The KRAS gene family consists of three subtypes, namely KRAS, HRAS and NRAS. Among them, KRAS is the most common subtype, and mutations are found in various tumors, including nearly 90% of pancreatic cancer, 30-40% of colon cancer, and 15-20% of lung cancer. Lung cancer is one of the highest morbidity and mortality malignancies in China, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. KRAS gene mutation is an important factor affecting treatment selection and prognosis of patients with NSCLC. KRAS G12C mutation is a specific type of KRAS mutation, accounting for a certain proportion of all KRAS mutations, and is relatively common in NSCLC. Traditionally, the KRAS mutation has been considered a target of "unpalatable drugs" due to its key role in tumor growth.

KRAS G12C and G12D are target for direct KRAS inhibitors

However, the launch of Dalbert on August 21st shattered this stereotype and gave patients new hope of precise treatment. The medicament effectively inhibit GTP/GDP exchange mediated by KRAS protein by covalently and irreversibly modif cysteine residues of that KRAS G12C protein mutant, so as to down-regulate the activation level of the KRAS protein, block a downstream signal conduction path, induce tumor cell apoptosis and cell cycle arrest, and achieve an antitumor effect.

Dalbert, a KRAS G12C inhibitor developed by Innoventbio in cooperation with JHY Pharmaceuticals, has been officially approved for marketing by National Medical Products Administration, China (NMPA). This approval marks the birth of China's first KRAS G12C inhibitor, providing a new treatment option for patients with advanced non-small cell lung cancer carrying the KRAS G12C mutation. Approval for Dalbert was based on positive results from a clinical Phase II single-arm enrollment study in China. Studies have shown that Dalbert is generally well tolerated in patients with advanced NSCLC mutant KRAS G12C who have received at least one systemic treatment, with an objective response rate of 49.1%, a disease control rate of 90.5%, and a median progression-free survival of 9.7 months. The listing in Dalbert is not only another important achievement of Innoventbio Biology in the field of tumor treatment, but also reflects the innovative ability and R&D strength of China in the field of biomedicine. As more of these innovative drugs are developed and marketed, they are expected to significantly improve the survival and quality of life of cancer patients, leading to more personalized and effective treatment options for patients.

SPACEGEN relies on the independent intellectual property rights PAP-ARMS^® and the independent patent RingCap^® to research and develop the detection kits as follows, which are capable of detecting multiple key gene mutations in tumor tissues of patients with non-small cell lung cancer, including KRAS G12C. Genetic testing will allow for more precise identification of patients who are eligible for treatment with a KRAS G12C inhibitor, leading to the development of individualized healthcare.

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