Mabwell Achieves Major GMP Inspection Success in Jordan for Biopharmaceutical Products
Mabwell, a prominent biopharmaceutical company trading under the stock code 688062.SH, has reached a significant milestone by successfully passing an on-site GMP (Good Manufacturing Practice) inspection conducted by the Jordan Food and Drug Administration (JFDA). This achievement is particularly noteworthy as it marks the first time Mabwell has received recognition from a regulatory authority in a PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) member country.
The inspection appraised the production processes of two biosimilar drugs, 9MW0311 and 9MW0321, which are generic versions of the well-known medications Prolia® and Xgeva®. The facility where these products are manufactured was granted a compliance rating, signifying their adherence to high standards set by international regulatory bodies. This validation confirms that Mabwell’s manufacturing practices are on par with the stringent norms required globally.
The PIC/S is a reputable international organization that aims to harmonize Good Manufacturing Practice inspections across its member countries. Its involvement signifies the high level of scrutiny applied to facilities within its framework, emphasizing the importance of maintaining rigorous adherence to manufacturing standards.
Mabwell’s facilities, particularly in Taizhou, received comprehensive evaluations that included assessments of equipment, quality systems, production processes, and batch release procedures. Auditors submitted positive feedback, which highlights the meticulous attention to detail employed by the company in ensuring the quality and safety of its products. This recognition positions Mabwell favorably for opportunities in the Middle Eastern market, presenting both growth potential and an avenue to improve local access to quality biopharmaceuticals.
Currently, Mabwell’s footprints extend across 33 countries with strategic collaborations established for its denosumab injection product line. The company has made significant strides in its application for marketing approvals, having submitted requests in eight countries and successfully acquiring approval in Pakistan as of 2025.
Highlights from this achievement were shared by Mr. Huiguo Hu, a Board Member and Senior Vice President at Mabwell, who emphasized the importance of passing this inspection. He remarked that such an accomplishment not only strengthens the company’s reputation but also aids in expediting the registration and marketing processes of their products internationally, thus enhancing the accessibility of high-quality biologics to more patients.
Mabwell's mission, "Explore Life, Benefit Health," reflects its commitment to developing innovative solutions that address pressing medical needs, particularly in oncology and aging-related health challenges. In this dynamic landscape of the biopharmaceutical industry, the company aspires to turn its innovative ideas into reality, ensuring that effective therapies are available to patients around the globe.
To conclude, Mabwell's successful GMP inspection by a respected regulatory authority is a cornerstone achievement in establishing its presence in the international biopharmaceutical market. This development not only marks a triumph for the company but also signifies progress toward better health outcomes for patients requiring biologic therapies in their regions.
The inspection appraised the production processes of two biosimilar drugs, 9MW0311 and 9MW0321, which are generic versions of the well-known medications Prolia® and Xgeva®. The facility where these products are manufactured was granted a compliance rating, signifying their adherence to high standards set by international regulatory bodies. This validation confirms that Mabwell’s manufacturing practices are on par with the stringent norms required globally.
The PIC/S is a reputable international organization that aims to harmonize Good Manufacturing Practice inspections across its member countries. Its involvement signifies the high level of scrutiny applied to facilities within its framework, emphasizing the importance of maintaining rigorous adherence to manufacturing standards.
Mabwell’s facilities, particularly in Taizhou, received comprehensive evaluations that included assessments of equipment, quality systems, production processes, and batch release procedures. Auditors submitted positive feedback, which highlights the meticulous attention to detail employed by the company in ensuring the quality and safety of its products. This recognition positions Mabwell favorably for opportunities in the Middle Eastern market, presenting both growth potential and an avenue to improve local access to quality biopharmaceuticals.
Currently, Mabwell’s footprints extend across 33 countries with strategic collaborations established for its denosumab injection product line. The company has made significant strides in its application for marketing approvals, having submitted requests in eight countries and successfully acquiring approval in Pakistan as of 2025.
Highlights from this achievement were shared by Mr. Huiguo Hu, a Board Member and Senior Vice President at Mabwell, who emphasized the importance of passing this inspection. He remarked that such an accomplishment not only strengthens the company’s reputation but also aids in expediting the registration and marketing processes of their products internationally, thus enhancing the accessibility of high-quality biologics to more patients.
Mabwell's mission, "Explore Life, Benefit Health," reflects its commitment to developing innovative solutions that address pressing medical needs, particularly in oncology and aging-related health challenges. In this dynamic landscape of the biopharmaceutical industry, the company aspires to turn its innovative ideas into reality, ensuring that effective therapies are available to patients around the globe.
To conclude, Mabwell's successful GMP inspection by a respected regulatory authority is a cornerstone achievement in establishing its presence in the international biopharmaceutical market. This development not only marks a triumph for the company but also signifies progress toward better health outcomes for patients requiring biologic therapies in their regions.
Topics Health）
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