Mabwell (Shanghai) Bioscience recently received the National Medical Products Administration (NMPA) approval for its 9MW2821, a novel nectin-4 targeting ADC (antibody-drug conjugate), to enter Phase II clinical trial in China. The preliminary clinical results of the Phase I/II study presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting demonstrated promising efficacy in metastatic TNBC patients. By gaining approval for Phase II trial, the company leads the development of nectin-4 ADCs in China, offering new hope to Chinese patients, says GlobalData, a leading data and analytics company.

9MW2821 is a new generation site-specific conjugated novel nectin-4-targeting ADC and is the first drug candidate to enter clinical study among the nectin-4-targeting ADCs developed by Chinese companies. The Phase II clinical trial aims to evaluate the efficacy and safety of 9MW2821 as monotherapy or in combination with a PD-1 (programmed cell death) inhibitor in patients with locally advanced or metastatic TNBC.

TNBC is the most aggressive type of breast cancer, with a higher risk of recurrence and a poor prognosis. Advanced TNBC is not responsive to targeted or endocrine therapies, and chemotherapy remains the standard treatment for advanced TNBC in China.  According to GlobalData’s Pharma Intelligence Center, the number of incident cases of TNBC in China is expected to increase at a compound annual growth rate (CAGR) of 2.5% from 59,625 in 2023 to 67,586 in 2028.

Nadim Anwer, Pharma Analyst at GlobalData, comments: “There is a significant unmet need for novel therapeutics among metastatic TNBC patients in China due to limited treatment options compared to other breast cancer subtypes. TNBC tends to grow and spread faster than other types of invasive breast cancer, so it is traditionally considered the most difficult breast cancer type to treat. 9MW2821, the next generation ADC, could positively impact the metastatic TNBC treatment landscape in China.”

The clinical results showed an overall response rate of 50.0% and a disease control rate of 80.0% in 20 evaluable patients with locally advanced or metastatic TNBC. The median progression-free survival was 5.9 months and one patient achieved a complete response (CR) and maintained CR for 20 months. The safety profile showed adequate tolerability. In addition, 9MW2821 was recently granted a fast-track designation by the USFDA.

As per GlobalData’s Pharma Intelligence Center, there are only two nectin-4-targeting ADC in clinical development in China for TNBC, including Mabwell’s asset. The second asset, SYS-6002 from CSPC Pharmaceutical Group, is in Phase I clinical development for TNBC.

Anwer concludes: “9MW2821 is expected to be the first nectin-4 ADC for TNBC in China, if successful in clinical trials and following approvals. Mabwell’s promising asset would bring a significant shift in current treatment approaches for metastatic TNBC as a first-line treatment, and with a larger patient population, it would generate lucrative sales. Mabwell would like to strengthen its position with differentiated innovation for metastatic TNBC, making it difficult for competitors. Notably, with an innovative asset, the company can attract and expand its strategic collaborations with foreign players.”