Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022.
Investors bailed on many med-tech companies last year, fearing that the frenzy surrounding GLP-1 agonists would tank companies in the weight-loss, diabetes and orthopedics segments. Their concerns now appear overblown in many instances, with some of the most directly affected businesses reporting a “rising tide” associated with an increased focus on obesity treatment that has lifted their boats rather than sinking them.
Sciwind Biosciences Co. Ltd.’s injectable glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW-003), achieved positive top-line results in a phase III trial in Chinese adults with type 2 diabetes. A long-acting, cAMP signaling biased GLP-1 analog, ecnoglutide is being developed for treating type 2 diabetes and obesity. GLP-1 receptor agonists are increasingly gaining attention in the obesity therapy area.
The U.S. Patent and Trademark Office’s inter partes review mechanism has drawn uneven reviews in the past decade or so and Dexcom Inc. has serious misgivings about an attempt by Abbott Diabetes Care Inc. to use the process to invalidate Dexcom patents for continuous glucose monitors.
Medtronic plc received CE mark for its latest miniature, leadless pacemakers, the Micra AV2 and Micra VR2. According to the company, they are the world's smallest pacemakers, provide a longer battery life, and are easier to program than previous Micra pacemakers, while maintaining the benefits of their predecessors such as reduced complications compared to traditional pacemakers.
Fractyl Health Inc. has nominated RJVA-001 as the first clinical type 2 diabetes candidate from its Rejuva gene therapy platform, which is designed to deliver locally administered genetic medicines to the pancreas.
Sciwind Biosciences Co. Ltd.’s injectable glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW-003), achieved positive top-line results in a phase III trial in Chinese adults with type 2 diabetes. A long-acting, cAMP signaling biased GLP-1 analog, ecnoglutide is being developed for treating type 2 diabetes and obesity. GLP-1 receptor agonists are increasingly gaining attention in the obesity therapy area.
Given what CEO Raymond Stevens called a space that’s “evolving extremely rapidly,” Structure Therapeutics Inc. chose – rather than wait for next year’s 12-week data – to unblind the eight-week obesity findings with GSBR-1290, an oral glucagon-like peptide-1 (GLP-1) agonist for which the firm also provided a phase IIa update in patients with type 2 diabetes.
Encellin Inc. has announced the closing of a US$9.9 million financing round that will support the company’s development of its cell encapsulation platform with an initial focus on type 1 diabetes.
Biomea Fusion Inc.’s diabetes treatment produced enhanced glycemic control at week 26 courtesy of its 200-mg cohort. It’s the latest advance for the company’s candidate that also has strong prospects in treating leukemia. Top-line data from the ongoing phase II Covalent-111 study of BMF-219, a covalent menin inhibitor for regenerating insulin-producing beta cells, demonstrated that about 40% of participants, four of 11 patients, in the 200-mg cohorts showed a durable reduction, 1% or more, in the amount of blood sugar attached to the type 2 diabetes (T2D) patients’ hemoglobin. The data came from participants who had received the last dose in a four-week treatment.
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