Yiyi Biotech submitted Ryzneuta(TM) Biological Products License Application (BLA) to the US FDA

•  Last Update: 2021-04-14
•  Source: Internet
•  Author: User

Ryzneuta™ is a new type of treatment for chemotherapy-induced neutropenia (CIN).
Neutropenia is a common side effect of various chemotherapy.
The symptom is the low level of neutrophils, which are anti-infective white blood cells.
Ryzneuta™ enhances the immune system's anti-infection ability by allowing these key white blood cells to proliferate, thereby preventing possible chemotherapy dose reduction and delay problems that may affect treatment results.
With the help of Yibio's proprietary DiKine™ fusion protein platform, Ryzneuta™ realizes a new structure and provides a unique and natural long-acting treatment plan, which is expected to replace the current PEGylated G-CSF therapy on the market.

Dr.
Jubo Liu, CEO of E-Bio, said: "This is an important milestone for E -Bio, and it also proves that we are fully capable of developing a new type of biological drug and bringing it from the laboratory to the global market.
We are fortunate to be the first company in China to submit a complete BLA application.
It is our own team that helped achieve this goal, which makes us very happy.
By submitting a BLA application, we look forward to working with partners to provide CIN patients with Ryzneuta™.
"

Ryzneuta™'s global development plan covers 10 clinical trials.
So far, it has recruited more than 1,200 patients in many countries and regions including the United States, the European Union, Australia and China, and all trials have reached all primary and secondary endpoints.
.
Ryzneuta™'s critical global phase III trial was conducted after reaching an agreement with the US FDA using the Special Program Evaluation (SPA) procedure.

Dr.
William Dailey , Chief Medical Officer of Yiyi Biotech , said: “For cancer patients, neutropenia is a common complication that may threaten their lives.
Our goal is to prevent the use of current treatment options or To provide effective first-line treatments and alternative therapies for patients who are incurable with current treatment plans.
Submitting a BLA application is an important measure that makes us one step closer to this goal.
I feel for every member of our team Proud, it's not easy for them to get to this point.
I congratulate them.
"

Dr.
John Glaspy , the principal investigator of the global clinical trial program and a professor of medicine at the Johnson Cancer Center (JCCC) at the University of California, Los Angeles Medical Center , said: “There are 8 million chemotherapy patients worldwide who are at risk of developing CIN every year.
We look forward to working with the FDA.
Promote the approval of Ryzneuta™ and introduce this new drug to critically ill patients.
"

FDA will generally inform whether to accept the application within 60 days after receiving the first BLA application.
In addition to submitting a BLA to the FDA, Yiyi Biotech is also preparing to submit a marketing authorization application to the European Medicines Agency (EMA) and a new drug application to the National Medical Products Administration (NMPA) of China.

Ryzneuta™ is a new type of treatment for chemotherapy-induced neutropenia (CIN).
Neutropenia is a common side effect of various chemotherapy.
The symptom is the low level of neutrophils, which are anti-infective white blood cells.
Ryzneuta™ enhances the immune system's anti-infection ability by allowing these key white blood cells to proliferate, thereby preventing possible chemotherapy dose reduction and delay problems that may affect treatment results.
With the help of Yibio's proprietary DiKine™ fusion protein platform, Ryzneuta™ realizes a new structure and provides a unique and natural long-acting treatment plan, which is expected to replace the current PEGylated G-CSF therapy on the market.

Dr.
Jubo Liu, CEO of E-Bio, said: "This is an important milestone for E -Bio, and it also proves that we are fully capable of developing a new type of biological drug and bringing it from the laboratory to the global market.
We are fortunate to be the first company in China to submit a complete BLA application.
It is our own team that helped achieve this goal, which makes us very happy.
By submitting a BLA application, we look forward to working with partners to provide CIN patients with Ryzneuta™.
"

Ryzneuta™'s global development plan covers 10 clinical trials.
So far, it has recruited more than 1,200 patients in many countries and regions including the United States, the European Union, Australia and China, and all trials have reached all primary and secondary endpoints.
.
Ryzneuta™'s critical global phase III trial was conducted after reaching an agreement with the US FDA using the Special Program Evaluation (SPA) procedure.

Dr.
William Dailey , Chief Medical Officer of Yiyi Biotech , said: “For cancer patients, neutropenia is a common complication that may threaten their lives.
Our goal is to prevent the use of current treatment options or To provide effective first-line treatments and alternative therapies for patients who are incurable with current treatment plans.
Submitting a BLA application is an important measure that makes us one step closer to this goal.
I feel for every member of our team Proud, it's not easy for them to get to this point.
I congratulate them.
"

Dr.
John Glaspy , the principal investigator of the global clinical trial program and a professor of medicine at the Johnson Cancer Center (JCCC) at the University of California, Los Angeles Medical Center , said: “There are 8 million chemotherapy patients worldwide who are at risk of developing CIN every year.
We look forward to working with the FDA.
Promote the approval of Ryzneuta™ and introduce this new drug to critically ill patients.
"

FDA will generally inform whether to accept the application within 60 days after receiving the first BLA application.
In addition to submitting a BLA to the FDA, Yiyi Biotech is also preparing to submit a marketing authorization application to the European Medicines Agency (EMA) and a new drug application to the National Medical Products Administration (NMPA) of China.

Ryzneuta™ is a new type of treatment for chemotherapy-induced neutropenia (CIN).
Neutropenia is a common side effect of various chemotherapy.
The symptom is the low level of neutrophils, which are anti-infective white blood cells.
Ryzneuta™ enhances the immune system's anti-infection ability by allowing these key white blood cells to proliferate, thereby preventing possible chemotherapy dose reduction and delay problems that may affect treatment results.
With the help of Yibio's proprietary DiKine™ fusion protein platform, Ryzneuta™ realizes a new structure and provides a unique and natural long-acting treatment plan, which is expected to replace the current PEGylated G-CSF therapy on the market.

Dr.
Jubo Liu, CEO of E-Bio, said: "This is an important milestone for E -Bio, and it also proves that we are fully capable of developing a new type of biological drug and bringing it from the laboratory to the global market.
We are fortunate to be the first company in China to submit a complete BLA application.
It is our own team that helped achieve this goal, which makes us very happy.
By submitting a BLA application, we look forward to working with partners to provide CIN patients with Ryzneuta™.
"

Ryzneuta™'s global development plan covers 10 clinical trials.
So far, it has recruited more than 1,200 patients in many countries and regions including the United States, the European Union, Australia and China, and all trials have reached all primary and secondary endpoints.
.
Ryzneuta™'s critical global phase III trial was conducted after reaching an agreement with the US FDA using the Special Program Evaluation (SPA) procedure.

Dr.
William Dailey , Chief Medical Officer of Yiyi Biotech , said: “For cancer patients, neutropenia is a common complication that may threaten their lives.
Our goal is to prevent the use of current treatment options or To provide effective first-line treatments and alternative therapies for patients who are incurable with current treatment plans.
Submitting a BLA application is an important measure that makes us one step closer to this goal.
I feel for every member of our team Proud, it's not easy for them to get to this point.
I congratulate them.
"

Dr.
John Glaspy , the principal investigator of the global clinical trial program and a professor of medicine at the Johnson Cancer Center (JCCC) at the University of California, Los Angeles Medical Center , said: “There are 8 million chemotherapy patients worldwide who are at risk of developing CIN every year.
We look forward to working with the FDA.
Promote the approval of Ryzneuta™ and introduce this new drug to critically ill patients.
"

FDA will generally inform whether to accept the application within 60 days after receiving the first BLA application.
In addition to submitting a BLA to the FDA, Yiyi Biotech is also preparing to submit a marketing authorization application to the European Medicines Agency (EMA) and a new drug application to the National Medical Products Administration (NMPA) of China.

• Following the completion of the global phase III clinical trial of chemotherapy-induced neutropenia for breast cancer patients, Yiyi Biotech submitted the relevant BLA application to the US FDA .
  
• Yiyi Biologics is the first Chinese biopharmaceutical company in China to advance a new biologic drug from preclinical research to submit a complete BLA application.
  

Following the completion of the global phase III clinical trial of chemotherapy-induced neutropenia for breast cancer patients, Yiyi Biotech submitted the relevant BLA application to the US FDA .

Following the completion of the global phase III clinical trial of chemotherapy-induced neutropenia for breast cancer patients, Yiyi Biotech submitted the relevant BLA application to the US FDA .

Yiyi Biologics is the first Chinese biopharmaceutical company in China to advance a new biologic drug from preclinical research to submit a complete BLA application.

Yiyi Biologics is the first Chinese biopharmaceutical company in China to advance a new biologic drug from preclinical research to submit a complete BLA application.

Bridgewater, Singapore and New Jersey, March 31, 2021/PRNewswire/ - Evive Biotech, a global biopharmaceutical company dedicated to the development of new biological therapies, announced today that the company has submitted a report to the U.
S.
Food and Drug Administration The Administration (FDA) submitted its Ryzneuta™ (also known as F-627) Biological Products License Application (BLA).
Prior to this, the company has successfully completed its F-627 global phase III clinical trials (NCT03252431 and NCT02872103), which reached the primary and secondary endpoints.
F-627 has also demonstrated significant and long-lasting efficacy in the trial.

Ryzneuta™ is a new type of treatment for chemotherapy-induced neutropenia (CIN).
Neutropenia is a common side effect of various chemotherapy.
The symptom is the low level of neutrophils, which are anti-infective white blood cells.
Ryzneuta™ enhances the immune system's anti-infection ability by allowing these key white blood cells to proliferate, thereby preventing possible chemotherapy dose reduction and delay problems that may affect treatment results.
With the help of Yibio's proprietary DiKine™ fusion protein platform, Ryzneuta™ realizes a new structure and provides a unique and natural long-acting treatment plan, which is expected to replace the current PEGylated G-CSF therapy on the market.

Dr.
Jubo Liu, CEO of E-Bio, said: "This is an important milestone for E -Bio, and it also proves that we are fully capable of developing a new type of biological drug and bringing it from the laboratory to the global market.
We are fortunate to be the first company in China to submit a complete BLA application.
It is our own team that helped achieve this goal, which makes us very happy.
By submitting a BLA application, we look forward to working with partners to provide CIN patients with Ryzneuta™.
"

Dr.
Liu Jubo, CEO of Yiyi Biotech

Ryzneuta™'s global development plan covers 10 clinical trials.
So far, it has recruited more than 1,200 patients in many countries and regions including the United States, the European Union, Australia and China, and all trials have reached all primary and secondary endpoints.
.
Ryzneuta™'s critical global phase III trial was conducted after reaching an agreement with the US FDA using the Special Program Evaluation (SPA) procedure.

Dr.
William Dailey , Chief Medical Officer of Yiyi Biotech , said: “For cancer patients, neutropenia is a common complication that may threaten their lives.
Our goal is to prevent the use of current treatment options or To provide effective first-line treatments and alternative therapies for patients who are incurable with current treatment plans.
Submitting a BLA application is an important measure that makes us one step closer to this goal.
I feel for every member of our team Proud, it's not easy for them to get to this point.
I congratulate them.
"

$ 110 bio Chief Medical Officer William Dailey William Dailey

Dr.
John Glaspy , the principal investigator of the global clinical trial program and a professor of medicine at the Johnson Cancer Center (JCCC) at the University of California, Los Angeles Medical Center , said: “There are 8 million chemotherapy patients worldwide who are at risk of developing CIN every year.
We look forward to working with the FDA.
Promote the approval of Ryzneuta™ and introduce this new drug to critically ill patients.
"

Global clinical trial principal investigator John Glaspy John Glaspy Dr.

FDA will generally inform whether to accept the application within 60 days after receiving the first BLA application.
In addition to submitting a BLA to the FDA, Yiyi Biotech is also preparing to submit a marketing authorization application to the European Medicines Agency (EMA) and a new drug application to the National Medical Products Administration (NMPA) of China.

Editor's note:

Editor's note:

For details, please contact:

Brunswick Group
Email: prnasia.

com/t/1G9U5b3T" rel="nofollow" target="_blank" style="box-sizing:border-box;background-color:transparent;color:#00837E;text-decoration-line:none;overflow-wrap:break-word;word-break:break-all;">evive.

Introduction to Ryzneuta™

Ryzneuta™ (efbemalenograstim alfa) is designed to treat cancer patients with neutropenia (CIN) after chemotherapy.

The pivotal phase III trial of Ryzneuta™ (NCT03252431) (the product is also called "F-627" in the trial) is a multicenter, randomized, single-dose, active controlled study that compares Ryzneuta™ and Neulasta® (pefigra Pavilion) efficacy and safety were compared.

Introduction

Introduction

EiBio is a global biopharmaceutical company rooted in Asia, dedicated to the development of new biological therapies for patients worldwide.
The company promotes the development of a series of innovative drug candidates for tumors and inflammatory diseases through a proprietary technology platform.
The company was founded in 2004 and currently has more than 200 employees in the United States, Singapore and China.
We adopt a comprehensive approach to drug development, combining excellent research and commercialization capabilities with world-class global regulatory expertise to quickly and effectively bring innovative therapies to the market.
We have advanced cGMP facilities that enable us to carry out commercial-scale production in accordance with the GMP standards of FDA, EMA and NMPA.
Through cooperation with industry, doctors and regulatory agencies, we have developed revolutionary innovative therapies, and we believe that these therapies will bring real and lasting changes to patients and their families all over the world.

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