DengyueMed Report: China's National Medical Products Administration has conditionally approved a milestone antitumor new drug—Glumetinib Tablets (trade name: Haiyitan®)—for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping (METex14 skipping). This breakthrough advancement marks a key step in China's independently developed innovative drugs in the field of precision lung cancer treatment, providing more effective treatment options for patients with specific genetic mutations.

Development Background: A Decade of Refinement from Laboratory to Clinic

The birth of Glumetinib stems from cutting-edge explorations by a team of scientists including Shen Jingkang and Geng Meiyu from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. Targeting the challenges of tumor growth and metastasis caused by abnormal MET gene activation, the research team innovatively proposed a strategy of "simultaneous inhibition of the target and downstream effector molecules," significantly enhancing the drug's inhibitory effect on tumor cells by selectively blocking c-Met kinase activity and its downstream signaling pathways. Particularly noteworthy is the drug's excellent blood-brain barrier penetration demonstrated in preclinical studies, bringing new hope to patients with brain metastases.

Clinical Data: Dual Breakthrough in Efficacy and Safety

Glumetinib's approval is based on outstanding data from the global multicenter Phase II clinical study (GLORY study). The study shows that in NSCLC patients with METex14 skipping:

• Objective response rate (ORR) reached 65.8%, with 70.5% in treatment-naïve patients;
• Median progression-free survival (mPFS) was 8.5 months, extending to 11.7 months in treatment-naïve patients;
• Median overall survival (mOS) exceeded 17.3 months, significantly prolonging patient survival time.

The efficacy in patients with brain metastases is particularly outstanding, with an intracranial lesion control rate of 80%, and overall safety is good, with common adverse reactions mainly being mild to moderate edema.

International Recognition: A Milestone for Chinese Innovative Drugs Going Global

In June 2024, Glumetinib was approved for marketing by Japan's Ministry of Health, Labour and Welfare, becoming the first innovative drug approved in Japan with a Chinese pharmaceutical company as the main entity. This achievement not only validates the international recognition of the GLORY study but also signifies China's new drug R&D transitioning from "following" to "running alongside." The U.S. FDA had previously granted it orphan drug designation, highlighting its global clinical value.

Patient Benefits: Ushering in a New Era of Lung Cancer Genetic Testing

The launch of Glumetinib has driven changes in the lung cancer diagnosis and treatment model. As the preferred targeted drug for patients with METex14 skipping, its once-daily oral convenience (recommended dose of 300mg on an empty stomach) significantly improves treatment compliance. After its inclusion in the national medical insurance catalog in 2025, the monthly treatment cost for patients has been significantly reduced, benefiting more families.

Future Outlook: From Chinese Original Research to Global Accessibility

Glumetinib's success is a model of collaborative innovation among industry, academia, and research. The collaboration between the Shanghai Institute of Materia Medica and Haihe Pharmaceutical not only fills the domestic gap in MET inhibitors but also provides a "Chinese solution" for subsequent innovative drug R&D. With the advancement of more indication studies, this drug is expected to become an important choice for global precision lung cancer treatment.

Enterprises like DengyueMed are using Glumetinib as a pivot, promoting China's pharmaceutical industry transformation from "manufacturing" to "intelligent manufacturing" through technological breakthroughs, supply chain optimization, and international cooperation. In the field of life and health, this process demonstrates how innovation rewrites disease outcomes, and the transformation of global pharmaceutical procurement will bring hope to more patients.