Chinese biopharmaceutical company Innogen Pharmaceuticals has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its Efsubaglutide alfa manufacturing facility in Suzhou, following a successful compliance inspection conducted under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standards.
The certification marks an important milestone for the company, validating that its manufacturing operations meet internationally recognised PIC/S GMP quality standards. It is expected to accelerate the registration, market access and commercial partnerships for Efsubaglutide alfa in Brazil and other PIC/S-recognising markets, while strengthening the company’s global expansion strategy.
Efsubaglutide alfa is an innovative, human-derived, ultra-long-acting GLP-1 receptor agonist developed by Innogen. It is approved in Mainland China and Macau for the treatment of adults with type 2 diabetes and is included in China’s National Reimbursement Drug List.
Clinical data from the pivotal SUPER series of studies demonstrated significant reductions in glycemic levels among patients with type 2 diabetes. After 24 weeks of once-weekly 3 mg treatment, treatment-naïve patients achieved an average HbA1c reduction of approximately 2.2%, while patients receiving metformin experienced an average reduction of around 1.8%. The therapy also showed a favourable safety and tolerability profile, with indications of improved pancreatic beta-cell function.
Professor Wang Qinghua, Founder, Chairman, and CEO of Innogen Pharmaceuticals, said, “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,” he added.
With Brazil serving as a key strategic hub, the company plans to expand its presence across South America and other PIC/S member countries, advancing the global development and overseas registration of additional indications for Efsubaglutide alfa while further strengthening its international footprint.
Promising Results in Weight Management
Beyond diabetes, Efsubaglutide alfa is also showing encouraging results in weight management.
In the China-based ENLIGHT Phase IIb study, participants receiving a 20 mg once-weekly regimen achieved an average weight reduction of 10.6% after 18 weeks, along with a waist circumference reduction of 8.9 cm. Patients receiving the same dose once every two weeks recorded an average weight loss of 9.7%, with improvements in body composition parameters including fat mass, liver fat content, and muscle‑to‑fat ratio.
Innogen is currently conducting a Phase II clinical trial in Australia to evaluate a once-monthly dosing schedule for obesity. The company is also expanding development into adolescent obesity, with China’s National Medical Products Administration approving a Phase Ib clinical trial in June 2026. The first subject was enrolled in July, marking the start of clinical implementation.
PIC/S (Pharmaceutical Inspection Co‑operation Scheme) is an international organization that harmonizes GMP regulatory standards for pharmaceuticals worldwide. It aims to unify GMP requirements among member countries, promote mutual recognition of GMP inspection results, and enhance cross‑border regulatory collaboration.
The organisation comprises 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. Brazil’s National Health Surveillance Agency (ANVISA) became a PIC/S member in 2021, and its rigorous GMP inspection standards are recognized as a regulatory benchmark in South America.
