Hengrui Medicine passed the consistency evaluation of generic drugs for 6 drugs within 1 month

Medical Network News on May 8 Recently, Hengrui Pharmaceuticals received the "Drug Supplementary Application Approval Notice" approved and issued by the National Medical Products Administration, which approved the company's irinotecan hydrochloride injection and palonosetron hydrochloride injection to pass the imitation Consistency evaluation of pharmaceutical quality and efficacy
.
Among them, irinotecan hydrochloride injection is a domestic injection approved for marketing in the United States.
This is a milestone event for Hengrui Medicine in implementing its "internationalization" strategy
.
In recent years, Hengrui Medicine has accelerated its internationalization process, and the number of preparations currently on the market in Europe, America and Japan has reached 21
.
It is reported that within one month of April this year, Hengrui Pharmaceuticals has passed the consistency evaluation of generic drugs in the number of drugs reached six, namely: irinotecan hydrochloride injection, palonosetron hydrochloride injection, iodixa Alcohol injection (specification: 100ml: 32g (I)), ropivacaine hydrochloride injection, docetaxel injection (specification: 0.
5ml: 20mg), and cisatracurium besylate injection
.
Irinotecan hydrochloride injection is suitable for the treatment of patients with advanced colorectal cancer, including: combined with 5-fluorouracil and folinic acid in the treatment of advanced colorectal cancer patients who have not previously received chemotherapy; as a single drug, the treatment fails with 5-fluorouracil-containing chemotherapy regimens Of patients
.
Epidemiological data show that colorectal cancer has become one of the main diseases that threaten people's health and affect the quality of life
.
Irinotecan (also known as CPT-11) is a classic anti-tumor drug.
Authoritative guidelines at home and abroad, such as CSCO and NCCN, recommend irinotecan as the standard treatment for colorectal cancer
.
In 2006, Irinotecan injection was approved by the National Food and Drug Administration; in December 2011, Irinotecan injection was approved by the U.
S.
Food and Drug Administration (FDA) and was approved for marketing in the United States
.
Hengrui has become a pharmaceutical company certified by the US FDA for injections.
This is a milestone event for Hengrui Pharmaceuticals in the implementation of its "internationalization" strategy
.
Within a month of April this year, Hengrui Medicine has 6 modelsThe drug passed the quality and efficacy consistency evaluation of generic drugs
.
Among them, more than half of the drugs have been approved for listing in overseas markets
.
Among them, the indications of Palonosetron Hydrochloride Injection include: it is suitable for adults to prevent acute nausea and vomiting caused by high-emetic-induced chemotherapy; prevention of acute and delayed nausea and vomiting caused by moderately vomitogenic chemotherapy; at the same time, it is suitable for 1.
Prevention of acute nausea and vomiting caused by chemotherapy (including highly emetic chemotherapy) for children aged from months to 17 years old
.
Iodixanol injection is an X-ray contrast agent, suitable for adult cardiovascular angiography, cerebrovascular angiography, peripheral arteriography, abdominal angiography, urography and CT enhanced examination; children cardiovascular angiography, urography and CT enhanced examination
.
In January 2019, the German FederalInstitute ofMedicines and Medical Devices approved Hengrui's iodixanol injection to be marketed in Germany, marking thecontinuous improvementof Hengrui Pharmaceutical 's ability to develop the international market and the quality of Chinese medicines has once again been recognized internationally
.
Ropivacaine is the first pure L-body long-acting amide local anesthetic.
It has dual effects of anesthesia and analgesia.
Large doses can produce surgical anesthesia, while small doses can produce sensory block (analgesia) with only limited effects.
Non-progressive motor block
.
This product is suitable for surgical anesthesia and acute pain control
.
Docetaxel is a paclitaxel anti-tumor drug, which plays an anti-tumor effect by interfering with the microtubule network necessary for cell mitosis and interphase cell function
.
Hengrui Pharmaceuticals docetaxel injection was approved by the US FDA in 2017
.
Cisatracurium benzenesulfonate is a neuromuscular blocker that binds to cholinergic receptors on the motor endplate to antagonize the effect of acetylcholine, thereby producing competitive neuromuscular blockade.
It is suitable for Surgery and other operations and intensive care treatment
.
Hengrui Medicine's cisatracurium benzenesulfonate injection was approved by the U.
S.
FDA in 2017
.
As an innovative national pharmaceutical company , Hengrui Pharmaceuticals has always been committed to making common people use and affordable domestically produced high-quality and good medicines.
Many products produced by Hengrui Pharmaceuticals have been approved by Hengrui Pharmaceuticals as of May 6.
Consistency evaluation, 17 products are deemed to have passed the consistency evaluation, 16 products have been submitted for approval, and 4 products are under development
.