Qilu:QLS2311 was approved

Recently (June 4), Qilu Pharmaceutical’s Category 1 new drug QLS2311 Injection received its first clinical trial approval. According to available information, this product represents Qilu’s first Category 1 new drug in the antithrombotic field, with the indication targeting acute ischemic stroke.

The initial clinical trial application for QLS2311 Injection was accepted on March 26, 2026, and the drug received its first clinical trial tacit approval on June 4 of the same year, securing the clinical trial authorization in just over two months. According to Mopheus Pharma data, the market size for antithrombotic chemical and biologic drugs is substantial, with sales in China’s terminal hospital market exceeding RMB 37 billion in 2025, representing a year-on-year increase of 2.81%, indicating sustained and stable clinical demand.

Qilu Pharmaceutical continues to increase its investment in innovation-driven transformation, with its R&D capabilities steadily improving. In 2025, the company’s R&D expenditure reached RMB 5.37 billion, a year-on-year increase of 23%, with R&D investment as a percentage of revenue rising to 14.5%. The company currently has over 120 innovative drug projects in its pipeline, covering multiple hot therapeutic areas including oncology and autoimmune diseases. According to the Mopheus Pharma database, since the beginning of 2026, Qilu Pharmaceutical has received first-time clinical trial approvals for 12 Category 1 new drugs, representing a concentrated burst in its innovative pipeline.

In addition to the impressive progress in its pipeline, the company’s already-marketed Category 1 new drugs are also performing strongly. To date, Qilu Pharmaceutical has three Category 1 new drugs approved for marketing, all of which have been included in the National Reimbursement Drug List (NRDL), with their commercial value continuing to be realized.

Iru alkal (Iruark®) , a Category 1 chemical new drug approved in 2023, achieved terminal hospital sales exceeding RMB 125 million in 2025, a substantial year-on-year increase of 654.02%; in Q1 2026, product sales increased 143.41% year-on-year.

Opafort (Opafort®) , a Category 1 biologic new drug launched in 2024, achieved terminal hospital sales of RMB 147 million in 2025, a year-on-year growth rate of 6,647%; in Q1 2026, product sales increased 41.64% year-on-year.

The rapid volume growth of these two flagship new drugs fully demonstrates Qilu Pharmaceutical’s product operation and market promotion capabilities, while also laying a solid foundation for the continued advancement of its extensive innovation pipeline. With multiple Category 1 new drugs entering the clinical stage, the company’s innovation-driven development momentum is expected to be further unleashed.

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