The 6th China International Import Expo (CIIE) is here, and this year’s medical devices and pharmaceutical healthcare exhibition area has attracted global pharmaceutical giants.
This year, GLP-1 (Glucagon-Like Peptide-1) drugs have gained unprecedented attention for their outstanding performance in diabetes and weight loss fields, being considered by some as a “miracle weight loss drug.” It was noted by The Paper that at this year’s CIIE, three multinational pharmaceutical companies, Novo Nordisk, Eli Lilly, and Boehringer Ingelheim, all showcased or introduced GLP-1 drugs in various forms, though none of them displayed physical products.
Novo Nordisk Presents Semaglutide Weight Loss Adaptation Literature
Founded in 1923 and headquartered in Denmark, Novo Nordisk operates in various disease areas such as diabetes, obesity, and rare diseases. In the GLP-1 field, Novo Nordisk has two major products: liraglutide and semaglutide. These drugs are not only approved for diabetes treatment worldwide but also for weight loss. In China, both GLP-1 drugs are currently approved for diabetes treatment.
At the exhibition, Novo Nordisk displayed NovoTai (the commercial name of semaglutide for diabetes adaptation) which was approved for sale in China in April 2021. It was later included in the 2022 National Medical Insurance Catalog and comes in two specifications: 0.25mg/0.5mg (2mg pre-filled pen) and 1.0mg (4mg pre-filled pen).
Semaglutide’s weight loss adaptation was not displayed with specific products or information, but rather with a paper version published in JAMA titled “Effects of Once-Weekly Subcutaneous Semaglutide vs. Placebo on Weight Loss in Overweight or Obese Adults: The STEP 4 Randomized Clinical Trial.”
In addition, Novo Nordisk briefly presented the oral version of semaglutide, which has been approved for sale in several countries and regions, including the United States, Europe, and Japan, with a new drug application submitted in China in May 2022.
In the global third-quarter report, Novo Nordisk emphasized the important contribution of the Chinese market to the company in the field of GLP-1 therapy for diabetes. In the first three quarters of 2023, calculated in Danish kroner, sales in China increased by 80%, and when calculated at a fixed exchange rate, it grew by 95%. This sales growth reflects the use of Ozempic (the English product name for semaglutide for diabetes adaptation), with GLP-1 drugs accounting for 3.3% of diabetes total prescriptions in the past 12 months, up from 2% a year ago. Novo Nordisk is the leader in the Chinese market, with a market share of 74.6%.
So when can semaglutide’s weight loss adaptation be approved in China? In early June, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) website showed that Novo Nordisk’s semaglutide injection’s new adaptation approval application had been accepted. It is widely believed within the industry that this approval application is likely related to weight loss. On November 5, staff at Novo Nordisk’s booth informed reporters that the “once-weekly injection of semaglutide 2.4 mg” for long-term weight management, known as Wegovy overseas, has been submitted for approval and accepted by the National Medical Products Administration in China.
Lilly Showcases “Diabetes and Obesity” with Dual Screens
Lilly Pharmaceuticals, founded in the United States in 1876, opened its first overseas representative office in Shanghai as early as 1918. Currently, Lilly’s business in China covers multiple areas, including diabetes, oncology, immunology, pain, and neurodegenerative diseases. In the GLP-1 race, Lilly’s Tirzepatide is a dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. It has been approved for type 2 diabetes treatment in the United States, the United Arab Emirates, the European Union, Japan, and is also used for diabetes treatment.
Tirzepatide contributed $483 million in revenue to Lilly in 2022 solely from diabetes adaptation. The latest third-quarter report shows that Tirzepatide’s total sales revenue in the first three quarters reached $2.96 billion, with first-quarter sales of $570 million, second-quarter sales of $980 million, and third-quarter sales revenue of $1.41 billion.
Unlike Novo Nordisk, Lilly made a more prominent display of GLP-1 drug-related content at this year’s CIIE. Reporters from The Paper observed that Lilly had set up a “Diabetes and Obesity” area, with one screen displaying Tirzepatide information and another screen showing educational content about obesity and weight management. In addition, the booth had intelligent body measurement devices, allowing attendees to learn about obesity-related body data.
In China, the application for Tirzepatide’s diabetes adaptation was accepted by regulatory authorities in September 2022. In August, Lilly China announced that its Tirzepatide injection had formally been accepted for registration for long-term weight management in overweight patients with at least one weight-related comorbidity following a low-calorie diet and increased physical activity.
On October 3, Lilly presented the latest research data on Tirzepatide at the 59th annual meeting of the European Association for the Study of Diabetes (EASD). The results showed that Tirzepatide (10 mg, 15 mg) achieved significant and clinically meaningful weight loss in Chinese adults with obesity and overweight who had completed a 12-week intensive lifestyle intervention and a total average weight loss of 26.6% during the 84-week trial period.
It’s worth noting that Lilly is also collaborating with Chinese biopharmaceutical company Innovent Biologics to advance Marzodegib (IBI362), a GLP-1/GCGR dual agonist. According to Innovent’s announcement on October 30, high-dose Marzodegib (9 mg) in a Phase II clinical study of Chinese overweight participants reached the main research endpoints after 24 weeks of treatment, demonstrating significant weight loss, excellent safety, and multiple metabolic benefits, suggesting its potential as a superior choice for long-term weight management in moderately to severely obese Chinese individuals. Innovent plans to initiate a Phase III clinical trial of Marzodegib 9 mg in Chinese overweight participants by the end of 2023.
Boehringer Ingelheim’s Low-Key Approach to the Obesity Field
Boehringer Ingelheim entered China in 1994, with its Chinese headquarters located in Shanghai. In the GLP-1 field, Boehringer Ingelheim’s investigational product, surVodutide, is also at a leading global stage. However, at this year’s CIIE, Boehringer Ingelheim did not display much related information at its booth, only mentioning its involvement in obesity in the area of cardiovascular, renal, and metabolic diseases in the human pharmaceutical R&D pipeline display.
Nonetheless, there is a substantial amount of public information about Boehringer Ingelheim’s GLP-1 weight loss drugs. SurVodutide is an innovative drug developed through a collaboration between Boehringer Ingelheim and Zealand Pharma. Previously released global multicenter Phase II clinical trial data indicated a 19% weight loss after 46 weeks of surVodutide treatment.
During the 2023 Boehringer Ingelheim China R&D Day held before CIIE, Zhang Wei, Senior Vice President of R&D and Medical for Greater China, stated in an interview with The Paper that Zealand focuses on innovative peptide drugs, while Boehringer Ingelheim specializes in developing new drugs for cardiovascular, renal, and metabolic system diseases. The collaboration between the two can achieve a synergistic effect.
Zhang Wei believes that obesity is not just a fashion or aesthetic concept, but a disease that can lead to many other health issues. Prior to the recent surge in interest in GLP-1 drugs, Boehringer Ingelheim had already been working on the development of surVodutide, not chasing trends.
Regarding the current popularity of GLP-1 drugs, Zhang Wei expressed to reporters that he hopes this “fire” is not just a temporary enthusiasm but a sustainable commitment. For pharmaceutical companies, “this is drug development, not a weight loss project; drug development needs scientific evidence supported by evidence-based medicine.” Clinical development for surVodutide in indications related to overweight, obesity, and their associated conditions is ongoing.
Reporters learned that in August, Boehringer Ingelheim submitted three simultaneous Phase III international multicenter studies worldwide to further confirm surVodutide’s efficacy and safety after a 46-week treatment period. In September, the company submitted another Phase III multicenter clinical trial, designed specifically for China, to provide evidence-based medicine evidence for surVodutide’s efficacy and safety in Chinese overweight or obese populations. More research details will be announced before the start of the study, with patient enrollment expected to begin in early 2024.