Drugs / F-627
F-627
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chemotherapy-induced toxicity 3 milestones | |||||
| Filed | China (NMPA) | Ryzneuta | chemotherapy-induced toxicity | 2022-02-28 | “the Chinese National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for F-627 (efbemalenograstim alfa) for the treatment of...” evivebiotech.com ↗ “Evive’s Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta™ are currently under review by European and Chinese regulators.” evivebiotech.com ↗ |
| Filed | EU (EMA) | Ryzneuta™ | chemotherapy-induced toxicity | 2021-10-08 | “Company’s Marketing Authorization Application (MAA) for Ryzneuta™ for treatment of chemotherapy-induces neutropenia (CIN) in cancer patients after chemotherapy has been accepted” evivebiotech.com ↗ “Evive’s Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta™ are currently under review by European and Chinese regulators.” evivebiotech.com ↗ |
| Filed | US (FDA) | Ryzneuta™ | chemotherapy-induced toxicity | 2021-03-31 | “the U.S. Food & Drug Administration (FDA) has accepted the company’s submission of a Biologics License Application (BLA) for Ryzneuta™ (also known as F-627)” evivebiotech.com ↗ “today announced the submission of its Biologics License Application (BLA) for Ryzneuta™ (also known as F-627) to the US Food & Drug Administration (FDA)” evivebiotech.com ↗ “The Biologics License Application (BLA) of Ryzneuta™ is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN).” evivebiotech.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Ryzneuta | — | 2024-03-21 | europa.eu ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02527746 | Dec 2012 → Dec 2013 | breast cancer, neutropenia | EVIVE Biotechnology | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02522234 | Feb 2014 → Aug 2015 | neutropenia | EVIVE Biotechnology | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT07187908 | Jan 2025 → Oct 2026 expected | chemotherapy-induced toxicity | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06251947 | Apr 2024 → Jun 2026 overdue | cervical cancer, ovarian cancer | Shandong University | Recruiting | No outcome recorded |
| Phase 2 | NCT02521441 | Jul 2014 → Sep 2015 | neutropenia | EVIVE Biotechnology | Completed | No outcome recorded |
| Phase 2 | NCT01648322 | Jun 2012 → Dec 2014 | breast cancer, neutropenia | EVIVE Biotechnology | Completed | Met primary |
| Phase 33 trials · 3 met primary | ||||||
| Phase 3 | NCT04174599 | Apr 2018 → Jan 2019 | breast cancer, neutropenia | EVIVE Biotechnology | Completed | Met primary |
| Phase 3 | NCT03252431 | Apr 2018 → Sep 2019 | female breast carcinoma, neutropenia | EVIVE Biotechnology | Completed | Met primary |
| Phase 3 | NCT02872103 | Aug 2016 → Dec 2017 | breast cancer, neutropenia | EVIVE Biotechnology | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT06649448 | Oct 2024 → Dec 2025 overdue | neutropenia | Shandong Cancer Hospital and Institute | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-03-18 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results “头对头”试验！艾贝格司亭α长效升白再添新证 cttq.com ↗
研究结果显示，艾贝格司亭α在预防化疗引起的中性粒细胞减少症（CIN）的临床试验中，非劣效于培非格司亭，且在后续化疗周期中表现出更低的严重中性粒细胞减少发生率[1]。 |
| 2024-03-24 | EVIVE Biotechnology | Regulatory Evive Biotech Announce EC Approval of Ryzneuta® (Efbemalenograstim alfa Injection) for Chemotherapy-Induced Neutropenia (CIN) evivebiotech.com ↗
Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., today announced that on March 21, 2024, the European Commission (EC) approved Ryzneuta® (Efbemalenograstim alfa) for marketing in EU. |
| 2023-11-22 | EVIVE Biotechnology | Regulatory Evive Biotech and Acrotech Biopharma Announce FDA Approval of Ryzneuta® (Efbemalenograstim alfa Injection) for Chemotherapy-Induced Neutropenia (CIN) evivebiotech.com ↗
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 |
| 2023-11-22 | Acrotech Biopharma Inc. | Regulatory FDA Approval of Ryzneuta™ for Chemotherapy-Induced Neutropenia acrotechbiopharma.com ↗
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. |
| 2023-05-09 | EVIVE Biotechnology | Regulatory Yifan Pharma Subsidiary Evive Biotech Announce the China NMPA Approval of Ryzneuta™ (Efbemalenograstim alfa Injection) for Chemotherapy-Induced Neutropenia evivebiotech.com ↗
May 9, 2023 – Evive Biotech (Evive), a subsidiary of Yifan Pharma announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) of Ryzneuta™ (Efbemalenograstim alfa Injection) for the prevention and treatment of Chemotherapy-Induced Neutropenia (CIN). |
| 2022-02-28 | EVIVE Biotechnology | Regulatory China NMPA accepts Evive Biotech’s NDA for F-627 to treat CIN evivebiotech.com ↗
Evive Biotech (“Evive”), a global biopharmaceutical company developing novel biologic therapies, announced that the Chinese National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for F-627 (efbemalenograstim alfa) for the treatment of chemotherapy-induced neutropenia (CIN). |
| 2021-10-08 | EVIVE Biotechnology | Regulatory Evive Biotech’s Ryzneuta™ Marketing Authorization Application Accepted for Review by European Medicines Agency evivebiotech.com ↗
Evive Biotech, a global biologics company developing novel biologic therapies, announces Company’s Marketing Authorization Application (MAA) for Ryzneuta™ for treatment of chemotherapy-induces neutropenia (CIN) in cancer patients after chemotherapy has been accepted and is now under EMA’s centralized review. |
| 2021-05-28 | EVIVE Biotechnology | Regulatory U.S. FDA Accepts Biologics License Application for Ryzneuta™ evivebiotech.com ↗
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 30, 2022. |
| 2021-03-31 | EVIVE Biotechnology | Regulatory Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta™ evivebiotech.com ↗
Evive Biotech, a global biologics company developing novel biologic therapies, today announced the submission of its Biologics License Application (BLA) for Ryzneuta™ (also known as F-627) to the US Food & Drug Administration (FDA). |
| 2020-07-07 | EVIVE Biotechnology | Results Evive Biotech Meets Primary and Secondary Endpoints in Global Phase III Clinical Trial for Their Novel Chemotherapy-induced Neutropenia Treatment evivebiotech.com ↗ |
| 2020-01-06 | EVIVE Biotechnology | Results Evive Successfully Concludes China Phase III Clinical Trial of F-627 for Chemotherapy-induced Neutropenia evivebiotech.com ↗
Evive Biotech, an innovative biotech company developing novel biological therapeutics, today announced that its pivotal Phase III study in China for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met its primary endpoint. |
| 2018-01-25 | EVIVE Biotechnology | Results Evive Successfully Concludes First Phase III Clinical Trial of F-627 for Chemotherapy-induced Neutropenia and met primary endpoints evivebiotech.com ↗
Jan 25, 2018, Shanghai, China — Evive Biotech, an innovative biotech company in China developing novel biological therapeutics, today announced that the first pivotal phase III study in the U.S. for F-627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met the primary endpoint. |
| 2017-10-10 | EVIVE Biotechnology | Regulatory Evive Receives Special Protocol Assessment for Global Phase 3 Trial of F-627 in Chemotherapy-induced Neutropenia evivebiotech.com ↗
The SPA provides a binding agreement with the FDA’s review division that the Phase III trial can adequately address objectives in support of a U.S. regulatory submission for approval of F-627 for the treatment of cancer patients with CIN. |
| 2014-12-08 | EVIVE Biotechnology | Results Evive Presents the Global Phase II Study Results for F-627 (benegrastim) at the American Society of Hematology 56th Annual Meeting at San Francisco evivebiotech.com ↗
Benegrastim demonstrated non-inferiority for the duration of moderate and severe neutropenia as compared to pegfilgrastim (Neulasta®) in patients with Stage I-IV breast cancer who received docetaxel / cyclophosphamide (TC) or Doxorubicin / docetaxel / cyclophosphamide (TAC) chemotherapy. |
| 2010-12-08 | EVIVE Biotechnology | Results Evive Presented a Poster in ASH 2010 evivebiotech.com ↗
Evive Biotech presented a poster entitled ‘F-627, a G-CSF dimer, reduced the duration and lessened severity of neutropenia in chemtherpay-induced neutropenia animal models’ at the 52nd Annual meeting of American Society of Hematology (ASH), Dec. 3rd to 7th, 2010, Orlando FL, USA. |
| 2010-09-09 | EVIVE Biotechnology | Regulatory Evive Submitted IND Document of F-627 to Shanghai SFDA evivebiotech.com ↗
Evive Biotech submitted IND document of F-627 to Shanghai SFDA. |
All press releases naming this drug 32 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | F-627 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03252431 ↗ |
| Known as | efbemalenograstim alfa | “F-627 (efbemalenograstim alfa) is a novel long acting granulocyte colony-stimulating factor (G-CSF) that contains two human G-CSF fused to a human immunoglobulin G2 (hIgG2) -Fc...” PMID 39272058 ↗ Sep 2024 |
| Known as | Ryzneuta | “This studyevaluated the efficacy and safety of F-627, also known as efbemalenograstim alfa (Ryzneuta®) in reducing neutropenia compared with filgrastim (GRAN®).” PMID 39272058 ↗ Sep 2024 |
| Modality | Protein / enzyme biologic | “rh G-CSF Fc Fusion Protein” NCT02522234 ↗ |
| Route | Subcutaneous | “by subcutaneous injection” NCT02522234 ↗ |