Under the agreement, a local strategic partner (who was not named in the release) will lead regulatory registration and commercialisation activities in Malaysia, while Mabwell will retain responsibility for development, manufacturing and supply of the products.
The deal covers MAILISHU, a biosimilar to Prolia and MAIWEIJIAN, a biosimilar referencing Xgeva.
Both products are based on denosumab, a monoclonal antibody widely used to treat osteoporosis and cancer-related bone conditions.
Malaysia offers growth and regulatory alignment
Mabwell highlighted Malaysia's position as one of Southeast Asia's more mature pharmaceutical markets, supported by a population of nearly 36 million and steady economic growth.
The country's membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides an internationally aligned regulatory framework, making it an attractive entry point for biologics and biosimilars.
The Malaysian pharmaceutical market reached an estimated value of $3.4bn in 2025 and is growing at a compound annual rate of around 6%, reflecting increasing demand for advanced therapies.
Expanding access to biosimilars in ASEAN
Huiguo Hu, Board Member and Senior Vice President at Mabwell, said the agreement marks another step in the company's regional expansion strategy.
"We are delighted to see that we have reached a collaboration on denosumab in another ASEAN country."
Malaysia has an internationally aligned regulatory environment, strong regional recognition and significant space for development. This collaboration will further deepen Mabwell's presence in the ASEAN market.
"We look forward to rapidly advancing the product's local registration and commercialisation with our partner's strong commercial capabilities, bringing high-quality, affordable treatment options to more patients in the region."
The collaboration also aligns with wider industry trends, as pharmaceutical manufacturers continue to expand biosimilar portfolios in emerging markets to improve the affordability and accessibility of biologic therapies.
With production and global supply responsibilities retained by Mabwell, the agreement positions the company to scale manufacturing while leveraging local expertise for market entry in Malaysia.