Recently, the Lasker Award, an important award in the field of biomedicine known as the "vane" of the Nobel Prize, was announced. Among them, the "Clinical Medical Research Award" was awarded to Joel Habener (Massachusetts General Hospital), Lotte Bjerre Knudsen (Novo Nordisk) ) and Svetlana Mojsov (Rockefeller University). The reason for the award is that they discovered and developed GLP-1-based drugs, which revolutionized the treatment of obesity.

GLP-1, glucagon-like peptide-1, is a peptide hormone encoded by the human glucagon gene and secreted by intestinal L cells. It can promote the synthesis and secretion of insulin and suppress appetite. Delaying the emptying of gastric contents, etc. Representative products include Novo Nordisk’s semaglutide and Eli Lilly’s tilpotide.

It is worth mentioning that the research on GLP-1 has not only received attention from academic awards, but also brought "vast wealth" to companies in the industrial chain due to the huge market demand.

The orders received are soft, and upstream companies are rushing to get rich.

The GLP-1 drug was originally developed to treat type 2 diabetes, but now it is a hot topic in the field of weight loss. Frost & Sullivan has predicted that the global GLP-1 drug market will reach US$24.6 billion in 2024.

And real-world market demand seems to be surging in an unimaginable way. In the first half of this year alone, the sales of semaglutide and tilpotide reached US$13 billion and US$6.658 billion respectively, totaling US$19.658 billion.

Since their launch, these two products have been in short supply in many places around the world. As of August this year, semaglutide and tilpotide are still on the shortage list of drugs in the United States. The two major pharmaceutical giants (Novo Nordisk and Eli Lilly) have also accelerated production capacity expansion this year, with investment amounts exceeding 10 billion. Dollar.

The popularity of downstream products has also driven the increase in demand for upstream APIs, driving performance growth.

On September 17, peptide supplier Sirnaomics announced that the company had signed a supply contract for glucagon-like peptide-1 (GLP-1) peptide raw materials not exceeding 350 million yuan. It is reported that the order amount is close to the company’s operating income in previous years.

Financial report data shows that from 2021 to 2023, Sirnaomics achieved operating income of 387 million yuan, 396 million yuan and 435 million yuan respectively, a year-on-year increase of 2.05%, 2.38% and 9.93%. In the first half of this year, Sirnaomics achieved total operating income of 199 million yuan, a year-on-year increase of 14.44%.

Another domestic leading peptide company, Nuotai Biotechnology, has also received a large number of orders and its performance has continued to rise. In May 2023, Nuotech announced that its company had signed a main service and supply contract with a large European pharmaceutical company, with a cumulative contract value of approximately US$102 million. The order has been delivered in the second quarter of this year, and it is expected that the delivery pace will be greatly accelerated from the second half of this year.

In 2023, Nuotech's annual revenue will be 1.034 billion yuan, a year-on-year increase of 58.69%. Among them, the main growth force is the self-selected product segment including peptide APIs. The revenue of this segment increased by 145% to 629 million yuan, accounting for about 60% of the total revenue. Among them, the revenue of semaglutide series, tilpotide series, and liraglutide series APIs were 125 million yuan, 59.4246 million yuan, and 29.2602 million yuan respectively, totaling 214 million yuan, accounting for 1% of the company's total revenue. /5.

In the first half of this year, Nuotai Biological Company achieved revenue of 831 million yuan, a year-on-year increase of 107.47%; net profit was 227 million yuan, a year-on-year increase of 442.77%, and its performance growth momentum is rapid.

Hanyu Pharmaceutical also began to sign multiple orders for APIs and liraglutide in the second half of last year, with a cumulative order value of approximately 630 million yuan. Taking this opportunity, Hanyu Pharmaceutical achieved a single-quarter loss in the second quarter of this year. Among them, the orders involving GLP-1 APIs cover three orders, worth approximately 460 million yuan, which are:

In September 2023, the customer is expected to purchase GLP-1 APIs with a total cumulative amount of US$30 million from the company and Hanyu Wuhan. In 2024 Completed by the end of the year.

In April 2024, Hanyu Wuhan signed a "Product Supply Agreement" with overseas customer DS3 RX LLC. It plans to purchase GLP-1 API from the company, with a product value of approximately US$22.4 million to US$24 million.

In July 2024, Hanyu Pharmaceutical signed another contract with DS3 RX LLC, planning to purchase GLP-1 APIs worth approximately US$8.1 million.

The patents of key varieties have expired, and the demand for imitations cannot be underestimated.

At present, the global enthusiasm for the research and development of GLP-1 drugs is high. In addition to the upstream demand stimulated by the short supply of original research products on the market, the demand for products under development cannot be underestimated.

As patents on key varieties expire, enthusiasm for research and development of generic products will continue to rise. The industry predicts that by 2030, the GLP-1 generic drug market will reach US$100 billion.

At present, the patents of Novo Nordisk's first-generation GLP-1 drug liraglutide have expired in the United States, China, Japan and other regions. The Chinese patent of the flagship product semaglutide is expected to expire in 2026, and the US patent is expected to expire in 2032. Expiration year. Eli Lilly’s tilpotide compound patent is expected to expire in 2036, and its product patent is expected to expire in 2039.

The liraglutide generic drug market has entered fierce market competition. On June 24, generic drug giant Teva Pharmaceuticals announced the launch of the first authorized GLP-1 generic version of Victoza (liraglutide injection 1.8 mg) in the United States.

The abbreviated new drug application for liraglutide injection jointly filed by Hanyu Pharmaceuticals and Hikma Pharmaceuticals to the FDA has been tentatively approved by the US FDA. In addition, Pfizer and Mylan launched biosimilars of liraglutide.

In the domestic market, the research and development of generic drugs of liraglutide is in full swing. Last year, Huadong Medicine launched the first domestic liraglutide-like drug.

Of course, the shortage of domestic product production capacity is also significant. Huadong Medicine is also actively planning for production capacity expansion like Novo Nordisk and Eli Lilly. On September 11, Huadong Medicine announced that it would invest 202 million yuan to expand the "Comprehensive Workshop for Polypeptide APIs".

"Expanding production" has become the annual keyword for GLP upstream companies

. According to calculations by Huafu Securities, the demand for raw materials for semaglutide injection per 1 million obese patients is 100.2-124.8kg; for every 1 million obese patients using semaglutide, The demand for raw materials corresponding to peptide tablets reaches an astonishing 13970-18200kg. Obviously, the current GLP-1 APIs are not enough to cover market demand.

It is worth noting that not only downstream companies are frequently launching production expansion plans, but also upstream companies in the domestic GLP-1 drug industry chain are also rapidly expanding production capacity, including API companies, carrier suppliers and CDMO service providers.

The Nuotai Biotech 601 peptide workshop is expected to complete installation and commissioning by the end of 2024, and the 602 peptide workshop is expected to complete construction, installation and commissioning in the first half of 2025, which will increase the peptide production capacity by a total of 10 tons/year.

Sirnaomics' current 400kg/year peptide API production capacity is at full production. The investment project "Peptide API Production Line Project with an annual output of 395kg" and the refinancing project "Peptide Innovative Drug CDMO, API Industrialization Project" will be successively Landed.

Orient has differentiated its semaglutide fermentation production capacity. Yangzhou Orient will achieve an annual output of 300 kilograms of semaglutide API.

In terms of carrier suppliers, the production capacity of Lanxiao Technology's solid-phase synthetic carriers has been expanded to 120 tons, and it provides a variety of products, including Wang, 2-CTC, Sieber, and Rink resins.

WuXi AppTec stated at this year's interim results meeting that "the 70% growth rate of the new molecule TIDES business this year is expected to include the production project of the GLP-1 dual-target blockbuster drug." Currently, its subsidiary Hequan Pharmaceuticals has launched The peptide production capacity expansion project of the two production bases in Changzhou and Taixing. After the expansion is completed, Hequan Pharmaceutical will add multiple peptide solid-phase synthesis production lines. The new production capacity is expected to be put into use in December 2023. By then, the peptide solid-phase synthesis reaction The volume of the kettle will be increased from the originally planned 20,000L to 32,000L.

Asymchem, the leading CDMO company, is also accelerating the construction of peptide production capacity. By the end of June 2024, the total solid-phase synthesis production capacity will reach 14,250L to meet the needs of commercial projects.

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