On November 3, 2026, Huadong Medicine Co.,Ltd. (SHE: 000963) announced that the marketing application for its self-developed Class 1 innovative drug, the oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist cavililong tromethamine tablets (development code: HDM1002 tablets), for long-term weight management in adults, has been accepted by the National Medical Products Administration (NMPA). The drug is intended for long-term weight control in adult patients on top of diet control and increased physical activity, with an initial body mass index (BMI) of 28 kg/m2 or above (obesity), or 24 kg/m2 or above (overweight) accompanied by at least one weight-related comorbidity such as hypertension, dyslipidemia, hyperuricemia, abnormal glucose metabolism, fatty liver disease, or cardiovascular disease. This acceptance marks a significant milestone in the product's development and will further consolidate and enhance the company's core competitiveness in the metabolic field.
The oral GLP-1 sector is hitting a milestone, with an early-mover advantage staked in a multi-billion-yuan blue ocean. According to the announcement, cavililong tromethamine tablets are a fully active oral small-molecule GLP-1 receptor agonist independently developed by Hangzhou Zhongmei Huadong Pharmaceutical, with global intellectual property rights, featuring oral activity, high potency, and high selectivity. It is administered once daily orally, with absorption unaffected by food or water intake, requiring no strict fasting conditions or post-dose waiting time, making the dosing method flexible and convenient. Obesity is a chronic, relapsing metabolic disease. Domestic epidemiological data show that the prevalence of adult obesity in China continues to rise, making it a prominent public health issue; obesity is closely associated with elevated risks of hypertension, abnormal glucose metabolism, dyslipidemia, cardiovascular disease, fatty liver disease, and multiple other comorbidities, and effective weight management can significantly improve patients' overall health status.
Current major weight-loss approaches include lifestyle intervention, pharmacological treatment, and surgical intervention. When lifestyle intervention proves insufficient, combination pharmacotherapy or metabolic surgery may be considered. However, there remains a significant unmet clinical need in the current market. Among these, oral small-molecule GLP-1 receptor agonists offer convenient administration with fewer dosing restrictions and can avoid injection-site reactions associated with injectable formulations, making them a potentially important option in weight-loss pharmacotherapy. They are regarded as a core direction for breaking down medication barriers and broadening population coverage, yet no product of this type has been approved in the domestic market, representing a clear market gap. Huadong Medicine Co.,Ltd.'s self-developed cavililong tromethamine tablets precisely target this core gap in the market.
As an oral small-molecule GLP-1 receptor agonist, the product uses a once-daily oral dosing regimen, with drug absorption unaffected by food or water intake and a flexible and convenient administration method that better suits the daily medication habits of chronic disease patients. This medication model, which aligns more closely with routine chronic disease management, is expected to significantly reduce patient discontinuation rates, greatly improve long-term treatment adherence, and fill a critical gap in oral formulations for the domestic GLP-1 market. This marketing application is based on a multicenter, randomized, double-blind, placebo-controlled, parallel-design pivotal Phase III clinical trial (study number: HDM1002-301) conducted in adult overweight or obese patients, aimed at evaluating the efficacy, safety, and tolerability of HDM1002 tablets at 200 mg and 400 mg compared with placebo in participants who were obese or overweight and had at least one weight-related comorbidity. Study results show that HDM1002 tablets demonstrated sustained weight-loss effects.
All primary endpoints and key secondary endpoints were met at Week 44 across all dose groups of HDM1002 tablets. The 200 mg QD and 400 mg QD groups showed mean body weight reductions from baseline of 9.2% and 10.7%, respectively, compared with 1.5% for the placebo group; at Week 52, the two groups showed mean body weight reductions from baseline of 10.7% and 12.2%, with continued treatment yielding sustained weight-loss effects and further reductions at Week 52, with no weight-loss plateau observed. Notably, HDM1002 exhibits a quality weight-loss profile of "fat reduction with muscle preservation," achieving not only potent weight reduction but primarily through adipose tissue loss while well preserving lean body mass. DEXA body composition analysis at Week 44 showed that total fat content percentage decreased by 7.0% and 8.3% from baseline in the HDM1002 tablet 200 mg and 400 mg dose groups, respectively, compared with only 0.6% in the placebo group; total lean body mass percentage actually increased rather than decreased, rising by 4.6% and 5.6% from baseline, and visceral fat content percentage decreased by 13.3% and 14.4% from baseline, all superior to the placebo group.
Meanwhile, the clinical trial observed that cavililong tromethamine tablets significantly improved multiple cardiovascular metabolic indicators, substantially reduced liver fat content, and optimized body composition, with simultaneous improvements in waist circumference, fasting blood glucose, glycated hemoglobin (HbA1c), blood pressure, hs-CRP, and triglycerides, further expanding comprehensive benefits beyond weight reduction alone. Safety and tolerability data were consistent with the GLP-1 receptor agonist drug class, with no new safety signals observed and good liver safety. Additionally, a China Phase III clinical trial of cavililong tromethamine tablets for type 2 diabetes is underway, potentially providing overweight/obese and type 2 diabetes patients with better weight management and blood glucose control strategies.
The acceptance of the marketing application for cavililong tromethamine tablets by the NMPA represents an important milestone in the advancement of Huadong Medicine Co.,Ltd.'s metabolic innovation pipeline and is expected to help the company secure a first-mover position in the domestic oral small-molecule GLP-1 sector, filling a critical gap in oral formulations for the domestic GLP-1 market. With a comprehensive GLP-1 pipeline layout and continuous deep cultivation, Huadong Medicine Co.,Ltd. is consolidating its differentiated leading advantages. Huadong Medicine Co.,Ltd. is not only a pioneer in GLP-1 biosimilars but also an explorer in domestic GLP-1 innovative drugs. Based on its forward-looking layout in the metabolic disease field, Huadong Medicine Co.,Ltd. has built a differentiated, multi-tiered GLP-1 innovative product pipeline echelon around GLP-1 and other metabolic regulation targets, covering oral, injectable, single-target, and multi-target molecules, continuously addressing unmet clinical needs in obesity, diabetes, fatty liver disease, and other metabolic areas.
The long-term growth logic of China's GLP-1 receptor agonist sector is clear, and the market size is expected to continue expanding at a high rate. According to Frost & Sullivan forecasts, the overall China GLP-1 drug market is expected to reach 23 billion to 45 billion yuan in 2026 and is expected to break through the 100 billion yuan mark by 2030; CITIC Securities estimates show that in the weight-loss sub-segment alone, the domestic market size was approximately 14.3 billion to 15.5 billion yuan in 2025 and is expected to exceed 38 billion yuan by 2030. With rising awareness of overweight and obesity management, continuous release of long-term diabetes treatment demand, and gradually increasing penetration of innovative formulations such as oral and long-acting products, both the overall GLP-1 market and the weight-loss sub-segment will maintain rapid expansion. Against this backdrop, multiple self-developed heavyweight products in Huadong Medicine Co.,Ltd.'s full GLP-1 matrix are about to enter the harvest period.
Liraglutide injection Liruping® was approved for marketing in 2023, making it the first domestic liraglutide biosimilar and the first GLP-1 product in China approved for obesity or overweight indications; moreover, the company's semaglutide injection has had its China marketing applications for both diabetes and weight management indications accepted, placing it in the domestic first tier in terms of progress. The self-developed cavililong tromethamine tablets have now been accepted by the NMPA and entered the review stage. In terms of later-stage clinical projects, the long-acting peptide GLP-1/GIP dual-target receptor agonist HDM1005 (poterepatide) injection has completed enrollment for its China Phase III clinical study in the weight management indication and recently achieved an interim analysis meeting the 40-week primary endpoint, with a Pre-NDA communication application planned for Q4 2026. Both China Phase III clinical studies for the diabetes indication have completed enrollment and are currently in the treatment follow-up and data collection stage.
Two China Phase III clinical studies for the obstructive sleep apnea syndrome (OSAS) indication are actively advancing toward clinical study initiation, with the first patient enrolled in October 2026. DR10624, a first-in-class candidate developed by Huadong Medicine Co.,Ltd.'s controlled subsidiary Doer Biologics, is an FGF21/GCG/GLP-1 triple-target receptor agonist; its two Phase III clinical studies (LOTUS-1 and LOTUS-2) for the treatment of severe hypertriglyceridemia (sHTG) completed first patient enrollment in September 2026. The Phase II clinical study for metabolic-associated fatty liver disease with high risk of concomitant liver fibrosis obtained topline results in Q3 2026, and the study results have been selected for a Late-Breaking Abstract (LBA) and will be presented orally at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in November 2026. In July 2026, DR10624 received China IND approval for the treatment of heart failure with preserved ejection fraction/mildly reduced ejection fraction (HFpEF/HFrEF) in adults. In October 2026, the Phase II clinical study of DR10624 for moderate hypertriglyceridemia with diabetic kidney disease completed first patient enrollment.
According to Huadong Medicine Co.,Ltd.'s disclosures, the company's endocrinology/metabolism field layout has gradually expanded from the initial weight-loss and glucose-lowering indications to metabolic complications, covering MASH, dyslipidemia, chronic kidney disease (CKD), heart failure, and other directions; it will further extend into multi-organ function protection and muscle preservation. Building on the first-generation self-developed products HDM1002, HDM1005, and DR10624, the company will successively launch iteratively upgraded pipeline products, including HDM1013 (triple-target weekly and monthly formulations), HDM1014 (INHBE siRNA), HDM1015 (long-acting, multi-target, novel mechanism), HDM1017 (novel mechanism), and HDM1018 (oral, novel mechanism).
This time, the acceptance of the marketing application for cavililong tromethamine tablets, an oral formulation, is expected to break the inherent barrier of traditional GLP-1 drugs relying on injectable administration. HDM1002 not only avoids medication limitations caused by injection pain, needle aversion, and cold-chain storage and transportation requirements, but also, through its flexible once-daily dosing with absorption unaffected by food or water intake, significantly lowers patient medication thresholds and long-term treatment discontinuation rates, providing a more convenient and easier-to-maintain treatment option for overweight and obesity management and long-term type 2 diabetes control, and will effectively broaden the population coverage boundary of GLP-1 drugs. Huadong Medicine Co.,Ltd. is further deepening its full-spectrum GLP-1 product matrix, and in the future, this product is expected to form multi-dimensional synergies in formulation and mechanism with the company's long-acting injectable formulations and dual-target and triple-target innovative drugs, continuously consolidating the company's full-chain competitive advantages in the metabolic disease field and potentially injecting new incremental momentum into the company's long-term performance growth.
Comments