Qilu Pharmaceutical's Qibei'an® New Indication NDA for Cervical Cancer Accepted by CDE, Reshaping Treatment Landscape

Apr 24, 2026 13:44 CST Updated 13:44

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

The latest information disclosed on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) shows that on April 24, 2026, Qilu Pharmaceutical Co., Ltd. submittedAipalolitovorelimab Injection (Trade Name: Qibean ®, R&D Code: QL1706)New Indication NDA Officially Accepted by CDE, with Reference Number CXSS2600072, Classified as Category 2.2 Therapeutic Biologic Product. This marks another key milestone in the field of oncology treatment since the product's market approval in September 2024, signifying that this world-first bifunctional combination antibody is formally advancing towards first-line treatment for advanced cervical cancer.

World's First Dual-Function Combination Antibody, Solving the Pain Points of Dual-Immunotherapy Industry

Epaloplituzumab Injection is a Class 1 innovative biologic developed by Qilu Pharmaceutical based on its independently researched and developed MabPair® combination antibody technology platform over a period of 7 years, and it is alsoThe World's First Approved PD-1/CTLA-4 Bispecific Combination Antibody。

This product is composed of Aipalolizumab, an IgG4-type antibody targeting PD-1, and Tovorolizumab, an IgG1-type antibody targeting CTLA-4, combined in a fixed optimized ratio of 2:1. Its core innovation lies in simultaneously blocking the two key immune checkpoint signaling pathways, PD-1/PD-L1 and CTLA-4/B7, which not only relieves the immunosuppression of T cells by the tumor microenvironment but also enhances their anti-tumor activity during the early activation of T cells, achieving synergistic efficacy at dual targets.

More importantly, the product, through antibody engineering modifications, significantly reduces the half-life of the CTLA-4 antibody component in the body. While retaining the synergistic anti-tumor efficacy of dual immunotherapy, it markedly decreases the high incidence of immune-related adverse reactions associated with the traditional PD-1 and CTLA-4 combination therapy, perfectly addressing the industry pain point of "difficulty balancing efficacy and safety" in dual immunotherapy.

On September 30, 2024, the product received conditional approval from the National Medical Products Administration (NMPA) for marketing in China. It is indicated for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy, becoming an important innovative option for second-line treatment of advanced cervical cancer in China. Key data from the Phase II pivotal registration clinical trial showed that at a median follow-up of 17.5 months, the objective response rate (ORR) reached 33.3%, the disease control rate (DCR) was 65.3%, the median progression-free survival (PFS) reached 5.4 months, and the median overall survival (OS) reached 17.1 months. Notably, in PD-L1 CPS <1 negative populations, an ORR of 25.6% was still achieved, breaking through the limitation of traditional immunotherapy benefiting only PD-L1 positive populations.

First-line Phase III Clinical Trial Meets Dual Endpoints, Benefits Entire Population and Fills Clinical Gap

The acceptance of this new indication marketing application is mainly based on the positive results of the QL1706-301 study published by Qilu Pharmaceutical in March 2026. This is a double-blind, placebo-controlled, randomized multicenter Phase III clinical study aimed at evaluating the efficacy and safety of Qibean ® combined with platinum-based chemotherapy ± bevacizumab for the first-line treatment of persistent, recurrent, or metastatic cervical cancer.

The research results show that the program is effective across the entire population,Both pre-set primary endpoints, progression-free survival (PFS) and overall survival (OS), achieved statistically significant improvements., achieving the primary endpoint of the study. At the same time, in the PD-L1 CPS < 1 negative population accounting for 19.1%, clear therapeutic benefits were also demonstrated, fully reflecting the differentiated advantages of bifunctional immunotherapy. In terms of safety, the overall tolerance of this combination regimen was good, no new safety signals were observed, and the safety profile was consistent with the results of previous clinical studies.

Cervical cancer is the third most common malignant tumor among women globally. In China, there are approximately 100,000 new cases each year, with over 30,000 annual deaths, posing a serious public health threat to women. For recurrent or metastatic cervical cancer, platinum-based chemotherapy combined with bevacizumab is currently the standard first-line treatment regimen, but patients' long-term survival benefits remain limited, with a 5-year survival rate of less than 20%.

Despite the dual immunotherapy combining PD-1 and CTLA-4 demonstrating excellent efficacy across multiple solid tumors, the high incidence of adverse reactions has limited its widespread application as a first-line treatment for cervical cancer. The success of Qilu Pharmaceutical's Phase III study on Qibean ® as a first-line therapy, along with the acceptance of this marketing application, is expected to bring a new, highly effective, and low-toxicity dual immunotherapy option to patients with advanced cervical cancer in China, addressing the clinical gap for PD-L1 negative populations who currently lack effective immunotherapy options.

From Second-line to First-line, China-produced Innovative Drugs Continue to Broaden Treatment Boundaries

As the first large-molecule innovative drug approved for marketing by Qilu Pharmaceutical, Qibean ® has drawn significant industry attention since its inception. Its market entry achievements have been successively selected as one of the Top Ten Scientific and Technological Innovation Achievements in Shandong Province in 2024 and featured in the 2025 Shandong Provincial Government Work Report, becoming one of the benchmark products of China-produced biologic innovation drugs.

The acceptance of this new indication for marketing application means that the product is expected to achieve full-course coverage from second-line treatment to first-line treatment for cervical cancer, further consolidating its therapeutic position in the field of gynecological oncology. In addition, the product is also conducting clinical research in several high-incidence solid tumors such as liver cancer, non-small cell lung cancer, colorectal cancer, and nasopharyngeal cancer. Several Phase II clinical studies have shown excellent efficacy data, and in the future, it is expected to continuously broaden the indications boundary to benefit more cancer patients.

In recent years, domestically produced innovative drugs have continued to make breakthroughs in cutting-edge fields of tumor immunotherapy such as dual immunotherapy and bispecific antibodies. The acceptance of the new indication application for Qibeian® by the CDE not only represents another significant achievement for Qilu Pharmaceutical in the field of tumor immunotherapy but also marks that China-produced innovative drugs have achieved a leap from following to leading in the dual immunotherapy track, contributing a Chinese solution to global cancer treatment.

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