{"id":12278,"date":"2024-11-11T23:01:11","date_gmt":"2024-11-11T16:01:11","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=12278"},"modified":"2024-11-11T23:01:11","modified_gmt":"2024-11-11T16:01:11","slug":"obesityweek%ef%b8%8f-2024-gan-lee-pharmaceuticals-orally-presents-phase-2b-clinical-data-for-gzr18-injection-in-chinese-overweight-and-obese-adults","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=12278","title":{"rendered":"ObesityWeek\u00ae\ufe0f 2024 | Gan & Lee Pharmaceuticals Orally Presents Phase 2b Clinical Data for GZR18 Injection in Chinese Overweight and Obese Adults"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n
  • Obese or overweight participants receiving bi-weekly doses of 12 mg, 18 mg, 24 mg, 48 mg, and once-weekly dose of 24 mg GZR18 for 30 weeks achieved mean percent changes in body weight from baseline of -11.15%, -13.22%, -14.25%, -17.29%, and -17.78%, respectively, with the placebo group at -0.99%; and at 30 weeks, participants’ body weight continued to decrease.<\/i><\/li>\n
  • The clinical efficacy and safety of bi-weekly 48 mg and once-weekly 24 mg GZR18 injections were comparable, with no significant difference in mean percent change in body weight from baseline between the two groups (one-sided test, P > 0.025).<\/i><\/li>\n
  • GZR18 injections were safe and well tolerated, with the most commonly reported adverse events being gastrointestinal reactions, comparable to similar drugs.<\/i><\/li>\n<\/ul>\n

    BEIJING<\/span><\/span>, Nov. 11, 2024<\/span><\/span> \/PRNewswire\/ — Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the results of the Phase 2b<\/span> clinical study of GZR18 injection, a bi-weekly (twice a month) glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by the company, in adult overweight\/obese patients in China<\/span> were presented as an oral presentation at ObesityWeek\u00ae\ufe0f<\/sup> 2024.<\/p>\n

    \n<\/div>\n

    Statement:<\/i><\/b><\/p>\n

      \n
    1. GZR18 is an investigational drug and is not approved for use in any country.<\/i><\/li>\n
    2. Gan & Lee Pharmaceuticals does not endorse the use of any unapproved drug or indication.<\/i><\/li>\n<\/ol>\n

      The Phase 2b<\/span> clinical trial (CTR20231695) was a multicenter, randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy and safety of bi-weekly (Q2W) and once-weekly (QW) dosing regimens of GZR18 injection. The study enrolled a total of 340 participants, all of whom were obese (BMI\u226528 kg\/m\u00b2) or overweight (BMI\u226524 kg\/m\u00b2) with at least one weight-related comorbidity and whose weight was poorly controlled by diet and exercise. Participants were randomly assigned to receive 12 mg (n=52), 18 mg (n=53), 24 mg (n=52), 48 mg (n=64) GZR18 injections bi-weekly, or 24 mg (n=53) once-weekly GZR18 injection, or placebo (n=66) for 30 weeks (including a dose escalation period). The primary efficacy endpoint was the percentage change in body weight from baseline after 30 weeks of treatment.<\/p>\n

      The study results showed a significant reduction in body weight from baseline at week 30 in participants receiving different doses and dosing frequencies of GZR18 injection, with weight loss not yet reaching a plateau<\/b>. In the Q2W GZR18 dose groups, participants experienced dose-dependent weight loss: 11.15% (1.04) in the 12 mg group, 13.22% (0.95) in the 18 mg group, 14.25% (1.01) in the 24 mg group, and 17.29% (0.99) in the 48 mg group. In the QW 24 mg group, participants experienced a weight reduction of 17.78% (1.01), while the placebo group showed only a -0.99% (0.91) change. Moreover, there was no significant difference in efficacy between the 48 mg Q2W and 24 mg QW groups (one-sided test P>0.025). In the 48 mg Q2W GZR18 group, the proportions of participants achieving \u22655%, 10%, and 20% weight loss were 97.8%, 82.2%, and 37.8%, respectively.<\/p>\n

      GZR18 injection was safe and well tolerated, with the most common adverse events being mild to moderate gastrointestinal reactions. No serious adverse events were reported in any treatment group.<\/p>\n

      *Trial data are presented as mean (standard error).<\/i><\/p>\n

      The detailed results of the Phase 2b<\/span> study of GZR18 Injection will be published in a peer-reviewed journal.<\/p>\n

      Dr. Zhong-ru Gan, Chairman of Gan & Lee Pharmaceuticals, commented: <\/b><\/p>\n

      “The results of this Phase 2b<\/span> study further validate the excellent performance of GZR18 injection in weight management, particularly with the bi-weekly dosing regimen, which has shown comparable efficacy to the once-weekly regimen. The bi-weekly formulation of GLP-1 has the potential to enhance patient adherence, thereby improving long-term weight management outcomes. GZR18 injection, as the first single-target GLP-1 biweekly formulation, clinical data has demonstrated weight loss effects comparable to or even better than multi-target GLP-1 once-weekly formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for patients with obesity, and we look forward to further validating these findings in the upcoming Phase 3 clinical trials.”<\/p>\n

      Forward-looking statements<\/b><\/p>\n

      Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.<\/p>\n

      About Gan & Lee<\/b><\/p>\n

      Gan & Lee Pharmaceuticals\u00a0developed the first Chinese domestic insulin analog. Currently, Gan & Lee has\u00a0six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin\u00ae<\/sup>), fast-acting lispro injection (Prandilin\u2122<\/sup>), fast-acting aspart injection (Rapilin\u00ae<\/sup>), mixed protamine zinc lispro injection (25R) (Prandilin\u2122<\/sup>25), aspart 30 injection (Rapilin\u00ae<\/sup>30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin\u00ae<\/sup>30).\u00a0The company\u00a0has two approved medical devices in China<\/span>, namely\u00a0reusable insulin injection pen\u00a0(GanleePen),\u00a0and\u00a0disposable pen needle (GanleeFine\u00ae<\/sup>).<\/p>\n

      In\u00a0China’s\u00a02024 National Insulin-Specific Centralized Procurement,\u00a0Gan & Lee Pharmaceuticals ranked\u00a0first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine\u00ae<\/sup>) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.<\/p>\n

      In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.<\/p>","protected":false},"excerpt":{"rendered":"

      <\/p>\n\n\n\n
      \"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
        \n
      • Obese or overweight participants receiving bi-weekly doses of 12 mg, 18 mg, 24 mg, 48 mg, and once-weekly dose of 24 mg GZR18 for 30 weeks achieved mean percent changes in body weight from baseline of -11.15%, -13.22%, -14.25%, -17.29%, and -17.78%, respectively, with the placebo group at -0.99%; and at 30 weeks, participants’ body weight continued to decrease.<\/i><\/li>\n
      • The clinical efficacy and safety of bi-weekly 48 mg and once-weekly 24 mg GZR18 injections were comparable, with no significant difference in mean percent change in body weight from baseline between the two groups (one-sided test, P > 0.025).<\/i><\/li>\n
      • GZR18 injections were safe and well tolerated, with the most commonly reported adverse events being gastrointestinal reactions, comparable to similar drugs.<\/i><\/li>\n<\/ul>\n

        BEIJING<\/span><\/span>, Nov. 11, 2024<\/span><\/span> \/PRNewswire\/ — Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the results of the Phase 2b<\/span> clinical study of GZR18 injection, a bi-weekly (twice a month) glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by the company, in adult overweight\/obese patients in China<\/span> were presented as an oral presentation at ObesityWeek\u00ae\ufe0f<\/sup> 2024.<\/p>\n

        \n<\/div>\n

        Statement:<\/i><\/b><\/p>\n

          \n
        1. GZR18 is an investigational drug and is not approved for use in any country.<\/i><\/li>\n
        2. Gan & Lee Pharmaceuticals does not endorse the use of any unapproved drug or indication.<\/i><\/li>\n<\/ol>\n

          The Phase 2b<\/span> clinical trial (CTR20231695) was a multicenter, randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy and safety of bi-weekly (Q2W) and once-weekly (QW) dosing regimens of GZR18 injection. The study enrolled a total of 340 participants, all of whom were obese (BMI\u226528 kg\/m\u00b2) or overweight (BMI\u226524 kg\/m\u00b2) with at least one weight-related comorbidity and whose weight was poorly controlled by diet and exercise. Participants were randomly assigned to receive 12 mg (n=52), 18 mg (n=53), 24 mg (n=52), 48 mg (n=64) GZR18 injections bi-weekly, or 24 mg (n=53) once-weekly GZR18 injection, or placebo (n=66) for 30 weeks (including a dose escalation period). The primary efficacy endpoint was the percentage change in body weight from baseline after 30 weeks of treatment.<\/p>\n

          The study results showed a significant reduction in body weight from baseline at week 30 in participants receiving different doses and dosing frequencies of GZR18 injection, with weight loss not yet reaching a plateau<\/b>. In the Q2W GZR18 dose groups, participants experienced dose-dependent weight loss: 11.15% (1.04) in the 12 mg group, 13.22% (0.95) in the 18 mg group, 14.25% (1.01) in the 24 mg group, and 17.29% (0.99) in the 48 mg group. In the QW 24 mg group, participants experienced a weight reduction of 17.78% (1.01), while the placebo group showed only a -0.99% (0.91) change. Moreover, there was no significant difference in efficacy between the 48 mg Q2W and 24 mg QW groups (one-sided test P>0.025). In the 48 mg Q2W GZR18 group, the proportions of participants achieving \u22655%, 10%, and 20% weight loss were 97.8%, 82.2%, and 37.8%, respectively.<\/p>\n

          GZR18 injection was safe and well tolerated, with the most common adverse events being mild to moderate gastrointestinal reactions. No serious adverse events were reported in any treatment group.<\/p>\n

          *Trial data are presented as mean (standard error).<\/i><\/p>\n

          The detailed results of the Phase 2b<\/span> study of GZR18 Injection will be published in a peer-reviewed journal.<\/p>\n

          Dr. Zhong-ru Gan, Chairman of Gan & Lee Pharmaceuticals, commented: <\/b><\/p>\n

          “The results of this Phase 2b<\/span> study further validate the excellent performance of GZR18 injection in weight management, particularly with the bi-weekly dosing regimen, which has shown comparable efficacy to the once-weekly regimen. The bi-weekly formulation of GLP-1 has the potential to enhance patient adherence, thereby improving long-term weight management outcomes. GZR18 injection, as the first single-target GLP-1 biweekly formulation, clinical data has demonstrated weight loss effects comparable to or even better than multi-target GLP-1 once-weekly formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for patients with obesity, and we look forward to further validating these findings in the upcoming Phase 3 clinical trials.”<\/p>\n

          Forward-looking statements<\/b><\/p>\n

          Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.<\/p>\n

          About Gan & Lee<\/b><\/p>\n

          Gan & Lee Pharmaceuticals\u00a0developed the first Chinese domestic insulin analog. Currently, Gan & Lee has\u00a0six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin\u00ae<\/sup>), fast-acting lispro injection (Prandilin\u2122<\/sup>), fast-acting aspart injection (Rapilin\u00ae<\/sup>), mixed protamine zinc lispro injection (25R) (Prandilin\u2122<\/sup>25), aspart 30 injection (Rapilin\u00ae<\/sup>30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin\u00ae<\/sup>30).\u00a0The company\u00a0has two approved medical devices in China<\/span>, namely\u00a0reusable insulin injection pen\u00a0(GanleePen),\u00a0and\u00a0disposable pen needle (GanleeFine\u00ae<\/sup>).<\/p>\n

          In\u00a0China’s\u00a02024 National Insulin-Specific Centralized Procurement,\u00a0Gan & Lee Pharmaceuticals ranked\u00a0first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine\u00ae<\/sup>) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.<\/p>\n

          In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.<\/p>\n

          <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-12278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/12278","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=12278"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/12278\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}