On November 8th local time, Lilly announced that its GLP-1R/GIPR dual target agonist Tirzepatide injection has been approved by the FDA for weight loss indications. Affected by this news, overseas biopharmaceutical and weight loss drug concepts have both surged, but today the domestic weight loss drug concept has surged and fallen back.
The approval of the weight-loss indication for Tilposide may be like the moment when PepsiCo was born and faced the competition from Coca Cola. "Wang Heng, the general manager of Beijing Besley Marketing Planning Co., Ltd., described this moment to a reporter from Cailian News Agency, and stated that Lilly is much stronger in terms of commercialization ability and accessibility compared to Pinot and Nord. Moreover, Tilposide is a dual target, and the weight loss effect" me better "is more obvious, In the golden expansion period of weight loss pills, the situation of Novo Nordisk and Lilly Dragon Fighting has basically taken shape.
The Battle of Coca Cola
On November 8th local time, the US FDA announced a news that caught the attention of global investors: Lilly's Tirzepatide injection has been approved for long-term weight management under the trade name "Zepbound".
The press release on Lilly's official website mentioned that Zepbound is expected to be launched in the United States by the end of this year, with a total of 6 doses listed at $1059.87, which is about 20% lower than the selling price of Novo Nordisk Wegovy.
As one of the evidence for this approval, the detailed results of the Phase III clinical study SURMOUNT-2 showed that the average body weight of subjects receiving Tirzepatide 10mg and 15mg decreased by 13.4% (13.5 kg) and 15.7% (15.6 kg), respectively, while those receiving placebo decreased by 3.3% (3.2 kg).
This is Lilly's rapid progress in the expansion of tilporide indications after FDA approved tilporide to improve the blood sugar control of adult type 2 diabetes patients in May last year, with the trade name of "Mounjaro".
Especially, Lilly has also made rapid progress in the global listing of Tilposide. On August 21, 2023, the marketing application of Lilly Pharmaceuticals GLP-1R/GIPR dual target agonist Tirzepatide injection for weight loss indications was accepted by NMPA. On September 7, 2022, the application for listing of tilposide for hypoglycemic indications was submitted in China.
In addition, Tilpodide has been approved for marketing in Europe and Japan to treat type 2 diabetes. In these regions, the weight loss indication of the drug is also in the process of marketing declaration.
According to official disclosure from Lilly, the SURMOUNT series Phase III clinical development project for long-term weight management of tilposide began at the end of 2019, recruiting over 5000 obese or overweight patients in six clinical registration studies, including four global studies, one Chinese study, and one Japanese study. In addition, a Phase IIIb clinical trial SURMOUNT-5 study is being further conducted in adult obese or overweight patients, aiming to compare the efficacy and safety of Tilposide and Smegglutide 2.4mg for 72 weeks of treatment.
In fact, Lilly's third quarter report shows that Tilposide has fully demonstrated its potential to compete with Smegglutide. During the reporting period, Lilly's revenue was 9.5 billion US dollars, a year-on-year increase of over 37%, exceeding the expected 9.02 billion US dollars. For the first time, Tilposide's revenue exceeded the 1 billion US dollars mark, a 44% increase month on month, accounting for nearly 15% of Lilly's revenue.
The approval of Lilly's weight-loss indications for Tilposide is like the cola debate back then, but now there is no way to determine who is Coca Cola or PepsiCo, and Tilposide may not be a 'first come, first come' option. Wang Heng told the Associated Press that Tilposide has slightly better weight loss effects in clinical trials than Smeglutide, and Tilposide is different from Smeglutide single target agonists, As a GLP-1R/GIPR dual target agonist, it has a certain "me beta" characteristic and is priced lower than Smeglutide. Therefore, I am very optimistic about the rapid development of this drug in the global weight loss market. I have two drugs to choose from myself, and I also choose Telpol
Market Concerns about Squeezing Effect: Domestic GLP-1 Double Target Fast Catching Up
Affected by this news, as of the close of the day, Lilly rose 3.2%, with a market value approaching $590 billion. As the news spread to China, domestic weight-loss drug concept stocks opened higher, with Bowling Treasure (002286. SZ), dubbed as the "weight loss sugar" concept, approaching the limit and quickly falling back afterwards. As of the close of the market, Nuotai Biotech (688076. SH) and Hanyu Pharmaceutical (300199. SZ) fell more than 10%, while Borui Pharmaceutical (688166. SH) fell 9.08%.
The situation of domestic concept stocks falling despite positive news from abroad also occurred once when Lilly and Novo Nordisk released their "brilliant" third quarter reports.
It is possible that the market is worried about being seized by foreign pharmaceutical companies, as it will take several years for domestic companies to go public and foreign investment will expand rapidly, "Zhao Heng, founder of Latitude Health, a medical strategy consulting company, told Cailian News Agency.
According to Frost& Sullivan predicts that the market size of GLP-1 drugs in China will reach 51.5 billion yuan by 2030, showing a rapid development trend. Based on the vast market space, domestic pharmaceutical companies have entered the market one after another. According to institutional research reports, as of August 2023, there are a total of 106 clinical trial projects for GLP-1 class weight loss drugs, with 43 Chinese companies accounting for approximately 40%. As of now, two domestically produced GLP-1 weight loss drugs have been approved for sale, namely Renhui Biotech's Benarutide Injection and Huadong Pharmaceutical's Liraglutide Biomimetic, both of which were approved for sale in July this year.
Regarding the GLP-1R/GIPR dual target agonist track, which is similar to Tilposide, domestic enterprises have also made rapid progress.
According to public information, in August 2019, Xinda Biotechnology (01801. HK) signed an authorization license agreement with Lilly, and Xinda Biotechnology obtained the development and potential commercialization rights of IBI362 (Mazdutide) in China. The action of Marsdol peptide is believed to be mediated by the binding and activation of GLP-1R and GCGR, and has a similar mechanism of action to OXM. Therefore, it is expected to improve glucose tolerance and reduce weight.
In June 2022, Xinda Biotechnology disclosed the results of low-dose cohorts (3.0mg, 4.5mg, and 6.0mg) of Mazdutide in phase II clinical studies of Chinese obese subjects. In a 24 week clinical study, 248 subjects received 3.0mg, 4.5mg, and 6.0mg Mazdutide or placebo, administered subcutaneously once a week. After 24 weeks, subjects in the 3.0mg, 4.5mg, and 6.0mg groups showed weight loss of 8.3%, 11.6%, and 12.6% compared to the placebo group, respectively.
At the same time, Mazdutide can significantly reduce body mass index, waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content. The study achieved the primary clinical endpoint and all key secondary clinical endpoints. Xinda Biotechnology began actively promoting the development of Mazdutide Phase III clinical research in October 2022, and has completed enrollment. It is expected to apply for listing in China by the end of 23 or early 24.
It is worth noting that the weight loss effect achieved after 24 weeks of continuous use of Mastiglutide has exceeded the injection effect of Smeglutide for 68 weeks.
In addition, GLP-1 dual target drugs from Hengrui Pharmaceutical (600276. SH), Dongyangguang Pharmaceutical, Borui Pharmaceutical, Haosen Pharmaceutical/Hansen Pharmaceutical (03692. HK) have advanced to the Phase II clinical stage, while GLP-1 dual target drugs from companies such as Zhongsheng Pharmaceutical (002317. SZ), Minwei Biology, and Zhengda Tianqing are currently in the Phase I clinical stage.
Zhao Heng told the Cailian News Agency that the application of GLP-1 in the field of weight reduction is currently in the "golden age" of rapid demand and volume increase. There are few market products, insufficient supply, and the market is mainly self funded. Pharmaceutical companies are in the golden age of pricing and product promotion, and the rapidly growing market has the ability to accommodate multiple competitors. In a self funded environment where the product side has an advantage, the product side has a pricing advantage. This pricing advantage will be maintained until a large number of competitors are launched, which is the best stage for product volume expansion.
Therefore, competing for the GLP-1 weight loss market is a race against time, "Zhao Heng further told Cailian News Agency reporters. Currently, there are a large number of competitors in the clinical research stage, and major companies are increasing their investment to accelerate. In the future, there will be a node where a large number of competitors will be launched on the market, ultimately shaking the current price advantage of the product. Relevant enterprises will not be able to earn such rich profits, and the original research can only engage in price wars.
The golden age of the GLP-1 weight loss drug market should be at least 3-5 years away, "Wang Heng predicted to a reporter from Cailian News Agency in the end.