Qilu Pharma's Trispecific Antibody QLS2404 Receives CDE Clinical Trial Approval in June Innovation Milestone

Jun 04, 2026 21:50 CST Updated 21:50

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

June 4, 2026: Latest Acceptance Data Disclosed on the CDE Official Website, a Class 1 innovative biological product independently developed by Qilu Pharmaceutical Co., Ltd.QLS2404 Injection, the two clinical trial applications were officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, with acceptance numbers respectively beingCXSL2600600、CXSL2600601, classified as a Class 1 new drug for registration purposes. According to the review public notice information, this product is another original large-molecule new drug from Qilu Pharmaceutical that has entered clinical trial application this year, continuously expanding the company’s pipeline portfolio in targeted biologics.

I. Official acceptance information finalized; dual acceptance numbers simultaneously approved for processing

As can be seen from the details on the CDE Information Disclosure - List of Accepted Varieties page, two acceptance entries for QLS2404 Injection were publicly disclosed simultaneously, with the drug classified asTherapeutic Biological Products, New Drug Class 1 Registration, with Qilu Pharmaceutical Co., Ltd. as the applicant for both submissions, which were accepted on the same day. This represents a rare case in China’s pharmaceutical industry where a single product received two separate clinical trial application acceptance numbers. Industry insiders generally speculate that the two acceptance numbers likely correspond toDifferent Indications, Different Dosing Regimens, or Differentiated Clinical Development Pathways, the CDE will subsequently conduct review and inspection work through separate tracks.

As a long-established leading pharmaceutical company in China, Qilu Pharmaceutical has significantly accelerated its pace in the field of large-molecule innovative drugs over the past two years. The company has comprehensively laid out its portfolio, ranging from bispecific antibodies and trispecific T-cell engagers (TCEs) to antibody-drug conjugates (ADCs) and immune combination antibodies. The QLS series of large-molecule pipelines has become the forefront of the group’s R&D efforts. Previously, several products with the same sequence code, such as the trispecific antibody QLS2401 and the trispecific antibody QLS4131, have progressively advanced to clinical stages. With QLS2404 subsequently submitted for clinical trial approval, the QLS targeted therapy product matrix is being further perfected.

II. Anchoring to the Frontier of Large Molecules, Continuing the Technical Logic of QLS Pipeline

Based on the disclosed patterns in Qilu Pharmaceutical’s QLS R&D pipeline, the QLS-prefixed series of injections are all focused on \\T Cell Engager Bispecific Antibody (TCE)\\Therapeutic area: Targets focused on popular targets for solid tumors/hematologic malignancies. QLS2404 follows the same platform technology system, leveraging Qilu Pharmaceutical’s self-developed antibody engineering optimization platform to design its molecular structure:

Structural Design Optimization: Drawing on the design rationale of QLS2401 (a PSMA/STEAP1/CD3 trispecific antibody), a trispecific molecular architecture comprising dual tumor antigens plus CD3 will most likely be adopted. This approach mitigates the common clinical issue of resistance due to single-target antigen loss by engaging two tumor antigens. Furthermore, fine-tuned modulation of the CD3-binding affinity reduces the risk of cytokine release syndrome caused by systemic T-cell hyperactivation, thereby widening the therapeutic safety window.

Indication Portfolio Forecast: Referencing the product development direction of the same platform, candidate indications focus on high-incidence solid tumors (prostate cancer, gastrointestinal tumors) or refractory hematologic malignancies. There is a significant unmet clinical need for these targets in patients with advanced-stage disease who have failed multiple lines of therapy. Most global drugs targeting similar mechanisms are in early-stage clinical development, indicating broad commercialization potential;

Preclinical Data Foundation: Based on the preclinical data benchmark for the same platform presented at the Qilu AACR Annual Meeting, QLS2404 demonstrated excellent tumor inhibition in preclinical animal models. Compared with imported investigational drugs targeting the same molecule, it offers differentiated advantages in terms of drug half-life, in vivo stability, and therapeutic window, serving as the core rationale for the company’s rapid advancement of clinical trial applications.

3. Qilu’s innovative drugs continue to see sustained volume growth, with multiple Class 1 new drugs intensively advancing into clinical trials throughout the year

2026 is a pivotal year for the centralized realization of Qilu Pharmaceutical’s innovative pipeline. Since the beginning of the year, more than ten Class 1 new drugs have sequentially received implicit clinical trial approval from the Center for Drug Evaluation (CDE). The product portfolio covers antibody-drug conjugates (ADCs), multispecific antibodies, siRNA therapies, small-molecule targeted drugs, and innovative agents in the neurological field, among others:

Oncology Pipeline: B7-H3 ADC (QLC5508), CLDN18.2/CD3 bispecific antibody (QLS31905), and GPRC5D/CD3 bispecific antibody (QLS32015) are steadily advancing through Phase III registrational clinical trials;
Non-oncology Sector: The novel siRNA drug QLS7320 has received approval to initiate clinical trials for three indications, including paroxysmal nocturnal hemoglobinuria (PNH) and IgA nephropathy. The Alzheimer’s disease candidate drug QLH2405 has entered early-stage clinical exploration, and the weight-loss biologic QLS2322 has successfully commenced clinical studies. The clinical trial application for the QLS2404 injection has been accepted, making it the first Class 1 novel biologic drug publicly announced as accepted by Qilu Pharmaceutical in June. This further solidifies the company’s position in the first tier domestically within the niche segment of trispecific T-cell engagers (TCEs).

IV. Industry Impact: Intensified Competition in the Domestic Multi-specific Antibody Sector Accelerates Breakthroughs by Local Pharmaceutical Companies

The global development of multispecific antibody drugs is currently experiencing an explosive growth phase. Several CD3-engaging bispecific antibodies have been successively approved for market launch overseas, while domestic pharmaceutical companies are clustering their efforts around T-cell engager (TCE) platforms. However, products featuring proprietary, fully integrated manufacturing processes and differentiated preclinical data remain scarce. Leveraging its large-scale, in-house R&D platform, Qilu Pharmaceutical continues to deliver a pipeline of differentiated multispecific antibody products under the QLS series. The successful entry of QLS2404 into clinical trials signifies that the development of domestically produced trispecific antibodies in China is transitioning from a phase of “target following” to a new stage characterized by “structural innovation.”

From a clinical value perspective, if QLS2404 meets subsequent clinical data targets, it will provide a new precision targeted therapy option for patients with advanced solid tumors who have exhausted all available treatments, thereby breaking the technological monopoly held by overseas pharmaceutical companies in TCE drugs. We will continue to monitor the CDE review progress and Qilu Pharmaceutical’s announcements regarding clinical trial initiation, while tracking information on the first patient enrollment in QLS2404’s clinical trials and the official disclosure of its indications.

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