FDA's 4 new drugs hit the Chinese market and are increasingly valued!

According to statistics from the US Food and Drug Administration (FDA), the FDA approved 4 innovative drugs in July 2021, all of which are new molecular entities
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Since 2021, the US FDA has successively approved 33 innovative drugs, of which 25 are new molecular entities, 6 are new biological products, and the remaining 2 are cell therapies
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Source of the number of new drugs approved by the FDA in the past ten years: FDA website, public information July 2021, a total of 4 innovative drugs approved by the US FDA, involving multiple disease fields, including the first non-steroidal option for the treatment of diabetic chronic kidney disease Mineralocorticoid receptor antagonist Kerendia (finerenone); the first oral drug Fexinidazole (fexinidazole) for the treatment of African trypanosomiasis caused by Trypanosoma brucei Molecular inhibitor Rezurock (belumosudil), and the world's first drug Bylvay (odevixibat) to obtain regulatory approval for the treatment of progressive familial intrahepatic cholestasis
.
Among the 4 innovative drugs in July, except for the treatment drug fexinidazole for African trypanosomiasis, which has a very low incidence in China, the other 3 new drugs have been registered in the CDE
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Among them, finerenone (non-Nelrenone) is already in the application for production stage, while belumosudil tablets were introduced by Yehui Medicine and are currently undergoing phase 2 clinical trials; Albireo Pharma's odevixibat obtained the CDE clinical trial implied license at the end of 2020
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In recent years, more and more innovative brand-name drugs have accelerated the pace of entering the Chinese market.
This is because the country encourages the entry of innovative brand-name drugs into the country, and R&D companies can enjoy various policy dividends; With the continuous rise of the domestic economic level, the advantages of China's pharmaceutical market with large potential and full potential are becoming more and more obvious, and foreign innovative and original research companies are paying more and more attention to the Chinese market.

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Sources of detailed information on new drugs approved by the FDA: FDA website,Meinenet Global Drug Research and Development Library
Kerendia (finerenone )
On July 9, 2021, the US FDA approved Bayer’s Kerendia (finerenone) to be marketed for use in the company.
In patients with type 2 diabetes with chronic kidney disease (CKD), reduce the risk of renal failure, delay the decline in estimated glomerular filtration rate (eGFR), reduce cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure Risk
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Kerendia is the first non-steroidal selective mineralocorticoid receptor (MR) antagonist for the treatment of diabetic chronic kidney disease
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Earlier, Kerendia had obtained the fast track qualification granted by the FDA, and this application was also approved through the priority review route
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At present, the drug is also undergoing domestic regulatory review by NMPA
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Finerenone specific information source: Meinenet Global Drug Research and Development Library In the United States, diabetes is the main cause of chronic kidney disease and renal failure
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Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally
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Due to imperfect filtration, patients may also experience complications related to the accumulation of body fluids, electrolytes and waste in the body
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Chronic kidney disease sometimes develop kidney failure, patients are also suffering from heart disease in high-risk
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In China, diabetic chronic kidney disease has surpassed glomerulonephritis-related chronic kidney disease and has become the leading cause of chronic kidney disease in China
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This approval is mainly based on a pivotal phase 3 clinical trial called FIDELIO-DKD, which enrolled approximately 5,700 patients with diabetic chronic kidney disease from 48 countries around the world
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The results show that, compared with placebo, Kerendia will have the risk of renal failure for the first time, delay the estimated glomerular filtration rate (eGFR) for at least 4 weeks from the baseline level and continue to decrease by ≥40%, and the compound risk of kidney death is significantly reduced 18%, the combined risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospital stay was reduced by 14%
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　　Fexinidazole (fexinidazole )
On July 16, 2021, fexinidazole (fexinidazole ) jointly developed by Sanofi and DNDi was approved by the US FDA for the treatment of African trypanosomiasis caused by Trypanosoma brucei gambiae (HAT, also known as sleeping sickness) )
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Fexinidazole is the first direct oral treatment for sleeping sickness.
The drug is not only suitable for the first stage of the disease, but also for the second stage of the disease where parasites cross the blood-brain barrier and cause neuropsychiatric symptoms in patients
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Previously, fexinidazole has been granted priority review and orphan drug designation by the US FDA
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Source of specific information on fexinidazole: Menet.
com Global Drug Research and Development Library African trypanosomiasis is one of the serious diseases that are zoonotic in Africa.
Endemic in 36 countries
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Among them, Trypanosoma brucei gambiae is mainly distributed in West and Central Africa.
This type currently accounts for more than 95% of the reported cases of African trypanosomiasis
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After the patient was initially bitten, trypanosomes reproduce in the subcutaneous tissues of the human body, and then enter the blood and lymphatic system to parasitize, and later invade the central nervous system.
The patient begins to lose consciousness, sensory disturbances and drowsiness, sleep cycles are completely disturbed, and lethargy during the day Without waking up, it is difficult to fall asleep at night
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In 2012, DNDi initiated key clinical trials of fexinidazole in the treatment of sleeping sickness in several locations in the Congo and the Central African Democratic Republic, and completed the trial in 2017
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After screening more than 2 million people for sleeping sickness, the researchers included 749 sleeping sickness patients in the early and late stages of the disease, and verified the effectiveness of the drug as a first-line therapy in both adult and pediatric patients.
Sex and safety
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　　Rezurock (belumosudil )
On July 16, 2021, the U.
S.
FDA announced the approval of Kadmon Holdings’ ROCK2 inhibitor Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease that has previously failed at least two systemic therapies ( cGVHD) pediatric patients (age ≥12 years old) and adult patients
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Rezurock is the first and only ROCK2 small molecule inhibitor approved by the US FDA
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Previously, the FDA has granted Rezurock Breakthrough Drug Designation (BTD) and priority review qualifications
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Yehui Pharmaceutical has reached a strategic cooperation with Kadmon Holdings in 2019, and obtained the exclusive authorization for the clinical development and commercialization of belumosudil for the treatment of graft-versus-host disease in China
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At present, the drug is in Phase 2 clinical stage in China
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Belumosudil specific information source: Minet.
com Global Drug Research and Development Library Allogeneic hematopoietic stem cell transplantation is currently an important method for the treatment of hematopoietic malignancies, certain hereditary and bone marrow failure diseases .
Chronic graft-versus-host disease is after allogeneic hematopoietic stem cell transplantation.
One of the most common late complications
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30%-50% of patients who survive more than half a year after allogeneic hematopoietic stem cell transplantation will develop chronic graft-versus-host disease
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It is a systemic syndrome involving multiple organs, similar to autoimmune diseases
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Rezurock's superior performance in a randomized, open-label, multi-center pivotal Phase 2 clinical trial laid the foundation for this approval
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The clinical trial called ROCKstar enrolled 65 patients with chronic graft-versus-host disease who had previously failed systemic treatment at least 2 times and at most 5 times
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The results of the study showed that patients receiving Rezurock treatment achieved an overall response rate (ORR) of 75%, with a complete response rate of 6% and a partial response rate of 69%
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The median duration of remission was 1.
9 months
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The median time to remission for the first time was 1.
8 months, and 62% of responding patients did not require new systemic therapy for at least 12 months after remission
.

　　Bylvay (odevixibat )
On July 20, Albireo Pharma announced that the US FDA has approved its development of Bylvay (odevixibat) for the treatment of all subtypes of itching caused by progressive familial intrahepatic cholestasis (PFIC)
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Bylvay is the world's first drug approved for the treatment of progressive familial intrahepatic cholestasis
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Prior to this, Bylvay has obtained the qualifications of orphan drug, fast track and priority review granted by the FDA
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Source of specific information on odevixibat: Mi Nei.
com Global Drug Research and Development Library Progressive Familial Intrahepatic Cholestasis (PFIC) is a rare genetic disease.
Due to genetic mutations, it is difficult for liver cells to produce and secrete bile, and intrahepatic bile accumulation occurs.
Cause liver cell damage, and may develop into more serious liver disease
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Worldwide, about one in every 50,000 to 100,000 births will be affected by PFIC
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Previously, the only option for patients with progressive familial intrahepatic cholestasis was liver transplantation or other invasive surgery, and there were no approved drugs to treat PFIC
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The safety and effectiveness of Bylvay have been verified in two global phase 3 clinical trials of PEDFIC-1 and PEDFIC-2
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In the randomized, double-blind, placebo-controlled PEDFIC-1 study, the Bylvay treatment group significantly reduced bile acid response, significantly improved skin pruritus, and was well tolerated, and the incidence of diarrhea/frequent defecation was very low
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In the long-term, open-label Phase 3 extension study PEDFIC-2, the data reaffirmed the strong efficacy of Bylvay.
The results of the study showed that in patients treated for up to 48 weeks, the bile acid response was continuously and persistently reduced, and the evaluation of pruritus was improved, The liver and growth function indicators are encouraging
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Note: The information comes from the FDA official website, corporate announcements, and Minet.
com database.
Please correct me if there are any errors or omissions
.