INNOVENT BIOLOGICS(1801.HK):MAZDUTIDE(9MG)CONTINUES TO SHOW ITS BIC POTENTIAL WITH 48-WEEK RESULTS
INNOVENT BIOLOGICS(1801.HK):MAZDUTIDE(9MG)CONTINUES TO SHOW ITS BIC POTENTIAL WITH 48-WEEK RESULTS
Mazdutide (9mg) continues to show its BIC potential with 48-week results.
Mazdutide（9mg）以48周的业绩继续显示其BIC潜力。
Innovent released the 48-week results of mazdutide (9mg) in Ph2 study in Chinese obesity patients (link). After 48 weeks of treatment, the placebo-adjusted mean percent change in body weight from baseline was -18.6% (-17.8kg) in 59 of the 80 enrolled patients with treatment extended.
信达生物发布了针对中国肥胖患者的Mazdutide（9mg）在Ph2研究中的48周结果（链接）。治疗48周后，在80名延长治疗的入组患者中，有59名经安慰剂调整后的体重与基线相比的平均变化百分比为-18.6％（-17.8kg）。
Recall in May 2023, mazdutide (9mg) met the primary endpoint of its Ph2 trial in Chinese obesity patients, showing 15.4% placebo-adjusted weight loss at week 24 (vs 12.0% of tirzepatide 15mg and 8.0% of semaglutide, CMBI report, link).
回想一下，2023年5月，mazdutide（9mg）达到了针对中国肥胖患者的Ph2试验的主要终点，显示在第24周经安慰剂调整后的体重减轻了15.4％（CMBI报告称，链接，相比之下，替扎肽15mg为12.0％，西马鲁肽为8.0％）。
Mazdutide showed global BIC efficacy potential with the highest placebo-adjusted weight loss percentage among the major competing GLP-1 drugs in Chinese subjects. Tirzepatide realized 17.4% (15mg) and 11.5% (10mg) placebo-adjusted weight loss at week 48 in its China Ph3 trial (link) and semaglutide showed 9.9% weight loss in its Asian Ph3 trial (link) at week 44.
Mazdutide 显示出全球 BIC 疗效潜力，在中国受试者的主要竞争 GLP-1 药物中，安慰剂调整后的减肥百分比最高。Tirzepatide在其中国Ph3试验（链接）的第48周实现了经安慰剂调整后的体重减轻了17.4％（15mg）和11.5％（10mg），而西玛鲁肽在第44周的亚洲Ph3试验（链接）中显示减肥9.9％。
Multiple cardiometabolic benefits observed. In the above-mentioned Ph2 trial, mazdutide demonstrated significant improvement in multiple cardiometabolic indicators (such as waist circumference, blood pressure, liver enzyme, triglyceride, LDL-C, and serum uric acid, etc). After the 24-week treatment, mazdutide reduced subjects' liver fat content (baseline liver fat content ≥5%) by 73.3% (vs -6.5% in placebo) and induced 45.5% placebo-adjusted reductions in ALT levels, and these benefits maintained to 48 weeks.
观察到多种心脏代谢益处。在上述Ph2试验中，mazdutide在多种心脏代谢指标（例如腰围、血压、肝酶、甘油三酯、LDL-C和血清尿酸等）方面表现出显著改善。经过24周的治疗，mazdutide将受试者的肝脏脂肪含量（基准肝脂含量≥5％）降低了73.3％（相比之下，安慰剂为-6.5％），并导致经安慰剂调整的ALT水平降低了45.5％，这些益处维持在48周。
In addition, after the 24-week treatment, mazdutide significantly reduced triglyceride, total cholesterol, LDL-C and serum uric acid levels, with HDL-C levels stable throughout the 48-week treatment. Similarly, Hanmi GCGR/GLP-1 agonist efinopegdutide also demonstrated 72.7% reduction in liver fat content (vs 42.3% in semaglutide arm, Ph2, link) at week 24. We see the potential of mazdutide to expand additional indication beyond diabetes and obesity.
此外，经过24周的治疗，mazdutide显著降低了甘油三酯、总胆固醇、低密度脂蛋白和血清尿酸水平，在48周的治疗中，HDL-C水平保持稳定。同样，Hanmi GCGR/GLP-1激动剂依非诺培杜肽在第24周也显示肝脏脂肪含量降低了72.7％（而semaglutide arm，Ph2，link的肝脏脂肪含量为42.3％）。我们认为，mazdutide有可能将其他适应症扩展到糖尿病和肥胖以外。
Continued to show favourable safety profile. The Ph2 obesity study of mazdutide (9mg) is still in progress with detailed safety data to be disclosed, while the drug was overall well-tolerated. Similar with the 24-week results, there was no AE-led drop-out, or no SAE was observed at week 48 in the Ph2 trial in both the treatment and placebo groups. Meanwhile, in tirzepatide and semaglutide's China/Asian trials, 2.9% (tirzepatide 10mg), 7.0% (tirzepatide 15mg) and 2.8% (semaglutide) of subjects discontinued due to AE, and the rates of SAE were 4.3%, 11.3% and 5.2%, respectively. Heart rate increase in mazdutide group was similar to placebo after 24 weeks of treatment, with no further increase till week 48.
继续显示出良好的安全形象。马兹杜肽（9mg）的Ph2肥胖研究仍在进行中，详细的安全数据有待披露，而该药物总体耐受性良好。与24周的结果类似，在Ph2试验中，治疗组和安慰剂组均未出现AE引发的退出或在第48周未观察到SAE。同时，在替西帕肽和西马鲁肽的中国/亚洲试验中，2.9％（替西帕肽10mg）、7.0％（替西帕肽15mg）和2.8％（西马鲁肽）因AE停药，SAE的比率分别为4.3％、11.3％和5.2％。治疗24周后，mazdutide组的心率升高与安慰剂类似，直到第48周才进一步加快。
Front runner in China with NDA submission to happen soon. Innovent is developing two doses of mazdutide, 9mg and 6mg, to target different obesity populations. For the 9mg dose, Innovent expects to initiate a Ph3 obesity study by end-2023. The 6mg dose has also demonstrated promising results in Ph2 trial (12.6% adjusted weight loss at week 24, link), and the full Ph2 data is about to publish by end- 2023. Innovent expects to submit NDA of mazdutide (6mg) for obesity to NMPA in late 2023 or early 2024, based on the results of its Ph3 trial (GLORY-1). Mazdutide also has two Ph3 trials for diabetes. Innovent plans to release Ph2 full data in diabetes in late 2023 or early 2024 and to submit NDA for diabetes in 2024. Additionally, Innovent will initiate clinical trials of mazdutide for NASH with the IND already approved.
即将提交保密协议，在中国名列前茅。信达生物正在开发两剂马兹杜肽，分别为9mg和6mg，以针对不同的肥胖人群。对于9mg的剂量，Innovent预计将在2023年底之前启动一项Ph3肥胖研究。在Ph2试验中，6mg的剂量也显示出令人鼓舞的结果（第24周调整后的体重减轻幅度为12.6％，链接），完整的Ph2数据即将在2023年底之前公布。根据其Ph3试验（GLORY-1）的结果，信达生物预计将在2023年底或2024年初向NMPA提交用于肥胖的马兹杜肽（6mg）的保密协议。Mazdutide还进行了两项针对糖尿病的Ph3试验。信达生物计划在2023年底或2024年初发布糖尿病的Ph2完整数据，并在2024年提交糖尿病新药上市申请。此外，信达生物将在IND已获批准的情况下启动用于NASH的马兹杜肽的临床试验。
Maintain BUY. We see the BIC potential of mazdutide for the treatment of obesity. To factor in higher sales projections for mazdutide, we revised up our DCF-based TP to HK$57.35 from HK$50.34 (WACC: 9.6%, terminal growth rate: 4.0%).
维持买入。我们看到了马兹杜肽在治疗肥胖方面的BIC潜力。考虑到mazdutide更高的销售预期，我们将基于DCF的目标价从50.34港元上调至57.35港元（WACC：9.6％，终端增长率：4.0％）。