Just this past April, the global "medicine king" quietly changed hands.
On April 28, Merck's first quarter 2022 results showed that the PD-1 inhibitor Keytruda (K drug) sold $4.809 billion, surpassing adalimumab "Humira" for the first time in a single quarter and becoming a new generation of "drug kings".
K-drug has been on the market for eight years, sales have not been weak, the first quarter of this year increased by 27%, in the third negative breast cancer, renal cell carcinoma and melanoma and other key tumor markets to maintain excellent growth momentum.
At that time, "Humira" appeared as a challenger, stepping on infliximab under his feet to become the king of medicine; K medicine was similar, listed after O medicine, but had already slapped the front wave on the beach.
However, the competitive situation faced by K Medicine is more complicated than that of Humira. There are currently 12 competitors in the Chinese market. In the overseas market, in addition to foreign varieties, domestic varieties are also sharpened to go to sea, and in the future, K medicine is facing comprehensive competition.
For the new medicine king, this is not a good sign.
The new medicine king is in danger
The global "medicine king" is the vane of the pharmaceutical industry. Once switched, it often means a big shift in the technology platform or therapeutic field.
In 2012, "Humira" replaced "Lipitor", and has been the king of medicine for ten consecutive years. "Lipitor" is Pfizer's cardiovascular drug, representing the era of chronic disease demand dominated, "Humira" is the representative of autoimmune drugs.
In ten years, Humira's sales rose from $9.48 billion to $20.696 billion, with cumulative sales exceeding $180 billion. Looking at the trend now, the pharmaceutical myth will be continued by PD-1.
In September 2014, K drug was launched, and since then it has been riding the dust on the drug sales list. In 2021, K-drug sales reached $17.2 billion, up 20% year-on-year. According to this growth rate, K-drug sales this year are expected to exceed $20 billion. While the patent for adalimumab will expire in full in 2023, AbbVie is already cultivating new varieties.
However, the resistance encountered by the sales growth of K-drug is much greater than that of adalimumab. It is clear that the revenue growth rate of K drug has been declining year by year. In addition to the varieties of foreign capital, China's PD-1 new forces have also caused a certain impact on K medicine, on the one hand, in China K medicine can not be a dominant one, on the other hand, Cinda, BeiGene, Junshi and other enterprises are still seeking to go to sea and grab more cakes in the world.
Figure: The basic situation of PD-1 drugs in China
Although from the current point of view, Cinda and Junshi have successively gone to sea and suffered setbacks, there must be those who are more and more courageous, and there are also those who have gone forward and succeeded.
The inner volume of PD-1 is a global phenomenon. In December 2021, two of the FDA's top cancer physicians jointly posted in the New England Journal of Medicine that the global PD-1/PD-L1 market has become redundant, but data shows that more than 2,000 clinical trials are still underway.
Holding a "bombshell" means that relying on a single product can bring at least $1 billion in annual sales, which is the dream of all pharmaceutical companies; holding the "medicine king" means that it can also play a good result in the final of the master of recruiting blood, just as Pfizer relies on "Lipitor" to quickly become the world's first pharmaceutical company in terms of sales, Abbvie relies on "Humaleus" to sit firmly in the top ten positions of drug sales.
This time, the baton was handed over to Merck, in front of the Pfizer new crown vaccine, after there were countless chasers, how long can K medicine run, what kind of performance can it run?
No one knows. What one can see is that the giants of the onlookers have tightened their clockwork and are ready to rush to the next trip.
Under the inner volume, indications are king
In March 2022, Henlius' PD-1 "Slullimonab" was listed, becoming the 13th PD-1/PD-L1 product in China. Currently, these PD-1/PD-L1 products involve a total of 14 cancer species and 49 indications.
As an epoch-making product, PD-1 is regarded as a "universal anti-cancer drug" because of its broad-spectrum mechanism, and pharmaceutical companies are scrambling to develop new indications. Merck ran the fastest. K-drug currently has nearly 30 indications and continues to carry out clinical trials, which has become the driving force for its continuous sales growth and the superiority of its position among countless competitors.
In China, Merck has eight indications, one of the most among the 13 companies, like Baekje and Hengrui. The old rival Bristol-Myers Squibb has 6 indications. New players such as Kang Fang and FuHong Henlius have only one indication approved.
Figure: Approved indications for some PD-1 in China
Not only that, whether it is to prove the superiority of their own drugs, or the "positive control" of CDE's anti-pseudo-innovation requirements, many pharmaceutical companies have chosen to carry out head-to-head or control trials for K drugs. As is customary, other PD-1s are subject to FDA approval, and the indications are the same as K drugs, which are generally subject to head-to-head trials.
According to the previous statistics of the Health Bureau, at least companies including Hengrui, BeiGene, Junshi, Cinda, and Lepu have all been too head-on with K medicine.
The patent for K-drug will expire in 2028, and dozens of indications have forged its moat.
In the intense inner volume, expanding the scope of indications has become the focus of "comparison". K medicine is not all good, some unfinished indications have become shortcuts for other companies to "pick up leaks", bringing some opportunities to domestic enterprises. For example, the indications for small cell lung cancer with the withdrawal of K drugs and O drugs have a number of domestic companies in research.
Executives such as Henlius and Junshi Bio have expressed that the story of PD-1 is not over, and the treatment needs of patients still exist.
But the enthusiasm of business and capital has diminished a lot. Since the beginning of this year, in more than four months, only one product of Henlius' s slullimonumab has been approved, and in terms of indications, only 5 have been approved in China.
There is no eternal medicine king, only eternal competition. The next story is simple: other products are responsible for surpassing K medicine, and K medicine is responsible for surpassing itself.
Text | Zhang Ling operates | Twenty-thirteen
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