On July 19, Shenzhen Chipscreen Biosciences Co., Ltd. (“Chipscreen Biosciences”) announced that its wholly-owned subsidiary, Chengdu Chipscreen Pharmaceuticals Co., Ltd., received the Drug Registration Certificate from the National Medical Products Administration (NMPA), officially approving the marketing of Chiglitazar Sodium—the company’s self-developed novel PPAR pan-agonist—in combination with metformin for the treatment of type 2 diabetes. Following its initial approval as a monotherapy for type 2 diabetes in October 2021, this new approval further broadens Chiglitazar Sodium’s clinical applications, offering patients additional combination therapy options.

As of 2021, China has 141 million people living with diabetes, the highest number globally, with type 2 diabetes accounting for over 90% of cases. As a progressive disease, it not only severely affects patients’ quality of life but also places a significant burden on society. Over time, monotherapy often becomes insufficient. Studies indicate that 50% of newly diagnosed patients require combination therapy within three years of treatment, rising to 75% after nine years. Patients with high baseline glucose levels (HbA1c >9%) typically need combination therapy from the outset to achieve optimal glycemic control. For these reasons, combination therapy is a critical strategy in diabetes management.

Addressing insulin resistance—a key pathological driver of type 2 diabetes—remains a central challenge in both drug development and clinical care. Insulin resistance not only drives hyperglycemia but also contributes to dyslipidemia, overweight/obesity, fatty liver disease, and atherosclerotic cardiovascular complications. The newly approved indication for Chiglitazar Sodium states: “In combination with metformin hydrochloride: when glycemic control is inadequate with metformin alone, this product may be used alongside metformin, together with diet and exercise, to improve glycemic control in adult patients with type 2 diabetes.” Results from the pivotal randomized, double-blind, placebo-controlled Phase III trial showed that Chiglitazar Sodium combined with metformin delivered superior clinical benefits compared with placebo plus metformin, including sustained glycemic control, improved lipid profiles, and reduced cardiovascular risk. These findings underscore Chiglitazar Sodium’s potential as part of combination therapy with other antidiabetic agents targeting complementary mechanisms.

Dr. Lu Xianping, Chairman of Chipscreen Biosciences, stated: “Despite the availability of multiple treatments for type 2 diabetes, the rapid rise in patient numbers highlights that significant unmet clinical needs remain, both in monotherapy and combination therapy approaches.” As the world’s first approved PPAR pan-agonist for type 2 diabetes, Chiglitazar Sodium’s novel mechanism addresses the longstanding challenge of insulin resistance at its root. By effectively targeting metabolic syndrome disorders, it opens new therapeutic avenues for type 2 diabetes, providing clinicians and patients with more flexible and effective combination options to better meet clinical needs and improve patient outcomes.