Evive Biotech

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a thumbs up to Bristol Myers Squibb's Abecma and a thumbs down to Apellis' geographic atrophy drug Syfovre. Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre, the company said it will appeal the guidance. On the positive side of the ledger, the European Medicines Agency committee recommended marketing authorizations for four products, including a label expansion for Bristol Myers Squibb's multiple myeloma CAR-T Abecma. The thumbs down for Apellis' groundbreaking drug—which became the first treatment for GA upon its approval by the FDA in February of last year—was not a surprise. Last month, Apellis revealed that a panel of experts voted down the treatment after an “oral explanation meeting,” triggering a 17% slide in the company’s share price. Apellis' drug stumbled soon after its U.S. launch because of reports of vascular retinitis. The CHMP determined that the benefits of using Syfovre don't outweigh the risks. “Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP concluded. “It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies.” For its part, the Massachusetts-based company pointed to results from two phase 3 trials which showed that the treatment reduced GA lesion growth, with treatment benefits accumulating over time.  “We are very disappointed in this outcome on behalf of the millions of Europeans with GA who currently have no treatment options for this irreversible form of blindness,” Jeffrey Eisele, Ph.D., Apellis’ chief development officer, said in a statement. “We plan to promptly initiate the re-examination of our application and address CHMP questions.” BMS scores with Abecma Meanwhile, the CHMP’s positive opinion on BMS’s Abecma is the first in earlier lines of treatment for a CAR-T cell therapy for multiple myeloma, according to the drugmaker.  CHMP specifically recommended the drug for patients who've tried two prior therapies, as opposed to the drug's initial EU nod in the fourth line of treatment. Samit Hirawat, M.D., BMS’s chief medical officer, called the endorsement an “important milestone.” “(It) moves us closer to offering a first-in-class, personalized therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care.” Also gaining recommendations for label extensions were Apellis and Sobi's PNH drug Aspaveli, Pfizer's pneumococcal vaccine Prevnar 20 and Eli Lilly's thyroid cancer drug Retsevmo.  CHMP gives thumbs up to 3 products The CHMP recommended a marketing authorization for Allecra’s Exblifep (cefepime/enmetazobactam) for urinary tract infections accompanied by hospital-acquired pneumonia and for the treatment of patients with bacteria in the bloodstream. The antibiotic combination treatment also is under review by the FDA. Also getting a positive recommendation from the committee was Evive Biotech and Acrotech Biopharma’s Ryzneuta (efbemalenograstim alfa) for neutropenia and febrile neutropenia caused by chemotherapy. The FDA signed off on the leukocyte growth factor two months ago. The CHMP also said yes to Neuraxpharm’s schizophrenia medicine Niapelf (paliperidone), which is the generic version of Johnson & Johnson’s Invega Sustenna, which was approved in the U.S. in 2009 and in Europe as Xeplion in 2011. CHMP recommends rejection of Nezglyal Minoryx Therapeutics’ Nezglyal (leriglitazone) got a negative recommendation from the committee. The drug is for the treatment of the genetic condition cerebral adrenoleukodystrophy, which damages the brain and spinal cord. The Spanish company gained FDA fast-track designation for the treatment in 2020.

CAMBRIDGE, Mass., Dec. 10, 2023 /PRNewswire/ -- Nona Biosciences, a global pioneer of technology innovation and antibody discovery and development solutions, and Evive Biotech, a global biopharmaceutical company devoted to developing a portfolio of novel biological therapies for patients worldwide, today announced a collaboration agreement on antibody discovery based on the Harbour Mice® antibody technology platform of Nona Biosciences. The collaboration brings together professional advantages of Nona Biosciences and Evive Biotech, aiming to accelerate the process of antibody discovery and drug development to benefit patients faster. Harbour Mice® is a proprietary antibody technology platform that utilizes the transgenic mouse to generate fully human monoclonal antibodies in both a traditional two heavy and two light chain (H2L2) format and a heavy chain only (HCAb) format. This platform holds significant potential for the development of therapeutic antibodies and the acceleration of drug discovery and development. "Nona Biosciences is committed to bringing antibody discovery and research solutions to our partners better and faster," said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences. "With the capabilities of Harbour Mice®, we look forward to empowering our partners in antibody drug discovery and development, and helping more patients benefit from cutting-edge technologies and therapies." "There is tremendous potential in antibody-based therapy, and I am very excited about this collaboration," said Simon Li, MD, PhD, CEO & CMO of Evive Biotech. "Evive Biotech's mission is to develop innovative biologic therapies for patients worldwide. We eagerly anticipate collaborating with Nona Biosciences to accelerate the discovery of innovative antibody therapies to benefit patients across the globe." About Nona Biosciences Nona Biosciences (a wholly-owned subsidiary of HBM Holdings Limited, HKEX: 02142) is a global biotechnology company committed to cutting-edge technology innovation and provides a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research. The integrated antibody discovery services range from antigen preparation, animal immunization, highly robust antibody screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® technology and the experienced therapeutic antibody discovery team. Harbour Mice® generate fully human monoclonal antibodies in a traditional two heavy and two light chain (H2L2) format, and a heavy chain only (HCAb) format. Integrating Harbour Mice® with highly robust antibody screening platforms, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs. For more information, please visit: About Evive Biotech Evive Biotech (a subsidiary of Yifan Pharmaceutical Co., Ltd., SZSE: 002019) 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 regulatory expertise and extensive international management experience. Through partnerships with industry, physicians, and regulatory authorities, we strive to bring revolutionary remedies to the global market quickly and efficiently to address unmet medical needs, making a real and lasting difference to patients and their families worldwide. For more information, please visit: SOURCE Nona Biosciences

- 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