Mabwell Signs GCC Licensing Deal with Saudi Arabia’s SVAX for Aflibercept Biosimilar

Healthcare Author: EqualOcean News Updated 1 hour ago (GMT+8)

Mabwell (Shanghai) Bioscience Co., Ltd.(迈威(上海)生物科技股份有限公司)has entered into a licensing agreement with Saudi Arabian biopharmaceutical company SVAX Inc. covering its aflibercept biosimilar, 9MW0813, in the Gulf Cooperation Council market.

Mabwell

The agreement, announced on July 29, calls for the two companies to work together on the registration, manufacturing and commercialization of 9MW0813, an intravitreal aflibercept injection developed as a biosimilar to Eylea. Mabwell said the collaboration would be centered in Saudi Arabia and extend to other GCC markets.

The announcement does not disclose financial terms, a launch timetable, or the location and timing of any manufacturing transfer. It therefore represents a licensing and commercialization partnership, rather than a completed regulatory approval or an already operating local production line.

The GCC comprises Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates. Mabwell said SVAX has an established Saudi market network and experience in registration and local manufacturing. SVAX general manager Mazen Hassanain said the companies aim to localize production of the aflibercept biosimilar as part of Saudi Arabia’s Vision 2030 and National Biotechnology Strategy, which seek to expand domestic biopharmaceutical capacity and reduce reliance on imports.

For Mabwell, the agreement adds a Gulf-market route to a growing overseas commercialization network. Its denosumab biosimilars received marketing authorization in Pakistan in 2025, while its adalimumab biosimilar has been approved in Indonesia. In April, Mabwell’s wholly owned subsidiary T-mab passed a GMP inspection by Jordan’s drug regulator covering two denosumab biosimilars.

The company is also advancing a broader oncology and immunology pipeline. Its Nectin-4-targeting antibody-drug conjugate, 9MW2821, entered a Phase III trial in China for triple-negative breast cancer in April, while its LILRB4/CD3-targeting bispecific antibody, 6MW5311, received U.S. FDA clearance to begin clinical trials in June.

The SVAX agreement shows how Chinese biopharmaceutical companies are seeking to enter overseas markets through local partners with regulatory and commercial infrastructure. Whether the arrangement produces a marketed product in the Gulf will depend on regulatory submissions, manufacturing implementation and subsequent commercialization.