Qilu Pharmaceutical's Class 1 New Drug QLC1101 Granted IND Approval for KRAS G12D-Mutant Solid Tumors

On April 8, according to the CDE official website, Qilu Pharmaceutical Co., Ltd. (hereinafter referred to as "Qilu Pharmaceutical") received clinical trial implied permission for its Class 1 new chemical drug QLC1101 capsule, intended for use in advanced solid tumors carrying the KRAS G12D mutation.

Source of the image: CDE official website

KRAS G12D Mutation
Advanced Solid Tumors

The RAS gene is one of the most commonly mutated genes in tumors, with studies showing that approximately 30% of tumors carry RAS mutations. Among the RAS family, KRAS is the most common type of mutation, widely distributed in tumor cells, and drugs targeting it have relatively fewer toxic side effects, making it a highly focused target in drug development.

Currently, research in the KRAS field has been conducted on subtype mutations such as G12C, G12D, and G12V. Among them, the development of KRAS G12C inhibitors is proceeding more rapidly, with multiple drugs reaching the marketing authorization stage or successfully launched. Meanwhile, for subtypes with higher mutation rates, such as G12D and G12V, several companies have also initiated research.

QLC1101 is a Class 1 new chemical drug developed by Qilu Pharmaceutical. Its clinical trial application was accepted by the CDE on January 25, 2024, targeting advanced solid tumors carrying the KRAS G12D mutation. Currently, Qilu Pharmaceutical has not yet officially disclosed its specific target.

Source of the image: CDE official website

Following this clinical approval, the development progress of QLC1101 may accelerate, potentially bringing new therapies to the KRAS field.

Innovation Accelerates
ADC、siRNA…

In recent years, Qilu Pharmaceutical has accelerated the progress of drug research and development, establishing a pipeline that includes biosimilars, improved new drugs, and innovative drugs. According to public data, Qilu Pharmaceutical also possesses a series of internationally advanced scientific research platforms, such as monoclonal antibodies, bispecific antibodies, combination antibodies (MabPair), ADC, siRNA, PROTAC, and tissue-targeted delivery.

Source of the image: Pharma Data Enterprise Edition —— Global Drug Analysis System

Among them, the oncology field is a key focus area for Qilu Pharmaceutical.

Iruak Tablets

Iruac Tablets, self-developed by Qilu Pharmaceutical, are an ALK inhibitor approved by the National Medical Products Administration in June 2023 for marketing in China. They are used to treat patients with ALK-positive locally advanced or metastatic NSCLC who have experienced disease progression after prior crizotinib treatment or are intolerant to crizotinib. In January this year, the drug was approved to cover the entire population of ALK-positive locally advanced or metastatic NSCLC patients.

Source of the image: NMPA official website

QL1604

QL1604 (Ipalolimab) is a self-developed PD-1 monoclonal antibody by Qilu Pharmaceutical. At the 2023 ESMO Asia Congress, Qilu Pharmaceutical presented the latest results of a single-arm, Phase II pivotal clinical study on QL1604 monotherapy for unresectable or metastatic dMMR/MSI-H solid tumors in poster format, demonstrating favorable efficacy of the drug. On September 17, 2023, the marketing application for QL1604 was accepted by the CDE, further accelerating Qilu Pharmaceutical's expansion in innovative drug development.

QLF31907

QLF31907 is a PD-L1/CD137 bispecific antibody independently developed by Qilu Pharmaceutical. While binding to PD-L1 to block the PD-1/PD-L1 immune suppression pathway, it activates downstream immune activation signals of CD137, thereby promoting the killing of tumor cells by immune cells. Currently, QLF31907 is being studied for the treatment of melanoma, urothelial carcinoma, and other diseases, with related clinical research already in phase II.

Conclusion

Not long ago, Li Yan, President of Qilu Pharmaceutical, mentioned in an exclusive interview with Taishan Finance that in 2024, Qilu Pharmaceutical is expected to submit 35 new products for production, including two Class 1 new drugs, which are likely to be approved for marketing successively.

By increasing investment in research and development and accelerating the pace of innovation, Qilu Pharmaceutical will reap more innovative achievements.

Editor: Mu Mian

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