Qilu Pharma Submits New Indication Application for Groundbreaking PD-1/CTLA-4 Bispecific Antibody Qibei’an® (Iparomlimab and Tuvonralimab Injection) for First-Line Treatment of Advanced Cervical Cancer

Apr 30, 2026 09:51 CST Updated 09:51

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

According to the CDE official website, on April 24, 2026,Qilu Pharmaceutical Co., Ltd. ReportedEpalumab Injection (Qibean®/QL1706)New indication marketing application officially accepted by CDE.

The application number is CXSS2600072, and the registration category is Class 2.2 therapeutic biological products.

This is the product'sSeptember 2024Another key milestone in the field of cancer treatment after receiving approval for marketing, marking the official launch of this world-first dual-function combination antibody.First-line Treatment for Advanced Cervical CancerLaunch the final push.

Epalumab 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 seven years.AlsoThe World's First Approved PD-1/CTLA-4 Bispecific Combination Antibody。

On September 30, 2024, the product was granted conditional approval for marketing by the National Medical Products Administration (NMPA).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.

Its pivotal Phase II registration clinical trial data 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; particularly noteworthy is that in the PD-L1 CPS <1 negative population, an objective response rate of 25.6% was still achieved, breaking through the limitation of traditional immunotherapy benefiting only PD-L1 positive populations.

The acceptance of this new indication marketing application is primarily based on the positive results of the QL1706-301 study published by Qilu Pharmaceutical Co., Ltd. in March 2026.

This is a double-blind, placebo-controlled, randomized multicenter Phase III clinical study aimed at evaluating the efficacy and safety of Qilu Pharmaceutical's Zebenac ® in combination 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 in 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, with about 100,000 new cases annually in China and over 30,000 deaths per year, posing a serious public health threat to women's health.

For recurrent or metastatic cervical cancer, platinum-based chemotherapy combined with bevacizumab is the current first-line standard treatment regimen, but the long-term survival benefit for patients remains limited, with a 5-year survival rate of less than 20%.

Although the dual immunotherapy of PD-1 combined with CTLA-4 has demonstrated excellent efficacy in multiple solid tumors, the high incidence of adverse reactions has limited its widespread application in first-line treatment for cervical cancer.

The success of Qilu Pharmaceutical's Phase III study on Qibean ® as a first-line treatment, as well as the acceptance of this marketing application, is expected to bring a new, highly effective, and low-toxicity first-line dual immunotherapy option to patients with advanced cervical cancer in China, addressing the clinical gap for PD-L1 negative populations who lack effective immunotherapy options.

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 recognized in the Top Ten Scientific and Technological Innovation Achievements of Shandong Province in 2024 and the 2025 Shandong Provincial Government Work Report, establishing itself as one of the benchmark products among China-produced biologic innovative drugs.

The acceptance of this new indication marketing application means that the product is expected to achieve full-course coverage from second-line to first-line treatment for cervical cancer, further consolidating its therapeutic position in the field of gynecological oncology.

Reference: Antibody Circle

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Editor-in-Chief of PharmaCircle—Huaji Meiren (Ww_150525)

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