Innogen Pharmaceuticals has announced that its Efsubaglutide alfa manufacturing facility in Suzhou has officially passed a compliance inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) in accordance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) standards, and has received the GMP certificate issued by ANVISA.

This milestone represents a significant recognition of the company's quality systems by an international regulatory authority, confirming that its manufacturing site has achieved PIC/S GMP international standards. It will further accelerate the registration, market access, and commercial partnerships for Efsubaglutide alfa in Brazil and other emerging markets that recognise the PIC/S GMP framework, providing a critical quality assurance foundation for the product's internationalisation.

With Brazil as a key strategic hub, the company will further expand into South American and other PIC/S member markets, laying a solid groundwork for the global development and overseas registration of additional indications of Efsubaglutide Alfa, and continuously strengthening Innogen's global footprint.

According to the International Diabetes Federation (IDF), approximately 16.6 million adults in Brazil live with diabetes, ranking among the highest globally. Meanwhile, the overweight adult rate exceeds 60 percent and obesity prevalence stands at around 26 percent, driving sustained demand for innovative metabolic therapies. With the continuous improvement of the local healthcare system, opportunities are opening for global products and services to enter the Brazilian medical market.

IQVIA reports indicate that Brazil's pharmaceutical market reached USD 35.6 billion in 2023, accounting for 2.2 percent of the global market, making it a key focus for Innogen's overseas commercialisation strategy.

Efsubaglutide alfa is an innovative, human-derived, ultra-long-acting GLP-1 receptor agonist independently developed by Innogen Pharmaceuticals. It has been approved in Mainland China and Macau for the treatment of type 2 diabetes in adults and has been included in China's National Reimbursement Drug List. The pivotal SUPER series clinical studies demonstrated that Efsubaglutide alfa provides significant glycemic reduction in patients with type 2 diabetes.

After 24 weeks of once-weekly 3 mg treatment, mean HbA1c decreased by approximately 2.2 percent from baseline in treatment-naïve patients, and by approximately 1.8 percent in patients with inadequate glycemic control on metformin background therapy, with a favorable safety and tolerability profile and observed signals of improved β-cell function.

The clinical value of Efsubaglutide alfa in weight management continues to be validated. In the China-based ENLIGHT phase 2b study, subjects receiving 20 mg once weekly (Q1W) for 18 weeks achieved a mean weight reduction of 10.6 percent and a waist circumference decrease of approximately 8.9 cm; the 20 mg once-every-two-weeks (Q2W) group showed a mean weight loss of 9.7 percent, with improvements in body composition parameters including fat mass, liver fat content, and muscle-to-at ratio. The company is currently conducting a phase 2 clinical trial for obesity in Australia, exploring a once-monthly (Q4W) dosing regimen, to continuously accumulate evidence-based data for future global registration and commercialisation. In June 2026, the phase 1b clinical trial of Efsubaglutide alfa in adolescent obesity was approved by China's National Medical Products Administration (NMPA), and the first subject was enrolled in July, marking the official progression of this study into the clinical implementation stage.

Professor Wang Qinghua, Founder, Chairman, and CEO, Innogen Pharmaceuticals, commented, “This recognition under the PIC/S GMP framework marks a significant milestone in the development of our global quality systems. It will accelerate the registration and commercial launch of Efsubaglutide alfa across all PIC/S-aligned emerging markets, including Hong Kong, Southeast Asia and Latin America. Looking ahead, Innogen Pharmaceuticals will continue to adhere to international quality standards, leveraging independent innovation and proprietary intellectual property to advance the global development of Efsubaglutide alfa in metabolic diseases such as diabetes and obesity, bringing China's original innovative achievements to more patients worldwide.”