Good News! Shijiazhuang Sihua Pharmaceutical Group’s High-End Complex Formulation, Propofol Medium- and Long-Chain Fat Emulsion for Injection, Has Been Approved.


发布时间:2024-02-20

【概要描述】 Good news for the New Year—auspicious signs fill the home. On February 19, Shijiazhuang Sihua Pharmaceutical Group achieved another significant breakthrough in R&D and innovation: its application for Class 4 chemical drug Propofol Medium- and Long-Chain Fat Emulsion Injection (10 mL: 0.1 g; 20 mL: 0.2 g) was approved by the National Medical Products Administration, resulting in the issuance of a drug production registration certificate and deeming the product to have passed the consistency evaluation. This marks a landmark innovative achievement for the Group in expanding into the high-end, complex formulation segment.
Good news for the Spring Festival—auspicious signs fill the home. On February 19, Shijiazhuang Sihua Pharmaceutical Group achieved another significant breakthrough in research and development innovation: its application for Class 4 chemical drug Propofol Medium- and Long-Chain Fat Emulsion Injection (10 mL: 0.1 g; 20 mL: 0.2 g) was approved by the National Medical Products Administration, resulting in the issuance of a drug production registration certificate and deeming the product to have passed the consistency evaluation. This marks a landmark innovative achievement for the Group in expanding into the high-end, complex formulation segment.
To date, the Group has had 98 product specifications across 73 varieties either approved or deemed to have passed the consistency evaluation.
According to available information, propofol medium- and long-chain fat emulsion for injection is a short-acting intravenous general anesthetic. Currently, two formulations of propofol are approved for marketing in China: propofol medium- and long-chain fat emulsion for injection and propofol emulsion for injection. Data from MeneNet show that in the first half of 2020, sales of propofol medium- and long-chain fat emulsion for injection at the end-user level in public medical institutions in China totaled nearly RMB 2 billion.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, closely aligned with national strategic priorities and market demands, and steadfastly committed to the mission of “researching, developing, and manufacturing more ‘Chinese medicines’ that are tailored to the genetic heritage and physical characteristics of the Chinese population.”
To better meet market demand, while consolidating its traditional strengths in large-volume parenterals, Shijiazhuang Sihua Pharmaceutical is aggressively pursuing new growth areas by vigorously advancing the R&D of high-end, complex generic drugs and innovative medicines, including emulsions, liposomes, lyophilized formulations, sustained- and controlled-release systems, microspheres, and microcrystals. The company currently has nearly 200 products in development, with high-end complex formulations, improved new drugs, and innovative drug projects accounting for close to 30% of the pipeline. This increasingly rich and diversified product portfolio is serving as a powerful new engine and source of momentum for high-quality development, enabling the company’s industrial chain to move up the value chain toward the mid- to high-end segments. As a result, the product mix has undergone a remarkable transformation—from a single dominant injectable formulation to a diversified portfolio of dosage forms.

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