Novo Nordisk's Semaglutide Receives CDE Acceptance for Third Indication in China: Chronic Kidney Disease

Sep 02, 2024 00:00 CST Updated 00:00

Novo Nordisk

Insulin Developer and Manufacturer

August 26, 2024, Novo NordiskThe company's "Semaglutide Injection"New IndicationsThe marketing application for "Chronic Kidney Disease CKD" has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).As of now, Novo Nordisk's semaglutide has been approved in China.Two indications: "Type 2 Diabetes" and "Long-term Weight Management."

It is reported that CKD (Chronic Kidney Disease) isCommon Complications of Type 2 DiabetesApproximately 40% of patients with type 2 diabetes will develop CKD. For patients with type 2 diabetes, CKD imposes a significant burden and is a leading cause of morbidity, includingIncrease Cardiovascular Risk and MortalityRate. Although there are currently effective treatments for such patients, individuals with type 2 diabetes still exist.Significant CKD Progression and Cardiovascular EventsThe residual risk. According to the results of the Phase 3 FLOW trial presented by Novo Nordisk at the 84th Scientific Sessions of the American Diabetes Association in June 2024, participants who were randomly assigned to receive 1.0 mg of semaglutide once weekly had a reduced risk of nephropathy-related events.Decreased by 24%。SemaglutideAsNovo Nordisk's star product, first half of the yearRevenue was 88.652 billion Danish kroner, or 13 billion US dollars, a year-on-year increase of 43%,Accounting for 66% of the company's total revenue。Among them,Semaglutide "Hypoglycemic Injection Version" - OzempicSales revenue of 56.685 billion Danish kroner, a year-on-year increase of 36%;Semaglutide "Oral Version for Blood Sugar Control" - RybelsusSales reached 10.931 billion Danish kroner, a year-on-year increase of 32%;Semaglutide "Weight Loss Injection Version" - WegovySales reached 21.036 billion Danish kroner, a year-on-year increase of 74%.Novo NordiskSemaglutide "Oral Version for Blood Sugar Control"Approved in the United States in September 2019 under the brand name Rybelsus, and approved in China in January 2024 under the brand name "Novo Xing". Oral semaglutide is currently the only approved oral GLP-1 drug on the market.As of now,Semaglutide "Oral Weight Loss Version"Not yet approved in any country or region。

About Novo Nordisk

Novo Nordisk is a world-leading biopharmaceutical company dedicated to human health, benefiting patients, doctors, and society with advanced biotechnology. Novo Nordisk hasThe Most Widely Used Diabetes TreatmentProducts, including the most advanced insulin delivery systems, moreover, Novo Nordisk also leads globally in hemostasis management, growth care hormones, and hormone replacement therapy.

Novo Nordisk, headquartered in Copenhagen, the capital of Denmark, currently has branches in 79 countries worldwide, production facilities in 6 countries, over 26,300 employees, and sales in 180 countries. In early 1994, the Novo Nordisk Board of Directors approved a strategic investment plan for China and established a presence in Beijing.Novo Nordisk (China) Pharmaceuticals Co., Ltd. and Biotechnology Research and Development Center have built a modern production plant in Tianjin and established operations in Beijing, Tianjin, Shanghai, Guangzhou, Shenyang, Wuhan, Jinan, and Hong Kong.Centered around a sales network spread across China.

On April 27, 2021, Novo Nordisk's "Semaglutide Injection" (brand name: Ozempic®) was officially approved by the National Medical Products Administration.，Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Registration Certificate No.: National Medicine Approval No. SJ20210014 and SJ20210015, Product Specifications: 1.34:1.5ml and 1.34:3ml.

On August 16, 2022, Novo Nordisk® Semaglutide Injection as an "auxiliary treatment for low-calorie diet and increased physical activityThe phase III clinical trial for the indication of "adult patients with an initial body mass index (BMI) ≥30kg/m² (obese), or ≥27kg/m² and <30kg/m² (overweight) and accompanied by at least one comorbidity associated with overweight" has been completed.

On March 24, 2023, Novo Nordisk® announced the treatment of adult patients with type 2 diabetes using oral semaglutide Rybelsus (25mg and 50mg).Positive Key Results of the IIIb Phase PIONEER PLUS Study Show Reductions in Blood Sugar and Weight Loss.

In the field of oral weight-loss medicationsIn September 2022, Pfizer also announced the results of a Phase 2b clinical trial of its oral GLP-1 receptor agonist Danuglipron.As a result, data shows that danuglipron has achieved good results in reducing patient weight and is suitable for the treatment plan of obesity. Its phase III clinical trial is planned to start in early 2022, with market application submitted in 2025 and approval obtained in 2026.

On April 6, 2023, Novo Nordisk's oral semaglutide tablet initiated its first Phase III clinical trial for "weight loss" in China.This clinical trial will enroll 200 patients and will be conducted across 15 hospitals, including Peking University People's Hospital, Shanghai Pudong New Area People's Hospital, Huashan Hospital Affiliated to Fudan University, and the Second Affiliated Hospital of Nanjing Medical University.

On May 22, 2023, Novo Nordisk announced the weight loss Phase IIIa OASIS 1 study data for the oral version of semaglutide 50mg tablets.The study results showed that after 68 weeks, patients in the oral semaglutide 50mg group had lost 17.4% (18.34kg) of their body weight, while patients in the placebo group had lost 1.8% (1.9kg).

In June 2023, Eli Lilly announced a drug named OrforglipronGLP-1RA Oral TabletsPhase 2 Clinical Trial Data for Obese or Overweight PatientsAfter taking Orforglipron for 36 weeks, patients experienced an average weight loss of 14.7%. In August 2023, according to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, Eli Lilly has launched a Phase 3 clinical trial of Orforglipron in China for adults with obesity or overweight.

On January 26, 2024, Novo Nordisk's oral semaglutide tablets were approved for marketing., used to treat adult Type 2 diabetes, with the brand name "NovoRin". It is reported that,Novo Xinx is the world's first and only innovationOral GLP-1RA receptor agonists are expected to lead the new standard for oral hypoglycemic treatment in China.

On January 31, 2024, Novo Nordisk released its 2023 financial report, with total sales of approximately USD 34.43 billion in 2023., a year-on-year increase of 36%; net profit was approximately US$12.405 billion, a year-on-year increase of 51%. Among this, the products Ozempic, Rybelsus, and Wegovy containing semaglutide had annual sales of approximately US$21.615 billion, a year-on-year increase of 88.78%, accounting for 62.78% of total revenue.

On May 9, 2024, Novo Nordisk entered into a strategic collaboration with Flagship and its subsidiary Metaphore to jointly develop two next-generation therapies for weight loss.Metaphore will collaborate withFlagship'sPioneering Medicines, the internal drug development division, and Novo Nordisk jointly conduct R&D projects. Metaphore is responsible for product development and preclinical research, while Novo Nordisk advances these projects to the clinical stage.

On June 24, 2024, Novo Nordisk announced that the company will invest $4.1 billion inConstruction of Second Filling and Finishing Manufacturing Plant in Clayton, North Carolina, USADrug for the production of Semaglutide with two indications: "Weight Loss and Diabetes". It is reported that,New FactoryTotal area reached26 acres, adding 1.4 million square feet of production space for aseptic manufacturing and finished product production processes, with construction to be completed in phases between 2027 and 2029.

On June 25, 2024, Novo Nordisk announced that its "Semaglutide Injection" (brand name: Wegovy®), developed and manufactured for long-term weight management, has been officially approved for marketing by the National Medical Products Administration.。It is reported that,NovoErect® is the world's first and currently the only GLP-1RA weekly formulation for long-term weight management, capable of achievingAverage 17% (16.8kg)TheBodySignificant Reduction。

On August 7, 2024, Novo Nordisk released its financial report for the first half of 2024, with revenue of 133.4 billion Danish kroner, equivalent to 19.5 billion US dollars, increasing by 24% year-on-year. Net profit was 45.5 billion Danish kroner, equivalent to 6.65 billion US dollars, increasing by 16% year-on-year.