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周的業績繼續顯示其BIC潛力。
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.
信達生物發佈了針對中國肥胖患者的Mazdutide（9mg）在Ph2研究中的48周結果（鏈接）。治療48周後，在80名延長治療的入組患者中，有59名經安慰劑調整後的體重與基線相比的平均變化百分比爲-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）達到了針對中國肥胖患者的Ph2試驗的主要終點，顯示在第24周經安慰劑調整後的體重減輕了15.4％（CMBI報告稱，鏈接，相比之下，替扎肽15mg爲12.0％，西馬魯肽爲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 顯示出全球 BIC 療效潛力，在中國受試者的主要競爭 GLP-1 藥物中，安慰劑調整後的減肥百分比最高。Tirzepatide在其中國Ph3試驗（鏈接）的第48周實現了經安慰劑調整後的體重減輕了17.4％（15mg）和11.5％（10mg），而西瑪魯肽在第44周的亞洲Ph3試驗（鏈接）中顯示減肥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.
觀察到多種心臟代謝益處。在上述Ph2試驗中，mazdutide在多種心臟代謝指標（例如腰圍、血壓、肝酶、甘油三酯、LDL-C和血清尿酸等）方面表現出顯著改善。經過24周的治療，mazdutide將受試者的肝臟脂肪含量（基準肝脂含量≥5％）降低了73.3％（相比之下，安慰劑爲-6.5％），並導致經安慰劑調整的ALT水平降低了45.5％，這些益處維持在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，經過24周的治療，mazdutide顯著降低了甘油三酯、總膽固醇、低密度脂蛋白和血清尿酸水平，在48周的治療中，HDL-C水平保持穩定。同樣，Hanmi GCGR/GLP-1激動劑依非諾培杜肽在第24周也顯示肝臟脂肪含量降低了72.7％（而semaglutide arm，Ph2，link的肝臟脂肪含量爲42.3％）。我們認爲，mazdutide有可能將其他適應症擴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.
繼續顯示出良好的安全形象。馬茲杜肽（9mg）的Ph2肥胖研究仍在進行中，詳細的安全數據有待披露，而該藥物總體耐受性良好。與24周的結果類似，在Ph2試驗中，治療組和安慰劑組均未出現AE引發的退出或在第48周未觀察到SAE。同時，在替西帕肽和西馬魯肽的中國/亞洲試驗中，2.9％（替西帕肽10mg）、7.0％（替西帕肽15mg）和2.8％（西馬魯肽）因AE停藥，SAE的比率分別爲4.3％、11.3％和5.2％。治療24周後，mazdutide組的心率升高與安慰劑類似，直到第48周才進一步加快。
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.
即將提交保密協議，在中國名列前茅。信達生物正在開發兩劑馬茲杜肽，分別爲9mg和6mg，以針對不同的肥胖人群。對於9mg的劑量，Innovent預計將在2023年底之前啓動一項Ph3肥胖研究。在Ph2試驗中，6mg的劑量也顯示出令人鼓舞的結果（第24周調整後的體重減輕幅度爲12.6％，鏈接），完整的Ph2數據即將在2023年底之前公佈。根據其Ph3試驗（GLORY-1）的結果，信達生物預計將在2023年底或2024年初向NMPA提交用於肥胖的馬茲杜肽（6mg）的保密協議。Mazdutide還進行了兩項針對糖尿病的Ph3試驗。信達生物計劃在2023年底或2024年初發布糖尿病的Ph2完整數據，並在2024年提交糖尿病新藥上市申請。此外，信達生物將在IND已獲批准的情況下啓動用於NASH的馬茲杜肽的臨床試驗。
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%).
維持買入。我們看到了馬茲杜肽在治療肥胖方面的BIC潛力。考慮到mazdutide更高的銷售預期，我們將基於DCF的目標價從50.34港元上調至57.35港元（WACC：9.6％，終端增長率：4.0％）。