How strong is semaglutide? Global sales surged by 38%, and behind China's 75% growth rate, 30 companies are competing for 30 tons of production capacity!

In 2024, global sales reached 29.296 billion US dollars, with sales in China reaching 6.57 billion RMB.

In terms of patents, China's core compound patents will expire in 2026, and there are differences between Europe and America.

Seven domestic enterprises have registered as CDE active pharmaceutical ingredients, and over 30 have completed FDA DMF filing, with a total production capacity of approximately 30 tons. However, they are facing competition, patent challenges, and potential overcapacity concerns, and the future market landscape remains to be observed.

It has a half-life of about one week and is administered once a week. It is mainly used for weight management of adult type 2 diabetes (T2DM) and obese/overweight patients.

Its chemical structure consists of 17 types of 31 amino acids, including histidine, alpha aminoisobutyric acid, glutamic acid, etc., with CAS number 99291-20-0.

How to operate the biosynthesis of semaglutide from 0 to industrial production? What are the difficulties?

2、 Mechanism of action 1 Hypoglycemia: binds to GLP-1 receptors in pancreatic beta cells and stimulates insulin secretion in a glucose concentration dependent manner; Inhibit the secretion of glucagon by pancreatic beta cells; Promote glycogen synthesis, inhibit liver glycogen output, and delay gastric emptying.

3. Weight loss: acts on the hypothalamic appetite regulation center, increasing satiety; Promote the conversion of visceral white fat to brown fat and increase energy expenditure; Reduce gastric acid secretion.

Heart: Reduce myocardial cell apoptosis and optimize myocardial energy metabolism. Kidney: improves metabolism, inhibits iron death, anti-inflammatory and antioxidant properties, and improves hemodynamics.

Amino acid substitution: Replace the 8th alanine (Ala) with alpha aminoisobutyric acid (Aib, resistant to DPP-4 degradation); Replace the 34th lysine (Lys) with arginine (Arg) to prevent incorrect binding of fatty acids.

Fatty acid modification: The 26th lysine is linked to diaminodethoxyacetic acid (ADO)+glutamic acid+C18 palmitic acid, prolonging the half-life to 165 hours (about 1 week) and increasing the affinity for albumin.

Preparation process: Adopting a mixed method of biological fermentation and chemical synthesis (CN101910193).

The Chinese core compound patent expires in 2026 and has been deemed invalid (on appeal). It is expected that generic drugs may be launched in 2026; The US compound patent expires in 2032, and there are no generic drugs before 2032;

The European compound patent expires in 2026, and generic drugs are expected to be launched after 2026. The market window for generic drugs in China is earlier than that in the United States and Europe, giving it a first mover advantage.

① Large scale production capacity, a single batch of 5kg workshop requires an investment of 30 million yuan and must comply with cGMP standards;

② Quality control requires FDA/EMA/NMPA certification to ensure purity (such as injection requirements of over 98%) and batch stability;

③ Registration and sales capabilities require completing a complete set of quality document declarations and being able to connect with overseas major clients or domestic pharmaceutical companies to obtain order support for production capacity.

① The demand growth brought about by the expansion of indications (such as NASH, cardiovascular disease); 

② The progress of formulation approval, especially the increase in volume of domestic generic drugs after their launch; 

③ Market expansion stimulated by price decline. If demand growth does not keep pace with capacity expansion, price wars and idle capacity may intensify.