Recently, Qilu Pharmaceutical's Vitamin K1 injection (Changshi®) received approval from the National Medical Products Administration for marketing and is considered to have passed the consistency evaluation. This approval further enriches the company's product pipeline in the field of anticoagulant drugs, providing new domestically produced drug options for clinical use.

Qilu Pharmaceutical's R&D personnel conduct formulation process research

Normal blood clotting function is essential for maintaining human life. Vitamin K1 is an essential coenzyme for the liver to synthesize four clotting factors (II, VII, IX, and X), playing an irreplaceable core role in the body's clotting and hemostasis processes. Clinically, excessive use of oral anticoagulants such as warfarin, obstructive jaundice, bile leakage, chronic diarrhea, or long-term use of broad-spectrum antibiotics can all lead to insufficient vitamin K synthesis or intake, causing abnormal blood clotting function, requiring timely exogenous vitamin K1 supplementation to correct the problem.

Currently, there is a large number of patients in China undergoing anticoagulation therapy, suffering from liver disease, and digestive disorders, creating a long-term and rigid clinical demand for high-quality vitamin K1 injections . Especially for high-risk pregnant women taking anticonvulsants, antituberculosis drugs, and coumarin anticoagulants during pregnancy, scientific prenatal vitamin K supplementation can effectively prevent neonatal vitamin K deficiency. Currently, vitamin K1 injections have become a first-line drug recommended by domestic and international guidelines for the prevention and treatment of neonatal vitamin K deficiency bleeding (VKDB), demonstrating significant clinical value .

Qilu Pharmaceutical's R&D personnel are performing instrument maintenance.

To address the shortcomings of some traditional vitamin K1 injections in terms of thermal stability and safety during intravenous administration, Qilu Pharmaceutical initiated the development of this product in 2022. Adhering to the philosophy of "quality by design," researchers employed mixed micelle technology to encapsulate the drug in nanoscale mixed micelles with phospholipids and other excipients. This effectively improved the thermal stability of vitamin K1 and avoided the use of excipients such as Tween 80, reducing the risk of adverse reactions such as allergies and hemolysis. The formulation has a small particle size, is less prone to stratification, exhibits better thermodynamic stability, and can withstand terminal sterilization, effectively improving clinical tolerability and safety.

Deeply committed to providing essential medicines for the people and safeguarding national health, Qilu Pharmaceutical consistently focuses on addressing unmet clinical needs and tackling complex formulation technologies to offer high-quality, accessible domestically produced drugs to patients and healthcare professionals. Qilu Pharmaceutical will continue its in-depth research into advanced complex formulations, constantly breaking through technological barriers, enriching its pipeline of high-end and specialty products, and leveraging its continuous innovation capabilities to contribute to the development of my country's healthcare system and protect the health of its citizens.

References:
1. Guo Wei, Shi Maojing, Guo Yang, et al. Expert consensus on the diagnosis and treatment of acute traumatic massive hemorrhage in patients taking oral antithrombotic drugs [J]. Chinese Journal of Emergency Medicine, 2021, 41(4):285-293.
2. Neonatology Committee of Chinese Medical Doctor Association, Neonatology Committee of Shaanxi Provincial Medical Doctor Association. Expert consensus on oral vitamin K for the prevention of vitamin K deficiency bleeding in infants (2024 edition) [J]. Chinese Journal of Neonatology (Chinese and English), 2024, 39(6):332-337.

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