Diabetes Drug Market Sees New Momentum as Shengdi Pharma, Huahai Pharma and Others Advance Key Products

　　【Pharmaceutical Network Industry Dynamics】 Shandong Shengdi Pharmaceutical's HR20031 Tablets (Ⅱ) and HR20031 Tablets (Ⅰ), Huahai Pharmaceutical Co., Ltd.'s Dapagliflozin Metformin Sustained-Release Tablets (I), and other products have been accepted by the CDE for production submission; JIANGSU CHENPAI PHARMACEUTICAL CO.,LTD.'s Voglibose Tablets, Shijiazhuang No. 4 Pharmaceutical's Epalrestat Tablets, Beijing Fu Yuan Pharmaceutical's Sitagliptin Phosphate Tablets, and others have been approved for marketing… Recently, the diabetes medication market has seen renewed activity.
 

On November 10, the production applications of HR20031 Tablets (Ⅱ) and HR20031 Tablets (Ⅰ) from Shandong Shengdi Pharmaceutical, Dapagliflozin Tablets from HuiSheng Biopharmaceutical, and Pioglitazone Metformin Tablets from Jiangsu Anbisheng Pharmaceutical Co., Ltd. were accepted by the CDE.
 

Among them, HR20031 tablets, developed by Shandong Shengdi Pharmaceutical, are a fixed-dose triple combination formulation of proline constant net, ripaglinide phosphate, and metformin hydrochloride (sustained-release), intended for once-daily oral administration to treat type 2 diabetes patients with inadequate glycemic control after metformin treatment. HR20031 tablets are expected to achieve better blood glucose reduction through three different mechanisms of action. According to available information, there are two similar SGLT2 inhibitors, DPPIV inhibitors, and metformin sustained-release triple combination formulations already on the market abroad: Trijardy XR (empagliflozin/linagliptin/metformin sustained-release tablets) from the Boehringer-Ingelheim and Eli Lilly Diabetes Alliance, and Qternmet XR (dapagliflozin/saxagliptin/metformin sustained-release tablets) from AstraZeneca. Sales data for these products have not been disclosed yet, and no similar drugs have been approved for marketing in China.
 

On November 8, the CDE website showed that Huahai Pharmaceutical Co., Ltd.'s Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (I), Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (III), and Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (IV) were all accepted for production on the same day as Category 4 generics. Currently, only AstraZeneca holds the production approval for these three products, and no pharmaceutical companies in China have been approved yet. Among them, Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (I) and Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (III) are under review with applications submitted by Beijing Fuyuan Pharmaceutical, with both acceptance dates in October this year; there are currently no companies with applications under review for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (IV).
 

According to reports, AstraZeneca's Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets were approved for marketing in June this year for the treatment of Type 2 diabetes. This is also currently the only once-daily, fixed-dose combination of an SGLT2 inhibitor and Metformin Hydrochloride Sustained-Release formulation approved in China.
 

Data show that dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor, which has previously been approved for the treatment of adult type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease. Metformin hydrochloride extended-release tablets are a once-daily oral biguanide tablet.
 

Data shows that China has approximately 129 million diabetes patients, with over 90% being type 2 diabetes. Many type 2 diabetes patients have poor blood glucose control, and 60% of patients have blood glucose levels outside the target range. Persistent high blood glucose can lead to damage in multiple organs, causing life-threatening complications such as cardiovascular diseases and kidney damage. More than half of type 2 diabetes patients need to take 3-6 pills daily, and complex medication regimens leading to poor medication adherence are one of the significant reasons for inadequate blood glucose control in these patients.
 

To better meet the needs of diabetes patients, pharmaceutical companies in China are also strengthening the development of related drugs. Data shows that since the beginning of this year, 26 products (83 specifications) of chemical drugs for diabetes treatment (including biologics) have been approved for marketing, and 51 products (175 application numbers) are under review for production, indicating fierce market competition.
 

It is reported that recently, in addition to the recent progress of the above products, the National Medical Products Administration also showed that the Voglibose Tablets of JIANGSU CHENPAI PHARMACEUTICAL CO.,LTD. have been approved for production as a Category 4 generic drug, which is considered to have passed the evaluation.
 

Voglibose tablets are included in the ninth batch of national procurement varieties. Data shows that in 2022, the terminal sales revenue of Voglibose tablets in Chinese urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) increased by 13.33% year-on-year, exceeding 400 million yuan. Prior to this, Shijiazhuang No. 4 Pharmaceutical's Epalrestat Tablets, Zhejiang Hengyan Pharmaceutical Technology's Epalrestat Tablets, Beijing Fuyuan Pharmaceutical's Sitagliptin Phosphate Tablets, Hefei Heyuan Pharmaceutical's Saxagliptin Metformin Hydrochloride Extended-Release Tablets (Ⅰ), and Saxagliptin Metformin Hydrochloride Extended-Release Tablets (Ⅲ) were all approved for production under the new classification.
 

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