Can the new indication of the neopodiazepine softgel enter Phase III help the annual sales to break 7 billion?

Recently, the China Biotechnology Development Center announced the results of the 8th batch of approval of the administrative licensing of Chinese genetic resources in 2020, and the phase III clinical approval for the treatment of vascular dementia was officially approved by the GeneticS Office.
Enbipu sold 5.6 billion yuan in 19 years, up 36.6% year-on-year, accounting for 1/4 of the total revenue of stone medicine, is a well-deserved heavy-duty drug.
(Source: China Biotechnology Development Center) A new class 1 drug in the cardiovascular field in China In 1999, stone medicine was purchased from the Chinese Academy of Medical Sciences for 50 million yuan at the time; Enbipu, with a specification of 0.1g, used for the treatment of stroke patients with light and moderate acute ischemic stroke, became the first class 1 new drug in the field of cardiovascular and cerebrovascular in China;
at present, the domestic butyl benzene raw materials and preparations only stone medicine one approved.
(Source: NMPA) butyl benzene is the first internationally innovative drug to act in multiple pathological aspects of acute ischemic stroke, with a number of national and international patents.
sodium phenyle chloride injection is more suitable for early use in patients with acute ischemic stroke than softgels, for acute ischemic stroke patients, can not be limited by the thrombotic treatment window, can improve ischemic brain perfusion, improve the degree of neurological defects, save semi-dark band brain cells.
since the market in 2005, due to the early miss of the year's health insurance adjustment, sales growth rate is relatively slow, until 2010, butyl benzene oral frequently released dosage form added to the 2009 version of the National Health Insurance Catalog, and butyl benzene injection agent successfully listed, become a turning point in the market.
sales in the past five years, butyl benzene sales revenue increased from 1.7 billion yuan in 2015 to 5.6 billion yuan in 2019, and is expected to break 6 billion yuan by 2020.
(Source: Minnet. Currently, butyl benzene softgels and injections are in the 2019 national new version of the health insurance Category B directory.
(Source: Pharmaceutical Intelligence Data) It is worth noting that the patent for butyl benzene is about to expire.
the compound patent expires in 2021, the injection patent expires in 2022, and the capsule patent expires in 2023.
new indications into Phase III Clinical Vascular Dementia is the second largest type of dementia after Alzheimer's disease, and its incidence is increasing significantly with the sharp increase of stroke, cardiovascular disease, etc., and is a clinical syndrome characterized by cognitive function loss caused by a series of cerebrovascular factors (ischemia, bleeding, acute and chronic hypoxia, etc.) caused by brain tissue damage.
more common in men, especially in patients with cerebral small blood vessel disease, while Alzheimer's disease is more common in women.
because vascular dementia has a relatively good prognosis, it is the only type of dementia that can be prevented.
because more than 80% of vascular diseases are preventable, genetics account for only about 15%.
the incidence of dementia in the elderly over 65 years of age in China is 0.039%, of which vascular dementia accounts for 68.5% of the first.
American epidemiological study showed that about 26.3 percent of patients over the age of 60 who survived ischemic cerebrovascular disease had dementia.
patients who have had stroke have a significantly higher risk of vascular dementia.
there is no clear and effective treatment for vascular dementia, vascular dementia (a neurodegenerative disease) is also included in the "major new drug creation" of one of the top ten key diseases.
multi-center, parallel, randomized, double-blind, placebo-controlled clinical studies conducted in 2008-2011 by a total of 17 clinical units with the Capital Medical University Xuanwu Hospital as the group leader, initially demonstrated the improved effect of butyl benzene softgels on cognitive dysfunction caused by ischemic cerebrovascular disease.
if the clinical trial is successful, butyl benzene softgels will fill the gap in the clinical absence of vascular dementia drugs, with very significant social benefits.
(Source: Drug Clinical Trial Registration and Information Disclosure Platform) In addition, clinical trials of butyl benzene softgels for the treatment of ischemic stroke have entered Phase II in the United States.
(Source: ClinicalTrials) was certified as a "frozen human orphan drug" in March 2018, and Stone Pharmaceuticals announced that it developed provoxiation-3-positive butyl phenylene dycena (butyl phenylene) certified by the U.S. FDA as an orphan drug for the treatment of amyotrophic lateral sclerosis (ALS).
is eligible for FDA orphan drug eligibility, you will have seven years of market access in the United States and tax breaks of up to 50% of the research and development fee.
(Source: Company Announcement) ALS, also known as motor neurone disease and frozen manalyses, is known for its "ice bucket challenge" that became popular on the web four years ago.
ALS is the progressive degeneration of motor nerve cells, resulting in gradual weakness and atrophy of muscles in the limbs, torso, chest and abdomen, as well as impaired speech, swallowing and respiratory function, until respiratory failure dies.
the disease is mostcommon in men between the ages of 40 and 50, the cause of which is still unknown, and some cases may be related to genetic and genetic defects. although the incidence of
is very low, almost ALS poses a great threat to the quality of life and life of patients, the current clinical use of drugs has no obvious effect.
patent of butyl benzene is about to expire, but there is a new indication of the addition of the United States market layout, there are industry insiders boldly predict edifying annual sales will break 1 billion U.S. dollars (about 7 billion yuan), into the global drug sales TOP200, the author believes that 2020 butyl benzene sales broke 6 billion yuan is a big probability event, but 7 billion yuan is difficult to say, after all, patent expiration and adaptation and other uncertainties.
References: Iemolo F, Duro G, Rizzo C, et al. Pathophysiology of the vascular dementia .J. Immunity Ageing, 2009, 6: 13. [2] Inglis WL, Winn P.The pedunculopontine tegmental nucleus: where the striatum meets the reticu Iar formation . Prog Neurobiol, 1995, 47 (1): 1- 29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dementia Therapy. Beijing: People's Army Medical Press, 2002.139.