Mabwell's Novel Long-Acting G-CSF Drug MAILISHENG Receives NMPA Approval for Chemotherapy-Induced Neutropenia
核心洞察
Mabwell (搜索) received NMPA approval for Albipagrastim alfa (MAILISHENG (搜索)), marking China's first novel G-CSF drug developed with albumin long-acting fusion technology.
Phase III trial data in 496 breast cancer (搜索) patients demonstrated superior efficacy with 42% relative risk reduction in febrile neutropenia (搜索) compared to control.
The drug addresses a significant unmet need, as 65.5% of patients receiving certain chemotherapy regimens experience grade 3 or 4 neutropenia (搜索).
Mabwell (搜索) (688062.SH) announced that its wholly-owned subsidiary T-mab (搜索) has received marketing approval from China's National Medical Products Administration (NMPA) for Albipagrastim alfa for Injection, marketed as MAILISHENG (搜索). The approval represents a significant milestone as China's first novel granulocyte colony-stimulating factor (G-CSF) developed using albumin long-acting fusion technology and marks Mabwell's first commercialized innovative drug.
Novel Albumin Fusion Technology
Albipagrastim alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (搜索), in adult patients with non-myeloid malignancies (搜索) receiving myelosuppressive anti-cancer (搜索) drugs associated with a clinically significant incidence of febrile neutropenia.
The drug represents a new generation of long-acting G-CSF developed using Mabwell (搜索)'s proprietary albumin fusion platform technology. By fusing highly active recombinant G-CSF with human serum albumin (HSA), the modification increases molecular weight and significantly inhibits the elimination pathway mediated by G-CSF receptor (搜索), thereby prolonging the drug's half-life in vivo. This approach improves treatment adherence by reducing administration frequency compared to existing therapies.
Compared to PEG-G-CSF, Albipagrastim alfa uses HSA as its natural carrier protein via a Pichia pastoris expression system, offering a simpler production process and superior product homogeneity.
Phase III Clinical Trial Results
Mabwell (搜索) presented results from a Phase III clinical study at the European Society for Medical Oncology (ESMO) annual meeting in 2023, with the full manuscript published in May 2025 in Breast Cancer (搜索) Research. The randomized study enrolled 496 patients with breast cancer, with 331 patients receiving 8MW0511 and 165 in the control group.
The study demonstrated that 8MW0511 was clinically effective and non-inferior to the positive control. The drug reduced the incidence of grade 4 neutropenia (搜索), significantly shortened the duration of grade 4 neutropenia, and lowered the incidence of febrile neutropenia (搜索) (FN). The overall safety profile was similar to that of the positive control group, indicating manageable safety and good tolerance.
Key efficacy outcomes showed the 8MW0511 group was superior to the control group across multiple parameters. The Absolute Risk Reduction (ARR) of grade 4 neutropenia (搜索) was 3.1%, 7.0%, 4.2%, and 2.8% during cycles 1-4 of chemotherapy, respectively. The Relative Risk Reduction (RRR) of grade 4 neutropenia was 15.6%, 68.4%, and 58.3% during cycles 1-4. Most notably, the RRR of febrile neutropenia (搜索) was 42.0%.
High-Risk Chemotherapy Regimens
The Phase III clinical trial included the TAC chemotherapy regimen (docetaxel, doxorubicin, and cyclophosphamide), which carries a high risk of febrile neutropenia (搜索). Stratified analysis revealed that compared to the control group, the incidence of grade 4 neutropenia (搜索) in the 8MW0511 group was slightly lower during the first cycle of chemotherapy and significantly lower during cycles 2-4.
Addressing Significant Medical Need
Neutropenia (搜索) represents a relatively common hematologic toxicity caused by chemotherapy with cytotoxic drugs. Studies show that 65.5% of patients treated with chemotherapeutic agents such as paclitaxel, adriamycin, and cyclophosphamide experience a grade 3 or 4 decrease in their neutrophil counts.
Febrile neutropenia (搜索), as a clinical complication of chemotherapy, commonly results in prolonged hospitalization, increased use of broad-spectrum antibiotics and therapy costs, reduction of chemotherapeutic agents or delayed chemotherapy, ultimately affecting antitumor therapy efficacy. In severe cases, it may lead to sepsis syndrome, infectious shock, and even death.
Market Opportunity
Globally, more than 50% of new cancer (搜索) cases require chemotherapy. The number of new tumor cases in 2025 is expected to reach 5.03 million. According to an article published in The Lancet Oncology, the number of patients requiring first-course chemotherapy annually will increase from 9.8 million (corresponding to about 50 million chemotherapy cycles) in 2018 to 15 million (corresponding to about 75 million chemotherapy cycles) by 2040, representing a 53% increase. By 2040, more than 57.7% of cancer patients worldwide are expected to require chemotherapy.
Company Background
Mabwell (搜索) is an innovation-driven biopharmaceutical company with an entire industry value chain. Since 2017, the company has established an advanced R&D system covering target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation. Mabwell has 16 pipeline products in different stages, including 12 novel drug candidates and 4 biosimilars, focusing on oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases.
Of the company's pipeline, 4 products have been approved and commercialized, 1 product has filed for pre-NDA meeting, and 2 products are in pivotal trials. The company'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.