Shanghai, China – August 4, 2026
Innogen Pharmaceuticals has announced that its Efsubaglutide alfa manufacturing facility in Suzhou has successfully passed a Good Manufacturing Practice (GMP) compliance inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) framework. The company has officially received the PIC/S GMP certificate, marking an important milestone in its global manufacturing and quality strategy. The certification confirms that Innogen’s production facility meets internationally recognized PIC/S GMP standards, strengthening the company’s regulatory credibility and accelerating the registration, commercialization and market access of Efsubaglutide alfa across Brazil and other markets recognizing the PIC/S framework. The achievement further reinforces Innogen Pharmaceuticals’ commitment to maintaining international manufacturing excellence while supporting the worldwide expansion of its innovative GLP-1 receptor agonist portfolio for the treatment of type 2 diabetes and obesity.
PIC/S GMP Certification Accelerates Global Commercial Expansion
The newly awarded PIC/S GMP certification represents a significant regulatory milestone for Innogen Pharmaceuticals, validating the company’s manufacturing quality systems against internationally recognized pharmaceutical standards. The inspection conducted by ANVISA, one of South America’s leading regulatory authorities and a member of the PIC/S network since 2021, confirms that the Suzhou manufacturing facility complies with stringent global GMP requirements. The certification is expected to accelerate regulatory submissions, facilitate commercial partnerships, and simplify market access for Efsubaglutide alfa across Brazil, South America, Southeast Asia, and other emerging pharmaceutical markets that recognize PIC/S GMP standards. By establishing Brazil as a strategic entry point for international expansion, Innogen plans to strengthen its presence across Latin America while supporting future overseas registrations for additional indications. The milestone also provides a robust manufacturing foundation for the company’s broader international commercialization strategy and demonstrates its ability to deliver globally compliant pharmaceutical production.
Efsubaglutide Alfa Strengthens Diabetes and Obesity Pipeline
Efsubaglutide alfa is Innogen Pharmaceuticals’ proprietary human-derived ultra-long-acting GLP-1 receptor agonist, developed for the treatment of metabolic diseases, including type 2 diabetes and obesity. The therapy has already received regulatory approval in Mainland China and Macau for adult patients with type 2 diabetes and has been included in China’s National Reimbursement Drug List, supporting broader patient access. Clinical evidence generated through the pivotal SUPER clinical trial program demonstrated significant reductions in HbA1c, with treatment-naïve patients achieving approximately 2.2% reductions after 24 weeks of once-weekly therapy, while patients receiving background metformin treatment experienced approximately 1.8% reductions, alongside a favorable safety and tolerability profile. Beyond diabetes, Efsubaglutide alfa continues to demonstrate promising results in obesity management. Data from the ENLIGHT Phase IIb study showed patients receiving 20 mg once-weekly treatment achieved an average 10.6% body weight reduction and meaningful improvements in waist circumference, body fat composition, liver fat content, and muscle-to-fat ratio, supporting continued global development across metabolic disease indications.
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Global Development Strategy Advances Precision Metabolic Care
Building on its expanding clinical evidence, Innogen Pharmaceuticals continues advancing the global development of Efsubaglutide alfa through multiple international clinical programs. The company is currently conducting a Phase II obesity study in Australia, evaluating a once-monthly dosing regimen, while recently initiating a Phase Ib clinical trial in adolescent obesity following regulatory approval from China’s National Medical Products Administration (NMPA). These ongoing studies aim to generate additional evidence supporting future global regulatory submissions and commercial expansion. Company leadership emphasized that obtaining PIC/S GMP certification represents another critical step toward establishing internationally recognized manufacturing excellence while expanding access to innovative therapies addressing the growing worldwide burden of diabetes, obesity, and other metabolic diseases. By combining robust clinical development, global intellectual property, international regulatory compliance and advanced manufacturing capabilities, Innogen Pharmaceuticals continues strengthening its position as an emerging global innovator in metabolic disease therapeutics while bringing China’s original pharmaceutical innovations to patients worldwide.
Source: Innogen Pharmaceuticals press release
