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Clinically in urgent need of overseas new drugs approved for listing in China (as of February 9) Note: This table is incomplete statistics (not formally included in the CDE three batches of "clinical urgent need for new drugs abroad" new drugs are not in the statistical scope), if there are omissions, welcome to leave a message in the background.
psoriasis psoriasis is a chronic, relapse, immuno-mediated multi-system disorder, reducing the patient's life treatment, serious disability.
of potential toxicity from traditional drugs such as methotrexate (MTX), ave A, cyclosporine and other drugs.
about five years ago, there were limited clinically available effective treatments for psoriasis patients in China, and the pain reduced or even disabled the quality of life of patients.
situation has improved considerably in recent years.
statistics, NMPA has approved four clinically urgent need for new drugs for psoriasis, and the adaptive disorders are moderate to severe plaque-like/type psoriasis.
are: 1) Novartis, the world's first all-human source IL-17A inhibitor, Scully and Company, target il-17A inhibitor Ichizhu single resistance; 3) Johnson and Johnson Johnson's Janssen is the world's first specific anti-IL-23 monoclonal antibody Gusechi monoantigen; 4) Kyowa Kirin targets the IR-17A receptor Broliyu monoanti.
C is one of the most common liver diseases worldwide and a common public health problem for all mankind.
, hepatitis C is one of the few chronic diseases in the history of human medicine that can be cured.
recent years, against the background of china's drug review and approval system reform and encouragement of innovation, Chinese hepatitis C patients have welcomed a number of heavy-duty therapies, which has led to a rapid increase in patient cure rates.
, there are three new hepatitis C drugs that are clinically in urgent need of new drugs from abroad and have been approved for sale in China.
It's worth noting that Gilead Sciences' Lydipaiwesophobwe and AbbVie's Gkarive pyrentawe, both pangene hepatitis C treatments, are effective in patients with hepatitis C 1-6.
The other sophosphovo, also from Gilead Sciences, offers hope for patients who have failed treatment in the past, and it has been approved in China for the treatment of chronic hepatitis C virus (HCV) infections in adults who have previously received a direct antiviral drug (DAA) program, no cirrhosis or companion cirrhosis.
pulmonary hypertension Pulmonary hypertension is a common disease, multiple morbidity, disability rate and death rate are very high.
pressure in the pulmonary arteries can increase significantly, which in turn leads to right heart failure and severe decreased exercise tolerance, which in severe cases can lead to death.
, the disease has been referred to by the medical community as "cancer in pulmonary vascular disease".
in an age when there are no targeted drugs, the survival of such patients is in dire need of improvement.
2018, three clinically urgent new drugs for pulmonary hypertension have been approved in China, providing patients with more clinical options.
Among them are two from Actelion, which has been acquired by Johnson and Johnson: Slepag, an orally effective, highly selective and long-acting non-prostatin-like prostatin-like prostatic cyclocycline (IP-like) astigtor;
addition is Sidina, from Pfizer, china's first approved type 5 phosphate phosphate (PDE-5) inhibitor for the treatment of pulmonary hypertension.
-sensitive dermatitis is the most common form of eczema, with recurrent chronic eczema-like rash as the main manifestation, accompanied by significant dry skin and itching.
the disease as "normal" but brings great itching and mental baggage to patients.
asthma can seriously affect a patient's daily life and can even pose a fatal risk.
, up to 10 per cent of adults and 20 per cent of children worldwide suffer from endexual dermatitis.
June 2020, Dupreyu monoanti resistance from Sanofi was approved in China for the treatment of moderate to severe endemic dermatitis in adults, which works by inhibiting IL-4 and IL-13 signaling path pathps.
In July 2020, Phosphate Desterase 4 (PDE-4) inhibitor Creboro from Pfizer was approved in China for topical topical treatment in patients 2 years of age and older with mild to moderate endexual dermatitis, the first non-hormonal external PDE-4 inhibitor.
Viscosity polysaccharide storage disorder (MPS) is a rare genetic disease, is due to the human cell lysase in the mucus polyhydrase activity decreased or lost, resulting in mucosal (GAGs) can not be degraded, stored in cells and caused by a group of diseases, has been included in China's "first rare diseases list."
mpS is divided into 7 types depending on the lack of enzymes.
recent years, the disease has gradually come to the fore, with some patients in some forms also seeing the first treatment.
of these, Ilothylase α, from BioMarin, is China's first mucosal polysaccharide storing drug approved by the NMPA for the treatment of MPS IVA patients.
a Laroni enzyme-rich solution from Sanofi's Genzyme, approved in China for long-term enzyme replacement therapy in patients diagnosed with MPS I.
In addition to the two above-mentioned varieties that are clinically in urgent need of new drugs from abroad, another Ado sulfate enzyme β injection introduced by North Sea Kangcheng was approved in China in September 2019 for use in MPS II patients.
Crohn's disease Crohn's disease (CD) is a chronic systemic disease that manifests it as inflammation in the gastrointestinal tract, causing persistent diarrhea, abdominal pain, and rectal bleeding, and worsens over time.
because the symptoms of Crohn's disease are difficult to predict, it can put a significant physical, emotional and financial burden on people living with the disease, and such patients are in dire need of a new drug to control their condition.
March 2020, NMPA approved two clinically urgent new drugs for Crohn's disease.
first is Takeda's new anti-inflammatory drug, Vidriju, which is approved by NMPA for moderate to severe active ulcerative colitis (UC) and Crohn's disease.
2 is Jansen's Usnu single resistance, approved for adult moderate to severe active Crohn's disease patients, it is the world's first all-human source "dual-target" leukocyte interleulin 12 (IL-12) and leukocyte interleulin 23 (IL-23) inhibitors.
Fabre disease Fabre disease is a congenital metabolic disease caused by X chain gene defects, which manifests it as a significant decrease or loss of the activity of α-semi-lactose glycosidease A in the patient's body, resulting in the pathological accumulation of glycolipids in the lysosomes of a variety of tissue cells.
the disease originated in the fetus and gradually deteriorated with the patient's life, causing heart, kidney and other important organ failure.
2018, the disease is listed in China's first list of rare diseases, is a serious life-threatening disease in China and there is no effective treatment.
In December 2019, China's first drug to treat Fabre disease was approved for the market.
this is the enzyme replacement therapy Aga glycosin β from Sanofi's Kenzan company, which is suitable for children and adolescents over 8 years of age and adults.
August 2020, Takeda's innovative drug Aga α was approved by NMPA for long-term enzyme replacement therapy for Fabre disease.
approval of these two new drugs is important to improve the quality of life of patients and their families.
, with the rise of immunotherapy, people in the field of cancer treatment continue to usher in breakthrough innovations.
for some cancer patients, clinical needs remain unsealed.
In the list of new overseas drugs urgently needed in the clinic, some new foreign anti-cancer drugs for leukemia, osteoblastoma, substrate cell carcinoma, adrenal cortical cancer, soft tissue sarcoma, neuroblastoma and other cancers were included.
among them, Jansen's new generation of androgen-inhibitor apatamines for non-metastatic degenerative resistance to prostate cancer (NM-CRPC) and metastatic endocrine therapy sensitive prostate cancer (mHSPC) have been approved.
Amgen's new RANKL inhibitor, desotrophation, has also been approved for osteoblastoma and osteoporosis adaptation.
addition, Astellas' FLT3-inhibiting fumarate gilitinib was approved in China late last month for FLT3 mutation-positive recurrence or refractic acute myeloid leukemia.
addition, NMPA has approved a number of clinically urgent overseas drugs to bring innovative therapies to patients with multiple types of diseases.
such as Novartis' multiple sclerosis drug, Fingomed, Teva's new hunting drug, fentanyl, and Dongpei Pharmaceuticals's S.p.A., which is used for moderate or severe neurotrophic keratin.
limited to the limited length of the article, this article will no longer be introduced.
hope that by 2021 and beyond, more clinically urgently needed new and other good drugs from abroad will be approved for sale in China, benefiting the wider patient population.