Qilu Pharmaceutical Advances Innovation Pipeline with Eight First-in-Class Drugs Granted IND Approval in China

Insight database shows that, since 2025, Qilu Pharmaceutical has already...8 Class 1 New DrugsFirst approved for clinical use in China, includingFour chemical drugs and four biologics. In terms of disease areas, the majority are anti-tumor products, with others being new drugs in the fields of cardiovascular, immune system, and other diseases.

Source of the image: Insight Database

   QLS1410

September 2,QLS1410 TabletsClinical Trial Application Approved in China. This is aCYP11B2 Inhibitor, developed for the treatment ofUncontrolled Hypertension。

Screenshot source: CDE official website

In the same month, Qilu Pharmaceutical registered a clinical trial on ClinicalTrials.Phase I Clinical Trial, Aiming toEvaluation of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Ascending Doses of QLS1410 Tablets in Adult Healthy and Mild Essential Hypertensive Participants, with a Planned Enrollment of 78 Subjects.

CYP11B2(Aldosterone Synthase)Inhibitors are a major research and development direction in the field of hypertension treatment. According to the Insight database, the company with the fastest R&D progress in this field isAstraZenecaTheBaxdrostat, has submitted an application for market approval to the FDA; in terms of domestic production, the fastest progress isSalubrisSAL0140, has initiated Phase II clinical trials.

Screenshot source: Insight database

   QLS2309

October 14, Qilu Pharmaceutical Biological ProductsClass 1 New DrugQLS2309 InjectionApproved for clinical use in China, with the indication beingHematological Malignancies。However, Qilu Pharmaceutical has not yet disclosed the specific target and mechanism of action of the drug.

Screenshot source: CDE official website

In September 2025, Qilu Pharmaceutical registered a clinical trial for QLS2309 Injection in China.CD70+ Relapsed/Refractory Hematologic MalignanciesAn open-label Phase I clinical study of tolerability, safety, pharmacokinetics, and preliminary antitumor activity in patients.

According toInclusion and Exclusion Criteria for Clinical Trials: This clinical trial requires the inclusion of CD70+ relapsed/refractory patients.Patients with hematological tumors, excluding those who have previously used antibodies, ADCs, or cell therapy products related to CD70.Insight database speculates that QLS2309 is an innovative drug targeting CD70.

   QLS5133

June 30, InjectableQLS5133 Approved for Clinical Trials in China, Intended for Use inAdvanced Solid Tumors。

Screenshot source: CDE official website

QLS5133 is a new ADC drug independently developed by Qilu Pharmaceutical, includingTargeting Cadherin 6（CDH6）Antibody, payload QLS6916 and cleavable tetrapeptide linker GGFG, with a drug-to-antibody ratio（DAR）It is 8, combining the powerful cytotoxic effects of traditional small-molecule drugs with the tumor-targeting properties of antibody drugs.

Preclinical data shows that, includingOvarian Cancer and Renal Cell CarcinomaIn a variety of animal models, including those resistant to Elahere, QLS5133 has demonstrated excellent efficacy and can still achieve sustained responses. Meanwhile, QLS5133 exhibits superior safety and PK characteristics compared to the reference product.

Insight database shows that currently, there are five CDH6-targeted drugs worldwide that have entered the clinical stage, all of which are ADC products. The fastest in development progress isDaiichi Sankyo/MerckTheRaludotatug deruxtecan has entered Phase II/III clinical trials; besides, the remaining four are all domestically produced in China, originating fromQilu, Simcere Pharma, Hansoh Pharma, Puzhong Discovery。

Screenshot source: Insight database

   QLS5132

On May 6, InjectableQLS5132 In ChinaApproved for clinical use, with the indication beingAdvanced Solid Tumors。QLS5132 isA Novel CLDN6-Targeted ADC。

Source of Screenshot: CDE Official Website

Preclinical data shows that, in animal models, QLS5132Efficacy superior to the reference product（TORL-1-23, Veyotamab）, durable responses can still be achieved in Elahere-resistant animal models. Meanwhile, in the cynomolgus monkey toxicology study, QLS5132Significantly safer than the benchmark product。

The Insight database shows that, currently, globally, there are no ADC drugs with the same target on the market, and only 5 have entered the clinical stage, coming fromQilu, Daiichi Sankyo, Puling Bioetc.

Screenshot source: Insight database

   QLC5513

On October 31, Qilu Pharmaceutical Biological ProductsClass 1 New Drug for InjectionQLC5513 Approved for clinical use in China, with the indication beingAdvanced Malignant Solid Tumors. CurrentlyQilu Pharmaceutical has not yet disclosed the specific target and mechanism of action of the drug.

Screenshot source: CDE official website

On December 9, Qilu PharmaceuticalA clinical trial has been registered on ClinicalTrials.Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate QLC5513 in CombinationEpalrestat/Tovorelizumab（QL1706）± Safety, Tolerability, Pharmacokinetics, and Efficacy of Platinum-based Drugs in Patients with Advanced or Metastatic Malignant Solid Tumors.

The trial plans to enroll 290 people, Exclude previous treatments targeting TROP2Or Topoisomerase 1 Inhibitor（TOP1i）For payloads of ADC or other TOP1i class drugs.Insight Database SpeculatesQLC5513 PossiblyIs a targetedTROP2 ADC drugs deliver cytotoxic agents through antibody-drug conjugation technology to selectively kill tumor cells.

   QLS1209

On March 19, Qilu Pharmaceutical QLS1209TabletApproved for clinical use in China, applicable toAdvanced Solid Tumors。QLS1209 is an orally bioavailable, highly potent, and selectivePKMYT1 Inhibitor。

Screenshot source: CDE official website

As the same targetThe First in ChinaQLS1209, an approved highly efficient and selective inhibitor for clinical use, has demonstrated superior activity in preclinical data within in vivo models featuring CCNE1 amplification and/or FBXW7 loss mutations. The drug is expected to bring a new treatment approach for cancer patients with genetic alterations such as CCNE1 amplification, FBXW7 loss, and PPP2R1A loss.

   QLS12010

On March 12, Qilu PharmaceuticalClass 1 New DrugQLS12010 CapsuleApproved for clinical use in China, intended to targetAtopic Dermatitis,Hidradenitis Suppurativa,Rheumatoid ArthritisThree Major Indications for Clinical Research。However, Qilu Pharmaceutical has not yet disclosed the specific target and mechanism of action of the drug.

Screenshot source: CDE official website

In the same month, Qilu Pharmaceutical launched a project in China.Phase I Clinical Study, ProposedEvaluation of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Ascending Doses of QLS12010 Capsules in Healthy Subjects and Subjects with Atopic Dermatitis.

   QLS1304

On January 14, Qilu Pharmaceutical Co., Ltd. submittedQLS1304 TabletsReceived implied permission for clinical trials, with the indication beingAdvanced solid tumors that have failed prior standard therapyPatient.

Screenshot source: CDE official website

QLS1304 isATargeting KAT6A/BA small molecule inhibitor with high activity, high selectivity, and good oral bioavailability. By inhibiting the acetylation of histone H3 and the estrogen receptor（ER）The expression affects cell cycle and important cell signaling pathways such as MYC, inhibiting tumor growth.

In ER+/HER2- breast cancer in vivo models, QLS1304 either as a single agent or in combination withExisting Standard Therapy（SoC）The combination demonstrated strong anti-tumor efficacy.Notably, QLS1304 also demonstrated efficacy in an ESR1-mutant ER+HER2- PDX model derived from patients resistant to standard therapies.

In addition,The drug has also received clinical tacit approval from the U.S. FDA and has been granted Fast Track designation.