Innogen Pharmaceuticals Receives PIC/S GMP Certificatation, Accelerating Global Expansion of Efsubaglutide Alfa

SHANGHAI, Aug. 4, 2026 /PRNewswire/ -- Innogen Pharmaceuticals (HK.2591), a biopharmaceutical company dedicated to innovative drug discovery and industrialization in metabolic diseases, today 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 Innogen Pharmaceuticals' quality systems by an international regulatory authority, confirming that the Company's 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 recognize the PIC/S GMP framework, providing a critical quality assurance foundation for the product's internationalization. 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.

Brazil is the largest country in South America and bears one of the heaviest diabetes burdens worldwide. 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% and obesity prevalence stands at around 26%, driving sustained demand for innovative metabolic therapies^[1]. 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 US$35.6 billion in 2023, accounting for 2.2% of the global market, making it a key focus for Innogen's overseas commercialization 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% from baseline in treatment‑naïve patients, and by approximately 1.8% 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 Ⅱb study, subjects receiving 20 mg once weekly (Q1W) for 18 weeks achieved a mean weight reduction of 10.6% 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%, with improvements in body composition parameters including fat mass, liver fat content, and muscle‑to‑fat ratio. The Company is currently conducting a phaseⅡclinical trial for obesity in Australia, exploring a once‑monthly (Q4W) dosing regimen, to continuously accumulate evidence‑based data for future global registration and commercialization. In June 2026, the phase Ib clinical trial of Efsubaglutide alfa in adolescent obesity was approved by China's National Medical Products Administration, 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 of 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.

Reference: 

1. Vigitel – Surveillance System for Risk and Protective Factors for Chronic Diseases by Telephone Survey, 2024

About PIC/S

PIC/S (Pharmaceutical Inspection Co‑operation Scheme) is a leading international organization that harmonizes GMP regulatory standards for pharmaceuticals worldwide. Its core objectives are to unify GMP requirements among member countries, promote mutual recognition of GMP inspection results, and enhance cross‑border regulatory collaboration. PIC/S members include drug regulatory authorities from major countries and regions globally, and its GMP standards carry high credibility in pharmaceutical markets worldwide, particularly in emerging markets such as Latin America and Southeast Asia. ANVISA officially joined the PIC/S scheme in 2021, and its rigorous GMP inspection standards are recognized as a benchmark regulatory authority in South America.

About Innogen Pharmaceuticals

Founded in 2014, Innogen (HKEX.2591) focuses on innovative metabolic disease drugs, with fully proprietary pipelines covering T1D, obesity, MASH, and AD, supported by global IP and patent portfolios. Its core product, Efsubaglutide Alfa (a next-generation human-derived ultra-long-acting GLP-1 receptor agonist), is approved for type 2 diabetes in Chinese Mainland and Macau SAR, included in China's National Reimbursement Drug List, and is under global development and registration. Learn more: www.innogenpharm.com.

SOURCE Innogen Pharmaceuticals