In the current hot development of GLP-1 drugs, veteran players in the hypoglycemic field, East China Medicine, have accumulated numerous pipelines and are one of the domestic companies that cannot be ignored. In addition to the Liraglutide biosimilar drug (trade name: Liraglutide) approved for weight loss in July 2023, the company also has clinical pipelines under its umbrella, including Smeglutide biosimilar drug, innovative drugs HDM1002, DR10624, HZ012, HDM1005, etc.
Among them, in the field of biomimetic analogues of Smegglutide, products from China, the United States, East China, and Hangzhou Jiuyuan Gene have both reached clinical phase 3, while new drugs DR10624 and HZ012 are products from Zhejiang Daoer Biotechnology. Huadong Pharmaceutical, through its wholly-owned subsidiaries, holds 75% of the shares in Daoer Biotechnology and 21.06% of the shares in Jiuyuan Gene, respectively. In addition, Huadong Pharmaceutical is the single largest shareholder of Jiuyuan Gene. In January of this year, Jiuyuan Gene also submitted a prospectus to the Hong Kong Stock Exchange to initiate an IPO.
Currently, there have been new developments in the aforementioned pipelines. On April 3rd, the official website of the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) showed that the marketing application (NDA) for the biologically similar drug JY29-2, a nine source gene injection of Smegglutide, has been accepted, making it the first domestically produced Smegglutide to be applied for marketing.
Smegglutide is one of the star products in the current GLP-1 field, developed by Danish pharmaceutical company Novo Nordisk. In 2023, the sales of Ozempic, Rybelsus and Wegovy, which are injection preparations for type 2 diabetes indications, and Wegovy, which are injection preparations for weight loss indications, will be US $13.889 billion, US $2.72 billion and US $4.548 billion respectively, reaching a total of US $211.57, approaching the revenue level of US $21.2 billion in 2022.
However, it is worth noting that JY29-2 declared the indication for type 2 diabetes (trade name: Jiyoutai), and its weight loss indication (trade name: Jikeqin) was approved for clinical use in January this year. In terms of future commercialization, it remains to be seen whether Jiuyuan Gene will face the competition of East China Medicine directly or entrust its products to the latter for sale.
In fact, there are many domestic companies following closely behind in the GLP-1 products of the two giants, Novo Nordisk and Eli Lilly, which are popular.
DXY Insight database shows that in addition to the above companies, Chengdu Beite, Aimeike, Zhengda Tianqing, Shiyao Group, Sihuan Pharmaceutical, Qilu Pharmaceutical, Chongqing Chen'an Biological, UL, and Lizhu Group all have products in the clinical phase 3, but the indications are concentrated in type 2 diabetes, and only the products introduced by Aimeike from Beijing Peptide Biological are in the clinical phase 1 in terms of weight loss indications. That is to say, it will take some time for domestically produced Smegglutide to be used in compliance for weight loss.
An industry insider analyzed to Interface News that this is mainly because the weight loss indication of the original research company Megglutide has not yet been approved in China, and domestic companies are facing clinical design and cost issues, as well as considerations in the registration path.
On April 1st of this year, CDE just released the "Guidelines for the Design of Clinical Trials for Weight Management Indications of Simeglutide Injection Biomimetic Drugs (Draft for Comments)", proposing suggestions and requirements for special attention in its clinical research and development.
At present, the indications for type 2 diabetes of Novo Nordisk megglutide have been approved in China in 2021. The company also revealed in March this year that its weight loss certificate will be approved for listing in China this year. And its strong competitor, Lilly's Telposide, was also accepted by CDE for NDA in September 2022 and August 2023, respectively, for these two indications.
In addition, the product iteration speed in the GLP-1 field is very fast, and it is unlikely that domestic medical insurance will pay for weight loss indications. In other words, this tests the selection and commercialization ability of the company entering the market.
In 2023, the sales of Zepbound weight-loss drug reached 175.8 million US dollars in one month. It is the world's first and currently the only GIPR/GLP-1R dual target agonist, with a weight loss effect better than Smegglutide. In addition to its sales of 5.163 billion dollars for type 2 diabetes indications (trade name: Mounjaro), the annual sales of the drug will reach 5.339 billion dollars in 2023.
According to the prediction of data and analysis company GlobalData, Telposide will surpass Smegglutide to become the best-selling drug in the field of blood sugar and weight loss in the future, with sales reaching $27 billion in 2029. In other words, for domestic companies, if they choose to follow the strategy, the key issue is to closely follow which company's product, in order to maximize the time difference between product iterations and share it with the market.
In addition, the competition among top companies in multiple products not only shows huge market demand to latecomers, but also reflects the breakthrough direction of GLP-1 in long-term, oral, multi target, combination therapy, and multi indication benefits.
Therefore, many domestic players, including East China Medicine, have chosen to develop new drugs. As mentioned above, HDM1002 is a chemical drug targeting GLP1R. HZ012 and HDM1005 are both polypeptide drugs targeting GLP1R/GIPR. The indications for type 2 diabetes and weight loss of these three drugs are in clinical phase 1. DR10624 is an antibody fusion protein targeting GLP1R/GCGR/FGF21, and is currently undergoing phase 1 clinical trials on weight loss indications.
In addition, BGM0504 from Borui Biotechnology, HS-20094 from Jiangsu Haosen, and HRS9531 from Hengrui Pharmaceuticals are all GLP1R/GIPR dual target peptide new drugs, which are in clinical stage 2 on both indications mentioned above. HEC88473 of Dongyangguang Biological Medicine is an antibody fusion protein targeting GLP1R/FGF21, which is in clinical phase 2 and phase 1 respectively in type 2 diabetes and weight loss.
Among them, the leading one is the GCGR/GLP-1R dual target new drug Masalidomide introduced by Xinda Biotechnology from Lilly. Its weight loss indication was accepted by CDE in February this year. The indication of the drug for type 2 diabetes is in clinical phase 3.