Another strong player has been added to the first echelon of domestic oral GLP-1! Huadong Pharmaceutical (000963.SZ)'s application for listing in China of the self-developed Class 1 new drug carvilleron tromettriol tablets was accepted
Zhitong Finance App learned that on November 3, 2026, East China Pharmaceutical (000963.SZ) issued an announcement that its self-developed first-class innovative drug, oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist cabrellone trometriol tablets (R&D code: HDM1002 tablets) for long-term adult weight control was accepted by the National Drug Administration (NMPA). It is suitable for long-term weight control of adult patients on the basis of diet control and increased physical activity. The initial body mass index (BMI) is: ≥28kg /m2 (obesity), or ≥24 kg/m2 (overweight) with at least one weight-related complication, such as high blood pressure, abnormal blood lipids, high uric acid, abnormal glucose metabolism, fatty liver disease, cardiovascular disease, etc.
This acceptance marks an important milestone in the product development process, and will further consolidate and enhance the company's core competitiveness in the field of metabolism.
The oral GLP-1 circuit has reached a milestone, with 10 billion card slots and a blue ocean first-mover advantage
According to the announcement, carvillerone aminotriol tablets are complete oral small molecule GLP-1 receptor agonists independently developed by Huadong in China and the US with global intellectual property rights. They have oral activity, potency, and high selectivity. Using oral administration once a day, their absorption is not affected by eating or drinking water, and there is no need for strict fasting conditions or waiting time after taking medication, and the dosage method is flexible and convenient.
Obesity is a chronic and recurrent metabolic disease. Domestic epidemiological data shows that the prevalence of obesity among adults in China continues to rise and has become a prominent public health issue; obesity is closely related to the increased risk of various complications such as high blood pressure, abnormal glucose metabolism, abnormal blood lipids, cardiovascular disease, and fatty liver disease, and effective weight management can significantly improve the overall health of patients. Currently, the main weight loss methods are lifestyle intervention, medication, and surgery. Combined medication or metabolic surgery may be considered when lifestyle interventions are not effective.
However, there are still significant unmet clinical needs in the current market. Among them, oral small-molecule GLP-1 receptor agonists are convenient to administer, have few dosage restrictions, and can also avoid injection site reactions caused by injectable preparations. Therefore, they are expected to become an important choice in weight loss drug treatment. They are seen as the core direction for breaking drug usage barriers and broadening population coverage. In the domestic market, no products of the same type have been approved, and there is a clear market gap.
Carvilleron trometriol tablets independently developed by Huadong Pharmaceutical are the core variety that accurately anchors this gap in the market. As an oral small-molecule GLP-1 receptor agonist, this product uses an oral administration plan once a day. Drug absorption is not affected by eating or drinking water, and the administration method is flexible and convenient, and is more suitable for the daily medication habits of patients with chronic diseases. This medication model, which is closer to conventional chronic disease management, is expected to significantly reduce patients' medication interruption rate, greatly improve long-term treatment compliance, and fill a key gap in the domestic GLP-1 market.
The marketing application is based on a multi-center, randomized, double-blind, placebo-controlled, parallel-designed key phase III clinical trial (study number: HDM1002-301) in adult overweight or obese patients to evaluate the efficacy, safety, and tolerability of HDM1002 tablets of 200 mg and 400 mg compared to placebo in treating obesity or overweight participants with at least 1 weight-related complication.
Research results showed that HDM1002 tablets showed sustained weight loss effects. Each dose group of HDM1002 tablets reached all major endpoints and key secondary endpoints in the 44th week. The weight of the 200mg QD group and 400mg QD group decreased by an average of 9.2% and 10.7% compared to the baseline, and 1.5% in the placebo group; in week 52, the weight loss effect of the two groups continued. The weight loss effect continued. Further decline in week 52 was not observed.
It is worth noting that HDM1002 shows the high-quality weight loss characteristics of “fat reduction and muscle preservation”. It not only achieved strong weight loss, but also maintained lean body weight well, mainly due to loss of adipose tissue. The 44th week DEXA body composition analysis showed that the total fat content percentage in the 200 mg and 400 mg dosage groups of HDM1002 tablets decreased by 7.0% and 8.3% compared to the baseline, and only decreased by 0.6% in the placebo group; the percentage of total lean body mass increased by 4.6% and 5.6% compared to the baseline, and the percentage of visceral fat content decreased by 13.3% and 14.4% compared to the baseline, all superior to the placebo group.
At the same time, the clinical trial observed significant improvements in multiple cardiovascular metabolic indicators, significant reduction in liver fat content, and optimization of body composition, simultaneous improvement in multiple cardiovascular metabolic indicators such as waist circumference, fasting blood sugar, glycated hemoglobin (HbA1c), blood pressure, hs-CRP, and triglycerides, further expanding the comprehensive benefits other than single weight loss. The safety and tolerability data were consistent with GLP-1 receptor agonist drugs. No new safety signals were observed, and liver safety was good.
In addition, the Chinese phase III clinical trial of cabrellone trometriol tablets for type 2 diabetes is underway, which is expected to provide better weight management and blood sugar control strategies for overweight/obese and type 2 diabetics.
The marketing application for cabrellone trometriol tablets was accepted by the State Drug Administration. It is an important milestone in the promotion of the East China Pharmaceutical Metabolism Innovation Pipeline. It is also expected to help the company seize the first-mover card advantage in the domestic small oral molecule GLP-1 circuit and fill the key gap in oral dosage forms in the domestic GLP-1 market.
The full layout of the GLP-1 pipeline continues to be cultivated to consolidate the leading edge of differentiation
Huadong Pharmaceutical is not only a pioneer of biosimilar drugs on the GLP-1 circuit, but also a pioneer of innovative domestic GLP-1 drugs. Based on a forward-looking layout in the field of metabolic diseases, Huadong Pharmaceutical has built a differentiated, multi-level GLP-1 innovative product pipeline around metabolic control targets such as GLP-1, covering oral, injectable, single-target, and multi-target molecules to continuously meet unmet clinical needs in metabolic fields such as obesity, diabetes, and fatty liver disease.
The medium- to long-term growth logic of China's GLP-1 receptor agonist circuit is clear, and the market size is expected to continue to expand rapidly. According to Frost & Sullivan's forecast, the overall market size of China's GLP-1 drugs will reach 23 billion to 45 billion yuan in 2026, and is expected to break the 100 billion mark in 2030; CITIC Securities estimates show that in the field of weight reduction alone, the domestic market size is about 14.3 billion to 15.5 billion yuan in 2025, and is expected to exceed 38 billion yuan in 2030. As the management awareness of overweight and obese people increases, demand for long-term diabetes treatment continues to be released, and the penetration rate of innovative dosage forms such as oral administration and long-term efficacy gradually increases, the overall GLP-1 market and weight loss segments will maintain a rapid expansion trend.
In this context, Huadong Pharmaceutical's GLP-1 full matrix is about to enter the harvest period for several self-developed major varieties. The liraglutide injection Liraglutide® was approved for marketing in 2023. It is the first domestically produced liraglutide biosimilar and the first GLP-1 product approved for obesity or overweight. Furthermore, the company's application for marketing of simeglutide injection for diabetes and weight management in China has been accepted, and progress is at the first level in China. The self-developed cavillerone tromettriol tablets have now been accepted by the NMPA and have entered the review stage.
In terms of late-stage clinical projects, the long-acting polypeptide GLP-1/GIP dual-target receptor agonist HDM1005 (poterepatide) injection has been enrolled in the Chinese phase III clinical study of weight management indications, and a 40-week mid-term analysis with major endpoints has recently been reached. It is planned to submit a pre-NDA communication application in Q4 2026. Both Chinese phase III clinical studies on diabetes indications have completed enrollment, and are currently in the treatment follow-up and data collection stages. Two Chinese phase III clinical studies on obstructive sleep apnea hypoventilation syndrome (OSAS) indications are being actively promoted, and the first patient was enrolled in October 2026.
The first-in-class candidate FGF21/GCG/GLP-1 three-target receptor agonist DR10624 developed by Doyle Biotech, a subsidiary of Huadong Pharmaceutical Holdings, completed the first patient enrollment in two phase III clinical studies (LOTUS-1 and LOTUS-2) for the treatment of severe hypertriglyceridemia (ShTG) in September 2026. A phase II clinical study combining metabolic fatty liver disease with a high risk of liver fibrosis obtained top results in Q3 2026. The study results were selected for the 2026 Latest Breakthrough Summary (LBA) of the American Association for the Study of Liver Disease (AASLD) in November 2026 and will be presented orally. In July 2026, DR10624 was approved for the Chinese IND for treating heart failure (HFPef/hFrEF) in adults with blood ejection fraction preservation/mild reduction in ejection fraction. In October 2026, the first patient was enrolled in the Phase II clinical study of DR10624 to treat moderate hypertriglyceridemia with diabetic nephropathy.
According to Huadong Pharmaceutical, the company's endocrine/metabolism field layout has gradually expanded from initial weight loss and sugar reduction indications to metabolic complications, covering MASH, abnormal blood lipids, chronic kidney disease (CKD), and heart failure; in the future, it will further expand to the fields of multi-organ function protection and muscle preservation. Based on the first-generation self-developed products HDM1002, HDM1005, and DR10624, the company will subsequently launch iteratively upgraded pipeline products, including HDM1013 (three-target weekly formulation and monthly formulation), HDM1014 (INHBE siRNA), HDM1015 (long-term, multi-target, new mechanism), HDM1017 (new mechanism), and HDM1018 (oral, new mechanism).
This time, the marketing application for the oral formulation of cavillelone aminotriol tablets has been accepted, which is expected to break the inherent barriers of traditional GLP-1 drug dependence on injectable administration. HDM1002 not only avoids medication restrictions caused by injection pain, needle resistance, and cold chain storage and transportation requirements, but also drastically reduces patients' medication threshold and long-term treatment interruption rate through flexible administration methods that absorb food and drinking water once a day, provides more convenient and easier treatment options for overweight obesity management and long-term control of type 2 diabetes, and also effectively broadens the coverage boundaries of GLP-1 drugs.
Huadong Pharmaceutical is further deepening its GLP-1 full-spectrum product matrix. In the future, the product is expected to form multi-dimensional collaboration with the company's long-acting injectable formulations, dual-target, and three-target innovative drugs, continue to consolidate the company's full-chain competitive advantage in the field of metabolic diseases, and inject new incremental impetus into the company's long-term performance growth.