Mailisheng (albipagrastim alfa) / Mabwell (Shanghai) Biosci - LARVOL DELTA

Mabwell Receives NMPA Approval for Albipagrastim alfa for Injection (MAILISHENG) (The Manila Times) - "Mabwell...announced that Albipagrastim alfa for Injection (trade name: MAILISHENG, R&D code: 8MW0511) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing approval by National Medical Products Administration (NMPA). MAILISHENG is Mabwell's first commercialized innovative drug, and is the first launched novel granulocyte colony-stimulating factor (G-CSF) developed with albumin long-acting fusion technology in China....Albipagrastim alfa for Injection is 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."

China approval • Chemotherapy-Induced Neutropenia

8MW0511, a novel, long-acting granulocyte-colony stimulating factor fusion protein for the prevention of chemotherapy-induced neutropenia: final results from the phase III clinical trial. (PubMed, Breast Cancer Res) - "The study findings confirm that 8MW0511 is not inferior to PEG-rhG-CSF in terms of efficacy and shows comparable safety profiles. Additionally, 8MW0511 has the potential to significantly decrease the duration of chemotherapy-induced neutropenia, along with a reduction in the occurrence of FN and severe neutropenia."

Journal • P3 data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Maiwei Bio: 8MW0511 new drug is under review and approval, and is expected to be approved for marketing in 2025 [Google translation] (Sohu.com) - "The company responded that its new drug application for 8MW0511 was accepted by the National Medical Products Administration in December 2023 and is currently under review and approval. It has completed the on-site drug registration verification and GMP compliance inspection and is expected to be approved for marketing in 2025."

China approval • Oncology

Two new drugs from Maiwei Biotech were returned, and the company lost more than 1 billion yuan last year [Google translation] (163.com) - "...Maiwei Bio announced that the company and its whollyowned subsidiary Taikang Biologics had entered into separate agreements with Haibo Biotech, a wholly-owned subsidiary of Yangtze River Pharmaceuticals (formerly known as: Shengsen Biopharmaceutical Co., Ltd., hereinafter referred to as 'Shengsen Biotech') signed a 'Negotiation' on the projects 9MW1111 (recombinant humanized antiPD-1 monoclonal antibody injection) and 8MW0511 (recombinant (yeast secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection) Termination of the Agreement....Maiwei Biotech stated that the reason for being 'returned' was mainly because during the cooperation period, the market competition pattern of PD-1 products and G-CSF products changed significantly, and the market prices of the products experienced significant adjustments."

Licensing / partnership • Oncology • Solid Tumor

Mabwell’s NDA for 8MW0511 for injection was accepted by the NMPA [Google translation] (Maiwei Biotech Press Release) - "Mabwell...announced that its New Drug Application (NDA) for recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein (R&D code: 8MW0511) for injection has been accepted by the National Medical Products Administration (NMPA) for adult patients with nonmyeloid malignancies when they are treated with myelosuppressive anticancer drugs that are prone to cause febrile neutropenia....The results of the phase III clinical study of 8MW0511 reported at the European Society for Medical Oncology (ESMO) in 2023 showed definite clinical efficacy, which was non-inferior to the active control drug Zinyuli^® and could improve the incidence and incidence of grade 4 neutropenia. duration, among which the incidence of grade 4 neutropenia in cycles 2-3 was significantly lower than that in the positive control group."

Non-US regulatory • Oncology

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 (ESMO 2023) - P2/3 | "Methods Patients with breast cancer were randomized 2:1 to receive MW05 or PEG-rhG-CSF after standard docetaxel plus cyclophosphamide with/without doxorubicin chemotherapy for 4 cycles. Conclusions These results demonstrate non-inferiority and comparable safety for MW05 versus PEG-rhG-CSF. As a novel, long-acting rhG-CSF modified with HSA, MW05 can effectively shorten DSN induced by chemotherapy and may reduce the incidence of FN and severe neutropenia."

P3 data • Breast Cancer • Chemotherapy-Induced Neutropenia • Oncology • Solid Tumor

Mabwell Announces Latest Clinical Progress and Data to be Reported on ESMO 2023 of 2 Novel Drugs (PRNewswire) - P3 | N=NA | "Up to now, Mabwell is in the preparation of New Drug Application submission of 8MW0511 within the year....Core data from phase III study of recombinant (yeast-secreted) human granulocyte-colony stimulation factor fusion protein 8MW0511 for injection, reported at ESMO, showed that 8MW0511 was clinically effective, non-inferior to the positive control. It is able to improve the incidence and duration of grade 4 neutropenia, with a significantly lower incidence and duration of grade 4 neutropenia observed at cycle 2-3 than in the positive control group. The overall safety profile is similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans."

NDA • P3 data • Oncology

Maiwei Biotech (688062.SH): is advancing the key registration clinical research plan for 9MW2821 and the marketing authorization application for 8MW0511 [Google translation] (Zhitong Finance) - P2/3 | N=586 | NCT04554056 | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | "Zhitong Finance APP News, Maiwei Biologics...announced that the company reported the...Phase III clinical study of 8MW0511 as of the time of ESMO abstract submission at the 2023 European Society for Medical Oncology (ESMO) Congress. Research result....The results of the Phase III clinical study of 8MW0511 showed definite clinical efficacy, which was non-inferior to the active control drug and could improve the incidence and duration of grade 4 neutropenia, among which grade 4 neutropenia in cycles 2-3 The incidence rate was significantly lower than that of the positive control group. The overall safety is similar to that of the positive control group....As of now, the company is advancing the application for marketing authorization of 8MW0511 and is expected to file for NDA within the year."

European regulatory • NDA • P3 data • Breast Cancer • Chemotherapy-Induced Neutropenia • Neutropenia • Oncology

Mabwell to Present Clinical Trial Data of 2 Programs at ESMO Congress 2023 (PRNewswire) - "Mabwell...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."

P1/2 data • P3 data • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Maiwei (Shanghai) Biotechnology Co., Ltd. voluntarily disclosed the announcement that 2 clinical research results were selected as the report of the European Society for Medical Oncology (ESMO) Congress in 2023 [Google translation] (Shanghai Securities News) - "Maiwei (Shanghai) Biotechnology Co., Ltd...recently received a notice confirming that it has two clinical research results that will be reported at the European Society for Medical Oncology (ESMO) Congress in 2023: the clinical phase I/II study data of the new antibody conjugate drug 9MW2821 targeting Nectin-4 targeting subjects with advanced solid tumors, and the recombinant (yeast-secreted) human serum albumin-human granulocyte Results of clinical phase III study of colony-stimulating factor fusion protein 8MW0511."

P1/2 data • P3 data • Oncology • Solid Tumor

Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF (clinicaltrials.gov) - P2/3 | N=586 | Completed | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Recruiting ➔ Completed | N=348 ➔ 586 | Trial completion date: Sep 2023 ➔ Nov 2022

Enrollment change • Trial completion • Trial completion date • Breast Cancer • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CSF3

Antibody-dependent enhancement (ADE) of SARS-CoV-2 pseudoviral infection requires FcγRIIB and virus-antibody complex with bivalent interaction. (PubMed, Commun Biol) - "Blocking endosome transportation and lysosome acidification could inhibit the ADE activity mediated by MW05. Together, our results identified a novel ADE mechanism of SARS-CoV-2 pseudovirus in vitro, FcγRIIB-mediated uptake of SARS-CoV-2/mAb complex with bivalent interaction."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Characterization of MW06, a human monoclonal antibody with cross-neutralization activity against both SARS-CoV-2 and SARS-CoV. (PubMed, MAbs) - "In addition, MW06 recognizes a different epitope from MW05, which shows high neutralization activity and has been in a Phase 2 clinical trial, supporting the development of the cocktail of MW05 and MW06 to prevent against future escaping variants. MW06 alone and the cocktail show good effects in preventing escape mutations, including a series of variants of concern, B.1.1.7, P.1, B.1.351, and B.1.617.1. These findings suggest that MW06 recognizes a conserved epitope on SARS-CoV-2, which provides insights for the development of a universal antibody-based therapy against SARS-related coronavirus and emerging variant strains, and may be an effective anti-SARS-CoV-2 agent."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF (clinicaltrials.gov) - P2/3; N=348; Recruiting; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CSF3

Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF (clinicaltrials.gov) - P2/3; N=348; Not yet recruiting; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Clinical • New P2/3 trial • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor