On May 11, 2026, Synermore Biopharmaceutical (Suzhou) Co., Ltd. ("Synermore Biopharmaceutical") announced that it had officially received the Good Manufacturing Practice (GMP) certificate issued by the Philippine Food and Drug Administration (FDA Philippines) . This is Synermore Biopharmaceutical's second overseas GMP certification , following its acquisition of the Turkish GMP certificate at the end of 2025. This signifies that the production quality management system of its core product, Zamerovic-Mazoprevir Injection (trade name: Cribi®), continues to be recognized by overseas regulatory agencies, further accelerating its internationalization process.

GMP certificate issued by the Philippine Food and Drug Administration (FDA Philippines)

Krebi® is a Class I innovative drug independently developed by Synermore Biotechnology, used for passive immunization in adult individuals exposed to rabies virus. It is the first domestically produced anti-rabies cocktail monoclonal antibody that meets the recommendations of the World Health Organization (WHO) and was approved for marketing by the China National Medical Products Administration (NMPA) in 2024. Krebi® is a mixture of equal parts zameropoiesisir and maczoprevir. The two monoclonal antibodies bind discontinuous and non-overlapping epitopes, exhibiting complementary advantages and effectively broadening the spectrum of virus neutralization. Previously, Krebi® had completed clinical trials in the United States, the Philippines, and other countries, and was granted "orphan drug" designation by the US FDA.

The consecutive acquisition of international GMP certifications from Turkey and the Philippines signifies that Synermore Biotech's global quality management capabilities have entered a stage of routine export, accelerating its overseas expansion strategy. Building on this foundation, Synermore Biotech will comprehensively accelerate the globalization of its Crizotinib® product, committed to contributing to public health in more countries.

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Disclaimer: This article is for informational purposes only and does not constitute a recommendation for treatment methods or medications. Please consult a professional physician for advice regarding the use of any medications.

About Synermore Bio

SINOVAC's Synermore Biopharmaceuticals (Suzhou) Co., Ltd. was registered and established in 2016. With the mission of "providing drugs to eliminate diseases for humanity," the company primarily engages in the research, development, production, and sales of innovative monoclonal antibody drugs and biosimilars. Synermore Biopharmaceuticals focuses on three major therapeutic areas: malignant tumors, autoimmune diseases, and infectious diseases, and has established a complete industrial chain for humanized monoclonal antibody drugs, encompassing design and modification, construction and expression, production process development, and quality assurance.

Synermore Biotech boasts an international biopharmaceutical R&D and manufacturing team. Its management team possesses extensive experience in antibody drug development, process optimization, production, and quality management, and is committed to becoming a uniquely competitive international biopharmaceutical company. Synermore Biotech has also established a commercialization team comprising sales, business development, and medical marketing departments to fully drive the expansion of its products in both domestic and international markets.

Synermore Bio has a rich pipeline of products under development and comprehensive patent protection. All of its products have been submitted for filing in both China and abroad.

In the future, Synermore Bio will closely follow global and domestic development trends, increase investment in Suzhou Industrial Park, and cultivate the biopharmaceutical field with meticulous care, continuously promote the launch of new products and high-quality development, and strive to become an internationally competitive and globally influential biopharmaceutical innovation company, providing services for global disease control.

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