Hengrui's Famitinib Approved for a New Indication: Combined with Camrelizumab as the First Chemotherapy-Free First-Line Treatment for Recurrent o

On July 23, 2026, China's National Medical Products Administration (NMPA) approved a new indication for Famitinib, a Class 1 innovative drug independently developed by Hengrui Pharmaceuticals, in combination with the PD-1 inhibitor Camrelizumab for the first-line treatment of patients with recurrent or metastatic cervical cancer.

This approval not only marks the second approved indication for Famitinib but also makes the Famitinib + Camrelizumab regimen the first approved chemotherapy-free first-line treatment (Chemotherapy-Free Regimen) for recurrent or metastatic cervical cancer in China, representing another significant milestone for China's innovative drug development in gynecologic oncology.

In this article, DengYueMed, a China pharmaceutical wholesaler, reviews the background of this new approval, the key Phase III clinical trial results, and its significance for the treatment of recurrent or metastatic cervical cancer.

What Is Famitinib?

Famitinib Malate is an orally administered, small-molecule multi-target tyrosine kinase inhibitor (TKI) independently developed by Hengrui Pharmaceuticals. It is an anti-angiogenic targeted therapy designed to inhibit multiple receptor tyrosine kinases involved in tumor growth and vascular development.

Its primary targets include:

● VEGFR (Vascular Endothelial Growth Factor Receptor)

● PDGFR-β (Platelet-Derived Growth Factor Receptor Beta)

● c-Kit

● Other receptor tyrosine kinases

By simultaneously blocking multiple angiogenesis-related signaling pathways, Famitinib can:

● Inhibit tumor angiogenesis

● Reduce the tumor blood supply and nutrient delivery

● Suppress tumor growth and metastasis

● Work synergistically with immunotherapy to enhance antitumor activity

What Were Famitinib's Previously Approved Indications?

Famitinib received its first NMPA approval in May 2025.

Its initial approved indication was:

In combination with Camrelizumab for the treatment of patients with recurrent or metastatic cervical cancer who had previously failed platinum-based chemotherapy and had not received bevacizumab.

With this latest approval, the indication has been expanded to include:

First-line treatment for patients with recurrent or metastatic cervical cancer.

This expansion moves the therapy to an earlier stage of treatment, providing patients with an opportunity for longer disease control and improved long-term outcomes.

Approval Based on the Phase III SHR-1210-III-329 Clinical Trial

The new indication was supported by positive results from the Phase III SHR-1210-III-329 clinical trial.

Key features of the study included:

● Phase III randomized trial

● Open-label design

● Controlled study

● Multicenter clinical trial

● Conducted across 45 clinical centers in China

● Enrolled 443 patients

The study compared:

● Famitinib plus Camrelizumab

● Versus

● Standard platinum-based chemotherapy

The primary endpoints were:

● Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

● Overall Survival (OS)

Phase III Results: Significant Improvements in Both PFS and OS

According to the primary analysis conducted as of June 10, 2025, the study successfully met all primary endpoints.

Progression-Free Survival (PFS)

Famitinib + Camrelizumab:

11.1 months

Standard chemotherapy:

7.5 months

Results:

● HR = 0.68

● P = 0.0007

These findings indicate a significant reduction in the risk of disease progression.

Overall Survival (OS)

Combination therapy:

34.4 months

Chemotherapy:

23.4 months

Results:

● HR = 0.65

● P = 0.0012

The combination therapy not only delayed disease progression but also significantly improved overall survival compared with chemotherapy.

Why Is a Chemotherapy-Free Regimen Important?

For patients with recurrent or metastatic cervical cancer, first-line treatment plays a critical role in determining long-term prognosis and quality of life.

Current international and Chinese clinical guidelines continue to recommend platinum-based chemotherapy, with or without bevacizumab, as the standard first-line treatment.

However, conventional chemotherapy has several limitations, including:

● Significant treatment-related toxicities

● Limited tolerability for some patients

● Development of drug resistance over time

● Negative impact on patients' quality of life

Therefore, developing effective chemotherapy-free treatment strategies has become an important goal in cervical cancer research.

The approval of Famitinib plus Camrelizumab represents the first approved chemotherapy-free first-line treatment for recurrent or metastatic cervical cancer in China, offering patients a new therapeutic option.

Potential Advantages of Famitinib Combined with Camrelizumab

Based on the available clinical data, this combination therapy offers several potential benefits:

● Eliminates the need for conventional platinum-based chemotherapy

● Significantly prolongs progression-free survival (PFS)

● Significantly improves overall survival (OS)

● Combines targeted therapy with immunotherapy for synergistic antitumor effects

● Provides an alternative treatment option for patients who are unable to tolerate chemotherapy

Treatment decisions should always be made by oncology specialists based on each patient's individual clinical condition.

China's Innovative Drugs Continue to Advance Cervical Cancer Treatment

In recent years, China's domestically developed innovative medicines have continued to expand treatment options across multiple oncology indications.

Represented by innovative therapies such as Famitinib and Camrelizumab, an increasing number of Chinese-developed treatment regimens have demonstrated clinical benefits in large Phase III trials and are gradually being incorporated into clinical practice.

The approval of this new indication not only broadens treatment strategies for cervical cancer but also highlights the progress China has made in combining targeted therapy with immunotherapy.

As additional clinical data become available and more findings are presented at international scientific meetings, this combination regimen is expected to benefit more patients with recurrent or metastatic cervical cancer worldwide.

Conclusion

The approval of Famitinib's new indication marks a new era of chemotherapy-free first-line treatment for recurrent or metastatic cervical cancer. As an innovative targeted therapy developed by Hengrui Pharmaceuticals, the combination of Famitinib and Camrelizumab has demonstrated significant improvements in both progression-free survival and overall survival while providing clinicians with a new treatment strategy.

As more Chinese innovative medicines continue to enter the market, cancer treatment in China is moving toward greater precision, personalization, and higher-quality care.

As a China pharmaceutical wholesaler specializing in the global pharmaceutical supply chain, DengYueMed is committed to supplying Chinese innovative medicines, specialty pharmaceuticals, and orphan drugs to pharmaceutical distributors, hospitals, pharmacies, and healthcare institutions worldwide. We also support pharmaceutical exports, international distribution, cross-border pharmaceutical supply chain management, and compliant drug procurement solutions for global healthcare partners.