On March 12, Huadong Medicine announced that the dual-target long-acting agonist for GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors developed by its subsidiary Huadong Medicine received approval from the National Medical Products Administration to conduct clinical trials. The GLP-1/GCG/GIP-Fc fusion protein of Shanghai Minwei Biotechnology Co., Ltd. has also joined the "battlefield." The Phase II clinical trial comparing this drug with semaglutide for the treatment of type 2 diabetes has been initiated, making it the third China-produced GLP-1 drug to challenge semaglutide. The star GLP-1 receptor agonist semaglutide was recently approved for cardiovascular indications in the United States.
GLP-1类产品具有减肥、降糖和心血管获益等作用，是相对成熟和安全的靶点。近年来，GLP-1受体激动剂“跨界”减重备受追捧，国内10余家本土企业布局研发。除GLP-1单靶点抑制剂（如司美格鲁肽、利拉鲁肽等）之外，多靶点GLP-1类药物更是备受关注。
Huadong Medicine: Comprehensive and Differentiated Layout of GLP-1 Target Product Line
Huadong Medicine Discloses HDM1005 Injection, a Long-Acting Dual Agonist Targeting GLP-1 and GIP Receptors: A Novel Class 1 Chemical Drug Independently Developed by Huadong Medicine with Global Intellectual Property Rights. Preclinical studies show that HDM1005 can promote insulin secretion and suppress appetite by activating GLP-1 and GIP receptors, significantly improving glucose tolerance, lowering blood sugar, and reducing weight. Additionally, existing data indicates that HDM1005 has favorable drug-like properties and safety.
Huadong Medicine stated that the company has built a comprehensive and differentiated product pipeline around the GLP-1 target, including long-acting and multi-target global innovative drugs and biosimilars in both oral and injectable forms. Among them, the Liraglutide Injection has been approved for marketing to treat adult Type 2 diabetes, obesity, or overweight, marking Huadong Medicine's first GLP-1 targeted product to be launched and also China's first approved Liraglutide biosimilar.
Among the GLP-1 products under development, apart from HDM1005 injection, the oral small molecule GLP-1 receptor agonist HDM1002 tablets have been approved for clinical trials in China and the United States. The Phase Ia clinical data in China has been obtained, and the Phase Ib clinical trial in China is currently underway, with Phase II clinical trials expected to commence within the year. The diabetes indication of semaglutide injection has completed patient enrollment for Phase III clinical trials and is expected to complete Phase III clinical trials within the year. The long-acting FGF21R/GCGR/GLP-1R triple agonist DR10624 has completed the Phase I single ascending dose (SAD) study in China and New Zealand and is currently conducting a Phase Ib/IIa multiple ascending dose (MAD) trial in New Zealand.
Novo Nordisk: Semaglutide Adds New Cardiovascular Disease Indication
As a highly representative star product of GLP-1 class drugs, semaglutide has gained significant attention in the past year. The product is a second-generation GLP-1 receptor agonist, regarded as a rising "dark horse" within the industry. There are three products currently available: Ozempic (injectable antidiabetic), Rybelsus (oral antidiabetic), and Wegovy (injectable weight-loss medication). Limited by production capacity, semaglutide is in short supply. To address this capacity bottleneck, Novo Nordisk has started building new factories and making large-scale acquisitions.
On March 9 this year, semaglutide Wegovy was approved for a new indication, which is to reduce the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke, in overweight or obese adult patients with established cardiovascular disease (CVD). This is also the first treatment in the United States to help people manage their weight and reduce cardiovascular risk. Novo Nordisk has also submitted a label extension application in the EU, with a decision expected in 2024.
Semaglutide is actively expanding its indications. In addition to the three major approved indications mentioned above, semaglutide is also being developed for non-alcoholic fatty liver disease, chronic kidney disease, and Alzheimer's disease. Among these, the development of semaglutide for non-alcoholic steatohepatitis (NASH) has now entered Phase III clinical trials, and the Phase III clinical trial for chronic kidney disease has already met its pre-set standards ahead of schedule due to excellent efficacy.
Minwei Bio: Triple-Target GLP-1 Class New Drug Candidate Joins the "Battle"
MWN101, the GLP-1/GCG/GIP-Fc fusion protein developed by Shanghai Minwei Biotechnology Co., Ltd., a participating company of Leap Therapeutics, has also joined the "competition." On March 11, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Minwei Biotechnology initiated a Phase II clinical trial comparing MWN101 with semaglutide for the treatment of type 2 diabetes. This product is China's first domestically produced GLP-1/GCG/GIP-Fc fusion protein and the third domestically produced GLP-1 drug to challenge semaglutide. In terms of mechanism, this drug is the fifth globally to enter clinical trials as a GLP-1R/GCGR/GIPR agonist.
Before MWN101, four similar products from multinational pharmaceutical companies had already entered clinical trials. Among them, Eli Lilly's Retatrutide is the most advanced, currently in Phase III clinical trials, targeting GLP-1R/GCGR/GIPR. Hanmi Pharm's HM15211 is in Phase II clinical trials, sharing the same target as Minwei Bio's MWN101. Novo Nordisk's NN9423 and Sanofi's SAR441255 are both in Phase I clinical trials, with the same target as Eli Lilly's Retatrutide. Additionally, another local pharmaceutical company, United Biotech's UBT251, has also entered Phase I clinical trials.
PegBio: Weight Loss Concept Boosts Restart of IPO
Recently, PegBio has restarted its IPO and submitted a prospectus to the Hong Kong Stock Exchange, with CICC acting as the sole sponsor. In 2021, PegBio had applied for listing on the STAR Market, but voluntarily withdrew the application in April 2022.
As an innovative biopharmaceutical company focused on the research and development of new drugs in the field of chronic diseases, PegBio has a pipeline of new drugs targeting several disease treatment areas such as type 2 diabetes, obesity, and congenital hyperinsulinism. However, none of its products have been approved for marketing yet. Its push for a Hong Kong IPO is primarily aimed at raising funds to support the development of its pipeline drugs. With the boost of a "weight-loss concept," its listing process has attracted attention.
In PegBio's R&D pipeline, the core product with the fastest progress is the long-acting GLP-1 receptor agonist PB-119, which has indications for both Type 2 diabetes and obesity. Currently, the National Medical Products Administration (NMPA) has accepted the drug's marketing application for treating Type 2 diabetes, and PegBio expects it to be approved for market launch as early as the fourth quarter of this year. The indication for overweight or obesity is in Phase I clinical trials.
However, faced with the highly competitive GLP-1 drug market, whether PB-119's approval for marketing can bring a turning point for PegBio remains to be seen in future market tests. In addition to this product, information disclosed on PegBio's official website shows that its R&D pipeline includes other GLP-1 class new drugs under development: a long-acting GLP-1/GIP dual agonist (for type 2 diabetes), a long-acting GLP-1/GIP/GCG triple agonist (for type 2 diabetes), a long-acting GLP-1/GCG receptor dual agonist (for non-alcoholic fatty liver disease, overweight or obesity), and a long-acting GLP-1 receptor dual agonist (for overweight or obesity).
Reporter Wang Kala from The Beijing News
Proofread by Baoqing Liu