Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that it has established a licensing and commercialization agreement with a strategic business partner ("the partner") in Egypt for its products, MAILISHU (Denosumab solution for injection, a biosimilar of Prolia^®) and 9MW0321 (Denosumab solution for injection, a biosimilar of XGEVA^®). Under the agreement, the partner has the exclusive sales rights for MAILISHU and 9MW0321 in Egypt, while Mabwell is responsible for the development, production, and commercial supply for MAILISHU and 9MW0321.

MAILISHU has been approved for marketing in China by National Medical Products Administration (NMPA) in March 2023. Based on the comparative and progressive development principle, comprehensive evaluation of pharmaceutical, non-clinical and clinical comparative results demonstrated the overall similarity of MAILISHU and 9MW0321 to the original drugs in terms of quality, safety, and efficacy. The partner is responsible for submitting the marketing application for MAILISHU and 9MW0321 in Egypt. Previously, Mabwell had granted the exclusive sales rights of JUNMAIKANG (Adalimumab solution for injection, a biosimilar of HUMIRA®) to the partner for Egypt market.

Mr. Huiguo Hu, Board Member and Senior Vice President of Mabwell, said, “We are pleased that a commercial cooperation has been established for Egypt market for the World's second approved biosimilars of denosumab developed by Mabwell. Egypt has a population of over 100 million and has always been one of the main gateways for drugs to enter Africa. Moreover, it is an important country in the “Belt and Road Initiative”. This new agreement following the cooperation of JUNMAIKANG® represents the full recognition of the development data of Mabwell's products. We will vigorously promote the registration and commercialization of the cooperative products in Egypt to provide high-quality drugs to more patients in the worldwide."