Chinese biopharma PegBio taps into high-potential Middle East and Africa markets via exclusive GLP-1 partnership

Under the proposed terms, PDC will be granted an exclusive license to develop, distribute, market, and commercialize the product in the Middle East and Africa regions. The license covers regional development, product registration, local production involving comprehensive technology transfer, and exclusive rights for full commercialization. The product will be sold in the region under a trademark owned by PDC.

The pipeline asset involved in this collaboration, PB-119, is a long-acting GLP-1 receptor agonist independently developed by PegBio and nearing the commercialization stage. It is primarily indicated for the first-line treatment of type 2 diabetes (T2DM) and obesity.

PB-119 is a GLP-1 derivative based on exenatide covalently linked to a polyethylene glycol (PEG) backbone. This design increases its relative molecular mass and reduces renal clearance, thereby extending the circulating half-life of exenatide. Furthermore, PegBio's PEGylation technology further prolongs the half-life of PB-119, enabling once-weekly administration compared to the daily dosing required for exenatide. Additionally, PB-119 features a single formulation and does not require dose titration, simplifying the administration process and potentially improving patient compliance.

In September 2023, the National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for PB-119 for the treatment of T2DM in China, marking a significant milestone ahead of its commercialization. PegBio anticipates obtaining NDA approval from the NMPA in 2025 and subsequently launching PB-119 commercially in China for T2DM.

Given the weight loss efficacy observed in the Phase III clinical trials for T2DM, PegBio also plans to evaluate the therapeutic effect of PB-119 for obesity. In June 2021, the NMPA approved the Investigational New Drug (IND) application for PB-119 for this indication in China. PegBio received approval to initiate the clinical trial in April 2024 and is currently conducting the Phase Ib/IIa clinical trial for PB-119 in the treatment of obesity.

In addition to its use as a monotherapy for T2DM and obesity, PegBio also plans to initiate three additional Phase III clinical trials for PB-119 within the year. These include:

Regarding the commercialization of PB-119, PegBio indicated in its interim report that the company "plans to price PB-119 competitively to ensure broad access for patients in need. Furthermore, we intend to partner with pharmaceutical companies that possess strong commercialization capabilities and extensive experience in our focused therapeutic areas. By leveraging their established sales networks and other resources, we aim to maximize the commercial value of PB-119 in a cost-effective manner."

This commercialization strategy aligns with PegBio's current decision to collaborate with PDC, a CRO leader in the Middle East and Africa.

PDC is a premier pharmaceutical R&D organization and a leading CRO giant in the Middle East and Africa region.

In terms of business scope, PDC specializes in providing end-to-end clinical trial solutions for pharmaceutical companies. Its services encompass Phase I to IV clinical trials, real-world evidence (RWE) studies, and consulting services in the life sciences sector. PDC offers comprehensive support across the entire process, including clinical trial design, execution, data management, and statistical analysis, assisting pharma companies in accelerating their drug development processes.

Regarding regional advantages, the organization boasts an extensive clinical trial network across the Middle East and Africa, covering 15 countries such as Egypt, Saudi Arabia, and South Africa, enabling rapid initiation of multi-center clinical trials. It has established strong collaborative relationships with local medical institutions and investigators, leveraging substantial regional resources and specialized expertise to enhance the efficiency and quality of clinical trials.

On the technical capabilities front, PDC possesses comprehensive technology transfer and local production capabilities, enabling it to assist pharmaceutical companies in achieving product localization within the Middle East and Africa. For instance, within the collaboration with PegBio, PDC will be responsible for the regional development, regulatory submission, and local production of PB-119, ensuring the product complies with all local regulatory requirements.

Beyond the inherent strengths of the PDC organization itself, the local Middle East and Africa region, characterized by a large and rapidly growing population, exhibits a significant projected increase in the number of diabetes and obesity patients. This demographic trend underscores a substantial and urgent clinical demand.

According to data from the 11th edition of the International Diabetes Federation (IDF) Diabetes Atlas, released in 2025, the Middle East and North Africa region had approximately 85 million adults (aged 20-79) living with diabetes in 2024, corresponding to a prevalence rate of 17.6% — the highest among all IDF regions. The number of adults with diabetes in this region is projected to increase by 92% by 2050, reaching 163 million. In contrast, the Africa region had approximately 24.6 million adults (aged 20-79) with diabetes in 2024, the lowest prevalence rate among all IDF regions at 4.2%. However, by 2050, the total number of people with diabetes in Africa is forecast to surge by 142% to 60 million, representing the highest projected increase of all IDF regions.

Regarding obesity, a 2025 study published in The Lancet projects the Middle East and North Africa region to be among the world's fastest-growing regions for obesity rates. By 2050, it is estimated that North Africa and the Middle East, alongside Latin America and the Caribbean, will be home to one-third of the world's adolescents with obesity (130 million), which is expected to have severe impacts on health, economy, and society.

Aiming to address this substantial clinical demand, PegBio's collaboration with PDC leverages the latter's professional expertise in clinical trials, regional resource advantages, and local production capabilities. This partnership is expected to effectively reduce overseas R&D costs, shorten the time to market, and enhance product accessibility and market competitiveness through local production. Furthermore, PegBio could potentially establish a production base in the UAE via technology transfer, which would not only cater to the high-end market demand in Middle Eastern countries but also enable the export of lower-cost generic drugs to Africa.

In summary, the collaboration with PDC represents a significant pathway for PegBio to expand into overseas markets and validate its technological capabilities, while also accumulating valuable experience for the company's future entry into European and American markets. As PegBio stated in its announcement, "This collaboration holds major strategic importance. Leveraging PDC's extensive regional expertise and infrastructure will accelerate PB-119's market access and penetration, validate PegBio's asset-out-licensing strategy, and make substantial contributions to the global deployment of PB-119 and the creation of long-term value for PegBio."