-
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
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
[Pharmaceutical Network Industry News] Giant cell tumor of tendon sheath (TGCT) is a group of synovial differentiated tumors originating from the synovium, bursa, and surrounding tissues of the tendon shea.
The lesions can be focal and diffu.
Data shows that about 43 people per million people suffer from this disease, so it is a rare disea.
At present, the main treatment for this disease is surgical resection, but its recurrence rate is high, and some patients have high risk of surgical resection, so patients have unmet clinical treatment nee.
Recently, there is good news that ABSK021, a highly selective CSF-1R inhibitor independently developed by Heyu Pharma, has been recognized by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China as a breakthrough therapy drug for the treatment of inoperable tenosynovial giant cel.
This will bring new treatment options for domestic patients with giant cell tumor of the tendon shea.
The so-called breakthrough therapy certification is one of the four accelerated procedures for the review of innovative drugs by CDE, which refers to innovative or improved new drugs in the clinical stage, which are used for the prevention and treatment of serious life-threatening diseases or seriously affect the quality of li.
Diseases for which there is no effective prevention and treatment method or sufficient evidence to show that innovative drugs are superior to existing treatment metho.
It is reported that ABSK021's breakthrough therapy designation is based on its excellent research results in the TGCT cohort of its Phase Ib clinical trial in Chi.
Studies have shown that ABSK021 can block the CSF1/CSF-1R signaling pathway and is expected to play a role in the treatment of various macrophage-related diseases including TG.
ABSK021 has completed the clinical phase Ia dose escalation trial in the United States, and demonstrated good safety and PK/PD characteristi.
Currently, the clinical phase Ib multi-cohort expansion phase study for TGCT is being carried out simultaneously in China and the United Stat.
So far, no highly selective CSF-1R inhibitors have been approved for marketing in Chi.
In addition to giant cell tumor of tendon sheath, Heyu Medicine is also exploring the clinical potential of ABSK021 in various solid tumors, and is exploring its application in non-tumor indications with other pharmaceutical compani.
For example, in July 2021, Heyu Pharma and Shufang Pharma announced to "join hands", and the two parties agreed that Shufang Pharma will develop, produce and commercialize ABSK021 in mainland China, Hong Kong and Macau for the treatment of rare diseases of the non-tumor nervous system The exclusive rights to the first study will be for amyotrophic lateral sclerosis (ALS, colloquially known as ALS), an irreversible and fatal motor neuron disease in which the main symptoms are the muscles of the extremities and trunk Gradual weakness and atrop.
According to public data, the global incidence of ALS (the proportion of new patients per year) is 9/100,000, and the prevalence (the proportion of existing patients in the total population) is 5/100,00Among them, in China, there are about 23,000 new ALS cases every ye.
Patients with this disease currently face very limited treatment options, so there is a huge need for new treatments that are safe and effecti.
According to the data, Heyu Pharma is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative and differentiated small molecule tumor therapi.
Since its establishment, the company has established a rich pipeline of oncology-focused drug candidat.
These products are mainly candidates for small-molecule tumor precision therapy and small-molecule tumor immunotherapy, and are intended to be developed for non-small cell lung cancer (NSCL.
NSCLC), hepatocellular carcinoma (HCC), urothelial carcinoma (UC), gastric cancer (GC) and other tumor typ.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
The lesions can be focal and diffu.
Data shows that about 43 people per million people suffer from this disease, so it is a rare disea.
At present, the main treatment for this disease is surgical resection, but its recurrence rate is high, and some patients have high risk of surgical resection, so patients have unmet clinical treatment nee.
Recently, there is good news that ABSK021, a highly selective CSF-1R inhibitor independently developed by Heyu Pharma, has been recognized by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China as a breakthrough therapy drug for the treatment of inoperable tenosynovial giant cel.
This will bring new treatment options for domestic patients with giant cell tumor of the tendon shea.
The so-called breakthrough therapy certification is one of the four accelerated procedures for the review of innovative drugs by CDE, which refers to innovative or improved new drugs in the clinical stage, which are used for the prevention and treatment of serious life-threatening diseases or seriously affect the quality of li.
Diseases for which there is no effective prevention and treatment method or sufficient evidence to show that innovative drugs are superior to existing treatment metho.
It is reported that ABSK021's breakthrough therapy designation is based on its excellent research results in the TGCT cohort of its Phase Ib clinical trial in Chi.
Studies have shown that ABSK021 can block the CSF1/CSF-1R signaling pathway and is expected to play a role in the treatment of various macrophage-related diseases including TG.
ABSK021 has completed the clinical phase Ia dose escalation trial in the United States, and demonstrated good safety and PK/PD characteristi.
Currently, the clinical phase Ib multi-cohort expansion phase study for TGCT is being carried out simultaneously in China and the United Stat.
So far, no highly selective CSF-1R inhibitors have been approved for marketing in Chi.
In addition to giant cell tumor of tendon sheath, Heyu Medicine is also exploring the clinical potential of ABSK021 in various solid tumors, and is exploring its application in non-tumor indications with other pharmaceutical compani.
For example, in July 2021, Heyu Pharma and Shufang Pharma announced to "join hands", and the two parties agreed that Shufang Pharma will develop, produce and commercialize ABSK021 in mainland China, Hong Kong and Macau for the treatment of rare diseases of the non-tumor nervous system The exclusive rights to the first study will be for amyotrophic lateral sclerosis (ALS, colloquially known as ALS), an irreversible and fatal motor neuron disease in which the main symptoms are the muscles of the extremities and trunk Gradual weakness and atrop.
According to public data, the global incidence of ALS (the proportion of new patients per year) is 9/100,000, and the prevalence (the proportion of existing patients in the total population) is 5/100,00Among them, in China, there are about 23,000 new ALS cases every ye.
Patients with this disease currently face very limited treatment options, so there is a huge need for new treatments that are safe and effecti.
According to the data, Heyu Pharma is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative and differentiated small molecule tumor therapi.
Since its establishment, the company has established a rich pipeline of oncology-focused drug candidat.
These products are mainly candidates for small-molecule tumor precision therapy and small-molecule tumor immunotherapy, and are intended to be developed for non-small cell lung cancer (NSCL.
NSCLC), hepatocellular carcinoma (HCC), urothelial carcinoma (UC), gastric cancer (GC) and other tumor typ.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
