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Pioneering The Future: Transferring technology and localizing insulin production in Saudi Arabia

Healthcare transformation is at the heart of Saudi Arabia’s Vision 2030, and at its core is the need for sustainable access to essential medicines. Diabetes remains one of the Kingdom’s most pressing health challenges, demanding solutions that go beyond innovation—solutions that build long-term resilience and self-sufficiency.
At Sanofi, we believe strong partnerships drive lasting progress. Our collaboration with Sudair Pharma Company (SPC) and NUPCO reflects a shared commitment to localizing insulin production, reducing reliance on imports, and strengthening Saudi Arabia’s pharmaceutical manufacturing capabilities.
With millions in the Kingdom affected by diabetes, securing a stable, high-quality insulin supply is not just a healthcare necessity—it’s a national priority. Local production advances Saudi Arabia’s ambition to lead in life sciences and biopharmaceutical manufacturing, reinforcing its position as a regional hub for innovation.

And beyond manufacturing, this -strategic, long-term partnership equips Saudi talent with the skills and expertise to shape the future of biopharmaceuticals. By embedding advanced technology and rigorous training into the local ecosystem, we are not just producing insulin—we are building a foundation for long-term healthcare innovation.
I am especially excited about the upcoming groundbreaking of the new state-of-the-art facility—a moment that underscores our commitment to healthcare security and self-sufficiency in Saudi Arabia. This specialized Insulin facility will not only enhance local production capabilities but also serve as a symbol of what is possible when the public and private sectors come together to deliver sustainable healthcare solutions.
Vision 2030 is about bold steps that drive economic growth, industrial progress, and healthcare excellence. Local insulin production is one of those steps—ensuring world-class treatment is available where it’s needed – by Saudis, for Saudi, in Saudi…
At Sanofi, we are proud to be part of this journey. By bringing our expertise, technology, and investment to Saudi Arabia, we are helping build a more self-sufficient and resilient healthcare system—one that delivers for patients today while shaping the future of medicine for generations to come.

Screening and monitoring are critical to managing autoimmune T1D and reducing the likelihood of diabetic ketoacidosis (DKA) hospitalization or emergency care at the time of Stage 3 autoimmune T1D diagnosis.1

<h4>Testing for islet autoantibodies against four major pancreatic autoantigens is currently available:</h4>

A combination of these four primary types of autoantibodies is recommended to detect autoimmunity.1-3
The presence of islet autoantibodies alongside metabolic status defines the three stages of T1D.4
These screening criteria are recommended by the most recent ADA Standards of Care.1

<h3>At-risk ≤1 autoantibody 
 Normoglycemia</h3>
How to confirm single IAb+ status1
CONFIRM RESULTS

After first detection of single IAb, follow the ‘rule of twos’, using two independent methods to confirm negative results for other IAbs.1

MONITORING FREQUENCY (children &lt;3 years old)

Monitor IAb+ status every 6 months for 3 years, then annually thereafter for 3 more years.1

Metabolic monitoring includes random venous or capillary blood glucose and HbA1c values at the same frequency.1

If no progression, stop autoantibody and metabolic monitoring and counsel for risk of clinical disease.1

MONITORING FREQUENCY (children ≥3 years old)

Monitor IAb+ status annually for 3 years.1

Metabolic monitoring includes annual random venous or capillary blood glucose and HbA1c testing for 3 years.1

Critical monitoring during early years 
 (first two years after seroconversion):1
<ul>
 <li>Islet autoantibody status and metabolic monitoring are most critical during this time.</li>
 <li>Ongoing metabolic monitoring is not essential beyond this period.</li>
</ul>

<h3>Stage 1 (early stage) ≥2 autoantibodies 
 Normoglycemia</h3>
How to confirm multiple IAb+ status1

After first detection of ≥2 IAbs, follow the ‘rule of twos’, using two independent methods to confirm positive status for other islet autoantibodies.1

TWO-TEST CONFIRMATION NOT POSSIBLE? A single blood test positive for multiple islet autoantibody status identifies a person with sufficient risk for metabolic monitoring.1

REVERTED STATUS? For adults with previously confirmed multiple IAb+ status who revert to single IAb+ or IAb− status, metabolic monitoring should follow the guidelines below for Stage 1.1

GENERAL GUIDELINES FOR METABOLIC MONITORING1
<figure class="table" style="width:671.989px;">
 <table style="background-color:rgb(255, 255, 255);border-bottom-width:1px;border-color:rgb(201, 201, 201);border-left-width:0px;border-right-width:0px;border-style:solid;border-top-width:0px;">
 <tbody>
 <tr>
 <td style="border-bottom-color:rgb(229, 231, 235);border-bottom-width:0px;border-left-color:rgb(229, 231, 235);border-left-width:0px;border-right-color:rgb(201, 201, 201);border-right-width:1px;border-top-color:rgb(229, 231, 235);border-top-width:0px;padding:1.5rem;text-align:center;vertical-align:top;">&lt;3 years old 
 Once every 
 3 months1</td>
 <td style="border-bottom-color:rgb(229, 231, 235);border-bottom-width:0px;border-left-color:rgb(229, 231, 235);border-left-width:0px;border-right-color:rgb(201, 201, 201);border-right-width:1px;border-top-color:rgb(229, 231, 235);border-top-width:0px;padding:1.5rem;text-align:center;vertical-align:top;">3–9 years old 
 At least every 
 6 months1</td>
 <td style="border-color:rgb(229, 231, 235);border-width:0px;padding:1.5rem;text-align:center;vertical-align:top;">&gt;9 years old 
 At least every 
 12 months1</td>
 </tr>
 </tbody>
 </table>
</figure>

Conduct monitoring based on staging criteria and modalities described in Tables 1 and 5 of the consensus guidelines.1

Ensure monitoring is done when the child is healthy and not experiencing intercurrent illness.1

Provide SMBG meters and strips to all children with multiple islet autoantibody positivity or their parents.1

During intercurrent illness (e.g., a cold), use SMBG to detect hyperglycemia.1

For recent confirmation of multiple IAb+ status, perform SMBG tests on two different days over a 2-week period, then once every 1–3 months.1

<h3>Stage 2 (early stage) ≥2 autoantibodies 
 Glucose intolerance or dysglycemia</h3>
How to confirm multiple IAb+ status1

CONFIRM RESULTS1

After first detection of ≥2 IAbs, follow the ‘rule of twos’, using two independent methods to confirm positive status for other islet autoantibodies.1

REVERTED STATUS? For adults with previously confirmed multiple IAb+ status who revert to single IAb+ or IAb− status, metabolic monitoring should follow the guidelines below for Stage 2.1

GENERAL GUIDELINES FOR METABOLIC MONITORING1

Monitor measures of glucose regulation (glycemic status) every 3 months.

A longitudinal change in HbA1c of ≥10% from the confirmed islet autoantibody date may indicate dysglycemia and disease progression.1

Perform an OGTT to assess T1D stage for therapy eligibility.1

Measure random venous or capillary blood glucose simultaneously with HbA1c.1

Use 10–14-day CGM periodically at a similar frequency as HbA1c measurement.1

Monitor objective weight trends using a growth chart and ensure a healthy meal plan to preclude disordered eating behaviors as a cause of weight change.1

OGTT is the established gold standard to classify Stage 1, Stage 2 or Stage 3 T1D however if OGTT is not possible:1
<ul>
 <li>Obtain a 2-hour postprandial capillary blood glucose measurement after a carbohydrate-rich meal to assess for dysglycemia.1</li>
</ul>

CGM should be blinded to the individual and interpreted by trained HCPs.1

Criteria for CGM metrics to diagnose Stage 2 or Stage 3 T1D require further research.1

<h4>All persons at risk through to Stage 2</h4>
PSYCHOSOCIAL SUPPORT FOR SINGLE AND MULTIPLE IAb+ INDIVIDUALS

Emotional, cognitive and behavioral functioning should be assessed in people at risk of or with early-stage autoimmune type 1 diabetes and their family members, when appropriate. Anxiety, risk perception and behavior changes should specifically be assessed.1

Ask the individual at risk or with early-stage type 1 diabetes and/or their caregivers and family members about their reactions upon receiving the news that they have type 1 diabetes-related autoantibodies. This can be accomplished using guiding questions and standardized and validated questionnaires.1

At each monitoring visit, there should be enquiries into current needs, particularly coping.1

Psychological care should be integrated into routine medical visits and, whenever possible, delivered by providers with diabetes-specific training.1

<h3>Stage 3 ≥1 autoantibodies Persistent hyperglycemia with or without symptoms</h3>

Screening and subsequent monitoring for presymptomatic T1D prior to clinical onset of Stage 3 have several benefits, including reducing the risk of DKA and hospitalization, and providing opportunities for education and preparation for chronic disease management.5,6
The decision to start insulin depends on a range of factors and consideration to do so should be referred to a specialist center.1

For the full guidelines together with the evidence rating (A–E), please consult reference 1.
ADA, American Diabetes Association; CGM, continuous glucose monitoring; DKA, diabetic ketoacidosis; GAD, glutamic acid decarboxylase; HbA1c, glycated hemoglobin; HCP, healthcare professional; IA-2, insulinoma-associated antigen-2; IAA, insulin autoantibody; IAb, islet autoantibody; OGTT, oral glucose tolerance test; SMBG, self-monitoring of blood glucose; T1D, type 1 diabetes; T2D, type 2 diabetes; ZnT8, zinc-transporter 8.

Reference

Consensus Guidance for Monitoring Children with Islet Autoantibody-Positive Pre-Stage 3 Autoimmune Type 1 Diabetes (T1D)

<table border="1" cellpadding="10" cellspacing="1">
 <tbody>
 <tr>
 <td colspan="3" style="background-color: rgb(244, 242, 246);">Additional&nbsp;Signals</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Physiological&nbsp;Signals</td>
 <td style="background-color: rgb(244, 242, 246);">Advantages</td>
 <td style="background-color: rgb(244, 242, 246);">Limitations</td>
 </tr>
 <tr>
 <td>Continuous ketone and lactate sensors</td>
 <td>Lactate increase with exercise and can differentiate moderate-intensity exercise and high-intensity exercise. 
 Ketone responds to different types of exercises. These levels ensure safety during exercise.</td>
 <td>Very limited ability to differentiate between the type of exercise, and mixed levels show a slow increase with exercise</td>
 </tr>
 <tr>
 <td>Accelerometers and heart-rate sensors coupled with lactate sensing</td>
 <td>Might have potential to inform CL on both exercise type (E.g., running, swimming or weights) and intensity (low, moderate, high or interval)</td>
 <td>Non-specificity to exercise with stress, illness, medications, dehydration, and all potential modulators</td>
 </tr>
 </tbody>
</table>

<ul>
 <li>
 Information from&nbsp;physiological signals&nbsp;like lactate, ketones, counterregulatory hormones, accelerometry, heart rate, galvaic skin response, skin temperature, and blood volume pulse could be used as potential adjunct for developing an algorithm about onset, offset and intensity of physical activity.</li>
 <li>
 Counterregulatory hormones&nbsp;can differentiate exercise intensity, however a lot of technical challenges were involved in measurement of them in real world.</li>
 <li>
 Other wearable&nbsp;sensors combining galvanic skin response, accelerometry, blood volume pulse, heart and skin temperature&nbsp;are able to classify the physical states and exercise type and could potentially differentiate exercise and physiological stress.</li>
</ul>

Additional signals

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="3" style="background-color: rgb(244, 242, 246);">
 Bi-hormonal CL systems 
 (Systems delivering both Insulin and glucagon)</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Strategies</td>
 <td style="background-color: rgb(244, 242, 246);">Advantages</td>
 <td style="background-color: rgb(244, 242, 246);">Limitations</td>
 </tr>
 <tr>
 <td>Glucagon helps in minimizing the impact of the delayed onset in insulin action by counteracting the persisting glucose-lowering effects of insulin</td>
 <td>
 <ul>
 <li>
 Bypass limitations of SC route</li>
 <li>
 Improved time-in-range</li>
 <li>
 Less hypoglycemia during excercise</li>
 </ul></td>
 <td>
 <ul>
 <li>
 Stability and cost</li>
 <li>
 Long-term safety of glucagon</li>
 <li>
 Increased complexity of the system</li>
 </ul></td>
 </tr>
 </tbody>
</table>

BI hormonal CL systems

<h2>Improved usability of existing strategies</h2>
An&nbsp;exercise button&nbsp;could be integrated into CL device activation which triggers several adaptive changes, such as:
<ul>
 <li>
 Automatic increase in glucose at a preset time</li>
 <li>
 Modifications in the algorithm so that it becomes less aggressive in minimizing rises in glucose levels and more aggressive in minimizing falls in glucose</li>
 <li>
 A function to preprogram future recurrent scheduling for exercise (date and time) which could automatically set temporary targets 90 minutes prior.</li>
</ul>

Improved usability


<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="3" style="background-color: rgb(244, 242, 246);">Development of insulin formulations and routes of delivery with more favorable pk characteristics</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Strategies</td>
 <td style="background-color: rgb(244, 242, 246);">Advantages</td>
 <td style="background-color: rgb(244, 242, 246);">Limitations</td>
 </tr>
 <tr>
 <td>Intranasal insulin</td>
 <td>Significantly faster onset and offset in action with potential to reduce residual insulin activity associated with pre-exercise meal bolus</td>
 <td>
 <ul>
 <li>
 Not widely available</li>
 <li>
 Long-term safety is not clear</li>
 </ul></td>
 </tr>
 <tr>
 <td>Continuous intraperitoneal insulin infusion</td>
 <td>
 <ul>
 <li>
 Faster onset and offset action</li>
 <li>
 Improves HbA1c with less hypoglycemia</li>
 </ul></td>
 <td>
 <ul>
 <li>
 Invasive procedures</li>
 <li>
 Carries risk of infection and immunogenicity</li>
 </ul></td>
 </tr>
 <tr>
 <td>Intravenous (IV) CL insulin delivery models</td>
 <td>
 <ul>
 <li>
 Rapid delivery with no delay in absorption</li>
 <li>
 Would bypass limitations of SC route</li>
 </ul></td>
 <td>
 <ul>
 <li>
 Invasive</li>
 <li>
 Prone to complications such as infections, thrombosis</li>
 <li>
 Less feasible for ambulatory use</li>
 </ul></td>
 </tr>
 </tbody>
</table>

Development of Insulin

<table border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="3" style="background-color: rgb(244, 242, 246);">Enhanced algorithms</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Strategies</td>
 <td style="background-color: rgb(244, 242, 246);">Advantages</td>
 <td style="background-color: rgb(244, 242, 246);">Limitations</td>
 </tr>
 <tr>
 <td>HCL systems incorporating heart rate, accelerometry along with energy expenditure and galvanic skin response</td>
 <td>For detection of physical activity and improvements in glycemic outcomes</td>
 <td>These algorithms reactive and remain subject to the slower PK of subcutaneous insulin absorption</td>
 </tr>
 <tr>
 <td>Machine learning for personalization of CL systems</td>
 <td>Recognizes habitual pattern of imminent exercises and trigger CL systems</td>
 <td>Potential risks associated with insulin dosing determined upon the basis of the probability of an event occurring</td>
 </tr>
 </tbody>
</table>

Enhanced algorithms


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