CSF-3R

SHANGHAI, Dec. 19, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National Medical Products Administration (NMPA) for use in adult patients with non-myeloid malignant neoplasms to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs that are susceptible to febrile neutropenia. 8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intellectual property rights owned by Mabwell. 8MW0511 is produced by fusing the N-terminus of the modified G-CSF mutant gene with the C-terminus of human serum albumin with gene fusion technology. It significantly inhibits the G-CSF receptor-mediated clearance pathway, which prolongs the half-life period, reduces the frequency of drug administration, and improves the treatment compliance in clinical use. 8MW0511 is produced by yeast expression system, which brings better homogeneity, simplifies production process, and is expected to reduce the cost of production by avoiding the PEG modification reactions. The results of the Phase III clinical study of 8MW0511 presented at the European Society for Medical Oncology (ESMO) in 2023 showed that 8MW0511 was clinically effective, non-inferior to the positive control, PEG-rhG-CSF (Jinyouli), and improved the incidence and duration of Grade 4 neutropenia, especially in cycle 2-3 where the incidence of Grade 4 neutropenia was significantly lower than that of the positive control group. The overall safety profile was similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

- 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

SHANGHAI, July 25, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that clinical trial data from phase I/II study for advanced solid tumor of Nectin-4-targeting ADC (9MW2821), and phase III study of Long-Acting Recombinant Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor (I) Fusion Protein (8MW0511) will be presented orally and as a poster respectively at ESMO Congress 2023, which will be held in Madrid, Spain, from Oct. 20th to 24th, 2023. ESMO Congress is one of the most influential oncology conferences in the world. Please pay close attention to Mabwell's reports during ESMO Congress 2023. Oral Presentation Abstract Title: Preliminary results from a phase I/II study of 9MW2821, an antibody-drug conjugate targeting Nectin-4, in patients with advanced solid tumors Abstract Number: 4613 Poster Presentation Abstract Title: MW05, a Novel, Long-Acting Recombinant Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor (I) Fusion Protein for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial Abstract Number: 3602 About 9MW2821 Developed by Mabwell's ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, 9MW2821 is the first clinical stage Nectin-4-targeting ADC developed by Chinese company. The site-specific modification of antibody is based on the coupling technology linker and optimized ADC coupling process with independent intellectual property rights. 9MW2821 received IND clearance from NMPA and FDA on Oct.19th, 2021 and Jul. 28th, 2022, respectively. Clinical trial application of combination therapy has also been approved by NMPA on Apr. 14th, 2023. The multiple ongoing clinical studies to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity of 9MW2821 show positive therapeutic signals in different types of advanced solid tumors and good safety profile at the recommended phase II dose (RP2D). About 8MW0511 8MW0511 is a novel, long-acting G-CSF (highly active modified cytokine) with independent intellectual property rights of Mabwell. It is intended to reduce the incidence of infection characterized by febrile neutropenia(FN) in the adult patients with non-myeloid malignant tumors, when they are treated with antitumor therapies that are susceptible to FN. 8MW0511 is produced by fusion of N terminal of modified G-CSF genes with C terminal of human serum albumin(HSA) through gene fusion technology, which can significantly inhibit the G-CSF receptor-mediated clearance pathway, prolong the half-life period, decrease the frequency of administration in clinical use, reduce the suffering of patients, and improve the treatment compliance. Meanwhile, 8MW0511 is produced by yeast-expression system, which brings better homogeneity. It is expected to reduce the cost by avoiding the complex PEG modifications and simplifying production process. The phase III clinical trial of 8MW0511 has been completed, and we are moving forward with the preparations of NDA. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to:environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell