CINXE.COM
Sciinov Group
<!DOCTYPE html> <html lang="en"> <meta http-equiv="content-type" content="text/html;charset=utf-8" /> <head> <meta charset="UTF-8"> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <meta http-equiv="X-UA-Compatible" content="ie=edge"> <title>Sciinov Group</title> <link rel="apple-touch-icon" sizes="180x180" href="assets/images/favicon/apple-touch-icon.png"> <link rel="icon" type="image/png" sizes="32x32" href="assets/images/favicon/favicon-32x32.png"> <link rel="icon" type="image/png" sizes="16x16" href="assets/images/favicon/favicon-16x16.png"> <link rel="manifest" href="assets/images/favicon/site.webmanifest"> <!-- For Window Tab Color --> <!-- Chrome, Firefox OS and Opera --> <meta name="theme-color" content="#cd2828"> <!-- Windows Phone --> <meta name="msapplication-navbutton-color" content="#cd2828"> <!-- iOS Safari --> <meta name="apple-mobile-web-app-status-bar-style" content="#cd2828"> <link href="https://fonts.googleapis.com/css?family=Arimo:400,400i,700,700i%7CMerriweather:400i&display=swap" rel="stylesheet"> <!-- plugins styles --> <link rel="stylesheet" href="assets/css/animate.css"> <link rel="stylesheet" href="assets/css/bootstrap.min.css"> <link rel="stylesheet" href="assets/css/bootstrap-datepicker.min.css"> <link rel="stylesheet" href="assets/css/bootstrap-select.min.css"> <link rel="stylesheet" href="assets/css/hover-min.css"> <link rel="stylesheet" href="assets/css/magnific-popup.css"> <link rel="stylesheet" href="assets/css/owl.carousel.min.css"> <link rel="stylesheet" href="assets/css/owl.theme.default.min.css"> <link rel="stylesheet" href="assets/css/nouislider.css"> <link rel="stylesheet" href="assets/css/nouislider.pips.css"> <link rel="stylesheet" href="assets/css/jquery.bootstrap-touchspin.min.css"> <link rel="stylesheet" href="assets/css/jquery.mCustomScrollbar.min.css"> <!-- icon styles --> <link rel="stylesheet" type="text/css" href="assets/css/politaro-icons.css"> <link rel="stylesheet" type="text/css" href="assets/css/simple-line-icons.css"> <link rel="stylesheet" type="text/css" href="assets/css/fontawesome-all.min.css"> <!-- main styles --> <link rel="stylesheet" href="assets/css/style.css"> <link rel="stylesheet" href="assets/css/responsive.css"> </head> <body> <div class="preloader" style="background-image: url(assets/images/resources/preloader.svg);"></div><!-- /.preloader --> <div class="page-wrapper"> <div class="site-header__header-one-wrapper"> <header class="site-header site-header__header-one "> <nav class="navbar navbar-expand-lg navbar-light header-navigation stricky"> <div class="container clearfix"> <!-- Brand and toggle get grouped for better mobile display --> <div class="logo-box"> <a class="navbar-brand" href="index.php"> <img src="https://sciinovgroup.com/uploads/images/11640844025.png" class="main-logo" alt="Awesome Image" /> </a> <button class="menu-toggler side-menu__toggler"> <span class="fa fa-bars"></span> </button> </div><!-- /.logo-box --> <!-- Collect the nav links, forms, and other content for toggling --> <div class="main-navigation main-nav__main-navigation"> <ul class=" navigation-box " id="mainNav"> <li class=" dropdown"><a href="index.php">HOME</a></li><!--current--> <li><a href="#about" class="">ABOUT US</a></li> <li><a href="#divisions">DIVISIONS </a> <ul> <li><a href="https://caucuscentric.com/" target="_blank">Caucus Centric </a></li> <li><a href="https://siconnects.com/" target="_blank">Siconnects </a></li> <li><a href="https://insights.sciinovgroup.com/" target="_blank">Sciinov Insights </a></li> <li><a href="https://tech.sciinovgroup.com/" target="_blank">SciTechnologies </a></li> <li><a href="https://sciinovhr.com/" target="_blank">SciinovHR Solutions </a></li> <li><a href="https://www.sciinovhealthcare.com/" target="_blank">Sciinov Healthcare </a></li> </ul> </li> <li><a href="#contact">REQUEST INFO</a></li> </ul> </div><!-- /.navbar-collapse --> <div class="right-side-box"> <a href="contact.php" class="thm-btn header-donation__btn">Get in Touch</a> </div><!-- /.right-side-box --> </div> <!-- /.container --> </nav> </header><!-- /.site-header --> </div> <section class="inner-banner" style="background-image: url(assets/images/backgrounds/inner-banner-about-bg.jpg);"> <div class="container text-center"> <h2 class="inner-banner__title">News and Announcements</h2><!-- /.inner-banner__title --> <ul class="list-unstyled thm-breadcrumb"> <li><a href="index.php">Home</a></li> <li>News and Announcements</li> </ul><!-- /.thm-breadcrumb --> </div><!-- /.container --> </section><!-- /.inner-banner --> <section class="about-three mt-5 pt-4 pb-2" > <div class="container "> <div class="row"> <div class="col-lg-12 shadow-lg mb-5"> <div class="about-three__content"> <div class="block-title text-left" style="margin-bottom: 5px;margin-top: 20px;"> <div class="blog-one__single"> <h3><a >BeiGene Announces China NMPA Approval of BRUKINSA (Zanubrutinib) for the Treatment of Patients with Relapsed or Refractory Waldenstrom Macroglobulinemia</a></h3> <ul class="list-unstyled blog-one__meta"> <li> <a ><i class="far fa-calendar"></i>06/21/2021</a> </li> </ul><!-- /.list-unstyled --> </div><!-- /.blog-one__single --> </div><!-- /.block-title --> <div class="about-three__text"> <p>BeiGene,Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA in October 2020.</p> <p>With NMPA approval for BRUKINSA, our next generation BTK inhibitor, we are proud to be able to offer patients, their families, and physicians a new option for treating WM, an incurable disease that can cause significant morbidities” said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “This marks BRUKINSA’s third approval for the treatment of B-cell malignancies in China, and we believe it may serve an important role in addressing unmet needs for patients with blood cancers around the world.”</p> <p>WM often impacts older adults, and tolerability is a particular concern for these patients as longer duration of treatment has the potential to improve outcomes,” said Lugui Qiu, M.D., Professor, Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and a clinical trial leading principal investigator of BRUKINSA. “As shown in the trial, patients in China will now have access to an innovative treatment that offers cardiovascular safety advantages and deep and durable responses.”</p> <p>“BRUKINSA was specifically designed by BeiGene scientists to limit off-target effects seen with first-generation BTK inhibitors and we have built a broad clinical development program to assess clinical benefit, including the head-to-head ASPEN trial,” said Jane Huang, M.D., Chief Medical Officer, Hematology, BeiGene. “We are grateful to all of the patients and clinicians who participated in the trial and hope to increase access for additional people impacted by WM and other hematologic malignancies as we advance global registration for BRUKINSA.”</p> <p>The conditional approval granted by the NMPA was based on findings from a single-arm pivotal Phase 2 trial (NCT03332173) in China evaluating the safety and efficacy of BRUKINSA in patients with WM who have received at least one prior therapy. With a median study follow-up time of 14.9 months, the primary endpoint of major response rate (MRR) as assessed by independent review committee (IRC) was 72.1% (95% CI: 56.3, 84.7); MRR is defined as the combined rate of complete responses, very good partial responses, and partial responses. The adverse reaction profile was generally consistent with previous findings.</p> <p>The recommended total daily dose of BRUKINSA for WM in China is 320mg.</p> </div><!-- /.about-three__text --> </div><!-- /.about-three__content --> </div><!-- /.col-lg-6 --> </div><!-- /.row --> </div><!-- /.container --> </section><!-- /.about-three --> <section class="mailchimp-one " id="contact"> <div class=" text-center"> <div class="inner-container wow fadeInUp" data-wow-duration="1500ms" style=" padding-bottom: 24px;"> <div class="row justify-content-center"> <div class="col-md-9"> <div class="mailchimp-one__block-title"> <h3>Have a business Query? Let's Talk.</h3> <p class="mt-3">Email : info@sciinovgroup.com or Call : USA: +1 732 526 1166 <br> India: +91 7997224449</p> </div><!-- /.mailchimp-one__block-title --> <div class="cta-one" style="padding-bottom: 0;"> <div class="inner-container wow fadeInUp" style="background-color: #114f9a;padding-top: 20px;padding-bottom: 30px;"> <div class="cta-one__content"> <p>Get The Latest Updates</p> <h3><span>Signup For Newsletter</span></h3> </div><!-- /.cta-one__content --> <div class="cta-one__btn-block"> <form action="" method="post" class=""> <input type="email" required placeholder="Enter Your Email...." name="email" style="margin-left: -37px;"> <button type="submit" name="sbmt" value="submit" class="thm-btn">subscribe</button> </form> </div><!-- /.cta-one__btn-block --> </div> </div> </div><!-- /.inner-container --> <div class="mc-form__response"></div><!-- /.mc-form__response --> </div><!-- /.container --> </div> </div> </section><!-- /.mailchimp-one --> <section class="site-footer__wrapper "> <div class="site-footer__upper"> <div class="container"> <div class="site-footer__logo"> <a href="index.php"><img src="https://sciinovgroup.com/uploads/images/11640844025.png" alt="Awesome Image" /></a> </div><!-- /.site-footer__logo --> <div class="site-footer__counter"> <div class="site-footer__counter-single"> <p><a href="https://sciinovgroup.com/about.php">About Us</a></p> </div><!-- /.site-footer__counter-single --> <div class="site-footer__counter-single"> <p><a href="https://sciinovgroup.com/contact.php">Contact Us</a></p> </div><!-- /.site-footer__counter-single --> <div class="site-footer__counter-single"> <p><a href="https://sciinovgroup.com/privacy-policies.php">Privacy Policy</a></p> </div><!-- /.site-footer__counter-single --> <div class="site-footer__counter-single"> <p><a href="https://sciinovgroup.com/terms-conditions.php">Terms and Conditions</a></p> </div><!-- /.site-footer__counter-single --> <div class="site-footer__counter-single"> <p><a href="https://sciinovgroup.com/refund-policy.php">Refund Policy</a></p> </div><!-- /.site-footer__counter-single --> </div><!-- /.site-footer__counter --> </div><!-- /.container --> </div><!-- /.site-footer__upper --> <footer class="site-footer"> <div class="container"> <div class="row no-gutters"> <footer class="row grid"> <div class="col-md-12"> <div class="copyright"> <div> </div> <address> <p>All divisions owned by Sciinov Group.<br /> <strong>Asia-Pacific:</strong> 234C, 8th Street, Western Hills, KPHB, Hyderabad</p> </address> </div> </div> </footer> </div><!-- /.row --> </div><!-- /.container --> </footer><!-- /.site-footer --> <div class="site-footer__bottom"> <div class="container "> <div class="row "> <div class="col-sm-6"> <p>© 2021 <a href="#">Sciinov Group</a>. All rights reserved.</p> </div> <div class="col-sm-6"> <div class="footer-widget__social"> <a href="https://twitter.com/gender_congress" target="_blank"><i class="fab fa-twitter"></i></a> <a href="https://www.facebook.com/Sciinov/" target="_blank"><i class="fab fa-facebook"></i></a> <a href="https://www.linkedin.com/company/sciinovgroup/" target="_blank"><i class="fab fa-linkedin"></i></a> </div> </div> </div> </div><!-- /.container --> </div><!-- /.site-footer__bottom --> </section><!-- /.site-footer__wrapper --> <script src='https://www.google.com/recaptcha/api.js'></script> </div><!-- /.page-wrapper --> <div class="side-menu__block"> <a href="#" class="side-menu__toggler side-menu__close-btn"> <i class="fa fa-times"></i> </a> <div class="side-menu__block-overlay custom-cursor__overlay"> <div class="cursor"></div> <div class="cursor-follower"></div> </div><!-- /.side-menu__block-overlay --> <div class="side-menu__block-inner "> <a href="index.php" class="side-menu__logo"><img src="https://sciinovgroup.com/uploads/images/11640844025.png" alt="Awesome Image" /></a> <nav class="mobile-nav__container"> <!-- content is loading via js --> </nav> <p class="side-menu__block__copy">(c) 2021 <a href="#" class="text-uppercase">Sciinov Group</a> - All rights reserved.</p> <div class="side-menu__social"> <!-- only fontawesome's brand icon --> <a href="#"><i class="fa fa-facebook-f"></i></a> <a href="#"><i class="fa fa-linkedin-in"></i></a> <a href="#"><i class="fa fa-twitter"></i></a> <a href="#"><i class="fa fa-instagram"></i></a> <a href="#"><i class="fa fa-pinterest-p"></i></a> </div> </div><!-- /.side-menu__block-inner --> </div><!-- /.side-menu__block --> <a href="#" data-target="html" class="scroll-to-target scroll-to-top"><i class="fa fa-angle-up"></i></a> <script src="assets/js/jquery.min.js"></script> <script src="assets/js/bootstrap.bundle.min.js"></script> <script src="assets/js/bootstrap-datepicker.min.js"></script> <script src="assets/js/bootstrap-select.min.js"></script> <script> // Cache selectors var lastId, topMenu = $("#mainNav"), topMenuHeight = topMenu.outerHeight()+1, // All list items menuItems = topMenu.find("a"), // Anchors corresponding to menu items scrollItems = menuItems.map(function(){ var item = $($(this).attr("href")); if (item.length) { return item; } }); // Bind click handler to menu items // so we can get a fancy scroll animation menuItems.click(function(e){ var href = $(this).attr("href"), offsetTop = href === "#" ? 0 : $(href).offset().top-topMenuHeight+1; $('html, body').stop().animate({ scrollTop: offsetTop // scrollTop: $($(this).attr('href')).offset().top - 150 }, 850); e.preventDefault(); }); // Bind to scroll $(window).scroll(function(){ // Get container scroll position var fromTop = $(this).scrollTop()+topMenuHeight; // Get id of current scroll item var cur = scrollItems.map(function(){ if ($(this).offset().top < fromTop) return this; }); // Get the id of the current element cur = cur[cur.length-1]; var id = cur && cur.length ? cur[0].id : ""; if (lastId !== id) { lastId = id; // Set/remove active class menuItems .parent().removeClass("active") .end().filter("[href=#"+id+"]").parent().addClass("active"); } }); </script> <script src="assets/js/isotope.js"></script> <script src="assets/js/jquery.counterup.min.js"></script> <script src="assets/js/jquery.magnific-popup.min.js"></script> <script src="assets/js/jquery.validate.min.js"></script> <script src="assets/js/owl.carousel.min.js"></script> <script src="assets/js/TweenMax.min.js"></script> <script src="assets/js/jquery.enllax.min.js"></script> <script src="assets/js/waypoints.min.js"></script> <script src="assets/js/wow.min.js"></script> <script src="assets/js/jquery.mCustomScrollbar.concat.min.js"></script> <script src="assets/js/circle-progress.min.js"></script> <script src="assets/js/countdown.min.js"></script> <script src="assets/js/jquery.ajaxchimp.min.js"></script> <script src="assets/js/nouislider.js"></script> <script src="assets/js/jquery.bootstrap-touchspin.min.js"></script> <script src="assets/js/theme.js"></script> <script> $(document).ready(function(){ $('.myslider').owlCarousel({ items:1, nav: true, dots: true, dotsData: true, }); }); </script> </body> </html>