Hengrui Medicine's Recaticimab Injection Receives Approval for Phase III Clinical Trial

Product / TechRegulation
โดย Jiemian·CN·Read original
Summary · why it matters

Hengrui Medicine announced that its subsidiary Guangdong Hengrui has received the Drug Clinical Trial Approval Notice for Recaticimab Injection issued by the National Medical Products Administration, approving the product to proceed with a Phase III clinical trial. The indication sought is for adult patients with intracranial atherosclerotic stenosis, to reduce the risk of stroke recurrence. Recaticimab Injection is a self-developed anti-PCSK9 monoclonal antibody that inhibits the binding of PCSK9 to LDL receptors, increasing the number of LDL receptors available to clear low-density lipoprotein from the blood, thereby lowering LDL cholesterol levels. The announcement shows that the product was approved for marketing in China in 2025 for adult patients with hypercholesterolemia and mixed dyslipidemia. Cumulative R&D investment in this project is approximately 422 million yuan.

Impact on stocks 1

Others · 1 stocks
Jiangsu Hengrui Medicine Co Ltd
600276
▲ PositiveTechnologyrelevance

NMPA approved Recaticimab Injection for a Phase III trial in intracranial atherosclerotic stenosis, advancing its self-developed anti-PCSK9 antibody pipeline.

Theme Impact 1

Related news

Amgen Fair Value Target Rises to US$388.03 as Analysts Split on Pipeline Risks

Amgen's updated analyst model lifted its fair value price target to US$388.03 from a prior US$371.93, with the revenue growth assumption rising to 3.50% from 2.93%, the net profit margin assumption moving to 25.15% from 24.84%, the future P/E multiple changing to 25.1x from 24.6x, and the discount rate shifting to 7.96% from 7.70%. The revision reflects a split analyst view, with UBS, Argus, TD Cowen, Scotiabank and Oppenheimer raising their Amgen price targets into a US$420 to US$460 range on the strength of a strong product portfolio, Q2 beats and higher guidance. Wells Fargo and Piper Sandler lifted their targets to US$435, citing external survey work and prescription data they believe support higher long term sales potential for cholesterol and cardiovascular products such as Repatha and Lipfendra. On the bearish side, HSBC downgraded Amgen to Hold and cut its target to US$425 from US$445, saying the stock price now more closely matches its assessment of fair value with limited near term upside, while BMO Capital shifted to a neutral Market Perform stance even with a higher US$450 target, citing ongoing loss of exclusivity headwinds and a need for more clarity on the competitive profile and sales potential of MariTide.
Simply Wall St·10hRead more →

Edwards Lifesciences Targets $2 Billion TMTT Business by 2030 as CMS Expands TAVR Access

Edwards Lifesciences outlined a structural heart growth plan that targets more than US$2 billion in transcatheter mitral and tricuspid revenue by 2030, anchored by its PASCAL, EVOQUE, and Sapien M3 technologies. The plan sits alongside updated Medicare coverage that could enable 100 to 200 additional U.S. centers to perform TAVR procedures, reinforcing the company's transcatheter ecosystem. Edwards' broader narrative projects $8.5 billion in revenue and $2.2 billion in earnings by 2029, requiring 9.3% yearly revenue growth and an earnings increase of about $1.2 billion from $979.9 million today. Three fair value estimates from the Simply Wall St Community cluster between US$91.47 and US$100.96 per share, against a $100.96 fair value that implies 14% upside to the current price. The company still faces risks around margins, tariffs, and competitive pressure in international markets.
Simply Wall St·14hRead more →
impact 4

Novartis Shares Plunge 10% as Del-desiran Fails Late-Stage Trial

Novartis shares fell about 10% after the company said its experimental drug del-desiran failed to meet its primary goal in a late-stage trial for myotonic dystrophy type 1, marking its third clinical setback in a week. The earlier failures involved the cardiovascular drug pelacarsen and a pause of eight trials of the cell therapy rap-cel following three patient deaths. The decline erased roughly 24 billion Swiss francs, or about $29.6 billion, in market value and put Novartis on pace for one of its worst trading days in company history. Barclays had estimated peak annual sales of about $3.1 billion for del-desiran and assigned the drug a 60% probability of success after positive mid-stage results, and the failure raises questions about the $12 billion Avidity acquisition that brought the drug into Novartis' pipeline. Management reaffirmed its full-year financial guidance and maintained its target for 5% to 6% compound annual sales growth from 2025 through 2030, while the company reported successful late-stage results for remibrutinib in multiple sclerosis and expects more data later this year.