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.

PHILADELPHIA, June 22, 2026 /PRNewswire/ -- During the DIA Global Annual Meeting 2026 held in Philadelphia, the China Town Hall session was successfully convened, bringing together regulatory, industry and innovation leaders to discuss the development of China's innovative pharmaceutical industry, alignment with international regulatory standards, global clinical development and market access.

The session was chaired by DIA expert Dr. Ling Su. A representative from the China Center for Food and Drug International Exchange delivered a keynote speech, and representatives from both a multinational pharmaceutical company and a China-based innovative biopharmaceutical company participated in panel discussions.

As a representative of a China-based innovative biopharmaceutical company, Dr. Qinghua Wang, Founder, Chairman and CEO of Innogen Pharmaceutical Group, attended the China Town Hall session and shared Innogen's perspectives on original innovation, global clinical development and international commercialization in the field of metabolic diseases. Dr. Wang noted that China's biopharmaceutical industry has rapidly evolved from a foundation historically centered on generics and biosimilars into an increasingly important force in global innovation, playing a growing role in the worldwide clinical development pipeline. Against this backdrop, the continued growth and success of China's innovative pharmaceutical companies will depend not only on development speed, but also on original scientific foundations, globally aligned technical standards and clearly demonstrated clinical value.

Innogen's development journey reflects a "from 0 to 1" innovation pathway for China-originated biopharmaceutical companies. Although the company was founded in 2014, Dr. Wang's research in GLP-1 biology began more than two decades ago, before the first GLP-1 receptor agonist became clinically available. Building on this long-standing scientific foundation in GLP-1 biology, Innogen further applied recombinant fusion-protein engineering to extend GLP-1 activity, ultimately leading to the development of its core product, efsubaglutide alfa.

Efsubaglutide alfa is Innogen's self-developed, humanized, ultra-long-acting GLP-1 receptor agonist. It was designed to support prolonged drug exposure and convenient dosing for the management of chronic metabolic diseases, and has been approved in China for the treatment of type 2 diabetes. Efsubaglutide alfa is not approved for obesity or for use outside approved jurisdictions. Innogen stated that the development of efsubaglutide alfa reflects a complete innovation chain, from basic scientific research and molecular engineering to clinical development and product approval, demonstrating the continued progress of China-originated innovation in the metabolic disease field.

During the session, Dr. Wang emphasized that true globalization of China-originated innovation is not simply about bringing a product outside China. More importantly, it requires that R&D systems, quality systems, clinical evidence and patient value can withstand international scrutiny. Since its establishment, Innogen has continued to build its clinical development, CMC, quality management and pharmacovigilance systems in line with international technical expectations, with a focus on ICH guidelines, GCP, GMP, data integrity and rigorous benefit-risk assessment.

"True globalization of China-originated innovation requires that R&D systems, quality systems, clinical evidence and patient value can withstand international scrutiny," said Dr. Qinghua Wang. "Innogen will continue to build on original science, align with global technical standards and remain guided by patient access and clinical value."

In terms of global clinical development, in addition to advancing clinical programs in China, Innogen is also conducting metabolic disease-related clinical development in international markets. These efforts include a Phase 2 clinical study for obesity in Australia, as well as a registration-related bridging clinical study for type 2 diabetes in Brazil. Australia offers a high-quality and internationally recognized clinical research environment, supporting further evaluation of whether efficacy, safety, tolerability and patient-relevant value observed in China can be validated in broader populations and future global development. Bridging studies in emerging markets such as Brazil may also help support regulatory pathway exploration across different healthcare and patient settings, laying a foundation for future international access and commercialization.

Innogen also highlighted the significant clinical needs and development potential in emerging markets, including South America, South Asia and other regions where the burden of diabetes and obesity is rising rapidly, while access to innovative therapies remains limited. In these markets, regulatory approval is only the first step. Product quality, affordability, reliable supply, physician education and long-term safety monitoring must work together. For chronic metabolic diseases such as diabetes and obesity, dosing convenience, patient adherence and sustainable access are also important components of clinical value.

Innogen stated that, in the current environment of rapid innovation in China, companies seeking sustainable growth and long-term success should remain focused on three priorities. First, innovation must begin with real clinical needs, rather than technology alone. Second, innovation must meet globally recognized technical standards. Third, innovation must demonstrate clear clinical value, not only in terms of statistical efficacy, but also in meaningful value for patients, physicians, payers and healthcare systems.

The China Town Hall session at DIA Global Annual Meeting 2026 provided an important platform for dialogue among regulatory exchange organizations, multinational pharmaceutical companies and China-based innovative companies. Innogen stated that it will continue to build on original science, align with global technical standards and remain guided by patient access and clinical value as it advances China-originated innovation toward broader international markets.

About Innogen Pharmaceutical Group

Innogen Pharmaceutical Group is an innovation-driven biopharmaceutical company focused on metabolic diseases. The company is committed to developing innovative therapies with meaningful clinical value and international competitiveness. Its core product, efsubaglutide alfa, is a humanized, ultra-long-acting GLP-1 receptor agonist approved in China for the treatment of type 2 diabetes. Innogen continues to advance clinical development, international registration and global collaboration in the field of metabolic diseases.

Presentation Details

Poster Title: Efsubaglutide Alfa in Overweight or Obesity: Phase IIb ENLIGHT Study

Abstract Number: 2636-P

Presentation Time: June 8, 2026, 12:30 PM (Central Time)

Presenter: Qinghua Wang, Ph.D., Founder, Chairman and Chief Executive Officer of Innogen

Innogen's proprietary Efsubaglutide α met the primary endpoint of the Phase IIb ENLIGHT study conducted in Chinese overweight and obese adults. This randomized, double-blind, placebo-controlled, multicenter study enrolled 200 overweight and obese adults without diabetes to evaluate the efficacy and safety of Efsubaglutide α at doses ranging from 5 to 20 mg for 18 weeks. Results showed that all dose groups experienced significant weight loss from baseline, superior to the placebo group, and the weight loss was positively correlated with the dose. During treatment, patients in the Efsubaglutide α group showed a continuous weight loss trend without a plateau.

The study employed a concise and aggressive dose titration protocol (incrementing every 2 weeks to reach the target dose of 20 mg within 6 weeks, covering both QW and Q2W dosing routes). Results showed that after 18 weeks of treatment including titration and maintenance, Efsubaglutide α significantly reduced the weight of participants, with reductions of 10.58% and 9.70% in the QW and Q2W groups, respectively. Meanwhile, the subjects' waist circumference, visceral fat, and liver fat metabolism indicators all showed significant improvement. Notably, the weight loss was primarily due to fat rather than muscle, resulting in a significant increase in the muscle-to-fat ratio of 45.3%; furthermore, liver fat content decreased significantly by 46.9%. Regarding safety, no hypoglycemic events occurred during treatment, and gastrointestinal adverse reactions were mostly mild to moderate, transient, and self-limiting.

Dr. Wang Qinghua pointed out: The Phase IIb clinical trial results of Efsubaglutide α presented at this ADA Annual Meeting are very encouraging. As an innovative long-acting agonist originating from China, this drug, through its unique molecular structure design, combines potent weight loss with the efficacy of 'fat reduction and muscle protection,' possessing significant differentiated core advantages, good tolerability, and convenient administration. This set of high-quality clinical data fully demonstrates the broad prospects of Efsubaglutide α in the field of obesity treatment and provides strong scientific evidence for the upcoming Phase III clinical trial. We will go all out to accelerate subsequent research, promoting the early implementation of this original Chinese achievement to benefit patients both domestically and internationally.

Note: This content is for informational purposes only, not an advertisement, advice, or efficacy claim. Use prescription drugs only as directed by a physician.

About Innogen Pharmaceuticals
Founded in 2014, Innogen (HK.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.

The study was led by Academician Weiping Jia and co-corresponded by Professor Qinghua Wang, Distinguished Professor of Fudan University, Founder of Innogen Pharmaceuticals, and inventor of Efsubaglutide Alfa. The publication marks another important milestone in the clinical development of Efsubaglutide Alfa and provides further mechanistic insights into its therapeutic value beyond glucose lowering.

SUPER 2 was a randomized, double-blind, placebo-controlled, two-stage adaptive phase IIb/III trial evaluating Efsubaglutide Alfa as add-on therapy to metformin in patients with type 2 diabetes. The results showed that Efsubaglutide Alfa significantly improved HbA1c and other key glycaemic measures, with an overall safety profile consistent with the GLP-1 receptor agonist class, with mainly mild-to-moderate gastrointestinal adverse events.

Importantly, the study went beyond conventional efficacy endpoints and further examined β-cell functional responses using mixed-meal tolerance testing and related metabolic indices. Treatment with Efsubaglutide Alfa was associated with improved postprandial insulin and C-peptide responses, improvement in β-cell function-related parameters, and favorable changes in indices reflecting the integrated relationship between insulin secretion and insulin sensitivity. These findings suggest that the clinical benefit of Efsubaglutide Alfa may extend beyond glycaemic control to partial improvement of the underlying pathophysiology of type 2 diabetes.

This mechanistic signal is particularly meaningful in light of the team's earlier Diabetes Remission study, published in Advances in Therapy, which showed that Efsubaglutide Alfa treatment in drug-naïve patients with type 2 diabetes was associated with remission in a proportion of patients after treatment withdrawal. The SUPER 2 data now provide larger-scale clinical support for the concept that improvement in β-cell function may contribute to the longer-term disease-modifying potential of Efsubaglutide Alfa.

Innogen Pharmaceuticals is an innovation-driven biopharmaceutical company focused on the discovery, development, and translation of novel therapies for diabetes and other metabolic diseases. The publication of SUPER 2 in Nature Communications not only strengthens the clinical evidence base for Efsubaglutide Alfa, but also highlights the value of integrating mechanistic science, clinical development, and translational medicine to advance next-generation therapies for metabolic diseases.