China's "gradually frozen" new drug! Yibitan (edaravone sodium chloride injection), a new drug of Zhengda Fenghai, is on the market!

January 16, 2020 / BIOON/ --Recently, Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd., a subsidiary of Zhengda Pharmaceutical Group, was approved by the State Food and drug administration, and obtained the marketing license of new drug ibitan (edaravone sodium chloride injection) (approval number: gyzz h20193434) The product specification is 100ml (including edaravone 30mg and sodium chloride 855MG), glass bottle and three-layer co extrusion transportation Liquid bags are two kinds of packaging, which are the exclusive products that pass the consistency evaluation of 100ml product specifications Edaravone sodium chloride injection is a clinically effective neuroprotective agent, which can reduce cell damage and protect tissue function It is mainly used to improve neurological symptoms, activities of daily life and dysfunction caused by acute cerebral infarction The main applicable departments are internal, external and emergency departments There is great potential for the efficacy of authoritative recommendation Specialty: fengedaravone is recommended by many authoritative guidelines, such as the Chinese guide for the diagnosis and treatment of acute ischemic stroke and the Chinese guide for the diagnosis and treatment of cerebral hemorrhage, which can effectively improve the neurological damage of patients with acute cerebral infarction and cerebral hemorrhage According to the data of minenet, in 2018, the terminal market scale of edaravone injection, a public medical institution in China, exceeded 5 billion yuan With the progress of the application for clinical indications of this product in domestic ALS, the product will further expand its indications for specialized treatment and medication, with a broad prospect and promising future Exclusive specification, excellent quality, safety and convenience: ibitam ® edaravone sodium chloride injection is completely consistent with the original research in terms of specification and strictly controlled in terms of quality It is the only approved 100ml injection specification in China Compared with the small volume injection, ibitam ® is not easy to produce the impurity edaravone dimer in the storage process, and it does not increase the amount of antioxidant, so it has good stability and high safety Ibitam ® does not need dilution configuration It can be infused directly to avoid secondary pollution and provide convenience for clinical use Exclusive competitive track with early occupancy consistency evaluation: Zhengda Fenghai ibitan ® has been registered and approved as a new class 3 drug, which is deemed to have passed the consistency evaluation At present, many domestic manufacturers have applied for the consistency evaluation of edaravone small volume injection, and this product is an exclusive dosage form, which has obtained the consistency evaluation; this product can be preferentially linked to the Internet in some provinces and cities, which can be well separated from edaravone small volume injection, with considerable market potential and a promising future Zhengda Fenghai always adheres to the business philosophy of healthy people and benefiting the whole world, takes building a competitive pilot enterprise of perioperative therapeutic liquid (medicine + special medicine) as its duty, continuously enriches its product line, and constantly expands in various treatment fields during the perioperative period! Amyotrophic lateral sclerosis (ALS), commonly known as cryogenics, is an irreversible fatal motor neuron disease, which is characterized by the control of the brain and spinal cord nerve cells (motor neurons) in the muscles of the whole body to undergo sexual degeneration When nerve cells die, the brain can no longer start and control muscle movement, which leads to serious disability, paralysis and eventually death The main symptoms of ALS are progressive muscle weakness and atrophy of limbs and trunk muscles, gradually losing motor function, like being "frozen", so it is commonly known as "gradually frozen people" ALS is a relentless progressive disease in which patients gradually lose the ability to speak, eat, move and breathe The rate of disease progression among ALS individuals is variable, and natural history usually reflects progressive deterioration over time until death The average life expectancy after the first symptom attack is 2-5 years There are two different types of ALS: sporadic and familial Sporadic diseases are the most common, accounting for 85% - 90% of cases, and may affect anyone anywhere Familial ALS is a genetic disease type, accounting for 10% - 15% The etiology of ALS is still unknown At present, the drugs on the market can only slow down the progress of the disease, but als treatment is mainly supportive, palliative and symptom based, and there is no drug that can cure ALS In terms of ALS drugs, riluzole is the first drug approved by FDA to treat ALS Tablet products were launched in 1995 to delay patients' ventilator dependence So far, four drugs have been approved by FDA to treat ALS, among which three are different dosage forms of riluzole products: exservan (oral film agent of riluzole), Rilutek (tablet of riluzole), tiglutik (suspension of riluzole), radicava (edaravone, intravenous injection of Edaravone) Among the four drugs mentioned above, radicava from Mitsubishi Taguchi was approved by FDA in 2017, which is the first ALS new drug approved by the agency in the past 22 years Edaravone (Edaravone), the active drug component of radicava, is a kind of free radical scavenger, which is believed to alleviate the effects of oxidative stress, which may be the key factor in the pathogenesis and development of ALS The antioxidant effect of edaravone is believed to provide neuroprotective support for the nervous system, potentially delaying disease development or limiting additional damage In China, radicava (edaravone intravenous injection) was approved by the National Drug Administration (nmpa) at the end of July 2019 It is worth noting that it took less than two months for the drug to get priority review and approval It is estimated that up to 30000 people in China are affected by ALS Reference source: Zhengda pharmaceutical, Biovalley