Qilu Pharmaceutical Accelerates Global Expansion with Four Innovative Drugs Receiving FDA IND Clearance

　　【Pharmaceutical Network Product InformationRecently, Qilu Pharmaceutical announced that the company's Class 1 new drug QLC1101 capsule has received FDA approval for a new clinical trial protocol, intended for the treatment of solid tumors driven by KRAS G12D mutations, such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer.
 

Data shows that QLC1101 capsule is a highly selective, orally available small-molecule drug targeting KRAS G12D. The KRAS G12D mutation is considered a molecular target with significant therapeutic potential, but currently, there are no KRAS G12D inhibitors approved globally, representing a substantial unmet clinical need. If the drug successfully gains approval, it will offer patients a new treatment option.
 

According to statistics, in the past two months, Qilu Pharmaceutical has obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for four innovative drugs, including QLC1101 capsules, injectable QLS4131, QLS12010 capsules, and QLS1304 tablets.
 

On April 27, Qilu Pharmaceutical's QLS1304 tablet received clinical trial authorization by default from the U.S. FDA for the treatment of ER+/HER2- breast cancer. In early May, the project was granted Fast Track Designation (FTD) by the FDA. QLS1304 tablet is a small molecule targeted inhibitor with high activity, good selectivity, and excellent oral bioavailability, which is expected to reshape the treatment landscape for ER+/HER2- breast cancer. The U.S. FDA’s granting of Fast Track Designation to QLS1304 tablet will accelerate its clinical development and approval process, potentially bringing it to market faster and providing patients with a new treatment option.
 

On April 3, Qilu Pharmaceutical Co., Ltd. announced that its Class 1 new drug QLS12010 had received the FDA's Investigational New Drug (IND) approval by default, and is planned to conduct clinical research on three major indications: atopic dermatitis (AD), hidradenitis suppurativa (HS), and rheumatoid arthritis (RA). In March, these three indications had just been approved for clinical trials in China. The successive clinical approvals of this project in both China and the United States mark a critical phase in the company’s innovative R&D in the field of autoimmune disease treatment, with the potential to provide breakthrough therapeutic options for hundreds of millions of patients worldwide.
 

On February 26, Qilu Pharmaceutical's independently developed injectable QLS4131 received FDA approval to commence clinical trials for the indication of multiple myeloma, marking an acceleration in the global development process of this BCMA/GPRC5D/CD3 trispecific antibody drug. Injectable QLS4131 has already been approved for clinical trials in China for two indications. Early data from the project shows higher affinity and cytotoxicity against multiple myeloma cells. Currently, no trispecific antibody drugs are available on the global market.
 

The above products have successively received FDA's tacit approval, which not only demonstrates Qilu Pharmaceutical's innovative R&D capabilities but also serves as a vivid illustration of the steady advancement of its internationalization strategy. To ensure the efficient progress of innovative drug R&D, Qilu Pharmaceutical continues to increase its investment in R&D, constantly improving its global R&D network. It has established multiple R&D centers both in China and abroad, attracting high-level scientific research talent from around the world and forming a multidisciplinary, cross-field collaborative innovation mechanism.
 

It is reported that in the clinical trial phase, Qilu Pharmaceutical strictly adheres to international standards and collaborates deeply with globally renowned research institutions and hospitals to ensure the scientific nature and reliability of clinical data. Meanwhile, the company actively maintains close communication with international regulatory agencies such as the FDA, keeps abreast of the latest international regulations and policies in a timely manner, and plans drug development and submission strategies in advance, laying a solid foundation for its products to successfully enter the international market.
 

In the future, with the orderly development of these innovative drugs in global clinical trials, Qilu Pharmaceutical is expected to achieve significant breakthroughs in various disease treatment areas such as oncology and autoimmune disorders. This progress will further enhance the influence of Chinese pharmaceutical companies in the international innovative drug field, allowing more high-quality, original Chinese drugs to benefit patients worldwide and driving China's pharmaceutical industry towards higher quality and greater internationalization.
 

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