Benegrastim

- Ryzneuta ® is the first non-pegylated granulocyte colony-stimulating factor approved by both the US Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) for treatment for CIN - Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia PRINCETON, NJ, USA I November 22, 2023 I Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., and Acrotech Biopharma (Acrotech), a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc., today announced that on November 16, 2023 the U.S. Food and Drug Administration (FDA) approved Ryzneuta ® (Efbemalenograstim alfa) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The approval was based on results of the two pivotal Phase 3 Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] completed in the United States and Europe. Ryzneuta ® is a novel long-acting Granulocyte colony-stimulating factor (G-CSF), which can stimulate the proliferation, differentiation, and release of neutrophil precursors. It helps to enhance the immune function of cancer patients and prevent the side effects of neutropenia caused by chemotherapy. Study GC-627-05, is a multi-center, randomized, multi-dose, active-controlled study comparing the efficacy and safety of Ryzneuta ® and Neulasta ® (Pegfilgrastim). The trial met its primary and secondary endpoints, of efficacy and safety. Neutropenia is a common side effect of chemotherapy and is characterized by persistently low levels of neutrophils (a type of white blood cell with infection-fighting functions) due to the use of chemotherapy and other types of anti-cancer drugs, which increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy. Ryzneuta ® is a novel dimeric G-CSF long-acting fusion protein without PEGylation or Tween-80. Due to its unique molecular structure, Ryzneuta ® may possess stronger G-CSF receptor activation properties and avoid the potential problem (such as allergic reactions) caused by PEG or Tween-80. “Ryzneuta ® is the first innovative biologics independently developed by Evive Biotech, and this approval proves that the Evive R&D team has the capability to independently carry out the global development of innovative biologics, including preclinical research, regulatory affairs, clinical research, manufacturing following international standard, as well as commercialization,” said Simon Li, M.D., Ph.D., CEO & CMO of Evive. “We look forward to working with Acrotech to bring this novel treatment to more cancer patients with CIN in the US.” “Ryzneuta ® is a new treatment option that has demonstrated its efficacy and safety building on the comprehensive global development program of Ryzneuta ® , which includes 12 clinical trials and has enrolled over 1,200 subjects to date in multiple territories including the US, EU, and China,” said Dr. John Glaspy, Principal Investigator of the Ryzneuta global clinical trial program and professor of medicine at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles School of Medicine, “and I am proud of the achievement made by Evive team and the devotion of the patients and research teams involved in these studies. We hope that this promising therapy will benefit more CIN patients.” “Acrotech is very excited on the approval of Ryzneuta ® and is preparing to commercialize the product in the near future. We believe Ryzneuta ® will offer patients suffering from CIN a very compelling and accessible treatment option. We will leverage our strong and well-established commercial footprint to promote this unique treatment to key stakeholders.” said Dr. Ashish Anvekar, President of Acrotech Biopharma. In May this year, Ryzneuta ® was approved and launched in China. In addition, the facility producing Ryzneuta ® has successfully passed the on-site GMP inspections conducted by ANVISA and EMA. In the near future, Ryzneuta ® is expected to receive more regulatory approvals, which will enable Ryzneuta ® to help and provide worldwide cancer patients a much-needed effective first-line treatment and alternative therapy. About Ryzneuta ® Ryzneuta ® (Efbemalenograstim alfa) is developed for the treatment of Chemotherapy-Induced Neutropenia (CIN) in cancer patients after chemotherapy. Neutropenia is a common side-effect of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cell that fights infection. Ryzneuta ® is a recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal. Ryzneuta ® is expressed in Chinese Hamster Ovary (CHO) cells. Ryzneuta ® exists as a homodimer with two G-CSF-Fc molecules covalently linked through disulphide bonds formed between the Fc moiety of the molecule. Through specific binding to its receptor, G-CSF receptor, Ryzneuta ® stimulates survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils. Ryzneuta ® strengthens the immune system’s ability to fight infection by increasing the production of neutrophils, preventing potential chemotherapy dose reductions and delays that may compromise treatment outcomes. The three pivotal trials of Ryzneuta ® are all multi-center, randomized, multi-dose, active-controlled study comparing the efficacy and safety of the drug. About Evive Biotech and Yifan Pharma Evive Biotech, a subsidiary of Yifan Pharma, is a global biopharmaceutical company devoted to developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary technology platforms to advance a series of innovative drug candidates for oncology, inflammatory and metabolic diseases. Founded in 2004, we currently have operations in the US, Singapore, and China. As the first biopharmaceutical company to build a platform bringing innovative therapies from China to the world, Evive adopts a holistic approach to drug development, combining exceptional research and commercialization capabilities with our world-class in-house manufacture and regulatory expertise as well as extensive international management experience. Through partnerships with industry, physicians, and regulatory authorities, we strive to bring revolutionary remedies to the global markets quickly and efficiently to address unmet medical needs, making a real and lasting difference to patients and their families worldwide. To learn more about Evive Biotech, visit www.evivebiotech.com . Yifan Pharmaceutical is an innovative R&D and production company focusing on the pharmaceutical and health sectors. Our vision is to develop innovative drugs with definite clinical values, to help disease-afflicted patients regain health. Currently, we are focusing on four business areas, i.e., biologics, small molecules, synthetic biologics, and special traditional Chinese medicines (TCMs), expanding our product R&D pipelines and innovating drugs for disease treatment to address unmet medical needs. About Acrotech Biopharma Acrotech Biopharma Inc. was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patients as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research-based organization that strives to launch treatments which are accessible to patients that need them. To learn more about Acrotech Biopharma, visit https://acrotechbiopharma.com . SOURCE: Evive Biotech

The term "Fusion protein" has two distinct definitions. One refers to the expression product of two recombined genes obtained through DNA recombinant technology, while the other refers to a group of proteins that mediate the fusion of two cytoplasmic membranes, such as one of the two glycoproteins contained in the outer leaflet of theSendai virus lipid bilayer, which mediates the fusion of the enveloped virus with the host cell cytoplasmic membrane. The other glycoprotein is the erythrocyte agglutinin neuramidase. The two different proteins can be linked into a large molecule either by chemical methods or by the fusion of genes. Fusion protein technology is a purposeful gene fusion and protein expression method to obtain large amounts of standard fusion proteins. Using fusion protein technology, it is possible to construct and express novel target proteins with various functions. Clinical Application of Fusion Proteins1. DNA Vaccines At present, vaccines have gone through three generations: The first generation vaccines activate the immune system with attenuated or killed pathogens; The second generation vaccines are component vaccines developed using biotechnology and recombinant DNA technology to induce an immune response; The third generation vaccines directly inject gene-recombined antigen genes to activate the human immune system, namely DNA vaccines. DNA vaccines have obvious advantages compared to traditional vaccines, such as easy production, strong stability, low cost, and the ability to simultaneously induce both humoral and cellular immune responses. 2. Dual-Function Enzymes (Multi-Function Enzymes) Research has found that in a large enzyme molecule constructed using gene fusion, if the entire encoding sequences of each enzyme molecule used to form the fusion protein are preserved in the new enzyme molecule, then the fusion protein generally retains the enzymatic activity of each of the enzyme molecules it was constructed from. It has also been found that in these newly constructed fusion proteins, the proper folding of proteins and the active sites of each enzyme were not affected. Compared to single enzymes, the specific activity of the enzyme in the fusion protein is 50%-100%. For two or several enzymes that catalyze consecutive reactions, fusion proteins formed by gene fusion methods can produce a "proximity effect". 3. Targeted Drugs Targeted drugs generally consist of two parts: one part is the drug; the other part is a ligand that can bind specifically to the lesion. Through fusion protein technology, these two parts can be fused together to form a protein with unique conformation and function. 4. Gene Expression Gene fusion technology was first used to express exogenous proteins in bacteria (mainly E. coli). For foreign genes (especially eukaryotic genes), fusion expression in E. coli has many advantages. For one, since foreign genes are generally connected to the C-terminal encoding sequence of a suitable fusion protein, there's no need to design SD sequences separately. Also, due to the presence of N-terminal fusion genes, foreign gene expression is relatively easier. Secondly, the expression products of foreign genes are often degraded by the host cell's proteases. When a foreign gene forms a fusion gene with a certain protein of the host itself, such as a part of the encoding sequence of β-galactosidase, its expression as a fusion protein often reduces degradation by the host cell. Common fusion proteins include immunoglobulin (Ig) fusion proteins, parathyroid hormone (PTH) fusion proteins, and recombinant fusion proteins of cytokines. Fusion proteins possess superior pharmacokinetic properties. Therefore, these drugs can be used in lower doses and are more effective compared to their unfused equivalents. So far, Fc fusion and HSA fusion techniques are the most widely used, but in recent years, XTEN fusion, CTP fusion, ELP fusion, and transferrin fusion techniques have made significant progress. Some drugs based on these technologies have already been launched, and a large number of drugs are currently undergoing clinical trials; they hold the promise to produce excellent outcomes, benefiting patients with various diseases worldwide. Fusion protein Competitive LandscapeAccording to Patsnap Synapse, as of 24 Sep 2023, there are a total of 941 Fusion protein drugs worldwide, from 796 organizations, covering 448 targets, 555 indications, and conducting 3659 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications,  targets, organizations, clinical trials, and clinical results related to this drug type.  Approved Recombinant protein Medicinal: NirsevimabNirsevimab is a monoclonal antibody fusion protein drug that targets the RSV F protein. It falls under the therapeutic area of infectious diseases, specifically Respiratory Syncytial Virus (RSV) infections. The drug is developed by AstraZeneca AB, a renowned pharmaceutical organization. As of the highest phase, Nirsevimab has been approved globally. In China, it is currently in the NDA/BLA phase, indicating that it is awaiting approval from the Chinese regulatory authorities. The drug received its first approval globally in October 2022, with the European Union being the first country/location to grant approval. Nirsevimab has undergone various regulatory processes to expedite its development and approval. It has been granted priority review, indicating that it is considered a high-priority drug due to its potential impact on public health. Additionally, it has received designations such as PRIME (PRIority MEdicines) and Fast Track, which aim to accelerate the development and review process for promising drugs. The drug has also undergone accelerated assessment, a regulatory mechanism that allows for a faster evaluation of drugs that address unmet medical needs. Furthermore, Nirsevimab has been designated as a Breakthrough Therapy, indicating its potential to provide significant improvement over existing treatments. Lastly, it has been recognized as a Promising Innovative Medicine, highlighting its innovative nature and potential benefits. In summary, Nirsevimab is a monoclonal antibody fusion protein drug developed by AstraZeneca AB. It targets the RSV F protein and is indicated for the treatment of Respiratory Syncytial Virus (RSV) infections. The drug has received global approval, with the European Union being the first to grant approval. It has undergone various regulatory processes, including priority review, PRIME designation, Fast Track, accelerated assessment, Breakthrough Therapy designation, and recognition as a Promising Innovative Medicine. These regulatory mechanisms aim to expedite the development and review process for drugs that address unmet medical needs and have the potential to provide significant improvements in patient outcomes. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. BenegrastimBenegrastim is a fusion protein drug that targets CSF-3R and is used in the treatment of various diseases. It falls under the therapeutic areas of Nervous System Diseases, Endocrinology and Metabolic Disease, Other Diseases, and Hemic and Lymphatic Diseases. The drug is primarily indicated for the treatment of Neutropenia, Fever, and Parkinson's Disease. Benegrastim is developed by Evive Biopharmaceutical (Beijing) Ltd. and Evive Biotech Co. Ltd., both organizations based in China. It has received approval for use in the global market as well as in China. The drug's highest phase of development is approved, indicating that it has successfully completed clinical trials and met the necessary regulatory requirements. The first approval for Benegrastim was granted in China in May 2023. As a fusion protein drug, Benegrastim is designed to target CSF-3R, a receptor involved in regulating the production and differentiation of white blood cells. Neutropenia, a condition characterized by a low count of neutrophils (a type of white blood cell), is one of the active indications for Benegrastim. By targeting CSF-3R, the drug aims to stimulate the production of neutrophils and restore their levels in the body. In addition to Neutropenia, Benegrastim is also indicated for the treatment of Fever and Parkinson's Disease. The drug's therapeutic areas suggest that it may have potential applications in various diseases affecting the nervous system, endocrine system, metabolism, and the hematopoietic and lymphatic systems. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Overall, Benegrastim is a fusion protein drug developed by Evive Biopharmaceutical (Beijing) Ltd. and Evive Biotech Co. Ltd. It has received approval for use in China and globally, with its highest phase being approved. The drug targets CSF-3R and is indicated for the treatment of Neutropenia, Fever, and Parkinson's Disease. Its first approval was granted in China in May 2023.