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Breaking into the billion-dollar diabetes market! Hubei Guangchen secures the first generic version of linagliptin-metformin extended-release tablets.

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On October 28, 2025, according to an announcement on the official website of the NMPA, the Lixagliptin-Metformin Extended-Release Tablets submitted by Hubei Guangchen Pharmaceutical Co., Ltd. have been approved for marketing (Approval Number: National Drug Approval No. H20255813), making it the first generic version of this dosage form in China. This approval fills a significant gap in the Chinese market for this extended-release formulation and is expected to provide type 2 diabetes patients with a more convenient medication option.

On October 28, 2025, according to an announcement on the official website of the NMPA, the Lixagliptin-Metformin Extended-Release Tablets submitted by Hubei Guangchen Pharmaceutical Co., Ltd. have been approved for market launch (Approval Number: National Drug Approval No. H20255813), making it the first generic version of this dosage form in China. This approval fills a significant gap in the Chinese market for this extended-release formulation, and is expected to provide type 2 diabetes patients with a more convenient treatment option. Image source: NMPA official website

Liglibentaglin-Metformin Extended-Release Tablets are a combination antidiabetic medication marketed under the brand name Jentadueto® XR. Developed by Boehringer Ingelheim, this drug received U.S. FDA approval for launch in May 2016. Mechanistically, the combination formulation integrates two distinct classes of antidiabetic agents: Liglibentaglin, a DPP-4 inhibitor that works by boosting the body’s natural production of substances that stimulate the pancreas to release more insulin, thereby helping to control blood sugar levels—and simultaneously signaling the liver to stop producing glucose when blood sugar rises too high. Meanwhile, Metformin lowers blood sugar by reducing the absorption of sugar in the stomach, curtailing the release of stored glucose from the liver, and enhancing the body’s ability to utilize glucose effectively.

Jentadueto® XR is available in two strengths—5mg/1000mg and 5mg/1000mg—and is taken once daily, offering significant convenience for patients. However, this extended-release combination therapy has yet to be launched in China, leaving a notable gap in the market. Despite the absence of the extended-release formulation, the "golden duo" of linagliptin combined with metformin is already well-known in China. Currently, the market features only the conventional tablet versions of linagliptin-metformin. Boehringer Ingelheim's original branded product, "Oseni," entered China as early as 2017, followed by generic versions approved successively from domestic pharmaceutical companies such as Dongyang Guangyang, Qilu Pharmaceutical, and Huahai Pharmaceutical, creating a fiercely competitive landscape. According to data from the Yaozhi Terminal Sales Analysis System, sales of this product in China exceeded 100 million RMB in 2024, representing a remarkable 400% increase over the previous year—a testament to its explosive growth trajectory. As an important segment of the domestic pharmaceutical market, the diabetes drug sector has consistently maintained steady growth. Hubei Guangchen Pharmaceutical Co., Ltd.'s recent entry into this market comes at a time when it is experiencing rapid expansion. By becoming the first company to launch an extended-release formulation of this combination, Guangchen is poised to leverage its innovative dosage form and carve out a competitive edge in an increasingly crowded field.

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On October 28, 2025, according to an announcement on the official website of the NMPA, the Lixagliptin-Metformin Extended-Release Tablets submitted by Hubei Guangchen Pharmaceutical Co., Ltd. have been approved for marketing (Approval Number: National Drug Approval No. H20255813), making it the first generic version of this dosage form in China. This approval fills a significant gap in the Chinese market for this extended-release formulation and is expected to provide type 2 diabetes patients with a more convenient medication option.

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