FDA Awards Orphan Drug Status to 7MW3711

SHANGHAI, July 16, 2024 -- Mabwell (688062.SH) has announced a significant milestone for its self-developed drug, 7MW3711, which targets the B7-H3 antigen. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to 7MW3711 for the treatment of small cell lung cancer. ODD is a special status given to drugs intended to treat rare diseases affecting fewer than 200,000 patients in the United States. This designation provides various benefits to drug developers, including development assistance, tax credits for clinical trial costs, and seven years of market exclusivity after approval.

7MW3711 is an antibody-drug conjugate (ADC) created using Mabwell's IDDC™ platform. It features an innovative antibody, a novel linker, and a unique payload known as Mtoxin™ (TOP1i). Once administered, the drug binds specifically to the antigens on the surface of tumor cells, is internalized, transported to the lysosome, releases a cytotoxic drug, and induces tumor cell apoptosis.

This ADC boasts a stable structure, homogeneous composition, high purity, and is suitable for industrial-scale production. In preclinical trials, 7MW3711 demonstrated superior tumor-killing effects compared to other similar ADCs. The animal safety evaluations, including tests on cynomolgus monkeys, showed that both on-target and off-target toxicities are effectively managed, indicating a favorable safety profile and good pharmacokinetic properties. These findings suggest that 7MW3711 has the potential for clinical differentiation and promising future development.

Mabwell's IDDC™ platform is a cutting-edge technology for ADC development, featuring site-specific conjugation technologies such as DARfinity™, IDconnect™, Mtoxin™, and LysOnly™. These technologies ensure better structural uniformity, stability, efficacy, and tolerability of the ADCs developed. The Mtoxin™ payload has shown excellent pharmacodynamics, bystander killing efficacy, and resistance to multiple drugs.

The IDDC™ platform has been validated with various drug candidates currently in development. Mabwell has several ADCs in clinical trial stages. Notably, the Nectin-4-targeting ADC, 9MW2821, is in Phase III clinical trials for urothelial carcinoma. Meanwhile, the B7-H3-targeting ADC, 7MW3711, and Trop-2-targeting ADC, 9MW2921, are in different stages of clinical trials.

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company encompassing the entire pharmaceutical industry value chain. Since its establishment in 2017, Mabwell has built an advanced R&D system covering target discovery, early discovery, druggability, preclinical, clinical research, and manufacturing transformation. The company has a robust pipeline with 14 products in various stages of development, including 10 novel drug candidates and 4 biosimilars. Focus areas include oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases. Three products have already been approved and commercialized, one has been filed for market approval, and three are in pivotal trials.

Mabwell has been involved in significant national scientific and technological projects, including major new drug development initiatives and key R&D programs. The company’s Taizhou factory meets international GMP standards and has passed the EU QP Audit. Additionally, large-scale manufacturing bases in Shanghai and Taizhou are under construction.

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