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Medical Network, September 7 News On September 6, Yuandong Biotechnology issued an announcement that its wholly-owned subsidiary, Chengdu Youluo Biotechnology, has recently received the "Notice of Drug Clinical Trial Approval" approved and issued by the State Food and Drug Administration, EP-9001A injection The liquid clinical trial application was approved, and the registration of the product was classified as category 1 of therapeutic biological products, and it was planned to carry out clinical trials for bone metastasis cancer pain
.
.
Figure 1: Details of EP-9001A injection
Source: CDE official website
According to the announcement, EP-9001A injection is Yuandong Bio's first class 1 biological drug independently developed.
It is a humanized monoclonal antibody drug with a new mechanism of action.
The target is human nerve growth factor (NGF).
The mechanism of action is to selectively target binding and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action from other analgesics such as opioids and non-steroidal anti-inflammatory drugs.
.
Preclinical studies have shown that EP-9001A injection has a significant analgesic effect on a variety of pain models, with a low effective dose and a strong and long-lasting analgesic effect.
At present, no similar product has been approved for marketing at home and abroad
.
Yuandong Biology stated that advancing the research and development of EP-9001A injection will help enrich the company's product pipeline in the field of anesthesia and analgesia and enhance the company's market competitiveness
.
It is a humanized monoclonal antibody drug with a new mechanism of action.
The target is human nerve growth factor (NGF).
The mechanism of action is to selectively target binding and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action from other analgesics such as opioids and non-steroidal anti-inflammatory drugs.
.
Preclinical studies have shown that EP-9001A injection has a significant analgesic effect on a variety of pain models, with a low effective dose and a strong and long-lasting analgesic effect.
At present, no similar product has been approved for marketing at home and abroad
.
Yuandong Biology stated that advancing the research and development of EP-9001A injection will help enrich the company's product pipeline in the field of anesthesia and analgesia and enhance the company's market competitiveness
.
According to the 2021 semi-annual report released by Yuandong Biotechnology, the company has more than 10 category 1 innovative drugs under research, including key products yogliptin tablets, CX3002 tablets and EP-9001A injection.
In addition, the company still has one A series of new molecular entity drug candidates EP-0093I+EP0093A, D0025, D0037 and other projects are undergoing preclinical and early exploratory research
.
In addition, the company still has one A series of new molecular entity drug candidates EP-0093I+EP0093A, D0025, D0037 and other projects are undergoing preclinical and early exploratory research
.
Figure 2: The clinical situation of yogliptin tablets
Source: China Drug Clinical Trial Publicity Library of Meinenet
Eutagliptin tablets are a new class 1 chemical drug independently developed by the company.
It is the first oral long-acting hypoglycemic agent declared for type 2 diabetes in China, and it is planned to be administered once a week
.
The product has significant hypoglycemic effect and unique intestinal excretion pharmacokinetic characteristics.
Patients with renal impairment do not need to adjust the dose, which improves the compliance of patients with diabetic nephropathy and adapts to a wider population
.
At present, eutagliptin tablets have completed phase II clinical trials, and the preliminary results are in line with expectations, and they are now in the clinical summary stage
.
It is the first oral long-acting hypoglycemic agent declared for type 2 diabetes in China, and it is planned to be administered once a week
.
The product has significant hypoglycemic effect and unique intestinal excretion pharmacokinetic characteristics.
Patients with renal impairment do not need to adjust the dose, which improves the compliance of patients with diabetic nephropathy and adapts to a wider population
.
At present, eutagliptin tablets have completed phase II clinical trials, and the preliminary results are in line with expectations, and they are now in the clinical summary stage
.
Figure 3: Clinical situation of CX3002 tablets
Source: China Drug Clinical Trial Publicity Library of Meinenet
CX3002 tablet is a new class 1 chemical drug jointly developed by the company.
It is a new type of oral factor Xa inhibitor.
It is mainly intended to prevent the formation of acute deep vein thrombosis.
Compared with the same target drug, CX3002 has a clear mechanism of action and efficacy.
Stand out
.
At present, CX3002 tablets have completed phase I clinical trials and are preparing for phase II clinical trials
.
It is a new type of oral factor Xa inhibitor.
It is mainly intended to prevent the formation of acute deep vein thrombosis.
Compared with the same target drug, CX3002 has a clear mechanism of action and efficacy.
Stand out
.
At present, CX3002 tablets have completed phase I clinical trials and are preparing for phase II clinical trials
.
According to the data, Yuandong Biotech’s R&D investment in the first half of 2021 was 94,290,500 yuan, a year-on-year increase of 43.
16%, accounting for 18.
91% of operating income.
The company continued to increase R&D investment to strongly support the acceleration of R&D projects
.
16%, accounting for 18.
91% of operating income.
The company continued to increase R&D investment to strongly support the acceleration of R&D projects
.
Source: Company announcement, Mi Neiwang database
Clinical data statistics are as of September 3rd, please correct me if there are any errors or omissions
.
.
Medical Network, September 7 News On September 6, Yuandong Biotechnology issued an announcement that its wholly-owned subsidiary, Chengdu Youluo Biotechnology, has recently received the "Notice of Drug Clinical Trial Approval" approved and issued by the State Food and Drug Administration, EP-9001A injection The liquid clinical trial application was approved, and the registration of the product was classified as category 1 of therapeutic biological products, and it was planned to carry out clinical trials for bone metastasis cancer pain
.
.
Figure 1: Details of EP-9001A injection
Source: CDE official website
According to the announcement, EP-9001A injection is Yuandong Bio's first class 1 biological drug independently developed.
It is a humanized monoclonal antibody drug with a new mechanism of action.
The target is human nerve growth factor (NGF).
The mechanism of action is to selectively target binding and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action from other analgesics such as opioids and non-steroidal anti-inflammatory drugs.
.
Preclinical studies have shown that EP-9001A injection has a significant analgesic effect on a variety of pain models, with a low effective dose and a strong and long-lasting analgesic effect.
At present, no similar product has been approved for marketing at home and abroad
.
Yuandong Biology stated that advancing the research and development of EP-9001A injection will help enrich the company's product pipeline in the field of anesthesia and analgesia and enhance the company's market competitiveness
.
It is a humanized monoclonal antibody drug with a new mechanism of action.
The target is human nerve growth factor (NGF).
The mechanism of action is to selectively target binding and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action from other analgesics such as opioids and non-steroidal anti-inflammatory drugs.
.
Preclinical studies have shown that EP-9001A injection has a significant analgesic effect on a variety of pain models, with a low effective dose and a strong and long-lasting analgesic effect.
At present, no similar product has been approved for marketing at home and abroad
.
Yuandong Biology stated that advancing the research and development of EP-9001A injection will help enrich the company's product pipeline in the field of anesthesia and analgesia and enhance the company's market competitiveness
.
According to the 2021 semi-annual report released by Yuandong Biotechnology, the company has more than 10 category 1 innovative drugs under research, including key products yogliptin tablets, CX3002 tablets and EP-9001A injection.
In addition, the company still has one A series of new molecular entity drug candidates EP-0093I+EP0093A, D0025, D0037 and other projects are undergoing preclinical and early exploratory research
.
In addition, the company still has one A series of new molecular entity drug candidates EP-0093I+EP0093A, D0025, D0037 and other projects are undergoing preclinical and early exploratory research
.
Figure 2: The clinical situation of yogliptin tablets
Source: China Drug Clinical Trial Publicity Library of Meinenet
Eutagliptin tablets are a new class 1 chemical drug independently developed by the company.
It is the first oral long-acting hypoglycemic agent declared for type 2 diabetes in China, and it is planned to be administered once a week
.
The product has significant hypoglycemic effect and unique intestinal excretion pharmacokinetic characteristics.
Patients with renal impairment do not need to adjust the dose, which improves the compliance of patients with diabetic nephropathy and adapts to a wider population
.
At present, eutagliptin tablets have completed phase II clinical trials, and the preliminary results are in line with expectations, and they are now in the clinical summary stage
.
It is the first oral long-acting hypoglycemic agent declared for type 2 diabetes in China, and it is planned to be administered once a week
.
The product has significant hypoglycemic effect and unique intestinal excretion pharmacokinetic characteristics.
Patients with renal impairment do not need to adjust the dose, which improves the compliance of patients with diabetic nephropathy and adapts to a wider population
.
At present, eutagliptin tablets have completed phase II clinical trials, and the preliminary results are in line with expectations, and they are now in the clinical summary stage
.
Figure 3: Clinical situation of CX3002 tablets
Source: China Drug Clinical Trial Publicity Library of Meinenet
CX3002 tablet is a new class 1 chemical drug jointly developed by the company.
It is a new type of oral factor Xa inhibitor.
It is mainly intended to prevent the formation of acute deep vein thrombosis.
Compared with the same target drug, CX3002 has a clear mechanism of action and efficacy.
Stand out
.
At present, CX3002 tablets have completed phase I clinical trials and are preparing for phase II clinical trials
.
It is a new type of oral factor Xa inhibitor.
It is mainly intended to prevent the formation of acute deep vein thrombosis.
Compared with the same target drug, CX3002 has a clear mechanism of action and efficacy.
Stand out
.
At present, CX3002 tablets have completed phase I clinical trials and are preparing for phase II clinical trials
.
According to the data, Yuandong Biotech’s R&D investment in the first half of 2021 was 94,290,500 yuan, a year-on-year increase of 43.
16%, accounting for 18.
91% of operating income.
The company continued to increase R&D investment to strongly support the acceleration of R&D projects
.
16%, accounting for 18.
91% of operating income.
The company continued to increase R&D investment to strongly support the acceleration of R&D projects
.
Source: Company announcement, Mi Neiwang database
Clinical data statistics are as of September 3rd, please correct me if there are any errors or omissions
.
.
Medical Network, September 7 News On September 6, Yuandong Biotechnology issued an announcement that its wholly-owned subsidiary, Chengdu Youluo Biotechnology, has recently received the "Notice of Drug Clinical Trial Approval" approved and issued by the State Food and Drug Administration, EP-9001A injection The liquid clinical trial application was approved, and the registration of the product was classified as category 1 of therapeutic biological products, and it was planned to carry out clinical trials for bone metastasis cancer pain
.
.
Figure 1: Details of EP-9001A injection
Source: CDE official website
According to the announcement, EP-9001A injection is Yuandong Bio's first class 1 biological drug independently developed.
It is a humanized monoclonal antibody drug with a new mechanism of action.
The target is human nerve growth factor (NGF).
The mechanism of action is to selectively target binding and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action from other analgesics such as opioids and non-steroidal anti-inflammatory drugs.
.
Preclinical studies have shown that EP-9001A injection has a significant analgesic effect on a variety of pain models, with a low effective dose and a strong and long-lasting analgesic effect.
At present, no similar product has been approved for marketing at home and abroad
.
Yuandong Biology stated that advancing the research and development of EP-9001A injection will help enrich the company's product pipeline in the field of anesthesia and analgesia and enhance the company's market competitiveness
.
It is a humanized monoclonal antibody drug with a new mechanism of action.
The target is human nerve growth factor (NGF).
The mechanism of action is to selectively target binding and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.
It has a different mechanism of action from other analgesics such as opioids and non-steroidal anti-inflammatory drugs.
.
Preclinical studies have shown that EP-9001A injection has a significant analgesic effect on a variety of pain models, with a low effective dose and a strong and long-lasting analgesic effect.
At present, no similar product has been approved for marketing at home and abroad
.
Yuandong Biology stated that advancing the research and development of EP-9001A injection will help enrich the company's product pipeline in the field of anesthesia and analgesia and enhance the company's market competitiveness
.
According to the 2021 semi-annual report released by Yuandong Biotechnology, the company has more than 10 category 1 innovative drugs under research, including key products yogliptin tablets, CX3002 tablets and EP-9001A injection.
In addition, the company still has one A series of new molecular entity drug candidates EP-0093I+EP0093A, D0025, D0037 and other projects are undergoing preclinical and early exploratory research
.
In addition, the company still has one A series of new molecular entity drug candidates EP-0093I+EP0093A, D0025, D0037 and other projects are undergoing preclinical and early exploratory research
.
Figure 2: The clinical situation of yogliptin tablets
Source: China Drug Clinical Trial Publicity Library of Meinenet
Eutagliptin tablets are a new class 1 chemical drug independently developed by the company.
It is the first oral long-acting hypoglycemic agent declared for type 2 diabetes in China, and it is planned to be administered once a week
.
The product has significant hypoglycemic effect and unique intestinal excretion pharmacokinetic characteristics.
Patients with renal impairment do not need to adjust the dose, which improves the compliance of patients with diabetic nephropathy and adapts to a wider population
.
At present, eutagliptin tablets have completed phase II clinical trials, and the preliminary results are in line with expectations, and they are now in the clinical summary stage
.
It is the first oral long-acting hypoglycemic agent declared for type 2 diabetes in China, and it is planned to be administered once a week
.
The product has significant hypoglycemic effect and unique intestinal excretion pharmacokinetic characteristics.
Patients with renal impairment do not need to adjust the dose, which improves the compliance of patients with diabetic nephropathy and adapts to a wider population
.
At present, eutagliptin tablets have completed phase II clinical trials, and the preliminary results are in line with expectations, and they are now in the clinical summary stage
.
Figure 3: Clinical situation of CX3002 tablets
Source: China Drug Clinical Trial Publicity Library of Meinenet
CX3002 tablet is a new class 1 chemical drug jointly developed by the company.
It is a new type of oral factor Xa inhibitor.
It is mainly intended to prevent the formation of acute deep vein thrombosis.
Compared with the same target drug, CX3002 has a clear mechanism of action and efficacy.
Stand out
.
At present, CX3002 tablets have completed phase I clinical trials and are preparing for phase II clinical trials
.
It is a new type of oral factor Xa inhibitor.
It is mainly intended to prevent the formation of acute deep vein thrombosis.
Compared with the same target drug, CX3002 has a clear mechanism of action and efficacy.
Stand out
.
At present, CX3002 tablets have completed phase I clinical trials and are preparing for phase II clinical trials
.
According to the data, Yuandong Biotech’s R&D investment in the first half of 2021 was 94,290,500 yuan, a year-on-year increase of 43.
16%, accounting for 18.
91% of operating income.
The company continued to increase R&D investment to strongly support the acceleration of R&D projects
.
16%, accounting for 18.
91% of operating income.
The company continued to increase R&D investment to strongly support the acceleration of R&D projects
.
Source: Company announcement, Mi Neiwang database
Clinical data statistics are as of September 3rd, please correct me if there are any errors or omissions
.
.
