer of HUTCHMED International Corporation[1].

Key Statistics and Highlights

  • Progression-Free Survival (PFS): Median PFS was 10.9 months for patients treated with surufatinib, compared to 3.7 months for the placebo group (HR 0.491; 95% CI 0.391-0.755; p=0.0011)[3].
  • Objective Response Rate (ORR): 19.2% for the surufatinib group versus 1.9% for the placebo group[3].
  • Sales Growth: 66% increase in in-market sales in the first half of 2023 to $22.6 million[2].

Conclusion

Surufatinib represents a significant advancement in the treatment of neuroendocrine tumors, with robust clinical trial results and growing market acceptance. As HUTCHMED continues to navigate regulatory approvals and expand its global reach, surufatinib is poised to become a critical therapeutic option for patients with NETs worldwide.

Key Takeaways

  • Surufatinib has demonstrated significant improvement in PFS for patients with pancreatic and extra-pancreatic NETs.
  • The drug has received Fast Track and Orphan Drug Designations in the U.S.
  • Sales of surufatinib have shown substantial growth, with a 66% increase in the first half of 2023.
  • HUTCHMED is engaged in clinical collaborations to explore combination therapies with other drugs.
  • An expanded access program is underway in the U.S. to provide early access to the drug.

FAQs

Q: What is surufatinib used for? A: Surufatinib is used for the treatment of neuroendocrine tumors (NETs), specifically pancreatic and extra-pancreatic NETs.

Q: What are the key findings from the Phase III trials of surufatinib? A: The Phase III trials showed that surufatinib significantly improved progression-free survival (PFS) and reduced the risk of disease progression or death by 51% compared to the placebo group.

Q: Has surufatinib received any special designations from regulatory bodies? A: Yes, surufatinib has received Fast Track Designations and Orphan Drug Designation in the U.S. for the treatment of pancreatic and non-pancreatic NETs.

Q: What is the current status of surufatinib's regulatory submissions? A: The New Drug Application (NDA) for surufatinib has been submitted to the U.S. FDA and is awaiting approval.

Q: Are there any ongoing clinical collaborations involving surufatinib? A: Yes, HUTCHMED and BeiGene are collaborating to evaluate the combination of surufatinib with tislelizumab for various solid tumor cancers.

Sources

  1. Cancer Network: "New Drug Application Complete for Surufatinib to Treat Pancreatic and Extra-Pancreatic NETs"[1].
  2. BioSpace: "HUTCHMED Reports 2023 Interim Results and Provides Business Updates"[2].
  3. HUTCHMED: "Chi-Med Highlights Surufatinib Phase III Results in Neuroendocrine Tumors"[3].
  4. GlobeNewswire: "HUTCHMED Reports 2023 Interim Results and Provides Business Updates"[4].
  5. GlobeNewswire: "Chi-Med and BeiGene Enter into Clinical Collaboration to Evaluate Combinations of Surufatinib and Fruquintinib with Tislelizumab"[5].

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.