China's dual-target weight-loss drug BGM0504 has received IND approval, marking a breakthrough in oral formulation development.
Publish Time:
2025-07-31
BGM0504 tablets: A novel oral weight-loss drug with BIC potential
On July 10, 2025, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed that the Investigational New Drug (IND) application for BGM0504 tablets, a dual-target GLP-1/GIP receptor agonist developed by Borui Pharmaceutical, has been accepted. This progress brings a new breakthrough to the domestic metabolic disease treatment field.
Clinical data shows outstanding performance
According to data from the 2025 American Diabetes Association annual meeting:
BGM0504 injection achieved 19.78% weight reduction in 24 weeks
Oral formulations are expected to further improve patient compliance
Oral delivery technology for peptide drugs has become a focus of industry attention
Metabolic disease drug R&D landscape
Current status of peptide drug technology development
Domestic peptide drug R&D shows the following characteristics:
Technological innovation Companies including Borui Pharmaceutical are promoting the development of multi-target drugs
Process optimization Tongjun Pharmaceutical's EMPHASES® liquid-phase synthesis platform improves peptide synthesis efficiency (such as tirzepatide fragments CG-TIR-001 [CAS: 2682040-93-1], CG-TIR-002 [CAS: 3034670-52-2], etc.)
Cost control New synthesis technologies reduce raw material consumption and three-waste emissions
Synergistic development of the industrial chain
The GLP-1 drug industrial chain is becoming increasingly mature:
Borui Pharmaceutical: Focuses on innovative peptide drug R&D
Tongjun Pharmaceutical: Provides high-quality peptide raw materials and fragments (including tirzepatide fragments Tirzepatide-Frag-AA30-39 [CAS: 2656383-23-0], semaglutide key intermediate Fmoc-AEEA-AEEA-OH [CAS: 560088-89-3], etc.)
Multiple companies have formed synergistic effects upstream and downstream
Industry technology development trends
Innovation in drug peptide production technology
Features of Tongjun Pharmaceutical's EMPHASES® new liquid-phase peptide synthesis platform:
Uses liquid carriers instead of traditional solid-phase resins
Increased reaction speed, shortened time
Reduces the amount of amino acids and reagents used
Reduces three-waste emissions and controls costs
Challenges in the development of oral peptide drugs
Major technical challenges facing the industry:
Improving bioavailability (application of absorption enhancers such as Salcaprozate Sodium ( SNAC) [CAS: 203787-91-1])
Cost control of large-scale production
Stability assurance
Quality control of key intermediates (such as Fmoc-His-Aib-OH.TFA [CAS: 1446013-08-6], etc.)
Market outlook
With the increasing demand for metabolic disease treatment:
The market space for innovative peptide drugs is vast
Synergistic development of all links in the industrial chain
Production process innovation drives down costs (such as optimized production of key intermediates such as tBuO-Ste-L-Glu(AEEA-AEEA)-OtBu [CAS: 1118767-16-0])
High-quality raw materials and fragments supply guarantee the R&D process
Worth watching in the future:
Clinical progress of BGM0504 tablets
Breakthrough in oral peptide delivery technology (such as the application of absorption enhancers such as SNAC [CAS: 203787-91-1])
Synergistic innovation in the upstream and downstream of the industrial chain
Continuous optimization of the production process of key intermediates (such as Fmoc-L-Lys[tBuO-Ste-L-Glu(AEEA-AEEA)-OtBu]-OH [CAS: 1662688-20-1], etc.)
Above key intermediates, Congenpharma can offer high quality with high purity. More informations, please reach us. marekting@congenpharma.com
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