On July 25, 2023, China National Medical Products Administration (NMPA) approved Beinaglutide Injection (Feisumei), a glucagon-like peptide-1 receptor agonist (GLP-1-RA), for weight loss.
Beinaglutide, a new drug developed by Shanghai-based Benemae, is the second GLP-1-RA that has obtained China’s marketing authorization for weight control.
The first is Hangzhou Zhongmei Huadong Pharma’s Liraglutide Injection (Liluping), approved for diabetes treatment in March this year and greenlighted for obesity care about three months afterwards.
Right now, Feisumei and Liluping are the only two GLP-1-RAs with the pass to China’s weight management market. The industry and the market are enthusiastic about the drug’s obesity care function, with companies developing similar drugs and patients actively enquiring about them.
UPDATE: On Aug 21, 2023, CDE's website shows that Ei Lilly's Tirzepatide for weight control has been accepted for marketing authorization review, indicating that the competitive product is on the course to the Chinese obesity medication market. Tirzepatide is also under CDE's review for glycemic control. The global sales of the drug in H1 2023 has reached USD 1,548.2 million1&2.
GLP-1-RAs Shine with Their Advantages
Currently, GLP-1-RAs are mainly indicated for the treatment of type-2 diabetes, while weight control is fairly new as the drugs’ indication.
Compared to other antidiabetic medications, including metformin, sulfonylurea, thiazolidinediones (TZDs), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and insulins, GLP-1-RAs boast a combination of high efficacy in glycemic control, desirable function of weight loss, low risk of hypoglycemia, and even a mild benefit on the cardiovascular system.
Medications for treatment of type-2 diabetes
Benefit: dulaglutide, liraglutide, semaglutide; Neutral: exenatide once weekly, lixisenatide.
Hypo: hypoglycemia; ASCVD: atherosclerotic cardiovascular disease; HF: heart failure.
Adapted from: “Standards of Medical Care in Diabetes – 2022” Supplement 1, p. 133; diabetes.org. American Diabetes Association
Source: Novo Nordisk 2022 Annual Report
Under comprehensive evaluation, the excellent performance is one of the reasons why GLP-1-RAs are being developed by many companies.
Over 100 GLP-1-RAs Are Eyeing Chinese Market
Another reason why quite a few companies try to market GLP-1-RAs in China is the vast market. According to chinabgao.com’s and Frost & Sullivan’s estimations, China’s 2022 diabetes market reached CNY 86.2 billion (circa USD 12 billion) with 141 million patients. A Chinese consulting firm, chyxx.com, predicts that the number of overweight and obese people in China will exceed 265 million by 2025.
In the Chinese market, there are already 10 GLP-1-RAs authorized for sale.
Market authorization holder (MAH)
Semaglutide Injection (Ozempic)
Liraglutide Injection (Victoza)
Insulin Degludec and Liraglutide Injection (Xultophy)
Insulin Glargine and Lixisenatide Injection
Polyethylene Glycol Loxenatide Injection (Fulaimei)
Qinghai Chenfei Pharma
Liraglutide Injection (Liluping)
In addition to the above enterprises, more players are preparing to enter the market. According to Insight Database, clinical trials for 112 GLP-1-RAs are going on in China at the beginning of June 2023. The clinical trial sponsors include foreign giants such as Eli Lilly, AstraZeneca, and MSD, as well as Chinese domestic companies, e.g., Hengrui Pharmaceuticals, Gan & Lee, and Tonghua Dongbao.
Among a throng of GLP-1-RAs, Novo Nordisk’s Semaglutide Injection has grabbed attention in China. Semaglutide Injection (Ozempic) for type-2 diabetes was approved by China in 2021. Semaglutide Injection (Wegovy) for weight loss is now under review, following the authorization application submitted in June 2023.
According to Novo Nordisk, Ozempic and Wegovy respectively generated DKK 59.75 billion (circa USD 8.4 bn) and DKK 6.19 bn (874 mn) globally in 2022. Expected to get approval for weight control in China, semaglutide holds much hope for sales growth.
Challenges for GLP-1-RAs in China
Despite GLP-1-RAs’ advantages, the pharmaceutical market in China is not completely rosy. As mentioned above, there are already numerous companies vying for marketing authorization of their GLP-1-RAs. Apart from competitors, stakeholders need to consider some other factors:
1) Long-term dose:
An study published on Diabetes Obesity and Metabolism concludes that one year after withdrawal of once-weekly subcutaneous semaglutide 2.4 mg and lifestyle intervention, participants regained two-thirds of their prior weight loss. So, if patients want to prevent regaining weight, they may need to take the drug without withdrawal. Perhaps other GLP-1-RAs have the similar issue.
2) Patient compliance:
The way by which GLP-1-RAs are taken (subcutaneously or orally), and the frequency of taking each dose, are both factors influencing patients on whether they will strictly follow the medication instructions.
3) Product risk:
GLP-1-RAs may lead to suicidal and self-injury thoughts but without clear-cut conclusion yet. The Icelandic Medicine Agency are analyzing 150 reports of possible cases of suicidal and self-harm thoughts in people using liraglutide and semaglutide medicines. Thus, the European Medicines Agency is reviewing data of GLP-1-RAs, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), to see if the medicines are the cause of the adverse events.
4) Price and reimbursement:
If long-term dose is necessary for patients, price will become prominent when more GLP-1-RAs enter the market, which means patients have more choices. If GLP-1-RAs becomes “popular” or even essential, they may have to be enrolled into China’s basic health insurance system with inevitable price reductions. Like insulins, GLP-1-RAs will possibly be included in volume-based procurement (VBP), a program known for sharp price cuts of products for bulk purchases by hospitals.
In short, a comprehensive evaluation on variable dimensions is a must for market players. Contact BaiPharm if you’d like to know more about drug regulations and market dynamics in China.