Recently, the Chinese Diabetes Society ("CDS") released the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition) ("CDS Guidelines 2020"). Fulaimei (Polyethylene Glycol Loxenatide Injection), a GLP-1 receptor agonist weekly formulation independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma"), is included in the CDS Guidelines 2020 for its excellent efficacy and safety. As China's first independently innovative long-acting GLP-1 hypoglycemic drug, and the world's first PEGylated long-acting hypoglycemic drug, Fulaimei defends health with technology and benefits patients with innovation. It's part of key science and technology projects under the Major New Drug Innovations initiative; and has obtained two national invention patents, and also patents in other countries and regions such as Europe, the US and Japan.
▲ Fulaimei (Polyethylene Glycol Loxenatide Injection)
Reduced dosing frequency and optimized efficacy with innovation
The CDS Guidelines are updated every three years and are the authoritative guidelines in the field of diabetes treatment. With respect to hyperglycemia, the CDS Guidelines 2020 have made great adjustments in drug recommendation for second-line treatment: For "patients with combined ASCVD or high-risk factors, heart failure, or CKD", SGLT-2i (sodium-glucose cotransporter 2 inhibitor) or GLP-1RA (glucagon-like peptide-1 receptor agonist) is recommended in dual-agent therapy, which keeps consistent with foreign guidelines. The new guidelines specifically state that GLP-1RA is effective in lowering blood glucose and partially restoring pancreatic beta-cell function, as well as in lowering body weight, improving lipid profile and protecting kidney function. The efficacy of Fulaimei in lowering glucose is clear, with a rapid onset of action, the hypoglycemic effect can be exerted within 1 hour after injection, and steady-state plasma concentration can be achieved after 4-week continuous injection; the efficacy is stable, and only once-a-week self-administration is required. In the past two years since its launch, Fulaimei has provided doctors and patients with a new strategy for highly efficacious, safe and easy glucose control and a new drug treatment option.
It is worth mentioning that the polyethylene glycol loxenatide injection pen can be used many times, which is cost effective and environmentally friendly; long-term use can be easy for patients since the operation is simple and there's no need to mix evenly before use and to consider meal time for injection.
Higher safety, a new choice for intelligent glucose control
Traditional hypoglycemic drugs often increase the risk of hypoglycemia while intensively lowering glucose, and the high frequency of drug administration, adverse drug reactions and complexity of therapeutic regimens can lead to poor compliance, which not only affects patients' life health and quality of life, but also causes them to lose confidence in treatment and fall into a vicious circle of disease treatment.
Fulaimei has a good safety profile and can significantly reduce the incidence of adverse reactions while controlling glucose. Since the glucose-lowering mechanism of GLP-1RA is glucose concentration dependent, it has a significantly lower incidence of hypoglycemic events (≤2.2%) compared to traditional hypoglycemic drugs, whether in the case of monotherapy or combination with metformin.
Improved accessibility of high-quality drugs to benefit patients
As a national Class 1 new drug, Fulaimei was approved for marketing in China in May 2019, and was included in the National Reimbursement Drug List at the end of December 2020. The reimbursable price is now RMB 187/0.2mg, and the out-of-pocket part is only about RMB 8/day.
The inclusion of Fulaimei in the National Reimbursement Drug List is conducive to improving the accessibility and affordability of domestic innovative drugs as well as the standardization of clinical treatment, allowing more patients to benefit from high-quality domestic drugs and bringing more social benefits.
In addition to Fulaimei, other members of the "Fulai Family", such as Fulaidi (Repaglinide Tablets), Fulairui (Canagliflozin Tablets), and Fulaixin (Empagliflozin Tablets), have successfully won the bid for the fourth batch of national centralized drug procurement.
Fulaidi (Repaglinide Tablets) is a key variety of Hansoh Pharma's diabetes product line, indicated for patients with type II diabetes (non-insulin-dependent) whose hyperglycemia cannot be effectively controlled by diet, weight reduction and exercise; Fulairui (Canagliflozin Tablets) and Fulaixin (Empagliflozin Tablets) are highly selective sodium-glucose cotransporter 2 (SGLT-2) inhibitors that, in addition to having clear glucose-lowering effects, reduce body weight, the risk of cardiovascular events and the progression of nephropathy in patients with diabetes. Through the "Fulai Family", Hansoh Pharma offers differentiated treatment solutions catering for different medication needs of diabetic patients, innovating to address their personalized treatment needs while bringing all-round, multi-choice medication experience and survival benefits to more diabetic patients.
As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma always puts patient benefits in the first place, stays committed to improving human health through continuous innovation with a focus on the treatment of major diseases in the fields of oncology, CNS, anti-infectives, diabetes, etc., keeps working on the unmet medical needs in clinical practice, and strives to create excellence in pharmaceuticals, enhance innovation in China, help advance the Healthy China initiative, and contribute to improving people's health.
