The battle for the "Drug King" is full of thrills and dangers. Can K medicine reach the top? Can ADC become the next legend?

In 2019, the research institute EvaluatePharma released a forecast report that by 2024, Merck's star anti-cancer drug Keytruda (Keytruda, commonly known as "K drug") will replace AbbVie's Humira (Humei Le) as a new global " Medicine Kin.

However, it now seems that on the one hand, this forecast may be slightly conservative, and on the other hand, it ignores the impact of the market pattern brought about by the new crown epidem.

Earlier, overseas media released the "Top 20 Best-Selling Drugs in the World in 2021" repo.

2021 World's Best Selling Drugs List

However, if the new crown vaccine products that are prosperous due to the epidemic are excluded, the sales of Merck K drug in 2021 have reached 12 billion US dollars, once again becoming the best-selling anti-tumor drug in the wor.

Today, the impact of K drug market sales on the "King of Drugs" continu.

Between K medicine and Humira, you chase after .

K medicine hits the "King of Medicine"

Can the high growth be sustained?

Drug K is an anti-tumor drug developed and produced by Merck & .

In fact, the research and development project of K medicine started as early as 200 In 2003, the Organon team of the Dutch Oss company in Cambridge hoped to obtain an agonist that can activate the PD-1 receptor to shut down T cells in order to treat autoimmune diseases such as rheumatoid arthrit.

It was not until 2010, when Bristol-Myers Squibb (BMS) unexpectedly discovered the surprising effect of an immune drug trial, that Merck realized the potential significant commercial value of the PD-1 proje.

At present, K drug has been approved for many indications around the world, including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classic Hodgkin lymphoma, urothelial cancer, gastric cancer, and esophageal cancer It is the first-line, second-line and multi-line treatment of multiple cancer types such as cervical cancer and hepatocellular carcinoma, and K drug is still undergoing clinical trials to continue to expand its indicatio.

Relying on the many indications that have been first laid out, K medicine is firmly seated as the "first brother" in today's highly competitive PD-1 market, and it has launched an attack on the throne of the global "drug kin.

On the other hand, Humira has won the title of "Drug King" from Lipitor in 2012, and has been in the position for 9 consecutive yea.

It is understood that the patent of Humira will expire in 2023, and the biosimilar drug market is already full of smo.

Amgen will launch the first biosimilar of Humira in late January 2023, according to Ian Thompson, Amgen's senior vice president and general manager of.

Although a variety of PD-1 inhibitors have been approved for marketing, there are not many PD-1 drugs that can initiate "head-to-head" clinical trials for K dru.

However, K medicine cannot escape the patent cliff after a.

In search of a new "moat"

Where is the successor to K medicine?

As the "low-hanging fruit" in the field of tumor immunotherapy is gradually being picked, many PD-1/L1 products, including K drugs, can only climb higher and steeper fields for new explorations, which also directly It increases the risk of innovative R&.

Drug K appears to have hit a snag in its indication expansion efforts, with multiple expansion trials thwart.

Recently, Merck announced that the K drug failed to meet the primary goals of overall survival (OS) and radiological progression-free survival (rPFS) in a phase 3 clinical trial of certain prostate cancer patien.

Eliav Barr, Senior Vice President, Global Head of Clinical Development and Chief Medical Officer, Merck Research Laboratories, said: "We will continue to advance our clinical development program to evaluate K-drug-based combinations and new drug candidates for the treatment of this disea.

patien.

It is worth noting that this is another news of Merck's failure in less than a mon.

Previously, the Phase 3 LEAP-002 trial of K-drug combined with Lenvima (lenvatinib) in first-line treatment of patients with advanced unresectable hepatocellular carcinoma (uHCC) failed to achieve overall survival (OS) and radiographic progression-free survival ( rPFS), and the Phase III KEYNOTE-412 study in patients with unresectable locally advanced head and neck squamous cell carcinoma (HNSCC) failed to improve event-free survival (EFS) the primary endpoi.

Experts said that each product will go through such a "life cycle", which is long or sho.

A typical product life cycle can generally be divided into four stages, namely the introduction period, the growth period, the maturity period and the decline peri.

Different product life cycles Different moats need to be bui.

With many indications and first-line treatments, K medicine is "one-stop" in the market, and will step on the throne of "Drug King" in the futu.

If a new "moat" cannot be found in the future, it may also face the risk of declining sal.

The success of any product is by no means accident.

Drug K has captured the huge dividends of tumor immunotherapy, which also makes Merck must think: Where is the successor of Drug K?

Today, Merck is accelerating the development and acquisition of potential new drugs, which seems to be a very strong signal in the industry, or that it is seeking performance growth points other than K dru.

It is worth mentioning that, not long ago, the news that Merck wanted to acquire Seagen, an ADC (antibody-conjugated drug) company, came out, which caused a sensation in the global mark.

Seagen is a leading company in the field of ADC drug research and development in the world, focusing on the research and development of ADC drugs for a long ti.

Among the 14 ADC drugs currently on the market, 4 are from Seagen and its cooperative research with other compani.

It is reported that there are more than 10 new ADC drugs in Seagen's follow-up pipeline in different stages of developme.

The ADC project of Merck and Kelun Pharmaceuticals also sparked heated discussions in the indust.

On July 26, Kelun Botai exclusively licensed a clinical early-stage biomacromolecule tumor project B with independent intellectual property rights to Mer.

The proportion of net sales agreed by both parties is commission.

Just over two months ago, another ADC project of Colombo was acquired by Merck in the same way, with a cumulative milestone payment of no more than US$363 billi.

Quickly deploying in the ADC field and betting heavily, Merck's "ADC ambition" is clearly visib.

There are many innovative drug tracks, why did Merck choose to focus on ADC?

The industry view is that, on the one hand, it is not easy to find potential new technologies and new products in the "post-mAb er.

The target is more prominent; on the other hand, since the commercialization of CAR-T and gene therapy is still unclear, the deployment of ADC may be the best choice for Merck at the mome.

Facing the increasingly fierce competition in the ADC market, can Merck create the next "K drug legend" with ADC drugs in the future? Still the test of ti.