Huizhou Jizhong Biological Technology's Biological New Drug Obtained FDA Clinical Approval!

2018-07-02

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Recently, Huizhou Jizhong Biological Technology’s innovative drug local anesthetic injection - a new long-acting postoperative analgesic successfully obtained FDA (US Food and Drug Administration) new drug clinical trial approval!

The new long-acting postoperative analgesia was completed by Shanghai Medicilon in its full set of preclinical safety evaluation research, preclinical pharmacology, pharmacokinetics, and other projects.

Huizhou Jizhong Biological Technology’s Biological New Drug Obtained FDA Clinical Approval!.webp

Anesthetics include general anesthetics, local anesthetics, narcotic analgesics, and muscle relaxants. Among them, local anesthetics are a class of drugs that are applied locally around nerve endings or nerve trunks, which can temporarily, completely, and reversibly block the generation and conduction of nerve impulses, and temporarily disappear local pain sensation under conscious conditions. . Because local anesthetics are easy to use and have no damaging effects on various tissues, they have been widely recognized by clinicians. Currently, the commonly used local anesthetic drugs are procaine, lidocaine, bupivacaine, and tetracaine. Huizhou Jizhong Biological Technology's new long-acting postoperative analgesia has obtained the FDA's new drug clinical trial approval, which is a further development in accelerating the launch of new drugs and will provide patients and medical staff with better medication options, which is of great clinical significance.

Medicilon’s full set of preclinical research services includes API research and development, drug screening services, pharmaceutical preparations, pharmacology research services, pharmacokinetic research services, toxicology services, etc. There are currently 35 IND packages served by Medicilon that have been approved by CFDA to enter clinical trials, 3 IND packages have been accepted by FDA and approved to enter clinical trials, 3 IND packages have been accepted by TGA and approved to enter clinical trials, and 1 IND Package has been accepted by EMA and approved to enter clinical trials.

❖ Medicilon’s pharmacokinetics services

Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.

❖ Medicilon’s drug safety evaluation

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

Service Cases

Medicilon Assists | China's First CD19×CD3×CD28 Trispecific Antibody Obtained FDA Implicit Approval
Medicilon Assistant| Jimincare's lgE Antibody Drug JYB1904 has been Approved for Clinical Trials
Medicilon Assist| Sinovent's New Class 1 Anti-tumor Drug XNW14010 has been Approved for Clinical Trials

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