July 4 innovative drugs to "China's speed" to run out of the world synchronous innovation drug.

Pharmaceutical Network August 6 According to the U.S. FDA official website, in July 2020 the FDA approved four innovative drugs, namely Cosmo Pharmaceuticals' Byfavo, ViiV Healthcare's Rukobia, Otsuka Pharmaceuticals' oral Inqovi, and Dr. Reddy Labs' Xeglyze.
As of July 31, 2020, the FDA has approved 29 innovative drugs in 2020.
Figure 1: Number of new drugs approved by the FDA from 2000 to the present July 2020, the FDA approved four innovative drugs covering different therapeutic areas: the nervous system sedative drug Byfavo, the whole body antiviral drug Rukobia, the anti-tumor drug Inqovi, the dermatology drug Xeglyze.
anti-tumor drugs in the FDA approved in the innovation drug is called "iron-hit tumor drugs" is indeed well known, so far 2020 the FDA has approved 12 anti-tumor innovative drugs, almost every month will approve one or more related new drugs.
July, FDA-approved Inqovi is the first oral low methylation agent for the treatment of myelogenic hyperplasia syndrome and chronic bone marrow mononucleic leukemia.
revealed good news in july with the FDA-approved new drug combined with domestic new drug listing information.
the market time in Japan is only 6 months earlier than in China, in the United States approval time and China's approval gap is only 14 days, which means that the previous "innovative drugs in China than Europe and the United States 5 to 7 years later" situation has gone, now, a series of accelerated drug review policy and the efficient operation of the national drug regulatory authorities so that pharmaceutical companies and patients can share the global synchronous innovation drug dividends.
Table 1: Details of FDA Approvalofe Note: This list does not include Vaccines, Allergen Products, Blood and Blood Products, Plasma Derivatives, Cell and Gene Therapy Products or Other Products Byfavo (Benzosulazole) July 2 The U.S. FDA approves the listing of Cosmo Pharmaceuticals benzodiazepine sedative drug Byfavo (Benzosulazole) for induced and maintained sedation during medical procedures lasting no more than 30 minutes, such as colonoscopy and bronchoscopy.
Figure 2: Remimazolam Specific Source: Byfavo, the global drug research and development bank of Minne.com, has underlying the approval in three key clinical studies, with 630 of the 969 patients using Byfavo during colonoscopy or bronchoscopy.
trial results showed that 80%-90% of medical procedures were successfully performed due to Byfavo's excellent sedative effect, and the most common adverse events using Byfavo were low blood pressure and hypertension.
rematozole was first discovered and developed by GlaxoSmithKline, and later PAION improved the development of a more stable benzosulfonate.
at present, a number of enterprises in several countries around the world and PAION co-developed the benzodiazepine, in addition to the approval in the United States, in January 2020 by The Pharmaceuticals in Japan to apply for the listing of benzosulfonate ryazole and approved, in the European Union, South Korea has submitted the application for the listing of benzosulfoatric acid.
in China, Yichang Renfu Pharmaceuticals and PAION company in 2012 reached a cooperation to obtain the development rights of benzosulfonate ryazole (commodity name: Ruima), and on July 16, 2020, the State Drug Administration officially obtained approval for colonoscopy and bronchoscopy and other invasive treatments of sedation.
it is worth mentioning that the largest competitor of "Ruima" Jiangsu Hengrui Pharmaceuticals' class 1 innovative drug injection with toluene sulfonate rymalun (commodity name: Rebenin) has been registered in December 2019, and two indications have been approved: (1) gastroscopy sedation;
despite six months behind, human-fu pharmaceutical industry's benzene sulphate will certainly be a share of the Hengrui pharmaceutical toluene sulphate market, and finally how the domestic Ruima aron market distribution to look at the skills of each.
Figure 3: Remaazole Global Declaration Source: Public Data, database Rukobia (fossavir tromethamine) July 2, the U.S. FDA also approved a new antiretroviral drug Rukobia The drug, developed by ViiV Healthcare and used in conjunction with other antiretroviral drugs, treats people who have tried multiple HIV drugs in the past and have failed to treat successful HIV-infected people due to resistance, intolerance or safety.
previously, Rukobia has been granted the FDA's Breakthrough Therapy Recognition and Fast Track qualification, and its new drug application has also been qualified for priority review.
Figure 4: Fostemsavir tromethamine Source: Rukobia, Minernet's global drug research and development library, is the foundation for this approval in a Phase III clinical trial called Brighte.
371 HIV-infected patients participated in the study, most of whom had been treated with HIV for more than 15 years (71%) and were characterized by multidrug resistance.
results showed that 53% of patients treated with Rukobia and other antiretroviral drugs had low LEVELs of RNA in the blood at 24 weeks that were considered undetectable, 60% of RNA levels of HIV at 96 weeks continued to be suppressed, and CD4-plus cells associated with immune function continued to increase. The latest data from the
show that the total number of people living with HIV worldwide is growing steadily, reaching 36.8 million people in 2017.
the huge number of infections also means a huge drug market, anti-HIV drugs have been the major pharmaceutical companies layout of research and development of active areas, Johnson and Johnson, Gilead, Mercado and other pharmaceutical giants have one or more anti-HIV drugs in the clinical stage.
Minet global drug research and development data show that there are currently 449 anti-HIV drugs in the world in the research and development stage, of which the highest research and development phase for the listed anti-HIV drugs have 46, submitted 5 applications for listing, in clinical phase 3 has 11, in clinical phase 2 has 43, in clinical phase 1 has 45.
Figure 5: Global Anti-HIV Drug Development Phase (partial) Source: Inqovi, a global drug research and development bank for Mitanet, july 7, FDA approved the listing of Inqovi (Disita-sized-cedazuridine), a subsidiary of Otsuka Pharmaceuticals, for the treatment of myelal hyperplasia syndrome and chronic monocytomyleukemia patients.
Inqovi, an oral tablet drug that has been granted an FDA-granted orphan drug, has also been granted priority review status in its new drug application.
the drug is the first FDA-approved oral low methylation agent for the treatment of myelogenic hyperplasia syndrome and chronic bone marrow mononucleic leukemia.
Figure 6: Decitabine-cedazuridine Specific Source: Minnet Global Drug Development Bank Prior to the Bone Marrow Hyperplasia Syndrome and Chronic Bone Marrow MononucleocyStutic Leukemia Selective Treatment Needs to Be intravenous drips at medical facilities, and indococule oral approval allows patients to choose a more convenient new method of administration.
Inqovi oral tablets consisting of the anti-cancer drugs titabin and cedazuridine, which was approved in 2006 as a DNA demethylator, and cedazuridine's role is mainly to prevent oral delivery of the dysely temyelsase in the body from rapid degradation. the safety and efficacy of
Inqovi oral tablets have been validated in two Phase III clinical trials.
trial results showed that in two clinical trials, Inqovi oral tablets and intravenous sitabins reached similar concentrations of drugs in patients.
, about half of patients who had previously relied on blood transfusions did not need them for 56 consecutive days during treatment.
, in-the-way, Inqovi's safety characteristics are similar to those of the intravenous site of the sitabin.
Xeglyze (abametapir) July 24, the U.S. FDA officially approved Dr. Reddy's laboratory in India's Xeglyze (abametapir) lotion for local treatment of head lice infection in patients 6 months and older.
Xeglyze's active ingredient, abametapir, is a metalloproteine inhibitor that inhibits head lice hatching eggs after washing hair with Xeglyze, seriously affecting the development of eggs and survival of adult ticks.
Figure 7: Abametapir specific source of information: Minet global drug research and development bank head lice disease is a head lice blood-sucking and caused by severe head itching parasitic disease, although the disease is a common disease, and will not seriously endanger health, but the number of cases is highly contagious, affecting people's lives and work.
this approval is mainly based on two identical multi-center, randomized double-blind control trials.
704 patients with head lice aged 6 months or older were given Xeglyze alone or a single control excipient for 10 minutes.
trial results showed that in the first, 7th and 14th days of follow-up, the proportion of patients without head lice in the Xeglyze experimental group was more than 3% higher than that of the control group.
source: FDA website, company announcement, Mitan.com global drug research and development library.