作者: Yamashiro, Aoi ; Tanoue, Keiko ; Oshima, Naoki ; Uto, Asuka ; Sato, Hiroki ; Matsubara, Hidehito ; Kumagai, Hiroo ; Imakiire, Toshihiko ; Onimaru, Hiroshi ; Fukunaga, Tsugumi ; Goto, Hiroyasu

Hypertension is well-known to often coexist with diabetes mellitus (DM) in humans. Treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors has been shown to decrease both the blood glucose and the blood pressure (BP) in such patients. Some reports show that SGLT2 inhibitors improve the BP by decreasing the activities of the sympathetic nervous system. Therefore, we hypothesized that SGLT2 inhibitors might alleviate hypertension via attenuating sympathetic nervous activity. Combined SGLT2/SGLT1 inhibitor therapy is also reported as being rather effective for decreasing the BP. In this study, we examined the effects of SGLT2 and SGLT1 inhibitors on the bulbospinal neurons of the rostral ventrolateral medulla (RVLM). To investigate whether bulbospinal RVLM neurons are sensitive to SGLT2 and SGLT1 inhibitors, we examined the changes in the neuronal membrane potentials (MPs) of these neurons using the whole-cell patch-clamp technique during superfusion of the cells with the SGLT2 and SGLT1 inhibitors. A brainstem-spinal cord preparation was used for the experiments. Our results showed that superfusion of the RVLM neurons with SGLT2 and SGLT1 inhibitor solutions induced hyperpolarization of the neurons. Histological examination revealed the presence of SGLT2s and SGLT1s in the RVLM neurons, and also colocalization of SGLT2s with SGLT1s. These results suggest the involvement of SGLT2s and SGLT1s in regulating the activities of the RVLM neurons, so that SGLT2 and SGLT1 inhibitors may inactivate the RVLM neurons hyperpolarized by empagliflozin. SGLT2 and SGLT1 inhibitors suppressed the activities of the bulbospinal RVLM neurons in the brainstem-spinal preparations, suggesting the possibilities of lowering BP by decreasing the sympathetic nerve activities. RVLM, rostral ventrolateral medulla. IML, intralateral cell column. aCSF, artificial cerebrospinal fluid.

2023-03-01·Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis4区 · 医学

Dual SGLT1/SGLT2 inhibitor phlorizin reduces glucose transport in experimental peritoneal dialysis

4区 · 医学

Article

作者: Bergling, Karin ; Martus, Giedre ; Öberg, Carl M

Introduction: Glucose absorption during peritoneal dialysis (PD) is commonly assumed to occur via paracellular pathways. We recently showed that SGLT2 inhibition did not reduce glucose absorption in experimental PD, but the potential role of glucose transport into cells is still unclear. Here we sought to elucidate the effects of phlorizin, a non-selective competitive inhibitor of sodium glucose co-transporters 1 and 2 (SGLT1 and SGLT2), in an experimental rat model of PD. Methods: A 120-min PD dwell was performed in 12 anesthetised Sprague-Dawley rats using 1.5% glucose fluid with a fill volume of 20 mL with ( n = 6) or without ( n = 6) intraperitoneal phlorizin (50 mg/L). Several parameters for peritoneal water and solute transport were monitored during the treatment. Results: Phlorizin markedly increased the urinary excretion of glucose, lowered plasma glucose and increased plasma creatinine after PD. Median glucose diffusion capacity at 60 min was significantly lower ( p < 0.05) being 196 µL/min (IQR 178–213) for phlorizin-treated animals compared to 238 µL/min (IQR 233–268) in controls. Median fractional dialysate glucose concentration at 60 min ( D/ D 0) was significantly higher ( p < 0.05) in phlorizin-treated animals being 0.65 (IQR 0.63–0.67) compared to 0.61 (IQR 0.60–0.62) in controls. At 120 min, there was no difference in solute or water transport across the peritoneal membrane. Conclusion: Our findings indicate that a part of glucose absorption during the initial part of the dwell occurs via transport into peritoneal cells.

2022-12-23·Medicine

Clinical efficacy of SGLT2 inhibitors with different SGLT1/SGLT2 selectivity in cardiovascular outcomes among patients with and without heart failure: A systematic review and meta-analysis of randomized trials

Review

作者: Tang, Hsin-Ju ; Lin, Yu-Min ; Liao, Chia-Te ; Lee, Mei-Chuan ; Yang, Chun-Ting ; Chang, Hung-Yu ; Chang, Wei-Ting ; Siong Toh, Han ; Kuo, Fang-Hsiu ; Chen, Sih-Yao ; Hua, Yi-Ming

Background:Some sodium-glucose co-transporter-2 (SGLT2) inhibitors showed benefits on heart failure (HF), but different SGLT2/SGLT1 selectivity might influence the treatment effect. This study aimed to meta-analyze the treatment effects of SGLT2 inhibitors and the diversity of receptor selectivity for patients with and without HF.Methods:Randomized controlled trials were searched in PubMed, Embase, Cochrane databases and ClinicalTrials.gov registry from inception to October 2020. The interest outcomes were analyzed with random-effects models and presented with a risk ratio (RR) and 95% confidence interval (CI). Subgroup analyses examined the treatment effects among SGLT2 inhibitors with different SGLT2/SGLT1 selectivity.Results:The final analyses included 10 trials and 52,607 patients. The RR of total cardiovascular (CV) death or hospitalization for HF (HHF) between SGLT2 inhibitors and placebo was 0.79 (95% CI 0.74–0.84, I2 = 31%). With SGLT2 inhibitors, HF patients had reduced mortality risks (RR 0.89, 95% CI 0.80–0.99, I2 = 0), and non-HF patients had lower risks of major adverse CV events (RR 0.92, 95% CI 0.85–0.99, I2 = 0). The risk reduction of HHF was consistent in groups of HF (RR 0.72, 95% CI 0.64–0.80, I2 = 8%) and non-HF (RR 0.74, 95% CI 0.61–0.89, I2 = 0), but the effect of the low SGLT2/SGLT1 selectivity inhibitor was insignificant in non-HF patients.Conclusion:The efficacy of SGLT2 inhibitors on risk reduction of total CV death or HHF is consistent with the previous studies. The regimen is beneficial for reducing mortality in patients with HF and major adverse CV events in those without HF. Different SGLT2/SGLT1 selectivity may differ in the treatment effects in patients with and without HF.

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项与三靶点抑制剂 (通化东宝) 相关的新闻（医药）

2024-09-29

·微信

2024 CSCO | 先声再明科赛拉®、恩维达®、苏维西塔单抗等最新研究发表

第27届全国临床肿瘤学大会暨2024年CSCO学术年会于2024年9月25日至29日在厦门国际会议中心举办。先声再明的产品组合中，科赛拉®（注射用盐酸曲拉西利）、恩维达®（恩沃利单抗注射液）、恩度®（重组人血管内皮抑制素注射液）、苏维西塔单抗等创新药的临床研究共有9项成果在CSCO年会发表。本次再明产品相关研究发布形式含2项口头报告，4项壁报和3项摘要。其中，苏维西塔单抗的相关研究荣获第27届全国临床肿瘤学大会暨2024年CSCO学术年会优秀论文奖。相关数据为化疗引起骨髓抑制的预防，以及卵巢癌、恶性浆液性积液、肺癌的临床治疗带来新的启示。科赛拉® 口头报告：标题：在接受化疗的中国广泛期小细胞肺癌（ES-SCLC）患者中预防性使用曲拉西利的疗效和安全性：一项多中心、单臂、非干预性真实世界研究第一作者：柳影/吉林省肿瘤医院论文序号：19329 化疗是广泛期小细胞肺癌（ES-SCLC）等恶性肿瘤的基础治疗方案，但化疗导致的骨髓抑制（CIM）会严重影响患者用药依从性和预后。曲拉西利的出现，为 ES-SCLC 和多种常见实体瘤患者的骨髓保护提供了全新的治疗可能性。曲拉西利是一款短效、高选择性、可逆的细胞周期蛋白依赖性激酶（CDK）4/6 抑制剂，化疗前使用曲拉西利可使造血干/祖细胞短暂阻滞在 G1 期，使其免受化疗损伤，保护全系骨髓造血功能。 9月28日，吉林省肿瘤医院张良教授代表研究团队报告了一项评估在接受化疗的中国广泛期小细胞肺癌（ES-SCLC）患者中预防性使用曲拉西利的疗效和安全性的多中心、单臂、非干预性真实世界研究结果。研究共纳入在我国 35 个中心 153 例 ES-SCLC 患者，患者在每次化疗前 4 小时内，以 240 mg/m2 剂量完成曲拉西利静脉输注。研究结果显示，在使用曲拉西利后的首个治疗周期，严重中性粒细胞减少（SN）发生率为 0.8%（1/132），3/4 级血液学毒性发生率为 5.3%（7/132）；在使用曲拉西利后的所有治疗周期，SN 发生率为 3.0%（4/132），3/4 级血液学毒性发生率为 15.2%（20/132）。经中位时间 12.3 个月的随访（n=40），患者中位缓解持续时间（DoR）为 9.1 个月（95%CI 9.1-NA），疾病控制率（DCR）为90.0%；中位无进展生存期（PFS）为 8.1 个月（95%CI 8.1-NA），中位总生存期（OS）未达到（95%CI 9.1-NA）。可见，预防性使用曲拉西利在实现骨髓保护作用的同时，潜在可提高化疗抗肿瘤疗效。壁报交流：标题：曲拉西利预防晚期非小细胞肺癌化疗所致骨髓抑制的前瞻性、单臂、多中心II期临床研究第一作者：刘杰/河南省肿瘤医院论文序号：18658 曲拉西利在晚期非小细胞肺癌患者化疗前应用显示出初步的骨髓保护疗效，降低了骨髓抑制相关指标的发生率，且未影响抗肿瘤疗效。普通摘要：标题：曲拉西利（Trilaciclib）在小细胞肺癌化疗骨髓保护的真实世界研究阶段性分析第一作者：王丽春/大同市第二人民医院论文序号：19070 标题：1例高龄广泛期小细胞肺癌后线治疗联合曲拉西利预防化疗后骨髓抑制第一作者：张芳/空军军医大学西京医院论文序号：19902 苏维西塔单抗口头报告：标题：苏维西塔单抗联合化疗治疗铂类耐药复发性上皮卵巢癌、输卵管癌和原发性腹膜癌的III期SCORES临床研究：亚组分析第一作者：袁光文/中国医学科学院肿瘤医院论文序号：18635（2024年CSCO学术年会优秀论文奖三等奖）卵巢癌当前的主要治疗手段是手术联合含铂化疗±靶向药物维持治疗，但大多数患者会复发并最终进展为铂类耐药。铂耐药复发的卵巢癌患者预后差，且治疗选择有限。先声再明在研抗VEGF的血管靶向新药苏维西塔单抗在铂类耐药复发性卵巢癌治疗III期SCORES临床研究中已达到主要研究终点，并已国家药监局提交了新药上市申请（NDA）。9月27日，中国医学科学院肿瘤医院袁光文教授代表研究团队报告了苏维西塔单抗在SCORES研究中亚组分析最新结果。研究共入组421例患者。苏维西塔单抗联合化疗对比安慰剂联合化疗，盲态独立评审委员会（BIRC）评估的中位无进展生存期（PFS）延长2.76个月（5.49 vs 2.73）。所有预设亚组的无进展生存期（PFS）分析结果试验组均优于对照组，总生存期（OS）数据尚未成熟。其他次要疗效终点，包括研究者评估的PFS、研究者和BIRC评估的疾病控制率（DCR）及缓解持续时间（DOR）等，也呈现了一致的获益趋势。无论既往是否接受过抗血管生成治疗(如贝伐珠单抗)或PARP抑制剂，苏维西塔单抗联合化疗均显著延长患者PFS。恩维达® 壁报交流：标题：Phase II Clinical Study of Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as a First-Line Treatment for Driver Gene-Negative Advanced Non-Small Cell Lung Cancer 恩沃利单抗联合重组人血管内皮抑素和化疗作为一线治疗用于驱动基因阴性晚期非小细胞肺癌的II期临床研究第一作者：苗传望/山东第一医科大学附属肿瘤医院论文序号：17651 标题：全程新辅助治疗联合PD-L1抑制剂治疗pMMR/MSS型局部进展期直肠癌的初步疗效和安全性分析（ESTIMATE）：一项前瞻性、单臂、II期试验第一作者：张旋/北京大学肿瘤医院云南医院论文序号：17612 普通摘要：标题：首个皮下剂型免疫检查点抑制剂——恩沃利单抗治疗晚期肺癌患者的安全性与有效性：一项真实世界研究第一作者：窦梓轩/清华大学论文序号：19099 恩度® 壁报交流：标题：Phase II Clinical Study of Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as a First-Line Treatment for Driver Gene-Negative Advanced Non-Small Cell Lung Cancer 恩沃利单抗联合重组人血管内皮抑制素和化疗作为一线治疗用于驱动基因阴性晚期非小细胞肺癌的II期临床研究第一作者：苗传望/山东第一医科大学附属肿瘤医院论文序号：17651 标题：Intracavitary Infusion of Bevacizumab Versus Recombinant Human Endostatin in the Treatment of Malignant Serous Effusions: Efficacy and Safety 贝伐珠单抗与重组人内皮抑制素腔内输注治疗恶性浆膜腔积液的疗效与安全性比较第一作者：石薇/武汉大学人民医院论文序号：19406 以上研究进展，为相关创新药物的临床使用提供了最新循证医学证据，以帮助临床医生更科学地制定肿瘤治疗方案、改善患者的生活质量和生存预期。我们期待与广大临床医生开展更广泛、更前沿的合作研究，让肿瘤患者早日用上更有效药物。先声再明是先声药业集团旗下专注于抗肿瘤创新药研发、生产和商业化的生物医药公司，2023年起独立运营，致力于以突破性治疗手段, 解决中国乃至全球肿瘤领域巨大的未满足临床需求。再明着力打造高价值创新研发管线，已上市产品组合包含科赛拉®、恩维达®、恩度®、恩立妥®4款创新药，正创造业绩快速增长曲线。再明与全球合作伙伴的协同创新，为临床提供更有效的治疗手段，让更多肿瘤患者再现生机与光明。媒体联络：pr@zaiming.com 编辑 | 李逸玲供稿 | 高加索任冰鑫张佳婧校审 | 陈瑶审核 | 高兴元

CSCO会议临床结果临床申请

2024-08-13

·FiercePharma

Lexicon to lay off 50% of field force as it prioritizes heart failure drug, potential US diabetes launch

Lexicon Pharmaceuticals’ fortunes started to turn last May thanks to an FDA approval for its once-daily pill sotagliflozin in heart failure under the brand name Inpefa. Despite winning an FDA approval in 2023 and gaining clarity in May on the regulatory path forward for its Type 1 diabetes prospect sotagliflozin, Lexicon Pharmaceuticals hasn’t had an easy go of it in recent years.Now, following a strategic review of its commercial and pipeline programs, Lexicon has decided to channel its promotional efforts toward sotagiflozin in heart failure—where the drug is approved in the U.S. as Inpefa—and the molecule’s potential U.S. launch in patients with Type 1 diabetes and chronic kidney disease (CKD) under the market moniker Zynquista.As part of the restructuring initiative, Lexicon will lay off more than 75 staffers, or approximately 50% of its current field force, by the end of September, the company said in a release.All told, the move is expected to yield cost savings of around $40 million for 2025, while also ensuring certain clinical programs remain fully funded, Lexicon explained. “Lexicon entered 2024 with a number of exciting commercial and pipeline opportunities,” CEO Mike Exton, Ph.D., said in a statement. “Over the past few weeks, we have been working on a plan to allocate resources across these opportunities, build on the successes of our capable commercial team and focus on where we have the potential to lead and succeed.”Following an FDA rejection back in 2019, Lexicon recently announced plans to refile its U.S. application this year for Zynquista to help improve glycemic control in adults with Type 1 diabetes and CKD.Elsewhere, the company plans to “fully” invest in R&D programs, including for sotagliflozin in hypertrophic cardiomyopathy, its candidate LX9211 in diabetic neuropathic pain—where the company expects a data readout in the first half of 2025—and investigational new drug-enabling studies of its prospect LX9851 for obesity and weight management.Lexicon’s fortunes started to turn last May, thanks to an FDA approval for Inpefa as a once-daily pill for heart failure. The drug was specifically approved to curb the risk of heart failure in adults who have had the condition or have Type 2 diabetes, CKD and other cardiovascular risk factors.As an SGLT1/SGLT2 inhibitor, Inpefa has shown tantalizing potential to block both SGLT2 in the kidneys and SGLT1 in the intestines.Still, the regulatory path forward for sotagliflozin has been tortuous and filled with potholes.Back in 2019, the drug was rebuffed by the FDA after Lexicon attempted to snare an approval in Type 1 diabetes patients who can’t control their blood sugar with insulin. Lexicon appealed the decision, but the FDA rejected it again in 2020, citing a safety concern.Amid that pair of FDA rejections, sotagliflozin was approved in its diabetes indication as Zynquista in Europe, though, in 2022, Guidehouse Germany—which held Zynquista’s marketing rights in the bloc—withdrew the marketing authorization, saying it did not wish to commercialize the product.Still, Lexicon has held out hope for its medicine in the U.S.In March, after hearing recent regulatory feedback from the FDA, Lexicon said it planned to resubmit Zynqusita in the U.S. by the middle of the year. The company has since done so and received an FDA action date for Zynquista on Dec. 20.Lexicon is angling for an approval that will allow the med to be used as an adjunct to insulin therapy for Type 1 patients with CKD.

上市批准

2024-05-01

·药智网

胰岛素龙头「逆风翻盘」

胰岛素市场风云再起。近日，胰岛素国采接续结果公布，甘李药业全部中标的6个竞标产品均为涨价产品，成为本次集采的最大赢家，股价因此一度涨停。此外，甘李药业2023年归母净利润扭亏为盈，达3.4亿元，2024年一季度实现归母净利润9600.4万元，同比增长95.04%。胰岛素另一龙头通化东宝2023年业绩亦实现反转。继糖尿病领域后，国内两大胰岛素巨头将如何续写“新故事”？01胰岛素集采风向转变往年集采降价成风潮，但今年不一样。从上海阳光医药采购网在4月23日公示的全国药品集中采购（胰岛素专项接续）拟中选结果看，整体呈现出不一样的面貌。本次胰岛素专项接续共有13家企业携53个产品参与，最终有49个产品中选，中选率达到92%，整体看集采力度相对温和，价格相较首轮集采降幅为3.8%。但如果具体看各企业的中标价，则呈现“有升、有降”的情况。这跟以往集采后价格只会持续下降的情形有很大不同。之所以有此变化，一是因为首轮集采已挤出虚高空间、形成较为合理的价格，二是为了平衡采购量和价格，各企业选择了不同的打法。例如，甘李药业、礼来在首次集采中采取了“激进”的报价策略，因而在本次接续采购中将报价“上调”；反过来，在此前采取“保守”报价策略的通化东宝、联邦制药，此次则选择将报价“下调”。从中选情况看，甘李药业申报续约的6个竞标产品均全线涨价且全部中标，由此引发股价涨停；通化东宝的6个竞标产品也全部中标，其中5个产品的中标价相较上次集采均有所降低。图片来源：国金证券研报中选结果显示，国产企业多中标A类，外资企业大多中标B类或C类，反映出不同的策略：国产企业倾向“以价换量”，而销售能力强的外资企业则重售后服务以保市场。另外，根据集采续约规则，A类中选企业既可获得基础量占相应产品首年采购需求量的80%-100%，还可获得B类、C类企业调出的待分配量，再加上此次国产企业的报量同比大幅增长、外资企业报量出现下滑，国产替代进程将大幅加速。此外，在本次接续采购中，二代胰岛素报量下降、三代胰岛素报量提升，意味着将加速产品升级换代。据统计，本轮胰岛素接续采购报量共约2.41亿支，市场规模达到约115亿元。其中，三代胰岛素报量占比显著提升，从首次国采的58%增至70%，接近欧洲国家用药结构，表明国内胰岛素用药水平在升级。02胰岛素龙头「逆风翻盘」随着国产替代进程加速，甘李药业和通化东宝两大胰岛素龙头打赢了集采“逆风局”。其中，2023年甘李药业成功实现扭亏为盈，归母净利润达到3.4亿元，营业收入同比增长52.31%至26.08亿元。这主要得益于“以价换量”的打法奏效，使得公司产品销量较集采前实现翻倍增长，国内胰岛素制剂产品销量同期增长66.36%，其中基础（长效）胰岛素同比增长32.47%，餐时（速效）和预混胰岛素同比增长112.38%。图片来源：国信证券研报采取稳健经营策略的通化东宝，同样实现业绩的增长和市场份额的提升。2023年，通化东宝实现总营收30.75亿元，同比增长10.69%，扣非归母净利润为11.68亿元，同比增长38.88%。按季度看，2023Q2、2023Q3、2023Q4分别实现归母净利润2.34亿元、2.75亿元、4.08亿元，同比增长-33.30%、25.04%、127.61%。这得益于公司实现胰岛素各系列产品销量达到8322.12万支，同比增长12.84%，而且各系列产品实现全面增长，其中人胰岛素销量保持稳定增长，市场份额超过40%，稳居行业第一；胰岛素类似物延续高速增长态势，实现销量超60%增长，显示出强大的增长韧性。针对胰岛素产品，国产企业还做了深度的布局，其中进行产品迭代升级、研发第四代胰岛素和开拓海外市场是主要亮点。为了巩固国产胰岛素龙头地位，通化东宝布局了多条管线，其中赖脯胰岛素25R和超速效赖脯胰岛素（THDB0206）均已处于Ⅲ期临床阶段，可溶性甘精赖脯双胰岛素（THDB0207）已完成3项关键Ⅰ期试验、德谷胰岛素及注射液已进入临床阶段、德谷胰岛素利拉鲁肽注射液（胰岛素类似物GLP-1RA复方制剂）临床试验申请已获受理。甘李药业的胰岛素管线也颇具看点，其中第四代预混双胰岛素复方制剂GZR101注射液已完成两项I期研究、第四代超长效胰岛素周制剂GZR4注射液已处于II期临床阶段。甘李药业主要研发项目情况图片来源：甘李药业2023年财报在海外市场的布局上，甘李药业的胰岛素产品已在20个海外国家获批，在18个国家形成正式销售，助推2023年国际销售收入达到3.27亿元，同比增加131.78%。而且，甘精、赖脯和门冬胰岛素这三款产品在欧美的上市申请已获得FDA和EMA受理。通化东宝也在加速扩张国际化商业版图，不仅与健友股份合作共同将甘精、门冬、赖脯三种胰岛素产品进军美国市场，人胰岛素注射液的上市申请也已获得欧盟受理，而且还携手科兴制药共同将GLP-1产品利拉鲁肽注射液开拓至17个海外新兴市场。03龙头们的“新故事”有趣的是，两家国产胰岛素龙头的发展战略有着类似之处，即在巩固糖尿病龙头地位的基础上，拓展更多疾病领域，而且“新故事”也颇有看点。为巩固在糖尿病治疗领域的领先地位，通化东宝进行了全面布局，除胰岛素产品外，还涵盖了口服降糖药（DPP-4、SGLT-2）、GLP-1RA、长效GLP-1RA、多靶点一类创新药等多类产品，包括3款创新药（SGLT1/SGLT2/DPP4三靶点抑制剂、GLP-1/GIP双受体激动剂注射用THDBH120、THDBH110/THDBH110胶囊）。其中，SGLT1/SGLT2/DPP4三靶点抑制剂处于临床I期阶段；GLP-1/GIP双靶点受体激动剂（注射用THDBH120）针对糖尿病处于临床Ia期；口服小分子GLP-1受体激动剂（THDBH110胶囊）处于临床I期；DPP-4类药物磷酸西格列汀与复方制剂西格列汀二甲双胍已获得注册批件；SGLT-2类药物恩格列净与GLP-1类药物利拉鲁肽注射液已获批上市。与此同时，甘李药业也布局了多款口服降糖药。其中，DPP-4i磷酸西格列汀片已于2022年6月在国内获批上市；口服GLP-1RA产品GZR18片已处于I期临床；SGLT-2抑制剂恩格列净片上市申请已获NMPA受理，预计2025年获批。在热门的GLP-1领域，甘李药业的长效GLP-1RA周制剂产品GZR18注射液针对2型糖尿病已处于临床I期阶段。正如礼来、诺和诺德的“相爱相杀”，两家国产胰岛素龙头在新的糖尿病细分赛道终有一战。甘李药业主要降糖药品布局及器械产品图片来源：2023年财报除糖尿病领域外，这两家龙头公司还在积极开拓发展边界，延伸至更多疾病领域。其中，通化东宝拓宽至更大的代谢内分泌疾病治疗领域，涵盖了肥胖、非酒精性脂肪肝炎（MASH/NASH）、痛风/高尿酸血症等适应症。在减重领域，通化东宝的GLP-1/GIP双靶点受体激动剂（注射用THDBH120）已处于临床I期阶段；在痛风领域，创新管线URAT1抑制剂THDBH130/THDBH130片已完成Ⅱa期临床，国产首个痛风双靶点抑制剂THDBH150/THDBH151片已完成Ⅰ期临床，化学口服药物依托考昔片是最新一代的选择性环氧化酶-2（COX-2）抑制剂，报产已获受理。另一边，甘李药业在研的其他管线，涉及真核及原核蛋白质工程、肿瘤和心血管及代谢病等研究领域。其中，在减重领域布局的长效GLP-1RA周制剂产品GZR18注射液，较其他在研的单一适应症或日制剂产品更具竞争优势，目前已处于临床IIb期阶段，并开展了头对头司美格鲁肽的临床试验。在自免领域，甘李药业布局了治疗银屑病的司库奇尤单抗生物类似药GLR1023注射液，现已处于临床I期阶段。2023年，原研药司库奇尤单抗全球销售额达到49.8亿美元。目前，国内尚未有任何一款司库奇尤单抗的仿制药获批上市。04结语随着胰岛素集采风向的转变和市场格局的重塑，国内两大胰岛素龙头甘李药业和通化东宝成功实现了业绩反转。除了在胰岛素领域深度布局、持续创新外，两大龙头还积极拓展新的发展领域，正在展开新的故事，仍值得期待。参考资料：1.各家公司的财报、公告、官微2.国金证券、国信证券研报声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 金银花转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

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