Semaglutide has been predicted to be the next global "king of medicines", and no one wants to miss this feast
Text | Xin Ying, Zhao Tianyu
Ed Wang Xiao
The clarion call for the "diet pill war" sounded again.
On June 25, 2024, the NMPA approved semaglutide injection for long-term weight management in adults.
The drug is suitable for two groups of people, one is obese patients with an initial body mass index BMI greater than or equal to 30kg/m2; The other group is overweight, i.e., with a BMI between 27 kg/m2 and 30 kg/m2 and at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.
The prescription drug comes from the multinational pharmaceutical company Novo Nordisk, with the trade name Novo Balance, and the price has not yet been announced. The relevant person in charge said that the relevant process of drug supply has been officially launched.
In fact, semaglutide has been approved in China for three years as a hypoglycemic drug, with the trade name Novotechy, but what really makes it out of the circle has always been the "weight loss effect". This GLP-1 receptor agonist, by binding to GLP-1 receptors in areas of the brain associated with appetite regulation, helps patients reduce hunger, increase satiety, and reduce body weight by reducing caloric intake.
With soaring sales, semaglutide has been predicted to be the next global "king of medicines", and Novo Nordisk has taken advantage of this fame and fortune to gain both wealth and market value. As of June 26, 2024, Nord Nordisk's market capitalization reached 4.7 trillion yuan, second only to Eli Lilly's 6.1 trillion yuan in the global pharmaceutical industry, and the latter also has a GLP-1 drug Tirzepatide (tirzepatide) that has become a "hit".
At the same time, the army of generic drugs with low prices as a weapon is only waiting for the patent to expire, and on March 20, 2026, the patent of Novo Nordisk semaglutide compound in China is about to expire.
And those developers who have taken the lead are still trying their best to promote a number of clinical trials to dig a wider moat and expand a broader market.
Countdown to generic drug involution
Generic drug companies can't wait.
In January 2024, the marketing application submitted by Jiuyuan Gene for semaglutide injection "Jiyoutai" for the treatment of type 2 diabetes was accepted, becoming the first semaglutide biosimilar to be declared for marketing, that is, a generic drug. It is expected that when the patent door is opened, it will rush into the field as soon as possible.
There is a huge market space in the field. According to the Report on the Status of Nutrition and Chronic Diseases in China (2020), more than half of Chinese adults are overweight or obese, with 34.3% of adult residents (≥ 18 years old) being overweight and 16.4% obese.
The first wave of semaglutide to defend against is the "patent war", that is, Novo Nordisk has less than two years of good time.
In June 2021, Huadong Medicine has submitted a patent invalidation application for semaglutide. Although Novo Nordisk subsequently submitted self-supporting materials, the CNIPA considered these materials insufficient to prove the validity of its patent, so in September 2022, the CNIPA issued a patent invalidation. However, this decision has not yet taken effect, and Novo Nordisk has appealed to the Beijing Intellectual Property Court.
In the generic drug marketing application, Jiuyuan Gene also mentioned the issue of patent barriers, that is, during the validity period of Novo Nordisk's patent, even if the drug is approved, it cannot be commercialized.
Like Jiuyuan Gene, there are too many pharmaceutical companies that are optimistic about the future market. According to the records of the clinical trial website, at least 15 generic semaglutide drugs are in the clinical stage, and the existing CSPC Pharmaceutical Group, Chia Tai Tianqing, Qilu Pharmaceutical, Huadong Medicine, Sihuan Pharmaceutical, Livzon Group, etc., which have entered the phase III clinical trial, are mostly veteran enterprises with outstanding commercialization teams, and the degree of competition can be imagined.
Once the patent ban is lifted, the second round is the "hospital battle".
Whether it is hypoglycemic or weight loss, semaglutide, as a prescription drug, is still the first to open up the market in hospitals.
The entry of generic drugs into the hospital is more about the ability to commercialize, and the advantages of the sales network of some traditional domestic old pharmaceutical companies should not be underestimated. In 2022, Huadong Medicine has 8,496 sales personnel, and its huge sales team has supported Huadong Medicine to occupy 30% of the market share of acarbose, a commonly used diabetes drug, in the early stage, second only to Bayer, the original pharmaceutical company.
Of course, in the end, there is still a price war. Although the pricing of Novo in China has not yet been announced, it can refer to other markets. Semaglutide costs $1,349 per month in the U.S., $140 in Germany and $92 per month in the U.K.
According to Yicai, Novo Nordisk's global president and CEO Zhou Fude once said that the difference in drug pricing is due to the difference in the health care system of various countries. "Drug price reductions are mainly in different markets, through the payer's medical insurance negotiation, based on the value of the drug, and reach an agreed price with the payer."
Although the indication for weight loss is not included in the medical insurance, as a hypoglycemic drug, "Novotech" has entered the Chinese medical insurance. According to a person in the pharmaceutical industry, the price of the original 1.5ml specification of semaglutide is less than 500 yuan, which is basically enough for a month, and the terminal price of the same domestic generic drug may be reduced to 100 yuan.
According to an article published in the international journal Nature on June 19, some Indian generic drug companies have said that the cost of generic semaglutide may be reduced by at least half, and the price may eventually reach one-tenth of the current drug price.
Previously, the sales channel of semaglutide in Internet e-commerce has been opened, so the price of generic drugs of all parties in the future is almost transparent, and the stage for "price comparison" involution has been set up.
Beyond the star medicine
Novo Nordisk published clinical trial results showing that compared with placebo, Novo Ying achieved an average weight loss of 17% (16.8kg) and could last for 16 months.
If this kind of drug only has a weight loss benefit, it will not be enough in 2024. The world's major GLP-1 drug OEMs, Novo Nordisk and Eli Lilly, are ambitious and are promoting several clinical trials, covering more and more sophisticated areas to explore a broader market.
In the first quarter of 2024, Novo Nordisk completed a clinical trial confirming a clear renal benefit of semaglutide 1.0mg in adults with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), and a new development in the United States was approved to reduce cardiovascular risk in overweight or obese patients with confirmed cardiovascular disease.
Eli Lilly, on the other hand, focuses on sleep apnea. Results from a 2024 phase 3 clinical trial of tirzepatide showed a reduction in apnea-hypopnea index in adults with moderate to severe obstructive sleep and obesity compared with placebo.
The two multinational pharmaceutical companies are willing to raise their heads and make a big fuss about GLP-1 because this type of drug has indeed become an out-and-out "cash cow".
Novo Nordisk's sales in the first quarter of 2024 increased by 22% to DKK 65.3 billion (about 68 billion yuan), of which sales in diabetes and obesity treatment areas increased by 25% to DKK 61 billion.
Although Novo Nordisk's sales in the field of rare diseases showed a negative growth of 4% in the first quarter, the company's overall performance was still significantly boosted by GLP-1 drugs.
According to Novo Nordisk, the growth was mainly driven by the GLP-1 diabetes treatment area and the obesity treatment area. Among them, sales in the field of GLP-1 diabetes treatment increased by 30%, and sales in the field of obesity treatment increased by 41%.
Novo Nordisk's competitor in the GLP-1 field, Eli Lilly, also saw a growth of more than 20 percent.
According to the first quarter report of multinational pharmaceutical company Eli Lilly in 2024, global revenue was 8.77 billion US dollars (about 63.7 billion yuan), an increase of 26% compared with the same period last year, due to the sales of Mounjaro, Zepbound and other diabetes and anti-cancer drugs.
Among them, Mounjaro and Zepbound are all tirpatide, which is a GLP-1-related drug, but the indications are different, and different trade names are used, which are used in type 2 diabetes and adult weight loss.
This also led to a rise in net profit, which rose to $2.24 billion in the first quarter of 2024, an increase of 67% over the same period last year.
Only launched in September 2022, the hypoglycemic drug Mounjaro has reached $5.163 billion in sales in 2023, while the weight loss drug Zepbound has a revenue of $175.8 million in less than two months after its launch. For the full year of 2023, total sales of tirpatide have reached $5.339 billion.
Eli Lilly is looking for ways to solve the problem of short supply of medicines.
In Japan, Eli Lilly is investing 7 billion yen to expand production capacity at its Kobe plant, and Eli Lilly Japan President Simone Thomsen said it would complete the expansion by the end of the year. In May, Eli Lilly also announced an additional investment of $5.3 billion in its Lebanon, Indiana, U.S. manufacturing site to produce tirpatide to meet market demand for Mounjaro and Zepbound.
Eli Lilly raised its full-year 2024 revenue guidance by $2 billion to $42.4 billion to $43.6 billion, driven by strong performance from Mounjaro and Zepbound and capacity expansion.
Expanding production is the unified idea of these weight loss drug giants. On June 24, Novo Nordisk said it would spend $4.1 billion to build a new plant for the production of semaglutide for weight loss and diabetes. The 1.4 million-square-foot facility is located on the Clayton campus in North Carolina, USA.
Losing weight is a protracted tug-of-war with yourself. Even with the blessing of the diet pill "Overlord", human beings still can't do it once and for all.
A 2021 clinical trial published in the Journal of the American Medical Association (JAMA) to study the effects of semaglutide after discontinuation showed that about 800 participants who were given semaglutide once a week lost an average of 10.6% of their body weight over a 20-week period. Then, one-third of the participants were switched to a placebo for 48 weeks. The results showed that those who switched to a placebo rebounded 6.9% of their body weight.
Cleveland Clinic research showed that among obese patients who were prescribed weight loss drugs (semaglutide, liraglutide, phentermine-topiramate, naltrexone-bupropion, orlistat), 44% were still taking the drug after three months, 33% were still taking the drug after six months, and only 19% were still taking the drug after one year. Among them, 63%, 56% and 40% of obese patients who used semaglutide were still taking semaglutide after three months, six months and one year, respectively.
Whether to use drugs for a long time is not only a challenge for weight lossers, but also a continuous challenge for these pharmaceutical companies.