Qilu Pharmaceutical Accelerates Global Innovation with Four Investigational Drugs Granted FDA IND Clearance

　　【Pharmaceutical Network Enterprise News】On the global pharmaceutical innovation track, Qilu Pharmaceutical is accelerating with strong momentum. Since February this year, four innovative drugs from Qilu Pharmaceutical have successfully obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). This remarkable achievement not only demonstrates Qilu Pharmaceutical's R&D capabilities but also signifies a solid and crucial step forward in its internationalization process.
 

These four innovative drugs are QLS4131 for injection, QLS12010 capsules, QLS1304 tablets, and QLC1101 capsules. Each of them carries Qilu Pharmaceutical's earnest expectations for overcoming major diseases and improving patients' quality of life, and each demonstrates unique advantages and potential in different disease areas.
 

On May 7, Qilu Pharmaceutical's Class 1 new drug, QLC1101 capsule, received FDA approval for a new clinical trial protocol. It is intended for the treatment of various solid tumors driven by KRAS G12D mutations, such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer. The KRAS G12D mutation plays a key role in the development and progression of various solid tumors and is considered a molecular target with therapeutic potential. However, there are currently no KRAS G12D inhibitors approved globally, representing a significant unmet clinical need. As a highly selective, orally available small-molecule drug targeting KRAS G12D, the successful development and market launch of QLC1101 would provide a new treatment option for many patients with solid tumors, holding substantial clinical significance.
 

On April 27, Qilu Pharmaceutical's QLS1304 tablets received clinical trial approval from the U.S. FDA for the treatment of ER+/HER2- breast cancer. In early May, the project received another piece of good news when it was granted Fast Track Designation (FTD) by the FDA. The receipt of this designation signifies the FDA's high recognition of the clinical value and potential of QLS1304 tablets in treating ER+/HER2- breast cancer. ER+/HER2- breast cancer is a common subtype of breast cancer. While existing treatments have shown some efficacy, there is still room for further improvement. As a small molecule targeted inhibitor, QLS1304 tablets possess significant advantages such as high activity, excellent selectivity, and good oral bioavailability. These characteristics make it promising to reshape the treatment landscape for ER+/HER2- breast cancer, bringing new hope to a wide range of breast cancer patients. The Fast Track Designation will also significantly accelerate the clinical development and approval process of QLS1304 tablets, allowing them to enter the market more quickly and benefit patients.
 

On April 3, Qilu Pharmaceutical's Class 1 new drug, QLS12010 Capsule, successfully obtained the FDA's implied approval for a new drug clinical trial application. It plans to conduct clinical research on three major autoimmune disease indications: Atopic Dermatitis (AD), Hidradenitis Suppurativa (HS), and Rheumatoid Arthritis (RA). Notably, in March, these three indications were just approved for clinical trials in China. This successive approval for clinical trials both domestically and internationally fully demonstrates the significant potential of this drug in the field of autoimmune disease treatment and also marks that Qilu Pharmaceutical's innovative R&D in this field has officially entered a critical stage. Autoimmune diseases often have long courses, seriously affecting patients' quality of life, with hundreds of millions of patients worldwide being deeply troubled by them. If the QLS12010 Capsule can be successfully developed, it will potentially offer a breakthrough treatment option for these patients, improving their living conditions.
 

On February 26, Qilu Pharmaceutical's independently developed injectable QLS4131 also received FDA approval to commence clinical trials. This is an innovative BCMA/GPRC5D/CD3 tri-specific antibody drug, and currently, no similar drugs have been approved for marketing worldwide. The drug has received FDA approval for clinical trials targeting multiple myeloma, marking the acceleration of its global development process. Multiple myeloma, as a serious blood system malignancy threatening human health, still presents numerous unmet clinical needs. Injectable QLS4131 has already received clinical approval for two indications in China, with early research data showing exciting results—demonstrating higher affinity and potent cytotoxicity against multiple myeloma cells. It is expected to offer multiple myeloma patients a new and more effective treatment option, breaking the current therapeutic deadlock.
 

In recent years, Qilu Pharmaceutical has steadfastly adhered to an innovation-driven development strategy, continuously increasing investment in research and development. From an R&D investment of 3.89 billion yuan in 2022, accounting for over 10% of sales revenue, to a further increase in R&D investment to 4.43 billion yuan in 2023, with a year-on-year increase of 13.9%, these figures clearly demonstrate Qilu Pharmaceutical's high regard and determination for innovative R&D. Supported by continuous investment, Qilu Pharmaceutical’s innovative R&D pipeline has yielded abundant results, with approximately 40 Class 1 new drugs currently at the approved clinical stage or above in China (excluding already marketed new drugs and those undergoing new indications), among which anti-tumor and immunomodulatory agents account for more than 80%.
 

In addition to the four innovative drugs that have recently received FDA clinical approval, Qilu Pharmaceutical's Class 1 new drug, Ilualk Tablets, was approved for marketing in June 2023, providing a more cost-effective treatment option for ALK-positive non-small cell lung cancer patients in China. At the same time, Qilu Pharmaceutical has several other new drugs at various stages of development. For instance, the injection of Aipaloli Monoclonal Antibody and Toworili Monoclonal Antibody (PD-1/CTLA-4 combination antibody), as well as the injection of Aipaloli Monoclonal Antibody (PD-1 monoclonal antibody), have already submitted NDAs and are only one step away from being approved for market.
 

The consecutive granting of FDA clinical approvals for these four innovative drugs is a strong recognition of Qilu Pharmaceutical's R&D strength and innovation capabilities, and has also injected powerful momentum into the advancement of its internationalization strategy. Amidst the increasingly fierce competition in the global pharmaceuticals market, Qilu Pharmaceutical has begun to make its mark on the international stage with its deep R&D foundation, continuous innovation investment, and grasp of global pharmaceutical R&D trends.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice for any person.