On June 25th, Novo Nordisk China announced that the National Medical Products Administration (NMPA) had recently approved the marketing application of Novo Nordisk's research and production of Novo Nordisk's Novo Nordisk (Smegglutide Injection for long-term weight management) in China. It is understood that Novoying is the world's first and currently the only weekly preparation of glucagon like peptide-1 receptor agonist (GLP-1RA) used for long-term weight management.
It is worth noting that in another announcement released on June 24th, Novo Nordisk also announced that the company will invest $4.1 billion (approximately 27 billion Danish kroner) to expand its manufacturing capacity in the United States. In May, Lilly also invested heavily to increase the output of its key active ingredient "Tirzepatide" for weight loss and diabetes treatment.
The frequent expansion of the "weight loss drug duo" indicates that the next "battle" for GLP-1 drugs after approval will be production capacity.
Average weight loss of 17%
According to the official website of Novo Nordisk China, the STEP series clinical trial of Novo Nordisk (Smegglutide Injection for Long Term Weight Management) began in June 2018 and has completed 14 studies, with a duration of 11-24 months and an average treatment period of up to 34 months.
Specifically, the STEP series of clinical trial data show that no matter whether type 2 diabetes is combined or not, for overweight and obese adults in different regions, different races, different ages, and different sexes, Novoying can significantly reduce their weight, with an average weight loss of 17% (16.8kg), and has good safety and tolerance.
It is reported that in obese patients, Novoying can help reduce hunger, increase satiety, and lower food cravings, thereby helping patients reduce calorie intake and weight loss. In addition, Novo&Young; reg; Through gene recombination technology, while maintaining a high homology of 94% with human GLP-1, the half-life is extended to 7 days, achieving once a week administration.
As the original research and development enterprise of Smegglutide Injection, Novo Nordisk has obtained approval from the US Food and Drug Administration (FDA) for three Smegglutide drugs, namely Ozempic (injectable hypoglycemic drug), Wegovy (injectable weight loss drug), and Rybelsus (oral hypoglycemic drug).
In China, Novo Nordisk has previously approved a Smegglutide injection (Novo Nordisk) and an oral Smegglutide tablet (Rybelsus), both of which are indicated for hypoglycemic purposes. These two products have achieved good results in the Chinese market.
According to Novo Nordisk's 2023 annual report data, sales of Smegglutide injections in the China region increased by 97%. The sales growth is mainly reflected in the improvement of acceptance. The proportion of GLP-1 in the total prescription drugs for diabetes has increased from 1.6% a year ago to 3%, accounting for 71.1% of the market share in China. According to the company's first quarter report, the sales revenue of Rybelsus oral tablets in China has reached DKK 55 million (approximately RMB 57.24 million) since its approval for listing in China in January this year.
As Novo Nordisk's first weight-loss indication drug, Smegglutide, approved in China, it is worth looking forward to the changes it will bring to the company's performance in China in the future.
The next "battle" is production capacity
On June 24th local time, Novo Nordisk also announced another news on its global official website, stating that the company will invest $4.1 billion (approximately RMB 29.78 billion) to expand its manufacturing capacity in the United States.
Novo Nordisk plans to build a second filling and precision manufacturing plant in Clayton, North Carolina, USA, to enhance its production capabilities for the drugs Wegovy and Ozempic related to semaglutide.
Novo Nordisk also stated that a $4.1 billion facility has begun construction, covering a total area of 26 acres and adding 1.4 million square feet of production space for sterile manufacturing and finished product production processes. The construction will be gradually completed between 2027 and 2029.
In fact, since the second half of last year, Novo Nordisk has gradually expanded its supporting production capacity facilities for Smegglutide drugs. The reason is that the supply of Wegovy and Ozempic drugs is in short supply, resulting in intermittent shortages in the US market.
Last November, Novo Nordisk announced plans to invest over 42 billion Danish kroner (approximately RMB 44.1 billion) starting this year to expand its factory in Denmark to produce a product portfolio for current and future severe chronic diseases. This investment will enhance its ability to meet future market demand, including GLP-1 products.
In February of this year, Novo Nordisk acquired American pharmaceutical company Catalent in an all cash transaction for $11.5 billion. As part of the transaction, Novo Nordisk will acquire three filling factories belonging to Contilent from Novo Holdings. Novo Nordisk said that the acquisition will help its current and future manufacturing network for the treatment of diabetes and obesity. It is expected that the acquisition of the production base will be completed by the end of 2024, and the filling capacity of the company will be gradually improved from 2026 onwards.
Lilly, also known as the "weight loss drug duo" alongside Novo Nordisk, is accelerating its expansion of production. In May this year, Lilly announced that it would spend 5.3 billion US dollars (about 38.5 billion yuan) to expand its factory in Indiana to increase the production of the key active ingredient "Tirzepatide", which is used to treat weight loss and diabetes. It is understood that this is the largest investment in Lilly's nearly 150 year history.
On the domestic side, the research and development of GLP-1 drugs is still in a race. In addition to the approval of Liraglutide from East China Medicine and Benarutide from Renhui Biotechnology, Xinda Biotechnology is at the forefront of introducing the glucagon like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist Masalidomide from Lilly. In February of this year, the first new drug application for Xinda Biologics Masalidomide was accepted by the Drug Evaluation Center of the National Medical Products Administration for long-term weight control in adult obese or overweight patients.
