On January 17, the CDE official website announced,Qilu PharmaceuticalTheClass 1Innovative DrugQLS5132 for InjectionAndCategory 2.2New DrugQL2107 InjectionClinical ApplicationAccepted simultaneously. This "dual-launch" has refreshed the advancement rhythm of its biopharmaceutical pipeline.

Screenshot source: CDE official website

QLS5132 for InjectionThe acceptance marksQilu PharmaceuticalFormally entering the ADC high-barrier track. As the company's first self-developed CLDN6-targeted（Claudin-6）Antibody-Drug Conjugates（ADC），QLS5132A Class 1 innovative biologic agent intended for the treatment of advanced solid tumors.

CLDN6, as a member of the tight junction protein family, is highly expressed specifically in high-incidence solid tumors such as ovarian cancer, testicular cancer, and lung cancer, with minimal distribution in normal tissues. It has become a "golden target" for tumor-targeted therapy in recent years. According to publicly available information,QLS5132Was first approved for clinical use on May 6, 2025, and is currentlyQilu PharmaceuticalThe first self-developed ADC drug to enter the clinical stage.

Source of screenshot: Global Drug R&D Database (Check Data, Find Mozi)

Accepted on the same dayQL2107 Injection, isQilu PharmaceuticalPembrolizumab developed(Keytruda®, "K Drug")Biosimilar. Pembrolizumab, commonly known as "K drug" among Chinese patients, is a star drug in the field of immunotherapy. Since its first approval by the U.S. FDA in 2014, it has not only shown significant effects in the treatment of melanoma but also demonstrated good efficacy in various cancers such as non-small cell lung cancer and squamous cell carcinoma of the head and neck.

QL2107By binding to the PD-1 receptor, it blocks the PD-1/PD-L1 and PD-1/PD-L2 signaling axes, relieving T-cell immunosuppression and thereby activating anti-tumor immune responses. CurrentlyQilu PharmaceuticalMore than 10 biosimilar drugs have been approved for marketing.

Screenshot source: Global Drug R&D Database (Check Data, Find Moentropy)

Currently, multiple PD-1 analog drugs in China have entered the late clinical stage,The competition in the biosimilar track has reached a fever pitch.QL2107The pace of advancement will directly impact Qilu's position in the immunotherapy market.

Biological drugs areQilu PharmaceuticalOne of the key types of drugs in focus. Data from the Mosentropy pharmaceutical database shows that by 2025,Qilu PharmaceuticalA total of 11 new Class 1 drugs have been approved for clinical trials in China for the first time, six of which are biologics. The indications for these new drugs are highly concentrated in the anti-tumor field, covering several popular research and development directions such as ADCs, bispecific antibodies, and monoclonal antibodies.

Screenshot source: China Drug Evaluation Database (Check Data. Find MoEntropy)

In terms of R&D progress, all 11 Class 1 new drugs have been rapidly advanced to Phase I clinical trials or higher stages. Among them,QLC5508 for Injection、QLS5133 for Injection、QLS5132 for InjectionThree ADC new drugs, further enriching theQilu PharmaceuticalThe hierarchy of the biopharmaceutical pipeline.

At the beginning of 2026,Qilu PharmaceuticalThree Class 1 new drugs have been approved for clinical trials. From early exploration to clinical challenges, Qilu Pharmaceutical's biologics pipeline is transitioning from "single breakthroughs" to "full-scale advancements." Whether it’s the multi-target layout of ADCs or the upcoming clinical trials of bispecific antibodies and peptide drugs, these developments continuously inject momentum into the company’s innovative drug research and development.

Screenshot source: China Drug Evaluation Database (Check Data. Find Moentropy)

In the field of generic drugs，Qilu PharmaceuticalSimilarlyBuilt competitive barriers。Currently, the company has over 35 anti-tumor drugs approved and passed the evaluation, of which 16 are the first to pass the evaluation.These approved varieties, while solidifying their market share, effectively回馈了公司在Investment in R&D for cutting-edge fields such as ADC and bispecific antibodies.

This timeQilu PharmaceuticalTheQLS5132AndQL2107"Double Launch": Two New Drugs Enter Clinical Trials, Undoubtedly Accelerating Innovation and Pipeline Expansion, Bringing New Treatment Options to Patients!

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