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Shijiazhuang Sihua Pharmaceutical Group’s Second Class I Innovative Drug Approved for Clinical Trials; Rasagiline Mesylate Active Pharmaceutical Ingredient Approved

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Honors Announcement

发布时间：2024-01-27

【概要描述】 Innovation injects vitality and empowers the future. On January 26, SYN045, a Class I new drug developed by Shijiazhuang Sihua Pharmaceutical Group, received the Clinical Trial Approval Notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This milestone marks another substantial step forward in the group’s second innovative drug development program.
Shijiazhuang Sihua Pharmaceutical Group’s Second Class I Innovative Drug Approved for Clinical Trials; Rasagiline Mesylate Active Pharmaceutical Ingredient Approved
Shijiazhuang Sihua Pharmaceutical Group’s Second Class I Innovative Drug Approved for Clinical Trials; Rasagiline Mesylate Active Pharmaceutical Ingredient Approved
Innovation injects vitality and empowers the journey toward the future. On January 26, SYN045, a Class I new drug developed by Shijiazhuang Sihua Pharmaceutical Group, received the Clinical Trial Approval Notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This milestone marks another substantial step forward in the Group’s second innovative drug development program.
SYN045 is a selective, long-acting PGI2 receptor agonist intended for the treatment of pulmonary arterial hypertension and represents a Class 1 new drug independently developed by the Group. According to available information, preclinical studies have demonstrated that SYN045 exhibits favorable target selectivity, potent compound activity, and a favorable safety profile. The positive progress in the development of SYN045 offers hope and good news for patients with rare clinical diseases, while further underscoring the Group’s accelerated advancement in innovative drug R&D.
Meanwhile, the group’s developed rasagiline mesylate was approved by the National Medical Products Administration on the same day and registered as an active pharmaceutical ingredient for use in marketed formulations, marking the seventh new-product approval the company has obtained since the start of the year.
According to reports, rasagiline is indicated for monotherapy in patients with primary Parkinson’s disease and for combination therapy in patients with end-of-dose motor fluctuations.
 

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Wei Saili, an employee of Shijiazhuang Sihua Pharmaceutical Group, has been named one of the “Top Ten People Who Moved the Provincial Capital.”

Congratulations! Dr. Sun Lijie of Shijiazhuang Sihua Pharmaceutical Group has been approved to receive the State Council Government Special Allowance.

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Previous page:

Wei Saili, an employee of Shijiazhuang Sihua Pharmaceutical Group, has been named one of the “Top Ten People Who Moved the Provincial Capital.”

Next page:

Congratulations! Dr. Sun Lijie of Shijiazhuang Sihua Pharmaceutical Group has been approved to receive the State Council Government Special Allowance.