June 25th. Novo Nordisk announced that the National Medical Products Administration has approved its research and production of Novo Nordisk; reg; The marketing application of Smegglutide Injection for long-term weight management in China has been approved for the treatment of obesity in overweight and obese patients (with an initial BMI greater than or equal to 30kg/m2; or between 27kg/m2 and 30kg/m2, and at least one weight related comorbidities).
As the major indication was officially approved in China, on June 24th local time, Novo Nordisk announced on its official website that it plans to invest $4.1 billion (approximately 27 billion Danish kroner) to expand its manufacturing capacity in the United States.
Specifically, Novo Nordisk plans to build a second filling and precision manufacturing plant in Clayton, North Carolina, USA, and enhance its ability to produce existing and future injection therapy drugs for patients with obesity and other serious chronic diseases. The construction will be gradually completed between 2027 and 2029.
Novo Nordisk stated that this expansion is one of its largest manufacturing investments in history, adding 1.4 million square feet of production space for sterile manufacturing and finished product production processes, doubling the total construction area of its three existing factories in North Carolina. In addition to nearly 2500 Novo Nordisk employees already working in the region, this expansion will also add 1000 new job positions.
In fact, the production capacity issue of GLP-1 is currently a headache for several major global giants, including some domestic industry chain companies that are also starting to profit from it. For example, Nordic Biotech has announced consecutive overseas GLP-1 production orders in the past year, and its latest forecast shows that its performance in the first half of this year has exceeded that of the entire year last year.
In fact, Novo Nordisk has announced multiple times this year to expand production capacity. On February 5th, Novo Holdings, the controlling shareholder of Novo Nordisk, agreed to purchase Catalent located in Somerset, New Jersey for $16.5 billion (including debt). As part of the transaction, Novo Holdings will resell the three most critical bases in Catalent to Novo Nordisk for $11 billion; On March 19th, Novo Nordisk announced an investment of approximately 4 billion yuan (approximately 551 million US dollars) in Tianjin for the expansion project of sterile preparations; On June 23rd, Novo Nordisk announced that it had abandoned plans to build a large factory in Dublin, Ireland, but still planned to expand its factory in Aslon, Ireland.
By this calculation, Novo Nordisk's investment in expanding production in the first half of this year has reached $15.651 billion.
The main purpose of Novo Nordisk's multiple expansions is to expand the production capacity of Smegglutide. Smeglutide is a star product of Novo Nordisk, mainly including Smeglutide injection Ozempic and Smeglutide tablet Rybelsus for type 2 diabetes, and Smeglutide injection Wegovy for weight management.
In 2023, the total sales of Novo Nordisk's three Smegglutide products were approximately 145.811 billion Danish kroner (approximately 21.201 billion US dollars), a year-on-year increase of 88.78%, accounting for 62.78% of the total revenue. At that time, some in the industry believed that due to production capacity limitations, Smegglutide had not yet demonstrated its full potential for performance.
After the popularity of Smegglutide due to its "weight loss" effect, its market sales have been increasing day by day. And this high prosperity will continue, according to JPMorgan Chase's forecast, the GLP-1 market size will reach 71 billion US dollars by 2032.
But as Smegglutide is launched and sold in multiple countries and regions around the world, Novo Nordisk's production capacity is frequently in short supply. Last May, due to limited production capacity, Novo Nordisk halved the initial dose supply of Wegovy for new patients in the United States. In addition, at that time, Novo Nordisk also delayed the supply of Wegovy in the European market. A similar situation has also occurred in our country. In June last year, when answering questions from investors, the People's Pharmacy stated that due to a shortage of upstream supply, there are currently fewer stores operating Simeglufu Injection, and the company occasionally receives a small amount of goods. Today, Smegglutide injection has been approved for use in overweight and obese patients in China. If production capacity is not expanded, the shortage of Smegglutide production capacity will further exacerbate.
In this situation, Novo Nordisk also faces competition for food. In November last year, Novo Nordisk's longtime rival, Lilly, obtained approval from the US Food and Drug Administration (FDA) for the use of Zepbound as an indication for weight loss.
Compared to semaglutide, telposide has significant advantages in both price and efficacy. In terms of efficacy, telposide is the world's first GIPR/GLP-1R dual target agonist. According to a SURPASS-2 Phase III trial conducted by Lilly in 2021, patients who used 5mg, 10mg, and 15mg of telposide lost an average of 1.9kg, 3.6kg, and 5.5kg (P< 0.001) more weight compared to semaglutide. The proportion of patients with weight loss of 5%, 10%, and 15% was significantly higher in the different doses of telposide group than in the smeglutide group. In terms of price, Wegovy (the product name of Smegglutide Weight Loss Certificate) is priced at $1350 per month in the United States, while Zepbound is priced at $1059.87 per month, which is about 20% lower than the former.
According to data disclosed by Lilly at the beginning of this year, Zepbound's sales reached $175.8 million in just one month after its opening, and achieved a revenue of $517 million in the first quarter of 2024. According to a research report by Dongwu Securities, the sales growth rate of Tilposide is faster than that of Smegglutide, and it has great potential in the future.
But like Novo Nordisk, Lilly also faces capacity shortages. So, in the context of a market where supply is in short supply, whoever has higher production capacity has the possibility of winning a larger market share, and the production capacity war between the two giants has already begun.
In April of this year, Lilly invested $2.5 billion in the construction of a new factory in Frankfurt, Germany. The factory is mainly used for producing injectable drugs and pens, aiming to address drug shortages including the GLP-1 drug Zepbound. The factory is expected to start construction this summer and officially operate in 2027, with shipments to the world. On May 24, Lilly announced an additional investment of 5.3 billion dollars to expand the capacity of its manufacturing base in Lebanon, Boone County, Indiana, to meet the market demand for the diet drug Zepbound and the diabetes drug Mounjaro.