Recombinant insulin glargine(Gan & Lee Pharmaceuticals Co., Ltd.)

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly treatment in patients with type 2 diabetes mellitus (T2DM), with significant HbA1c reductions alongside comprehensive benefits for body weight, blood pressure and blood lipid profiles. In a Phase 2b clinical trial, the bofanglutide injection showed superior HbA1c and body weight reduction than semaglutide (Ozempic®) after 24 weeks of bi-weekly treatment in patients with T2DM, along with an acceptable safety and tolerability profile. In a Phase 2 clinical trial, the once-weekly insulin GZR4 injection demonstrated comparable efficacy and safety profiles in patients with T2DM after 16 weeks of treatment. Notably, GZR4 injection achieved superior HbA1c reduction in patients with inadequate glycemic control on prior basal insulin therapy compared to once-daily insulin degludec (Tresiba®). BEIJING and BRIDGEWATER, N.J., June 21, 2025 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) announced that the company presented multiple Phase 2 clinical study results of ultra-long-acting GLP-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection and once-weekly basal insulin analog GZR4 injection during a poster presentation at the American Diabetes Association (ADA)'s 85th Scientific Sessions. Statement: Bofanglutide injection and GZR4 injection are investigational drugs that have not yet been launched in any country. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. Bofanglutide injection: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bofanglutide (GZR18) Injection in Chinese Patients with Type 2 Diabetes Mellitus (T2DM) In this Phase 2a clinical trial (NCT06256523), 36 adults with T2DM who had inadequate glycemic control through diet and exercise and/or irregular use of antidiabetic medications, were randomized to receive either bofanglutide injection (N=27) or placebo (N=9) once weekly (QW) for 23 weeks, with a dose escalating from 1.5 mg to 13 mg. The key efficacy endpoint was HbA1c change from baseline to week 23. After 23 weeks of treatment, the mean HbA1c change from baseline in the bofanglutide groups was -1.81% compared to 0.12% in the placebo group, with an estimated treatment difference of -1.93% points*. The proportion of participants achieving an HbA1c target of <7.0% and ≤6.5% was 57.7% and 46.2%, respectively, compared to zero in the placebo group. In terms of weight management, participants treated with bofanglutide experienced a mean reduction in body weight of 6.92 kg from baseline, corresponding to a 9.3% decrease, compared to a minimal reduction of 1.2% in the placebo group. Furthermore, bofanglutide showed comprehensive improvements over placebo in multiple metabolic parameters, including fasting plasma glucose (FPG), glycated albumin (GA), waist circumference (WC), blood pressure, and lipid profiles. In terms of safety, bofanglutide was well tolerated in patients with T2DM. Consistent with known GLP-1 RAs, the most common adverse events were gastrointestinal-related, primarily observed during the early dose-escalation period with mostly mild to moderate in severity. No hypoglycemic events or investigational product-related serious adverse events were reported during the study. Bofanglutide injection: A Multicenter, Randomized, Open-label, Active comparator-controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of bofanglutide Injection versus Semaglutide (Ozempic®) in Chinese Patients with T2DM In this Phase 2b clinical trial (NCT06256549), a total of 272 eligible Chinese patients with T2DM, who had inadequate glycemic control either after lifestyle intervention or despite stable use of oral antidiabetic drugs (OADs) for at least 3 months, were randomized to receive bi-weekly (Q2W) 12 mg (N=55), 18 mg (N=54), 24 mg (N=55) bofanglutide injections, or once-weekly (QW) 24 mg (N=54) bofanglutide injections, or 1 mg semaglutide (Ozempic®, N=54) for 24 weeks of treatment, including the dose-escalation period. The primary endpoint was HbA1c change from baseline to week 24. After 24 weeks of treatment, the mean reductions in HbA1c from baseline were 1.87%, 2.28%, and 1.94% in the bofanglutide groups at 12 mg, 18 mg, and 24 mg Q2W, respectively, and -2.32% in the 24 mg QW group. All these treatment regimens showed greater HbA1c reductions compared to the semaglutide group (-1.60%), with the 18 mg Q2W and 24 mg QW bofanglutide groups demonstrating statistically significant superiority (p<0.001)*. Among drug-naïve patients with inadequate glycemic control despite lifestyle interventions, the 18 mg Q2W bofanglutide group achieved a mean HbA1c reduction of 2.98%, which was significantly greater than that observed with semaglutide (-2.04%; p<0.001)*. The proportions of patients achieving HbA1c target of <7.0% were 63.0% to 73.6% in the Q2W bofanglutide group, 75.0% in the QW bofanglutide group, and 70.0% in the semaglutide group. For the HbA1c ≤6.5% target, the corresponding proportions were 58.2% to 67.9%, 69.2%, and 62.0%, respectively. Furthermore, the mean change in body weight for all bofanglutide groups from baseline to week 24 ranged from -4.26 to -6.54 kg, compared to -3.25 kg in the semaglutide group*. Bofanglutide also greatly improved FPG, blood pressure, lipid profiles, and other metabolic parameters. In this study, bofanglutide was generally well tolerated, with safety and tolerability consistent with other known GLP-1 RAs. The most common adverse events were gastrointestinal-related, mostly mild to moderate in severity, and no severe hypoglycemic events were observed. GZR4 injection: A Multicenter, Randomized, Open-label, Active-controlled, Treat-to-target Phase 2 Clinical Study Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin degludec (IDeg, Tresiba®) in Chinese patients with T2DM This Phase 2 clinical study (NCT06202079) enrolled a total of 83 Chinese patients with T2DM who had inadequate glycemic control on OADs (Part A), and 96 patients with inadequate control on OADs combined with basal insulin therapy (Part B). Participants were randomized to receive QW GZR4 injection (Part A: N=42; Part B: N=41) or once-daily IDeg (Tresiba®) injection (Part A: N=48; Part B: N=48) for 16 weeks of treatment. The primary efficacy endpoint was the change in HbA1c from baseline to week 16. After 16 weeks of treatment, in patients from Part A, the mean change in HbA1c was comparable between GZR4 groups and IDeg groups (−1.50% versus -1.48%, p = 0.90). The proportion of participants achieving HbA1c target of <7.0% was 59.5% in the GZR4 group and 70.7% in the IDeg group, while the proportion achieving HbA1c target of ≤6.5% was 38.1% and 29.3%, respectively. In patients from Part B, GZR4 demonstrated significantly greater HbA1c reduction compared to IDeg (-1.26% vs -0.87%; p<0.01), with a higher proportion of patients achieving HbA1c targets of <7.0% and ≤6.5% (52.1% vs 29.2%; 25.0% vs 10.4%). In addition, improvements from baseline in FPG and time in range (TIR) were comparable between the GZR4 group and IDeg group. GZR4 achieved effective glycemic control without the need for a loading dose at the first administration, while the total weekly insulin dosage (mole) for GZR4 was approximately 40–50% of that for IDeg (p<0.001). In terms of safety, the incidence of adverse events was similar between the two groups. No severe hypoglycemic events or investigational product-related serious adverse events were reported during the study. * The clinical data were presented as mean (SE) value. The detailed results of the above Phase 2 clinical study will be published in a peer-reviewed journal. Conclusion and Future Direction The latest clinical results presented at this year's ADA conference highlight Gan & Lee Pharmaceuticals' leading position in the development of long-acting antidiabetic therapies. Building on these positive outcomes, the company will continue to advance the research and development of innovative treatments for diabetes. Currently, Gan & Lee has initiated and is accelerating large-scale Phase 3 clinical programs in China for bofanglutide injection and GZR4 injections for the treatment of type 2 diabetes, aiming to provide more effective treatment options for patients with diabetes. Forward-looking statements 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. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first 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®) 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. 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. SOURCE Gan & Lee Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

4月30日，通化东宝发布财报显示：2024年公司实现营业收入20.09亿元，相比于去年同期减少34.66%。利润总额亏损约1.43亿元，相比去年同期减少110.52%。这是通化东宝近十多年来首次亏损。2023年通化东宝的净利润还超过11亿元。让投资者气愤的是，在年报发布前通化东宝曾两次修正2024年度经营业绩预告，都没提到要亏损。1月20日，通化东宝第一次发业绩预告，表示去年净利润大幅下降，但公司依然处于盈利状态；而2月27日、4月27日，通化东宝两次发布修正公告，最终向外界坦诚：去年亏损。通化东宝亏损的原因其实很简单，去年，新一轮胰岛素集采在全国开展，通化东宝的产品降价降猛了，同时还要对渠道和库存商品调价，所以销售额和利润双双下降。这一情况甘李药业也遇到过，不过甘李已经挺过来了。2024年，甘李药业交出了一份不错的答卷：全年营业收入30.45亿元，同比增长16.77%；归属于母公司所有者的净利润6.15亿元，同比增长80.75%。通化东宝也必须承受阵痛的过程，只是痛过之后，也能像甘李药业那样很快复苏吗？错押“二代胰岛素”通化东宝最核心的产品是胰岛素，而且之前一直以二代胰岛素见长。2021年，国家第一轮胰岛素集采时，通化东宝的三代胰岛素还没成气候，报价较高，最终未获得最大的市场份额。当时甘李药业三代胰岛素大幅降价60%以上，进入集采范围，开始向下挤占二代胰岛素的市场。其核心产品甘精胰岛素注射液报出了每支48.71元的低价。集采政策实施两年之后，情况果然如甘李料想的那样，中国胰岛素临床使用发生变化：三代胰岛素的需求量占比已达70%，较集采之前增长36%。这从一个侧面说明，集采让高价药品平价化，吸引了更多患者的使用。2022年至2024年，甘李药业的营收从17.12亿元，跃升至30.45亿元，享受到改革的政策红利。但是，通化东宝就不同了，替代效应逼迫二代胰岛素加快退出市场，再如何守也是守不住了，通化东宝业绩遭遇重挫。“输在起跑线上”的通化东宝只能积极应对，在新一轮的集采调整策略。根据年报显示：在2024年胰岛素专项集采接续工作中，公司采取了以价换量策略，全线产品平均降价15%，以A类或A1类中选。2024下半年，集采接续工作全国多地实施以来，通化东宝的多款“三代胰岛素”新增准入上千家医院。今年3月，公司在投资者互动平台回应称：虽然2024年业绩受多重因素影响承压，但第三季度起营收已迅速恢复，预计2025年公司持续受益于集采，胰岛素类似物持续放量带来的双重红利，推动公司业绩的进一步恢复与增长。根据通化东宝的财报显示：2025年，公司第一季度营业收入为6.52亿元，同比增长10.17%。抢先开发GLP-1相比于集采策略失误，通化东宝与甘李药业的商标侵权案也令人唏嘘。早在2011年，甘李药业发现通化东宝研发的甘精胰岛素冻干粉针剂的名称为“长舒霖”（甘精胰岛素注射液)，与自研产品“长秀霖”（重组甘精胰岛素注射液）的读音仅一字之差，涉嫌构成侵权，随后向原国家工商行政管理总局商标局、北京知识产权法院和北京高级人民法院等多个部门提起诉讼，均败诉。这起商标官司历经十年之久。2021年1月，甘李药业向江苏省苏州市中级人民法院提起商标侵权及不正当竞争诉讼。2025年2月，江苏省高院终审判决通化东宝败诉，需向甘李药业支付6131.21万元赔偿。终审法院认定通化东宝商标注册存在“恶意”，与甘李药业“长秀霖”构成不正当竞争。此外，2024年的研发项目失利，同样是通化东宝业绩亏损的诱因之一。根据年报显示：通化东宝终止可溶性甘精赖脯双胰岛素注射液的临床研究开发工作，已经资本化的研发费用6455.82万元全部计提资产减值准备，同时对2018年已经支付给法国SA ADOCIA公司的商业化权利款金额2.54亿元确认为损失。这两项损失扣税后造成公司净利润减少2.70亿元。终止研发管线对通化东宝来说并非坏事。可溶性甘精赖脯双胰岛素注射液一旦强行上市，不仅要面临与德谷门冬双胰岛素竞争的局面，日后还要承担集采降价的风险。在及时止损的同时，通化东宝又引进了长效 GLP-1 产品司美格鲁肽注射液，目前已正在中国开展临床Ⅲ期试验。目前，通化东宝在长效GLP-1产品的进度上领先于甘李药业。当前GLP-1产品成为行业研发热点，诺和诺德、礼来、恒瑞、华东医药等多个药企积极布局，这种趋势对传统的胰岛素市场构成了潜在的威胁。通化东宝未来能否依靠三代胰岛素实现替代？依托集采获得的4500万支协议量能否实现渠道转化？一切有待时间来验证。撰稿｜小米编辑｜江芸 贾亭运营｜李木子插图｜视觉中国声明：健识局原创内容，未经许可请勿转载“近视神药”的销售，搞砸了！教科书级破局！艾伯维免疫业务狂飙16.6%，翻篇专利悬崖重塑增长逻辑新事 | 76亿元的交易黄了