
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

On May 27, according toNational Medical Products AdministrationThe official website shows,Qilu PharmaceuticalThe anti-infective drug tedizolid phosphate tablets have been approved for marketing and are considered to have passed the consistency evaluation. To date, Qilu Pharmaceutical Co., Ltd. has a total of 164 products that have passed the consistency evaluation, 56 of which are the first in China.

Tedizolid is a second-generation oxazolidinone antibiotic used to treat infections caused by Staphylococcus aureus and Streptococcus pyogenes.Streptococcus agalactiaeAcute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus) and Enterococcus faecalis. Compared with first-generation oxazolidinone antibioticsLinezolidIn comparison, tedizolid has more advantages: First, it has stronger antibacterial activity. Tedizolid exhibits potent in vitro antibacterial activity against certain linezolid-resistant strains and shows no cross-resistance with other types of antibiotics. Its antibacterial activity against clinically isolated Gram-positive bacteria is 4-16 times higher than that of linezolid. Second, it is more convenient to use. Compared with linezolid, tedizolid changes from twice daily for 10 consecutive days to once daily for 6 consecutive days, significantly reducing the frequency of administration and improving patient compliance. Third, it is safer. Clinical research data show that the incidence of adverse reactions related to the gastrointestinal tract and thrombocytopenia with tedizolid is significantly lower than that of linezolid, and the incidence of resistance is also lower. Additionally, in patients with liver and kidney dysfunction,Hemodialysis PatientsThere is no need to adjust the dosage for special populations such as elderly patients.
With its strong antibacterial ability and good clinical safety, tedizolid is recommended by the American Society of Surgical Infections, the World Society of Emergency Surgery, and the European Society of Surgical Infections as a Class IA recommended drug for the treatment of suspected or confirmed MRSA ABSSSI.
The anti-infective field is a key area of strength for Qilu Pharmaceutical. To meet clinical treatment needs, Qilu Pharmaceutical has implemented a dual-formulation strategy for Tedizolid Phosphate, successively developing Injectable Tedizolid Phosphate and Tedizolid Phosphate Tablets. During the development of Tedizolid Phosphate Tablets, researchers quickly established a stable production process route and set strict quality standards to ensure that the self-produced product matches the original research product in quality, ensuring safety and efficacy in clinical use. In June 2023, Qilu Pharmaceutical's Injectable Tedizolid Phosphate was approved for marketing. With the approval of the tablet formulation, Tedizolid Phosphate is now more convenient to administer and carry, making it suitable for home use by patients. Additionally, it allows for easy switching between intravenous infusion and oral administration during sequential therapy.
In the future, Qilu Pharmaceutical will continue to uphold the core values of "Great doctors are precise and sincere, with a commitment to the nation and the world," focus on unmet clinical medication needs, serve patients, bring more high-quality domestically produced drugs to the people, and continuously contribute Qilu's strength to the building of Healthy China.
(Source: Qilu Pharmaceutical Group Official Account)