Qilu Pharmaceutical Enters 2026 'Breakout Year' with Comprehensive Innovation Pipeline Expansion

(Source: YaoShiKong)

On June 9, 2026, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced that the new drug application for Qilu Pharmaceutical’s Class 1 innovative drug “QLS2319 for Injection” had been accepted. The product is classified as a therapeutic biological product, markingQilu Pharmaceutical Makes Another Strategic Move in the Biopharmaceutical Innovation Arena。

Continuously Increasing Investment in Innovation-Driven Transformation, Qilu Pharmaceutical’s R&D Strength Steadily Rises, and Its Innovation Pipeline Sees a Concentrated Breakthrough.

As a leading enterprise in China's pharmaceutical industry, Qilu Pharmaceutical has been accelerating its strategic layout in the field of innovative drugs in recent years, achieving remarkable results particularly in the sector of oncology biologics.

01

Leading Bispecific Antibody Pipeline

Its independently developed Claudin18.2/CD3 bispecific antibody, QLS31905, is the first Claudin18.2-targeted bispecific antibody globally to enter Phase III clinical trials. It is currently undergoing pivotal clinical studies as a first-line treatment for advanced pancreatic cancer. Having previously received FDA Orphan Drug designation, it holds promise for addressing an unmet clinical need in pancreatic cancer therapy.

02

Comprehensive Multi-Platform Technology Layout

In addition to bispecific antibodies, Qilu Pharmaceutical is advancing key projects in areas such as antibody-drug conjugates (ADCs), small-molecule targeted therapies, and RNA interference (RNAi) therapies, thereby building a diversified innovative pipeline covering various solid tumors and hematologic malignancies.

03

R&D Investment Continues to Increase

The company adheres to the development strategy of “combining imitation with innovation, with innovation as the core.” In recent years, the proportion of R&D investment has continued to rise, and multiple Class 1 new drugs have entered the late-stage clinical trials, gradually realizing the transformation from a “leading generic drug manufacturer” to an “innovative pharmaceutical enterprise.”

The impressive number and broad therapeutic coverage of this series of intensively approved and accepted innovative drugs are remarkable. Qilu Pharmaceutical’s pipeline has rapidly expanded from its traditional stronghold in oncology to multiple areas, including central nervous system disorders (Alzheimer’s disease), cardiovascular and metabolic diseases, autoimmune conditions, and anti-infectives, achieving a strategic leap from “single-point breakthroughs” to “broad-spectrum coverage.”

Currently, the target, indications, and preclinical data of QLS2319 for injection have not been disclosed. Subsequently, the approval status of its Investigational New Drug (IND) application, the progress in initiating first-in-human trials, and Qilu Pharmaceutical’s development plans for this drug will become the focus of industry attention.

@Pharma Space-TimeWe will continue to monitor the public announcements from the Center for Drug Evaluation (CDE) and official releases from Qilu Pharmaceutical, providing readers with the latest updates on this drug and other domestically produced innovative medicines.