Congratulations! Qilu Pharmaceutical's Class 1 New Drug Qibian® (Aipalolitovorilimab Injection) Approved for Market Launch with Efficient Support from Taimei Medical's IRC Services
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On September 30, the National Medical Products Administration announced that Qilu Pharmaceutical's Aiparoli-Tovorali Monoclonal Antibody Injection (Qibean®) has been approved for marketing to treat recurrent or metastatic cervical cancer. According to publicly available information, this drug is a bifunctional combination antibody independently developed by Qilu Pharmaceutical over seven years and is about to enter clinical use, offering the potential to provide more options for cancer patients.
Notably, Aipalolitovorelizumab Injection (Aito Combination Antibody, R&D code QL1706) is the world's first approved PD-1/CTLA-4 bifunctional combination antibody, consisting of an IgG4-type PD-1 antibody and an IgG1-type CTLA-4 antibody in a specific ratio.CTLA-4 and PD-1 pathways can both negatively regulate T-cell immune function. The combination of antibodies can simultaneously target and block these two immune checkpoint signaling pathways, activating anti-tumor immune responses.
Source of the image: National Medical Products Administration
As a long-term strategic partner, the Independent Review Center (IRC) of Taimei Medical Technology undertook the independent efficacy assessment for the pivotal study supporting this approval. Relying on extensive experience in independent efficacy assessments, a robust quality management system, an efficient digital collaboration platform, and premium services with rapid response, the project results were delivered on time with high quality, facilitating the product's approval and earning praise from the sponsor.
Previously, the two parties have collaborated on several key clinical studies, leading to the smooth approval of multiple innovative drugs and indications.
Relevant reports:
The pivotal Phase II registrational study (DUBHE-C-206) supporting the approval and market launch of Aipalolituo Weirili monoclonal antibody is a multi-center, single-arm, open-label Phase II clinical trial that enrolled patients with recurrent/metastatic cervical cancer who had failed first-line platinum-based chemotherapy ± bevacizumab and had not received prior immunotherapy. The study included 148 patients. At a median follow-up time of 17.5 months, the ORR was 33.3%, the DCR was 65.3%, the median PFS reached 5.4 months (all assessed by IRC), and the median OS reached 17.1 months. In terms of safety, a total of 107 patients (72.3%) experienced treatment-related adverse events (TRAEs), with 40 patients (27.0%) experiencing Grade ≥3 TRAEs.
The results show that the Aito combination antibody demonstrates good efficacy and safety in patients with recurrent/metastatic cervical cancer who have failed first-line standard treatment, and is expected to become a more effective and safer choice for later-line treatment of cervical cancer patients.
Taimei Medical Technology sincerely congratulates its partners on their achievements and looks forward to continuing the cooperation in the future, creating more brilliant results together!
About Taimei Medical Technology Independent Review Center (IRC)
The Independent Review Center (IRC) of Taimei Medical Technology, relying on its self-developed eImage system, supports remote imaging evaluation and full-process online operation management. With a professional medical and project operations team, as well as extensive resources from senior imaging medicine/imaging experts both domestically and internationally, the IRC ensures efficient, compliant, and accurate blinded independent central imaging review, reduces evaluation bias, enhances the accuracy and reliability of imaging results, accelerates trial progress and approval, and lowers costs. To date, the company has provided IRC services to over 150 sponsors, with experience in more than 350 projects, of which nearly 50 projects have passed inspection and 31 projects have been approved for marketing.
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