Merck’s 25 billion blockbuster drug domestic cancellation approval, AbbVie once starred hepatitis C drug from the market...

Generic drugs are forcing the original drugs to be withdrawn from the market.

On May 24, the State Food and Drug Administration issued a batch of drug registration certificate revocation announcements, involving 283 drugs.

In a general sense, cancellation of a drug certificate is equivalent to a product withdrawing from the market.

Merck’s sitagliptin currently has a number of generic drugs on the market, and more than 10 generic drugs are under review; Janssen’s prucalopride is the third batch of collected varieties, Janssen has not won the bid and has subsequently been cancelled in many provinces.

01 AbbVie's former star drug withdrew from the Chinese market

In the announcement of the Food and Drug Administration, AbbVie applied for the cancellation of the drug approval document for two products-Obiparil tablets (each tablet contains Obitarvir 12.

In May 2019, AbbVie launched a new generation of hepatitis C product in China-Gcarevir Pirentavir tablets, which are used to treat chronic hepatitis C virus type 1, 2, 3, 4, 5 or 6 Infected adults without cirrhosis or compensated cirrhosis.

Gcarevir pirentavir tablets is a new pan-genotype hepatitis C treatment program in China.

In the medical insurance negotiations in 2019, because the 6 products of the 4 companies that entered the negotiation at that time were not essentially the relationship between the original research and the imitation, and they were all hepatitis C drugs with similar efficacy, the medical insurance bureau adopted the same group competition method "only Allow 2 drugs with the lowest cost of the whole course of treatment to enter the catalog, and promise not to include new drugs of the same kind within 2 years.

From the company’s strategic perspective, a new generation of products with the same indications, higher efficacy, and lower side effects enter the market, and the withdrawal of the previous generation of products is also sparse.

In fact, the fierce competition in the domestic hepatitis C drug market is even more alarming.

Access to medical insurance is a top priority for market access for medicines, and the capital market's response to this is also very obvious.

In the 2020 medical insurance negotiations, the local company Kain Technology’s Klopavir capsules are included in the 2020 version of the medical insurance catalog, and the scope of application is for patients with chronic hepatitis C diagnosed with HCV genotyping tests other than gene 1b.

In terms of dosage form, the specification dosage form of Kellyn Technology's product klopavir is capsules, elbavir glarevir tablets, ledipavis sofosbuvir tablets and sofosbuvir vepatavir tablets are all oral , Pan-genotype, single tablet.

In the domestic hepatitis C new drug market, Chinese and foreign innovative drugs are already competing on the same platform.

02 Generic drugs force the original research to withdraw from the market

The announcement of the FDA also involved two major varieties-Merck's sitagliptin tablets (25mg and 50mg) and Janssen's prucalopride tablets.

The current status of these two products in China is very similar.

It is reported that Merck and Gliptin tablets were first approved in China in September 2009 for the treatment of type 2 diabetes.
Sitagliptin is the world's first oral dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor).
DPP-4 inhibitor is a type of type 2 diabetes treatment drug, because it has no effect on body mass.
Notable features such as impact, low incidence of hypoglycemia, and oral administration have gradually been fully recognized in clinical guidelines at home and abroad.
The status of treatment has been continuously improved, and the market share has increased year by year.
The global market share has approached one-fourth of the diabetes drug market.

Merck’s original research drug was approved by the FDA in 2006 and was approved by the NMPA to enter the Chinese market in 2009.
Sitagliptin tablets are currently the world's largest DPP-4 product with annual sales of 4 billion US dollars, which is close to the sum of other Liliptin products.

However, as the first generic drugs of CP Tianqing entered the market in February 2020, the generic drugs of CSPC and Dongyang Sunshine were also approved.
The market for Merck’s original research drugs was not as good as before.
There were also industry rumors that Merck had adjusted sitagliptin.
China sales team.

Public information shows that according to different mechanisms of action, hypoglycemic drugs on the market can be divided into biguanides, insulin sensitizers (thiazolidinediones), insulin secretagogues (sulfonylureas, glinides), and α -Glucosidase inhibitors (acarbose, voglibose), DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists and insulin are eight major drugs.
Among them, DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 receptor agonists are known as new anti-glycemic agents.

DPP-4 inhibitors mainly reduce the inactivation of GLP-1 in the body by inhibiting DPP-4, and increase the level of endogenous GLP-1, which means that the product is a gliptin product; SGLT2 inhibitors inhibit the renal tubules Reabsorption, promote urinary glucose excretion, thereby lowering blood sugar, the representative product is Liejing products; GLP-1 receptor agonists are macromolecular drugs, which can reduce blood sugar by stimulating GLP-1 receptors.
The representative product is that Peptides, glutin products.

An analysis report shows that in 2019, the new glucose-lowering mechanism drug DPP-4 inhibitor accounted for 25.
5%, which remained stable; the growth of SGLT-2 inhibitors tended to be stable, and it is currently unable to impact the market position of DPP-4; GLP- 1 Receptor agonists accounted for 16.
2%, maintaining rapid growth and being an important driving force for the expansion of the entire diabetes market.

It is worth noting that with the first domestic market GLP-1, Novo Nordisk’s liraglutide has entered the medical insurance catalog, the GLP-1 agonist market has rapidly increased, with sales of 530 million yuan in 2018, a year-on-year increase With an increase of 76.
7%, the sales of liraglutide in 2019 rose further, with sales jumping to 940 million yuan, a year-on-year increase of 77.
4%.
Novo Nordisk’s financial report shows that liraglutide occupies 92.
8% of the domestic GLP-1 market.

In the 2020 medical insurance negotiations, the long-acting inhibitors dulaglycotide and loxenatide, as well as two domestically-made GLP-1 and Sanofi's risenatide, are also included in the medical insurance list.
A variety of GLP-1 products with different curative effects and different administration methods compete on the same platform.
In addition, there are many DPP-4 inhibitors and SGLT-2 inhibitors on the market of generic drugs, and the competition in the domestic diabetes market is becoming increasingly fierce.

For example, the market situation of sitagliptin tablets, generic drugs are on the market, and "new" inhibitors are no longer "new"; all macromolecular drugs have also dropped by more than 50% into medical insurance, and resources are given to products with more competitive advantages, adjusted and optimized The sales team is also a more sustainable corporate strategy.