-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Avnib is China's first IDH1 inhibitor with clear efficacy and good safety in patients with relapsed or refractory acute myeloid leukemia
The National Medical Products Administration of China has accepted Afnib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with IDH1 susceptible mutations and plans to be included in priority review
August 3, 2021, Suzhou, China-CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616), a leading biopharmaceutical company focused on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs, today announced that The CS3010-101 study of ivosidenib in China has reached the expected end point.
At the same time, CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has accepted a new drug application (NDA) for Afnib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with IDH1 susceptible mutations.
"In the field of AML treatment, we are facing urgent clinical treatment needs, especially for R/R AML patients who are susceptible to IDH1 mutations.
"We are pleased to see that
In 2020, Afnib was included in the "List of New Drugs Urgently Needed for Clinical Use (Third Batch)" by the National Center for Drug Evaluation, and obtained the qualification for fast-track review and approval
Avnib is currently the only targeted therapy approved by the US FDA for AML patients with IDH1 susceptible mutations
About Acute Myeloid Leukemia
Acute myeloid leukemia is the most common type of adult leukemia, the disease progresses rapidly, and the vast majority of patients are elderly patients
About CS3010-101 Chinese Bridging Research
CS3010-101 is a phase I, multi-center, single-arm study being conducted in China
About Ivosidenib
Servier is a global independent pharmaceutical group managed by a non-profit fund, dedicated to the research, development, and commercialization of various tumor diseases including acute myeloid leukemia
Avnib has been approved by the U.
The U.
About CStone Pharmaceuticals
CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
The NDA submission of Afnib is CStone Pharmaceutical's subsequent use of Pujihua® for metastatic transfection rearrangement (RET) mutant medullary thyroid cancer and RET fusion-positive thyroid cancer, and Taijihua® for carrying PDGFRA D842V After the new drug listing application for mutant gastrointestinal stromal tumor (Hong Kong region) was accepted, it was the third new drug listing application accepted this year
Forward-looking statement
The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
references:
references: 1.
Miranda-Filho, A.
, et al.
, Epidemiological patterns of leukaemia in 184 countries: a population-based study.
2018.
5(1): p.
e14-e24
Miranda-Filho, A.
, et al.
, Epidemiological patterns of leukaemia in 184 countries: a population-based study.
2018.
5(1): p.
e14-e24
