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                                ●  VV116                            </h3>
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                                                                <p>公司的核心产品VV116 是一种RdRp抑制剂，其已在中国及乌兹别克斯坦获准用于治疗COVID-19，商品名分别为民得维® 及MINDVY®，并在中国进行用于治疗RSV 的II/III期临床开发。RdRp是一种酶，催化从RNA模板复制RNA，及在病毒中具有高度保守性。通过抑制RdRp功能，无法从RNA模板链复制新的RNA，从而干扰RNA病毒的复制。用于治疗COVID-19 的VV116 的疗效于其III期临床结果中得到充分验证。具体而言，数据显示，在患有轻中度COVID-19且有加重风险的成人患者中，VV116在持续临床康复的时间方面并不优于帕罗韦德，但安全问题较少。该等研究成果发表于权威期刊，包括《新英格兰医学杂志》及《柳叶刀－ 感染病学》。</p>
<p>作为RdRp抑制剂，VV116 在治疗各种已知RNA病毒（包括RSV、寨卡病毒、埃博拉病毒以及OC43及229E等其他类型的冠状病毒）引致的传染病方面拥有巨大潜力。其潜力已通过体外研究得到初步证实。此外，VV116亦与其他抗病毒药物（如3CL蛋白酶抑制剂奈玛特韦）产生协同效应，显示其具有作为抗病毒领域骨干药物的潜力。</p>
<p>VV116于2023年1月在中国获得用于治疗轻中度COVID-19的I类创新药的附条件上市批准，并于2025 年1 月获得完全批准。此外，VV116 于2021 年12 月在乌兹别克斯坦获得上市批准，用于治疗中度或重度COVID-19。</p>
<p>为满足对RSV感染进行有效抗病毒治疗的巨大临床需求，公司正在研究VV116 用于该适应症。考虑到相当一部分脆弱的患者群体（特别是婴幼儿）可能会出现吞咽困难，公司已开发口服干混悬剂VV116。该剂型旨在提供更好的药物依从性（相较药片和胶囊而言）。2023年5月，公司获得了国家药监局的IND批准，以开展VV116干混悬剂的I期临床试验。基于VV116干混悬剂的I期试验及先前用于COVID-19的VV116的临床试验收集的临床数据，公司获得了国家药监局的监管许可，并在中国启动用于治疗感染RSV的年龄为1 至24 个月的住院婴幼儿的II/III期临床试验。截至目前，II/III期临床试验正在中国进行。</p>
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                                ● 作用机制                            </h3>
                            <div class="mt-[20px] des">
                                                                    <img class="pads:max-w-[700px] pads:float-right pads:pl-[20px] pads:pb-[20px]" src="https://www.vigonvita.cn/wp-content/uploads/2024/11/2024111507054479.webp" alt="983f216c-0e7f-47ba-b686-b63ca4710b9d">
                                                                <p>RdRp是一种催化从RNA模板复制RNA的酶。不同于催化从DNA模板转录RNA的DNA依赖性RNA聚合酶，其催化与指定RNA模板互补的RNA链的合成。RdRp在病毒中具有高度保守性。拦截病毒RNA的延伸或诱发致死性突变，可有效破坏RNA病毒的复制，从而产生强大的抗病毒作用。</p>
<p>VV116 是以RdRp为靶点的I类创新药物。VV116 的三磷酸活性形式可通过RdRp<br />
融入新生RNA链，这导致RNA延伸停滞不前。</p>
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                            <div class="xinyaochuangzhi_pro_bd">
                                            <div class="item">
                            <h3 class="t">
                                ● TPN171                            </h3>
                            <div class="mt-[20px] des">
                                                                <p>TPN171 是一种潜在同类最佳、高选择性的强效PDE5 抑制剂，用于治疗ED。PDE5主要存在于平滑肌中，其尤其会降解环磷酸鸟苷，降低其浓度，从而抑制阴茎海绵体内平滑肌的松弛度，使阴茎保持松弛状态。PDE5 抑制剂会阻止环磷酸鸟苷的降解，从而增加其浓度，促进平滑肌松弛、动脉扩张及血液充盈，从而增强阴茎勃起。</p>
<p>作为一种PDE5 抑制剂，TPN171 具有新颖的化学结构，包括高活性、高选择性、良好的安全性、疗效显著、结构简单、易合成等多重优势。与西地那非、他达拉非等靶点相同的竞争产品相比，TPN171对其他PDE的活性明显较低，而对PDE5 的靶点选择性较好，使TPN171拥有更好的安全性及疗效，成为潜在同类最佳的PDE5抑制剂。</p>
<p>于2016年1月，公司获得国家药监局的IND批准，以于健康受试者中启动TPN171 的I期临床试验。基于I期试验令人鼓舞的安全性，公司于2020 年4 月获得国家药监局的IND批准，以开展TPN171 用于ED治疗的II期临床试验。TPN171于2022年9月在乌兹别克斯坦获批上市，商品名为Onvita®，于2025年7月在中国获批上市，商品名为昂伟达®，获批适应症均为男性勃起功能障碍（ED)。</p>
<p>&nbsp;</p>
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                        </div>
                                            <div class="item">
                            <h3 class="t">
                                ● 作用机制                            </h3>
                            <div class="mt-[20px] des">
                                                                    <img class="pads:max-w-[700px] pads:float-right pads:pl-[20px] pads:pb-[20px]" src="https://www.vigonvita.cn/wp-content/uploads/2025/05/2025052806595219.webp" alt="TPN171机制－遮盖版招股书（中文）-5">
                                                                <p>PDE5 主要存在于阴茎海绵体内平滑肌中，其专门在海绵体内分解环磷酸鸟苷， 而环磷酸鸟苷为响应平滑肌细胞中一氧化氮合成的第二传讯者。环磷酸鸟苷浓度降低抑制了海绵体内平滑肌的舒张，使阴茎处于松弛状态。</p>
<p>靶向PDE5 的药物可抑制血管平滑肌细胞中酶的存在。通过抑制这种酶，该等药物可抑制PDE5对环磷酸鸟苷的分解。环磷酸鸟苷可活化蛋白激酶G，从而导致血管平滑肌的舒张。抑制PDE5对环磷酸鸟苷的分解会导致血管平滑肌中环磷酸鸟苷的累积， 从而通过磷酸化不同下游效应分子令血管扩张。阴茎动脉的扩张令勃起时间更长。此外，PDE5 抑制剂亦改善内皮功能，减少海绵体内血管平滑肌细胞的凋亡。作为一种选择性PDE5 抑制剂，TPN171 在ED方面的疗效已通过注册III期试验得到证实，且TPN171在乌兹别克斯坦获得用于ED治疗的上市批准。</p>
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                仿制药管线            </span>
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            <p><img decoding="async" class="size-full wp-image-505 aligncenter" src="https://www.vigonvita.cn/wp-content/uploads/2025/05/2025052909180922.webp" alt="" width="1280" height="288" srcset="https://www.vigonvita.cn/wp-content/uploads/2025/05/2025052909180922.webp 1280w, https://www.vigonvita.cn/wp-content/uploads/2025/05/2025052909180922-300x68.webp 300w, https://www.vigonvita.cn/wp-content/uploads/2025/05/2025052909180922-1024x230.webp 1024w" sizes="(max-width: 1280px) 100vw, 1280px" /></p>
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                相关研究论文            </span>
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                    <div class="mt-[20px] common_txt pads:mt-[30px]">
                <table class="table-striped">
                    <thead>
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                            <th width="5%">
                                序号                            </th>
                            <th width="25%">
                                期刊名称                            </th>
                            <th width="50%">
                                文献标题                            </th>
                            <th width="10%">
                                发表时间                            </th>
                            <th width="10%">
                                影响因子                            </th>
                        </tr>
                    </thead>
                    <tbody>
                                                    <tr>
                                <td>
                                    1                                </td>
                                <td>
                                    The New England Journal of Medicine                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/1、VV116-versus-Nirmatrelvir–Ritonavir-for-Oral-Treatment-of-Covid-19.pdf" target="_blank">
                                            VV116 versus Nirmatrelvir–Ritonavir for Oral Treatment of Covid-19                                        </a>
                                                                    </td>
                                <td>
                                    2022                                </td>
                                <td>
                                    IF 158.5                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    2                                </td>
                                <td>
                                    Acta Pharmacologica Sinica                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/2、Safety-tolerability-and-pharmacokinetics-of-VV116-an-oral-nucleoside-analog-against-SARS-CoV-2-in-Chinese-healthy-subj.pdf" target="_blank">
                                            Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects                                        </a>
                                                                    </td>
                                <td>
                                    2022                                </td>
                                <td>
                                    IF 8.2                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    3                                </td>
                                <td>
                                    Signal Transduction and Targeted Therapy                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/3、Oral-remdesivir-derivative-VV116-is-a-potent-inhibitor-of-respiratory-syncytial-virus-with-efficacy-in-mouse-model.pdf" target="_blank">
                                            Oral remdesivir derivative VV116 is a potent inhibitor of respiratory syncytial virus with efficacy in mouse model                                        </a>
                                                                    </td>
                                <td>
                                    2022                                </td>
                                <td>
                                    IF 39.3                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    4                                </td>
                                <td>
                                    Emerging Microbes & Infections                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/4、An-open-prospective-cohort-study-of-VV116-in-Chinese-participants-infected-with-SARS-CoV-2-omicron-variants1.pdf" target="_blank">
                                            An open, prospective cohort study of VV116 in Chinese participants infected with SARS-CoV-2 omicron variants                                        </a>
                                                                    </td>
                                <td>
                                    2022                                </td>
                                <td>
                                    IF 13.2                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    5                                </td>
                                <td>
                                    Cell Research                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/5、Design-and-development-of-an-oral-remdesivir-derivative-VV116-against-SARS-CoV-2.pdf" target="_blank">
                                            Design and development of an oral remdesivir derivative VV116 against SARS-CoV-2                                        </a>
                                                                    </td>
                                <td>
                                    2021                                </td>
                                <td>
                                    IF 44.1                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    6                                </td>
                                <td>
                                    Acta Pharmacologica Sinica                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/6、Pharmacokinetics-mass-balance-and-metabolism-of-14CTPN171-a-novel-PDE5-inhibitor-in-humans-for-the-treatment-of-pulm.pdf" target="_blank">
                                            Pharmacokinetics, mass balance, and metabolism of [14C]TPN171, a novel PDE5 inhibitor, in humans for the treatment of pulmonary arterial hypertension                                        </a>
                                                                    </td>
                                <td>
                                    2022                                </td>
                                <td>
                                    IF 8.2                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    7                                </td>
                                <td>
                                    Drug Design, Development and Therapy                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/7、A-Phase-I-Study-to-Evaluate-the-Safety-Tolerability-and-Pharmacokinetics-of-TPN171H-a-Novel-Phosphodiesterase-Type-5-In.pdf" target="_blank">
                                            A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TPN171H, a Novel Phosphodiesterase Type 5 Inhibitor, in Healthy Subjects                                        </a>
                                                                    </td>
                                <td>
                                    2021                                </td>
                                <td>
                                    IF 4.8                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    8                                </td>
                                <td>
                                    Journal of Pharmaceutical and Biomedical Analysis                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/8、Liquid-chromatography-tandem-mass-spectrometric-assay-for-TPN171-in-human-plasma.pdf" target="_blank">
                                            Liquid chromatography-tandem mass spectrometric assay for TPN171 in human plasma                                        </a>
                                                                    </td>
                                <td>
                                    2020                                </td>
                                <td>
                                    IF 3.4                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    9                                </td>
                                <td>
                                    Journal of Medicinal Chemistry                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/9、Pharmacokinetic-Driven-Optimization-of-43H-Pyrimidinones-as-Phosphodiesterase-Type-5-Inhibitors-Leading-to-TPN171-a-Cli.pdf" target="_blank">
                                            Pharmacokinetics-Driven Optimization of 4(3 H)-Pyrimidinones as Phosphodiesterase Type 5 Inhibitors Leading to TPN171, a Clinical Candidate for the Treatment of Pulmonary Arterial Hypertension                                        </a>
                                                                    </td>
                                <td>
                                    2019                                </td>
                                <td>
                                    IF 7.3                                </td>
                            </tr>
                                                    <tr>
                                <td>
                                    10                                </td>
                                <td>
                                    Journal of Pharmaceutical and Biomedical Analysis                                </td>
                                <td class="!text-left">
                                                                            <a class="link" href="http://www.vigonvita.cn/wp-content/uploads/2024/11/10、Characterization-of-TPN171-metabolism-in-humans-via-ultra-performance-liquid-chromatographyquadrupole-time-of-flight-mas-1.docx" target="_blank">
                                            Characterization of TPN171 metabolism in humans via ultra-performance liquid chromatography/quadrupole time-of-flight mass spectrometry                                        </a>
                                                                    </td>
                                <td>
                                    2019                                </td>
                                <td>
                                    IF 3.4                                </td>
                            </tr>
                                            </tbody>
                </table>
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