Hengrui Medicine's Oral GLP-1 Drug HRS-7535 NDA Accepted by China's NMPA
nashnova research
China's NMPA has accepted Hengrui Medicine's marketing application for HRS-7535, an oral small-molecule GLP-1 drug backed by two Phase III trials showing glucose reduction superior to dapagliflozin — if approved, it would be the first such oral drug in China, targeting a market of 148 million diabetic patients.
What is this drug and where does it stand?
HRS-7535 is Hengrui's in-house oral small-molecule GLP-1 receptor agonist — a pill that activates the same weight-loss and blood-sugar target as injected GLP-1 drugs, no needle required.
China's National Medical Products Administration (NMPA) has formally accepted the marketing application. This means → the drug has entered the regulatory review pipeline; the next milestone is approve or reject.
Cumulative R&D spending stands at roughly RMB 494 million; the indication is adult type-2 diabetes (T2DM).
What do the clinical data show?
OUTSTAND-1: 46 sites, 284 patients whose T2DM was poorly controlled by diet and exercise alone. HRS-7535 cut HbA1c by 1.40%–1.68% across dose groups.
OUTSTAND-2: 104 sites, 810 patients still poorly controlled after metformin. HRS-7535 cut HbA1c by 1.50%–1.68%; the comparator dapagliflozin managed only 1.28%.
In plain terms = both large-scale trials showed solid glucose reduction and beat an existing oral drug; on top of that, HRS-7535 delivered weight loss, blood-pressure reduction, and lower urine protein.
Where does the global oral GLP-1 race stand?
The only approved oral small-molecule GLP-1 drug worldwide is Eli Lilly's orforglipron, which received US FDA approval in April 2026.
This means → the entire category has barely opened up. If HRS-7535 is approved, it would be the first of its kind in China — the timing window matters enormously.
China has roughly 148 million diabetes patients; T2DM accounts for over 90% of cases. An oral form carries a natural compliance advantage over injectables.
What does this mean for Hengrui and investors?
Acceptance is only the starting line. Clearing the review and winning approval is the real value-validation event.
This reflects Hengrui's GLP-1 pipeline moving from R&D into the eve of commercialization, tracking the global front-runners in pace.
Put simply = approval would hand Hengrui an exclusive ticket into China's largest chronic-disease market; a review setback would stretch the payback horizon on nearly half a billion yuan of R&D.
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