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<h4><span style="color:#ee7100;">DiKine<sup>TM</sup></span></h4> <p><span style="color:#000000;">Evive’s signature DiKine<sup>TM</sup> platform is a mature and versatile platform that manufactures therapeutic dimeric human cytokines, hormones or their agonist/antagonists with extended circulating half-life for improved clinical benefit. The DiKine<sup>TM</sup> platform has been implemented at Evive's Beijing GMP manufacturing facility which supplies fully GMP-compliant materials for clinical development and commercial production worldwide.</span></p> <p><span style="color:#000000;">Cytokines, hormones and their antagonists have long been used in clinical settings and have demonstrated significant benefits for patients with various diseases. However, these small proteins face significant challenges, as prohibitively frequent, or continuous, administration is necessary due to their short serum circulation half-life. This becomes a barrier for achieving the full clinical benefit from these therapies due to patient compliance, especially for our most vulnerable pediatric patients. Evive's DiKine<sup>TM</sup> assets significantly extend the circulating half-life of cytokines, hormones and their antagonists by taking advantage of the long serum half-life of the Fragment Crystallizable (Fc) region of antibodies. Evive's DiKine<sup>TM</sup> products are cytokine-, hormone- or antagonist-Fc homodimers that function without the need for such frequent dosing. Results from multiple completed Phase II and III trials have demonstrated that DiKine<sup>TM</sup> products are efficacious with weekly or biweekly administration. </span></p> <p><span style="color:#000000;">The safety and efficacy of DiKine<sup>TM</sup> products have been clinically validated by two of Evive's products:</span></p> <ol> <li><span style="color:#000000;">F-627, a recombinant human G-CSF-Fc dimer, once per chemotherapy cycle injection is as efficacious and safe as G-CSF, which requires 5 injections per chemotherapy cycle.</span></li> <li><span style="color:#000000;">F-652, recombinant human IL-22-Fc dimer, has also been shown to be safe and efficacious as weekly injections in treating acute graft-versus-host disease (aGvHD). The U.S. FDA granted F-652 orphan drug status for the treatment of aGvHD in October 2019.</span></li> <li><span style="color:#000000;">F-652 has also been shown to be safe and efficacious as weekly injections in treatment of acute alcoholic hepatitis (AH).</span></li> <li><span style="color:#000000;">F-899, recombinant long-acting growth hormone with targeting dosing frequency of 10-14 days.</span></li> </ol> <p><span style="color:#000000;">Another advantage of the DiKine<sup>TM</sup> platform is that it leverages a proven safety profile from the mammalian cell-based (CHO) expression system. Compared to bacteria-expressed cytokine or hormone therapies, the eukaryotic system provides folding and modifications of DiKine<sup>TM</sup> assets closer to their endogenous counterparts, optimizing safety, particularly in minimizing immunogenicity concerns.</span></p> <h4><span style="color:#ee7100;">Long-acting Multi-specific Antibodies Platform</span></h4> <p><span style="color:#000000;">Evive's long-acting multi-specific platform, serves as the basis of many of the products in Evive's pre-clinical product pipeline. The platform builds upon Itab<sup>TM</sup>, a partner platform that has historically yielded two products that have successfully entered human clinical trials. The platform provides significant flexibility to adapt to mono-targeting and multi-targeting agonists or antagonists, and is being used to quickly evaluate and develop new drug molecules.</span></p>
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<p>Evive research is focused on areas of unmet medical need in oncology, inflammatory diseases, metabolic disorders, and other major therapeutic areas. Our technology platforms are particularly capable of developing novel assets that capitalize on life changing innovations, enabling us to direct focus towards these disease areas.</p> <h4><span style="color:#ee7100;">Oncology</span></h4> <p>Cancer is a devastating disease that seriously endangers human health. Evive is aiming to deliver innovations that extend and improve the lives of people with cancer. Discovering and developing novel, potent, and safe anticancer therapeutics, including supportive care, is a core research area for Evive. Ryzneuta™ (F-627) has a unique potential to treat the chemotherapy induced neutropenia (CIN) which commonly occurs in patients receiving myelosuppressive chemotherapy during cancer treatments. CIN impacts millions of patients globally, is potentially life-threatening, and generally requires medical intervention.</p> <h4><span style="color:#ee7100;">Inflammation</span></h4> <p>Inflammatory diseases occur when the immune system attacks the body's cells or tissues; this can sometimes result in life-threatening symptoms without proper treatment. Standard treatments such as corticosteroids are often associated with inadequate response and potential severe side effects. Many researchers have dedicated their efforts to developing biologic therapies in the hopes of providing better treatments. F-652, our novel recombinant human interleukin-22 dimer, has applications across a range of inflammatory diseases and has received orphan drug designation for acute graft versus host disease (aGVHD) from FDA.</p> <h4><span style="color:#ee7100;">Metabolism</span></h4> <p>Metabolic diseases, such as diabetes and growth hormone deficiency, are a group of diseases that occur when the body's usual physical and chemical processes are disrupted. These diseases can be congenital or acquired. They constitute a major public health challenge and have attracted much concern over the years. For example, according to epidemiology data, one of the largest populations in the world suffers from diabetes, a common, potentially devastating, medical condition. Complications associated with diabetes include macrovascular and microvascular conditions that produce a great burden of disease. Growth hormone deficiency (GHD) is one of the most common causes of dwarfism, which is due to lack of GH, abnormal GH structure, receptor defects, etc. Evive has several products under development for metabolic diseases, including F-899 targeting growth hormone deficiency and PCR012 for diabetes.</p>
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