Sihuan Pharma wins approval for Phase I to III trial of EGFR inhibitor
Category: #health  By Pankaj Singh  Date: 2019-05-31
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Sihuan Pharma wins approval for Phase I to III trial of EGFR inhibitor

Sihuan Pharmaceutical Holdings Group, a leading cardio-cerebral vascular drug maker in prescription drug industry of China, has recently confirmed that the third generation of EGFR inhibitor XZP-5809 has been awarded drug clinical trial approval by the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC).

XZP-5809 is reportedly a novel category 1 drug being developed by Sihuan Pharmaceutical. Apparently, the new drug is an innovative third generation EGFR-TKI that can be taken orally and has a strong capability for targeting. It features established mechanism, innovative structure, and irreversible binding to EGFR. The drug has improved selection with lower activity for wild-type EGFR and against gene-mutation EGFR, it demonstrated higher activity.

Sources close to the matter informed that the New Drug has unique advantages in its safety and activity, based on the data accumulated from the completed preclinical trial, as compared with products of the same type. Against wild-type EGFR, the New Drug as well as its metabolite showed lower activity. Owing to worldwide competitive advantage and a higher safety profile, the New Drug could become a novel treatment option for cancer patients.

According to CEO and Chairman of Sihuan Pharmaceutical Holdings, Dr. Che Fengsheng, noteworthy progress has been made in the area of lung cancer treatment, including anti-cancer immunotherapy. However, for non-small cell lung cancer with EGFR mutation, targeted therapy is still considered the prime choice, Dr. Fengsheng said.

Seemingly, the toxicological and preclinical pharmacodynamic data show that the features of the New Drug include good efficacy against acquired resistance mutations and against EGFR sensitive mutations, potential clinical efficacy for patients suffering with lung cancer brain metastasis. It also has reduced impact on cardiac function and better safety profile when compared to drugs of the same type in the market.

The clinical indication for the New Drug candidate is likely to be solid tumors, like metastatic or locally advanced lung cancer with acquired resistance mutations and EGFR-sensitive mutations, sources added.

Source Credit: https://www.prnewswire.com/news-releases/sihuan-pharm-obtained-phase-i-to-iii-clinical-trial-approval-for-the-third-generation-of-egfr-inhibitor-xzp-5809-300857919.html



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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