Cold thinking: What exactly is barquoonase API?

Recently, the "Barquase concentrate API" because of a notice caused concern.
news, many people found that the "baroenzyme" of the understanding is almost zero.
is "barosterase"? Where does it come from? What is the clinical utility? What about market value? ...... In the spirit of curiosity, after consulting a series of documents, the editor tried to do an answer.
is barosterase? It is well known that venomous snakes are one of the deadliest animals on Earth, and they use venom as a deadly weapon to defend them against or attack.
years of scientific development, humans have long found ways to turn some of the most toxic substances on The Planet into life-saving drugs.
thrombin-like enzyme (TLE) in snake venom is the most studied and clinically proven snake venom biopic.
In 1936, scholars first isolated a partially purified clotting enzyme from the Brazilian snakeThe Sourcesnake venom, and since then researchers have found nearly 100 types of clotting enzymes in more than 30 species of snake venom.
called "baroenase", a serine protease extracted from the venom of the Bothrops atrox snake.
it is known that there are five subsexuals of the Brazilian spearsnake (Bothrops atrox), one of which bothrops moojeni snake venom contains barosterase with defibrinogen, which reduces blood viscosity and improves ishemia symptoms, also known as "defibase".
from other subseeds has coagulation properties that can be used to stop bleeding, also known as clotting enzymes.
the two are different in the nature of science and technology, bio-chemical characteristics, role and so on, belong to different related markets.
But because "baroenzyme" is the World Health Organization's generic name for the fibrinogen-promoting coagulase contained in Bothrops atrox snake venom, it was once referred to simply as "barosterase", which is particularly confusing and requires special clinical attention.
the "barquase injection" involved in this monopoly case belongs to the de-fibre enzyme, the reference referred to below as "baro-enzyme" refers to "de-fibrease".
and the "Barquase API" is mainly used in the production of "Barquase injections".
the global scope of the adaptation of barbarase, "barquotase" is currently only available in China and Japan, the approved adaptation is mainly concentrated in improving the cycle, especially the end cycle.
The original research party for the product "Baquase Injection" was Tobishi Pharm of Japan, and the adaptation was "chronic arterial astrology, improvement of terminal circulatory disorders of vibration disease, recovery of sudden deafness, and improvement of conscious symptoms" and was not used in the treatment of cerebral infarction (ischemic stroke).
In China, there is only one production unit for "baroenzyme injections", with adaptive disorders for acute cerebral infarction, improvement of various obstructive vascular diseases and improvement of end and microcirculation disorders (including the recovery of sudden deafness).
can be seen that, globally, "baquase" has only been approved in China for acute cerebral infarction (stroke) adaptation.
and "baroenzyme API" is the only API for the production of "Barquase injections", the composition of which cannot be replaced by any other API.
DSM Pentapharm is the world's only manufacturer of barosterase API.
it is understood that there have been previous attempts by Chinese pharmaceutical companies to mimic the "barosterase injection", but it does not appear to have succeeded.
data show that in 2011 Liaoning Nokang Biopharmaceutical Co., Ltd. to the National Drug Review Center (CDE) to declare generic drug approval, and ultimately failed.
market size according to IMS Health data, in 2019 "Baquase injection" Chinese hospital sales amounted to 156 million yuan, in China's hundreds of billions of stroke drug market, the share is not high.
: China Biopharmaceutical Industry Association this "Barquase injection" monopoly case due to the supply of raw materials, but in fact, "Barquase injection" competitive pressure has long been more than just from the pressure of raw materials.
because of the abundant resources of snakes in China, there are many kinds of snake poison products.
in several major adaptive aspects, "barquase" in China have a large number of similar similar processes and adaptive alternative drugs, especially in China has been listed many "injection of fiber-lowering enzyme" drugs.
"Slimase" was officially named in 1997, when China's Ministry of Health will kiss snake Agkistrodonacutus and Changbaishan white eyebrows snake Agkistrodonhalyssuriensis snake venom as raw material extracted blood clotting enzyme products officially named "Slender enzyme", developed and piloted a unified quality standard.
Example: The adaptors described in the instruction manual of anti-fibrease in a domestic enterprise describe the source, action factor and adaptive disorder of "baroenzyme" are very similar, and all the year round with "barquase" in the field of anti-fibre treatment in stroke.
according to the State Drug Administration website information, China's approved "slim-lowering enzyme" has 57 kinds of product regulations, the competition is extremely fierce.
level of clinical evidence for barbarase, although competitive as forest, in the treatment of ischemic stroke.
"slim-lowering enzyme" and "barquoase" are not clinical first-line drugs.
In the 2018 edition of the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China, vascular retransmosis therapy for acute ischemic stroke is the preferred venous thrombosis, and drugs include recombinant tissue fibrinogen activators (rt-PA), urine kinases, and tynabase.
addition to venous thrombosis treatment, clinical evidence is more adequate and mechanical hydrant therapy.
treatments such as antiplate plate plate, anti-fibre or anticoagulant are mainly used in patients who do not apply venous thrombosis/intravascular therapy, or in certain types of patients.
recommended grades of "slimase" and "barquoase" are grade II.recommended, and B-grade evidence is available for patients who are not suitable for thrombolytic therapy and who have under been strictly screened.
In addition, another adaptive disorder of "barosterase injections": improvement of microcirculation symptoms, including sudden deafness, has been recommended in the Chinese Medical Association's Guidelines for the Diagnosis and Treatment of Sudden Deafness, but at present, "barosterase injections" have been recommended to be reduced as a subtype treatment in non-essential treatments, becoming associated with glucosin, ginkgo extract, etc.
from the Chinese Medical Association Otolaryngology Branch of the "Sudden Deafness Diagnosis and Treatment Guide" can be seen, "baroenzyme"-related adaptations in a large number of clinical drugs, in addition to the above-mentioned drugs, there are clopidogrel, glycol, glycelaglycerides, There are dozens of corresponding drugs such as rice, high seepage salt water, albumin, pernisone, methamilon, tetrassamisone, compound pyrithrometamine, thiopental acid, neurotrophic factors, glucocorticoids, ginkgo biloba extract, etc.
can be seen that although there are some applications of "barquase injection" in our country clinically, but the clinical efficacy and recommendation level do not have an absolute leading edge, and there are many alternative drugs.
the API dispute, it still seems to be some distance from its dominant position in the field of related adaptations, and will face increasing market pressure.
: 1, Department of Neurology, Respiratory Medicine, Yan'an University Hospital, "Comparison of the efficacy of atipase and barquase in the treatment of acute cerebral infarction and its effect on patients' serum NSE, IL-6, TNF-α, hs-CRP levels" 2, Taizhou City, Jiangsu Province Comparison of the Recent Efficacy of Baquase and Aspirin in the Treatment of Acute Cerebral Infarction in Chinese Hospitals 3, Guidelines for the Diagnosis and Treatment of Sudden Deafness by the Otolaryngology Branch of the Chinese Medical Association 4, and Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2018