Qilu Pharmaceutical Launches Phase II Trial for CD3/CLDN18.2 Bispecific Antibody QLS31905, with Over 50 Class 1 New Drugs in Pipeline

On June 6, according to the official website of ClinicalTrials.gov, Qilu PharmaceuticalThe registration initiated a Phase II clinical trial to evaluateCD3/CLDN18.2 Bispecific Antibody QLS31905 And/Or QL1706 Combined with ChemotherapyTreatmentEfficacy of CLDN18.2-positive Advanced Solid Tumors(Registration No.:NCT06446388）。

From: ClinicalTrials.gov Official Website

QLS31905 is a Class 1 new drug independently developed by Qilu Pharmaceutical. According to the Insight database, there are currently 18 CD3/CLDN18.2 bispecific antibodies under research globally, of which only 6 have entered clinical trials, involving 5 Chinese companies.And Qilu is one of them, competing on the same stage with Innovent, BeiGene, and others.

Qilu Pharmaceutical is an old-established pharmaceutical company in China. Its strength in the field of generic drugs goes without saying, and its efforts in improved new drugs have gradually borne fruit over the past few years. Currently, its innovative drug development has also started to gain momentum. According to the Insight database, consistent with the overall trend in China, Qilu Pharmaceutical's innovative drug applications began to build up in 2020, gradually increased in 2021, and have now entered a peak period.

Trends in Qilu Pharmaceutical's Innovative Drugs in Recent Years (*Progress in China)

From:Insight Database Web Version (hereinafter referred to as the same source unless otherwise specified)

According to the Insight database, Qilu Pharmaceutical currently has 52 Class 1 new drugs in the clinical stage, including 21 chemical drugs and 31 biologics. The development of biologics has surpassed that of chemical drugs, with a majority being bispecific antibodies. Additionally, further developments have been made.Emerging Fields,Such as siRNA, PROTAC, etc.

Qilu Global: Distribution of 52 Class 1 New Drug Candidates in Clinical Trials

The first to achieve commercial launch isALK/ROS1 Inhibitor Irulak Tablets。First submitted for marketing approval in July 2021, and was approved for marketing in June of last year as a second-line treatment for ALK-positive NSCLC; then received approval in January this year.First-line therapy.

Two other products are in the marketing application stage, including the PD-1 and CTLA-4 combination antibody.QL-1706(Epalumab/Tovorinib) andPD-1 Monoclonal AntibodyEpalrestat, with their listing applications being accepted successively in August and September of last year.

QL-1706 AlsoIt is the first large-molecule innovative drug applied for marketing by Qilu Pharmaceutical.Based on Qilu's independent research and developmentMabPair Antibody PlatformDeveloped,Innovative technology was adopted to modify the heavy chain of the CTLA-4 antibody, reducing its toxic side effects while maintaining the characteristics of high expression, easy purification, high activity, and high stability.

Compared with conventional bispecific antibody platforms, the new drugs developed by MabPair are structurally closer to natural antibodies, demonstrating high druggability, and offer significant advantages in terms of the flexibility in configuring the ratio between two antibodies and selecting the Fc backbone.The platform addresses the issue of light and heavy chain mismatch through different interaction modes based on charge, ensuring greater stability of antibody drugs.

Comparison of MabPair Platform with Ordinary Bispecific Antibodies and Monoclonal Antibody Combinations

From:Corporate Website

QL1706 was announced at the 2023 ESMO CongressFirst-line treatment for cervical cancerPhase II Clinical Results: The mPFS for the bispecific antibody combined with chemotherapy cohort was 12.5 months, and the mPFS for the bispecific antibody combined with chemotherapy plus bevacizumab cohort was 16.4 months, showing an improvement of nearly 4 months.

Recently, the ASCO Annual Meeting announced QL1706.Combination of Gemcitabine and CisplatinFirst-line Treatment for Nasopharyngeal CarcinomaPhase II Trial Data:A total of 28 patients had at least one post-baseline tumor assessment, with an ORR of 82.1% and an mPFS of 12.5 months. In 13 patients with high PD-L1 expression (CPS≥50), the mPFS was 16.2 months.

Currently, QL1706 has launched clinical trials in multiple cancer types, including small cell lung cancer, colorectal cancer, and hepatocellular carcinoma, among others.Hepatocellular carcinoma, cervical cancer, NSCLC, and nasopharyngeal carcinoma have all progressed to Phase III clinical stages (including Phase II/III clinical trials).

Except for QL1706,CD20/CD37 Monoclonal Antibody CompoundPSB 202（QLP31907) is also a bispecific antibody developed based on the MabPair platform.

In the field of bispecific antibodies, according to the Insight database, 10 candidates have entered clinical trials, including the PD-L1/4-1BB bispecific antibody QLF31907, the CD3/LY6G6D bispecific antibody QL335, the CD3/CLL-1 bispecific antibody QL325, the DLL3/CD3 bispecific antibody QLS31904, and the CD47/PD-L1 bispecific antibody QL401.

In the early chemical drug pipeline, Qilu Pharmaceutical has also laid out multiple anti-tumor drugs, including the fourth-generation EGFR inhibitor QLH11811, the pan-RAF inhibitor QLH11906, and another drug that just entered Phase I clinical trials last month.KRAS G12D InhibitorQLC1101, etc.

In addition,According to the Insight database,Qilu Pharmaceutical Co., Ltd.More Than 40 Products in Preclinical Stage, In the ADC field, a MUC1 ADC has been developed through cooperation with Peptron, and CAR-macrophages have also been developed.