Congratulations to our partner Haihe Biopharma on the approval of its MET inhibitor Glumetinib in Japan. FAB IRC facilitates the internationalization of innovative drug R&D in China.

On June 24, 2024, Haihe Biopharma announced that its self-developed oral small-molecule MET inhibitor, Glumetinib, has been successfully approved by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations.

The marketing authorization application for this indication was primarily based on the efficacy and safety data from the pivotal Phase II study SCC244-108 (GLORY study, NCT04270591). This study was a multinational, multicenter, open-label, single-arm clinical trial designed to evaluate the efficacy and safety of Glumetinib Tablets in patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. The same indication had already received approval from the China National Medical Products Administration (NMPA) on March 7, 2023.

Since 2019, FAB has collaborated with Haihe Biopharma, deeply participating in the global multicenter clinical study for this project (GLORY study) by providing professional and efficient third-party independent image review (IRC) services.

As a long-term partner of Haihe Biopharma, FAB extends its warm congratulations on the approval of this product in Japan. This marks a milestone for Haihe Biopharma's self-developed innovative drug entering the global market and represents the achievement of in-depth collaboration and persistent efforts between both parties in the field of clinical research.

As of April 28, 2022, data from a 12-month follow-up of 79 patients with METex14 skipping mutations confirmed by a central laboratory in the GLORY study showed: The overall objective response rate (ORR) assessed by the Blinded Independent Image Review Committee (BIRC) was 65.8%, with an ORR of 70.5% in treatment-naive patients and 60.0% in previously treated patients. The median progression-free survival (mPFS) for the overall population was 8.5 months, reaching 11.7 months in treatment-naive patients and 7.6 months in previously treated patients. The median overall survival (mOS) for the overall population was 17.3 months, which was not yet reached in treatment-naive patients and was 16.2 months in previously treated patients, demonstrating clear efficacy.

In terms of safety, the drug was generally safe and tolerable. Common adverse reactions included edema, headache, gastrointestinal symptoms, and elevated liver transaminases, most of which were mild to moderate. These adverse reactions could be alleviated or resolved with symptomatic treatment. There was no potential phototoxicity, no related allergic reactions were observed, drug interactions were few, and the safety risk of concomitant medication was low.

As pharmaceutical innovation becomes increasingly globalized, international multicenter clinical trials (MRCTs) are emerging as a new trend in innovative drug research and development. FAB has been deeply involved in the field of clinical medical imaging services for many years and has accumulated extensive experience in MRCT projects. These projects span more than ten countries across Asia-Pacific, Europe, and North America, covering nearly 20 disease areas. Leveraging the FAB team and the global strategic partners and clinical expert resources of its parent company, Tigermed, we are able to provide multi-country, multi-region solutions for our clients, ensuring rapid project initiation and efficient operation, thereby facilitating the internationalization of pharmaceutical R&D.

FAB looks forward to joining hands with more partners to jointly promote the research, development, and marketing of more innovative drugs, bringing more treatment options and hope to patients worldwide.