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Recently, National Institute of Pharmaceutical R&D Co., Ltd. (NIP Pharm), a subsidiary of CR Pharmaceutical Group, received the Notice of Drug Clinical Trial Approval from the National Medical Products Administration (NMPA), approving its clinical trials of the NIP142 capsules for non-small cell lung cancer (NSCLC).

The epidermal growth factor receptor (EGFR), one of several mutant genes found in NSCLC, has a mutation rate of 30-50% among Asian NSCLC patients, and it has become one of the most successful targets for lung cancer targeted therapies. Although the first, second, and third-generation EGFR-TKIs have brought significant survival benefits to patients with classic EGFR mutations, they have no significant effect on NSCLC patients with EGFR exon20ins mutation, which has high heterogeneity, high malignancy, and poor clinical prognosis, and there are great unmet clinical needs. In 2021, the FDA has accelerated the approval of Amivantamab, an EGFR/cMet bispecific antibody, and Mobocertinib (TAK-788), a small-molecule EGFR inhibitor, for this type of mutation, but neither have been launched in China.

NIP142, a patented innovative Type-1 small-molecule drug developed by NIP Pharm, can block downstream signaling pathways by inhibiting the activity of EGFR or HER2 exon20ins mutants, thereby inhibiting tumor growth. In a series of non-clinical studies that have been completed, NIP142, as a potent and highly selective EGFR/HER2 exon20ins inhibitor, has shown excellent anti-tumor activity and high tolerance against a variety of xenograft models. Compared with TAK-788, a drug with the same mechanism of action, NIP142 has better pharmacokinetic properties and a wider safety window; therefore, NIP142 has the potential to become a new treatment option for EGFR/HER2 exon20ins mutation NSCLC.

NIP142 is a milestone in the development of NIP Pharm’s anti-tumor R&D pipeline. In the future, the company will continue to target clinical needs and provide more safe and effective innovative drugs for cancer patients.