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Shijiazhuang Sihua Pharmaceutical Group Launches Its First Three-Chamber Bag Infusion Product; “Infusion + Oral Solid” — Three Dosage Forms and Four Specifications of New Products Approved on the Same Day

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Honors Announcement

发布时间：2024-08-05

【概要描述】 On August 5, three products—Chemical Drug Category 4 Fat Emulsion (10%), Amino Acids (15%), and Glucose (20%) Injection (1000 ml and 1500 ml), Entacapone-Dopamine Tablets (II), and Fluvoxamine Maleate Tablets (100 mg)—submitted by Shijiazhuang Sihua Pharmaceutical Group were simultaneously granted drug production registration approvals by the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation. Notably, Entacapone-Dopamine Tablets (II) was the first such product approved in China, while the Fat Emulsion (10%), Amino Acids (15%), and Glucose (20%) Injection (1000 ml and 1500 ml) is the …

Shijiazhuang Sihua Pharmaceutical Group Launches Its First Three-Chamber Bag Infusion Product; “Infusion + Oral Solid” — Three Dosage Forms and Four Specifications of New Products Approved on the Same Day

On August 5, Shijiazhuang Sihua Pharmaceutical Group received, on the same day, drug production registration approvals from the National Medical Products Administration for three products—namely, Chemical Drug Category 4 Fat Emulsion (10%) Amino Acids (15%) Glucose (20%) Injection (1000 ml and 1500 ml), Entacapone Dopa Tablets (II), and Fluvoxamine Maleate Tablets (100 mg)—covering a total of four dosage forms. These approvals also confer deeming approval under the consistency evaluation framework. Notably, Entacapone Dopa Tablets (II) was the first such product to be approved in China, while the Fat Emulsion (10%) Amino Acids (15%) Glucose (20%) Injection (1000 ml and 1500 ml) became the second such product approved domestically and represents the Group’s first newly approved three-chamber bag infusion formulation.

According to available information, the fat emulsion (10%), amino acids (15%), and glucose (20%) injection solution (1000 ml; 1500 ml) is an parenteral nutrition product primarily indicated for parenteral nutritional support when enteral nutrition is impractical, inadequate, or contraindicated. Multi-chamber bag infusion products exhibit significant innovation, convenience, and safety, meeting the need for safe medication administration in a variety of specialized settings, including routine emergency care and major disaster response. They have thus become a key driver of innovation and technological advancement in infusion formulation development, with only a handful of domestic infusion manufacturers currently possessing the requisite R&D and production capabilities. As the group’s first three-chamber bag formulation for parenteral nutrition, this product not only plays a critical role in rapidly supplying essential nutrients to critically ill patients and those with severe trauma, thereby promoting recovery and shortening the course of illness, but will also further diversify the company’s infusion product portfolio and lay a solid foundation for accelerating the comprehensive development of a full range of parenteral nutrition formulations.

According to reports, Entacapone Benserazide is a triple-combination formulation comprising benserazide, entacapone, and levodopa, indicated for the treatment of adult patients with Parkinson’s disease whose motor fluctuations—either “on” or “off”—are either newly onset or accompanied by “end-of-dose” wearing-off phenomena and are not adequately controlled by levodopa/DDC inhibitor therapy. Parkinson’s disease (PD) is the second most common neurodegenerative disorder, with an incidence second only to Alzheimer’s disease. As a best-selling anti-Parkinsonian agent, Entacapone Benserazide is currently available in the Chinese market exclusively as an originator product.

Fluvoxamine Maleate Tablets are indicated for the treatment of depression and associated symptoms, as well as obsessive-compulsive disorder. Currently, Fluvoxamine Maleate Tablets are included in the National Basic Medical Insurance Category B Reimbursement List. According to data from YaoRongYun, nationwide hospital sales of Fluvoxamine Maleate Tablets reached RMB 439 million in 2022, representing a year-on-year increase of 25.6%. As of the third quarter of 2023, sales have already surpassed RMB 400 million, approaching the full-year sales figure for 2022, underscoring the product’s strong performance in the domestic market.

Seizing the momentum, the company is striving to scale new heights. In recent years, Shijiazhuang Sihua Pharmaceutical Group has steadfastly pursued a path of innovative development that integrates generic drug innovation with original research and development. The group has strategically positioned itself in key therapeutic areas—including anti-infectives, respiratory diseases, neurological disorders, cardiovascular and cerebrovascular conditions, gastroenterology, anesthesia, endocrinology, oncology, and dialysis—while actively building an innovative ecosystem matrix. This has enabled the formation of a new development paradigm driven by four pillars: high-end, complex generic drugs; innovative medicines; improved new drugs; and active pharmaceutical ingredients—thereby continuously shaping a distinctive product portfolio and cultivating a competitive edge in the industry. Since the beginning of this year, the group has secured registration approvals for 60 new products, bringing the total to 98 drug varieties comprising 131 dosage forms that have either passed or been deemed to have passed the consistency evaluation, underscoring its sustained leadership in innovation performance.

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