Oral Diabetes 'Blockbuster' Set for New Highs; Qilu and Deyuan Lead Generic Approval Rankings, East Sunshine Pharma Advances with Class 1 New Drug

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Recently, the market for oral diabetes medications has seen renewed activity. Lepu Pharmaceutical's Empagliflozin and Metformin Hydrochloride Extended-Release Tablets have been accepted by the CDE for production; Jilin Huisheng Biopharmaceutical's Vildagliptin Tablets and Shanghai Ambit Pharmaceuticals' Sitagliptin and Metformin Hydrochloride Extended-Release Tablets were approved on the same day. So far this year, seven varieties (13 acceptance numbers) have been approved for marketing. Currently, there are seven Class 1 new drugs under review for production, involving companies such as Dongyang Guang Medicine and Haisco. Additionally, 54 varieties have passed the evaluation, with 20 varieties evaluated by only one company, led by Qilu and Deyuan. According to data from the Menet database, in the first half of 2023, the market size of oral diabetes chemical drugs in China’s public medical institutions exceeded 13 billion yuan, increasing by nearly 5% year-on-year. Three products had sales exceeding 1 billion yuan, and Dapagliflozin Tablets are expected to reach a new high for the whole year. Brands like Yangtze River Nanjing Hailing Pharmaceutical, Sichuan Luye Pharmaceutical, and Jiangsu Hansoh Pharmaceutical Group made it onto the list.

Heavyweight new products keep coming! Lepu Pharmaceutical aggressively targets first generics, Qilu Pharmaceutical and Deyuan lead the approval rankings

On February 20, the CDE website showed that Lepu Pharmaceutical's Empagliflozin Metformin Hydrochloride Sustained-Release Tablets had been accepted for production under Category 3 of generic drugs. Prior to this, Lepu Pharmaceutical already had one production application under review and was the first company to apply for the production of this product. In addition, Shanghai Hui Lun Jiangsu Pharmaceutical and Chengdu Di Ao Pharmaceutical Group also have production applications under review. Currently, no generic drug companies in China have been approved for this product.

On February 19, the official website of the National Medical Products Administration (NMPA) showed that Jilin Huisheng Biopharmaceutical's Vildagliptin Tablets and Shanghai Ambit Pharmaceuticals' Sitagliptin Metformin Hydrochloride Sustained-Release Tablets were approved on the same day. Since the beginning of this year, seven types (13 acceptance numbers) of oral diabetes chemical drugs have been approved for marketing in China, including重磅品种 such as Jilin Huisheng Biopharmaceutical’s Class 1 new drug Proline Cagrilintide Tablets.

Status of Oral Diabetes Drugs Passing Evaluation

Source: MiNeiNet China Application Progress (MED) Database

As of now, 54 types of oral diabetes medications (with 402 acceptance numbers) have passed the evaluation. Metformin Hydrochloride Tablets and Metformin Hydrochloride Extended-Release Tablets are the most popular, with over 40 companies passing the evaluation for each. Sitagliptin Phosphate Tablets and Vildagliptin Tablets have both seen over 20 companies pass the evaluation. Notably, 20 types of medications, including Glimepiride Dispersible Tablets, Miglitol Orally Disintegrating Tablets, and Trelagliptin Succinate Tablets, have only been evaluated successfully by one company.

From the perspective of enterprises, more than 10 companies have five or more approved varieties. Among them, Qilu Pharmaceutical and Jiangsu Deyuan Pharmaceutical have the most, each with 10; Guangdong East Sun Pharmaceuticals and China Resources Pharmaceutical each have 9, while Yangtze River Pharmaceutical, Chia Tai Pharmaceutical, CSPC Holding, and Xincheng each have 8.

Oral Diabetes "Blockbuster Drug" May Hit New Highs! Yangtze River, Luye, and Hansoh Make the List

Sales of Oral Diabetes Chemical Drugs in Chinese Public Medical Institutions in Recent Years (Unit: Billion Yuan)

Source: MiNeiNet China Public Medical Institution Drug Terminal Competition Pattern

Data from MiNe Network shows that in the first half of 2023, the sales revenue of oral diabetes chemical drugs at terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) in China exceeded 13 billion yuan, increasing by nearly 5% year-on-year.

Top 20 Oral Diabetes Chemical Drugs in Chinese Public Medical Institutions in the First Half of 2023 (Unit: Billion Yuan)

Source: Terminal Competition Pattern of Pharmaceutical Products in China's Public Medical Institutions (MiNei Network)

Note: Sales below 5 billion yuan are indicated with *.

Among the top 20 products, Dapagliflozin Tablets, Sitagliptin Phosphate Tablets, and Metformin Hydrochloride Tablets rank in the top three, each with sales exceeding 1 billion yuan.

In terms of growth rate, Dapagliflozin Tablets, Sitagliptin Phosphate Tablets, Epalrestat Tablets, Pioglitazone Metformin Tablets (15mg/500mg), Linagliptin Tablets, Metformin Hydrochloride Sustained-Release Tablets, Sitagliptin Metformin Tablets (Ⅱ), Empagliflozin Tablets, and Alogliptin Benzoate Tablets all achieved double-digit growth.

Notably, 20 oral diabetes drugs have been included in the national procurement in China. Twelve of them, such as Metformin Hydrochloride Tablets, Acarbose Tablets, Metformin Hydrochloride Sustained-Release Tablets, and Gliclazide Sustained-Release Tablets, are among the TOP20 products, of which eight have seen a year-on-year decline in sales.

Top 20 Oral Diabetes Chemical Drug Brands in Chinese Public Medical Institutions, H1 2023 (Unit: Billion Yuan)

Source: MiNei Network's Competitive Landscape of Drug Terminals in China's Public Medical Institutions

Note: Sales below 5 billion yuan are indicated with *.

Among the top 20 brands, foreign pharmaceutical companies still occupy the leading positions. Only Yangtze River Nanjing Hailing Pharmaceutical, Hangzhou Sino-American Huadong Pharmaceutical, and Sichuan Luye Pharmaceutical, all China-based, made it into the top ten. Takeda’s Alogliptin Benzoate Tablets, Jiangsu Deyuan Pharmaceutical’s Pioglitazone Metformin Hydrochloride Tablets (15mg/500mg), and Boehringer Ingelheim’s Empagliflozin Tablets are newly listed brands.

In terms of growth rate, there were more increases than decreases. Takeda Pharmaceutical's Alogliptin Benzoate Tablets had the fastest growth rate, exceeding 30%. Boehringer Ingelheim's Linagliptin Tablets, Merck's Sitagliptin and Metformin Hydrochloride Tablets (Ⅱ), and Jiangsu Deyuan Pharmaceutical's Pioglitazone and Metformin Hydrochloride Tablets (15mg/500mg) all showed growth rates of over 20%.

Sales of Dapagliflozin Tablets in Chinese Public Medical Institutions in Recent Years (Unit: Billion Yuan)

Source: MiNeiNet China Public Medical Institution Drug Terminal Competition Pattern

Dapagliflozin Tablets are mainly used for the treatment of adult patients with type 2 diabetes, adult patients with heart failure, and adult patients with chronic kidney disease. Data from MiNe Network shows that the sales of Dapagliflozin Tablets in Chinese public medical institutions exceeded 3 billion yuan in 2022, claiming the top spot as the "best-selling product." In the first half of 2023, sales increased by over 20% year-on-year, and the total annual sales are expected to reach a new high. Currently, nine companies hold production licenses, including Shandong Lukang Pharmaceutical, Nanjing Chia Tai Tianqing Pharmaceutical, and Chengdu Better Pharmaceutical. More than 20 companies have applied for production approval, among which Shandong XSD Pharmaceutical and Jiangsu Wango Pharmaceutical both submitted applications this year. As more companies enter the market, competition for this product will become even fiercer.

Sales of Epalrestat Tablets in Chinese Public Medical Institutions in Recent Years (Unit: Billion Yuan)

Source: MiNeiNet China Public Medical Institution Drug Terminal Competition Pattern

Epalrestat Tablets are used for the prevention, improvement, and treatment of peripheral neuropathy (numbness, pain), abnormal vibration sensation, and cardiac arrhythmia (indicated by elevated glycated hemoglobin levels) associated with diabetes. Data from Menet shows that Epalrestat Tablets have continued to expand in the Chinese public medical institution market in recent years, with year-on-year growth exceeding 10% in the first half of 2023. Yangtze River Nanjing Hailing Pharmaceutical has the largest market share. Currently, seven companies hold production licenses for this product, while eight companies, including Lepu Pharmaceutical and Jilin Huisheng Biopharmaceutical, have applications under review.

New Type 1 Drug Gains Another Strong Player, Dongyang Light Medicine, Haisco…Launch an Assault

Status of New Category 1 Oral Diabetes Chemical Drugs under Review for Production

Source: MiNeiNet China Application Progress (MED) Database

As of now, there are 12 new oral diabetes chemical drugs under review for production in China, seven of which are Class 1 new drugs. These involve multiple companies such as Dongyang Light Pharmaceutical, CSPC Group, Salubris, and Haisco.

Source: MiNei Database on Project Progress

In January this year, the CDE accepted the production application for Jiaogulian Ronggelin Capsules from Yichang Dongy阳光长江药业. This is the company's first innovative oral hypoglycemic drug, currently under review and approval. Jiaogulian Ronggelin Capsules are SGLT2 inhibitors used for the treatment of type 2 diabetes. They work by reducing renal glucose reabsorption and lowering the renal glucose threshold, thereby increasing urinary glucose excretion and reducing blood glucose levels.

Source: National Medical Products Administration website, MiNeiNet database, etc.

Note: The terminal competition pattern of pharmaceuticals in Chinese public medical institutions by Menet, the statistical scope includes: urban public hospitals, county-level public hospitals, urban community centers, and township health centers, excluding private hospitals, private clinics, and village health stations; the sales mentioned above are calculated based on the average retail price of the products at the terminals. Any corrections or omissions are welcome!