① Tonight, Huadong Pharmaceutical announced that its new GLP-1/GIP dual-target drug HDM1005 injection has been clinically approved in the US, and Huadong Pharmaceutical is further expanding its pipeline layout in the weight loss market; ② Experts believe that Huadong Pharmaceutical may not have an advantage in the competition between Simei's first biosimilar and GLP-1 dual-target new drug, but its differentiated, fast and slow combination layout is expected to lay a strong foundation for future market competition.
Financial Services Association, April 22 (Reporter Lu Afeng) This evening, Huadong Pharmaceutical (000963.SH) announced that after being approved for clinical trials in China in March, its new GLP-1/GIP dual-target drug HDM1005 injection was clinically approved in the US, and Huadong Pharmaceutical's pipeline layout in the weight loss market was further expanded.
However, in view of Huadong Pharmaceutical's rich R&D experience and successful cases of GLP-1 drugs such as liraglutide, industry experts believe that Huadong Pharmaceutical may not occupy a leading position in the battle for the “first biosimilar” title with simeglutide and the progress of new GLP-1 dual-target drug development, but its differentiated pipeline layout combining speed and slow speed is expected to lay a strong foundation for future market competition.
China and the US were approved for clinical trials in a similar time
This evening, Huadong Pharmaceutical issued an announcement regarding its wholly-owned subsidiary receiving approval notice for clinical trials of new drugs from the US FDA. The announcement stated that recently, China and America Huadong, a wholly-owned subsidiary of Huadong Pharmaceutical, received a notice from the US FDA that the HDM1005 injectable drug clinical trial application submitted by China and US Huadong has been approved by the US FDA, and phase I clinical trials can be carried out in the US.
A Financial Services Association reporter learned that Huadong Pharmaceutical's HDM1005 injection was approved by the State Drug Administration in March 2024. The indication is weight management for people with type 2 diabetes, overweight, or obese people. In the same month, the Phase IA clinical study of HDM1005 injection in healthy subjects completed the enrollment and administration of the first subjects at the Second Affiliated Hospital of Anhui Medical University.
“Generally speaking, domestic innovative pharmaceutical companies can be approved to carry out clinical trials almost simultaneously in China and the US. This shows that the preclinical research results of this drug and target are very good, and the companies are very confident about the smooth level of the clinical trial process of this drug.” Wang Heng, general manager of Beijing Baisili Marketing Planning Co., Ltd., told the Financial Association reporter.
Wang Heng further analyzed that Huadong Pharmaceutical has accumulated rich R&D experience and experience in the process of emulating liraglutide weight loss, and that it is also a new GLP-1/GIP dual-target drug, Eli Lilly's breakthrough performance in the US market and marketing applications submitted domestically have also stimulated domestic innovative drug companies represented by Huadong Pharmaceutical in disguise. Therefore, Huadong Pharmaceutical will quickly set up a project and launch clinical trials of HDM1005 injection.
As a strong competitor to simeglutide, the number one weight loss drug already on the market in the world, Eli Lilly's terpotide weight loss indications were approved in the US in November 2023. The product name is Zepbound. According to Eli Lilly's financial reports, Zepbound achieved sales of 176 million US dollars in less than 2 months after launch.
Data and analysis company GlobalData believes that strong clinical data on weight loss efficacy will allow tirpotide to surpass simeglutide and become the best-selling drug in the obesity and diabetes market, and sales are expected to reach 27 billion US dollars in 2029.
Simei's competition is heating up, and East China Pharmaceutical's differentiated settlement
Naturally, there is no shortage of competitors in the broad GLP-1 weight loss drug market.
According to public information, in addition to tirpopeptides that have already been marketed, there are more than ten GLP-1/GIP dual-target agonists that have entered the clinical stage worldwide. Among them, the highest clinical stage for domestic varieties is clinical phase II. The main R&D companies include Borui Pharmaceutical (688166.SH), Jiangsu Hausen Pharmaceutical, and Fujian Shengdi Pharmaceutical (a subsidiary of Hengrui Pharmaceutical (600276.SH)).
Other GLP-1 dual targets are also progressing rapidly. On February 7, Cinda Biotech's first new drug marketing application (NDA) from the GLP-1/GCG dual agonist mast peptide authorized by Eli Lilly was accepted by the CDE for long-term weight control in adult obese or overweight patients. It is expected to be marketed in China in the first half of 2025.
Meanwhile, the battle for simeglutide for the first biosimilar in China is heating up. According to CDE's official website, this month, Jiuyuan Gene submitted the first domestic marketing application for simeglutide injections, which was officially accepted by the State Drug Administration. CDE's official website also shows that many companies, including Jiuyuan Gene, Huadong Pharmaceutical, Bowei Biotech, Sihuan Pharmaceutical (00460.HK), Federal Pharmaceuticals (03933.HK), Qilu Pharmaceuticals, Livingzhu Group (000513.SZ), and Shiyaku Group (01093.HK), are currently entering phase III clinical phase.
It is worth mentioning that according to Huadong Pharmaceutical's announcement, a comprehensive and differentiated product pipeline has been built around GLP-1 target companies, including long-term and multi-target global innovative drugs and biosimilar drugs, including oral and injectables. In terms of biosimilar drugs, there are both liraglutide, which has already been marketed for weight loss, and simeglutide, which is currently popular. Huadong Pharmaceutical's diabetes indications for this drug have now been enrolled in phase III clinical trials, and phase III clinical trials are expected to be completed within the year.
In terms of new drugs with independent intellectual property rights, the oral small molecule GLP-1 receptor agonist HDM1002 diabetes indications independently developed by Huadong Pharmaceutical were approved by both China and the US in May 2023, and achieved the first human trial in early June 2023. The Chinese IND application for weight management indications for overweight or obese people was approved in September 2023. Currently, the product has completed China's single-dose escalation (SAD) test and multiple dose escalation (MAD) tests, and phase II clinical studies have begun; The long-acting FGF21R/GCGR/GLP-1R three-target agonist DR10624 has completed the Chinese phase I SAD study and the New Zealand phase I SAD study. Currently, a phase Ib/IIa clinical trial of obesity with hypertriglyceridemia is being carried out in New Zealand, which is expected to be completed by the end of 2024.
“This shows that Huadong Pharmaceutical's determination to be deeply involved in the GLP-1 field is very strong. Although Huadong Pharmaceutical seems to be unable to catch up with Eli Lilly and Cinda Biotech, these pipelines are expected to blossom within the next two to three years. At that time, Simeglutide is definitely not just Novo & Nord, but it is estimated that tilbopeptide will also be marketed in the domestic market. Huadong Pharmaceutical's multi-target and differentiated forward-looking layout in the weight loss drug market will be revealed.” Wang Heng said at the end.