Medicare controls in the U.S. fail

It has been nearly a month since the signing of the US Inflation Reduction Act (IRA), and the content involving health insurance negotiations continues to ferment, suddenly attracting attention

Carefully splitting the US Medicare control clause was greatly shocked

01 Weak U.

1, not from January 1 next year to implement medical insurance price reduction, but dragged to 2026 to start, the first batch of 10 drugs, 2027, 2028 respectively increased 15 drugs, 2029 and later will add 20 kinds, it takes more than 7 years to implement

2, not every year the medical insurance negotiations include more than 60 drugs, as mentioned above, the time span of up to 7 years to include 60 drugs

3.

4.

5.

6.

Since the enactment of the Medicare Modernization Act in 2003, the U.

If domestic innovative drugs can enter the first batch of 10 drugs negotiated by US medical insurance in 2026, it is fortunate, indicating that it has become internationally competitive and will successfully achieve price-for-volume

02 Crossing the river in Japan

The history of the development of biotechnology in the United States does not eat human fireworks, and its reference value for domestic innovative pharmaceutical companies is limited

Since the 1980s, Japan has begun to review the prices of drugs in the medical insurance list every two years, with an average price reduction of 4% to 5% every two years, and in 2016, the inspection frequency was further adjusted to once a year

Pharmaceutical companies were forced to leave overseas

Liang Propyl Ruilin has been listed for more than 30 years, sales are still close to 1 billion US dollars, when only this sword is in hand, Takeda Pharmaceutical failed to get rid of the lost 8 years, the market value shrank by up to 2/3, when the four swords are gathered, Takeda Pharmaceutical can finally summon the dragon

Takeda Pharmaceutical's internationalization process is divided into three stages: the first stage (1975-1987), me-too dividend + overseas expectations, enjoying the first round of stock price increases, which is similar to the early days of China's innovative drugs; In the second stage (1987-1995), the economic bubble burst, the medical insurance control fee was strict, western pharmaceutical companies counterattacked, Takeda's performance declined, and was forced to turn to me-better, P/E decreased by 4 times; In the third stage (1995-2020), the best drug of its kind, Lansoprazole, was listed in the United States, confirming the bottom inflection point, bringing a 7-fold increase
.

Leuprolide microspheres (prostate cancer): Listed in the United States in 1989, sales peaked at $
3.
24 billion in 2010.

Lansoprazole (gastric ulcer): Listed in the United States in 1995, sales peaked at $
4.
3 billion in 2003.

Candesartan (hypertension): Listed in the United States in 1998, sales peaked at more than $
2 billion in 2007.

Pioglitazone (diabetes): Launched in the United States in 1999, sales peaked at $
4.
7 billion in 2010.

In 2007, Takeda Pharmaceutical's overseas revenue began to exceed that of Japan, and the top four global blockbuster products contributed about $10 billion in revenue
in 2010.

The speed to market of 4 blockbuster products is not the fastest in the same category, but it tries to be the best in the same class, and the target patient base is huge
.
Lansoprazole is more than 30% more bioavailable than omeprazole, which is more significant
in preventing mucosal damage and healing of acid-induced gastric ulcers.
Candesartan was listed later than losartan and valsartan, and is the world's third ARB antihypertensive drug product, but the antihypertensive amplitude is large and the effect time is long
.

Around 2010, Takeda Pharmaceutical encountered the patent cliff of its main products, shifting from self-research and growth to epitaxial mergers and acquisitions, achieving non-linear growth
.
Revenue in fiscal 2021 was JPY 3,569 billion (approximately US$27.
5 billion), with overseas revenue accounting for 82%.

Compared with Takeda Pharmaceutical, which has opened up and merged, the first three totals belong to the innovation focus type, and they have made the ADC track restless with their own efforts, and its third-generation ADC drug DS-8201, every time the key clinical data is released, it brings a sensational effect and becomes the brightest star
.

In the face of domestic cost control pressure and the squeeze of Western pharmaceutical companies, in 2005, the first pharmaceutical with a century-old history and the three communist pharmaceuticals merged
.
In the current capital winter, Chinese pharmaceutical companies have not yet seen merger cases
.

After the merger is completed, take the generic drug detour
first.
Acquired India's largest generic drug company for $4.
6 billion in 2008

Ranbaxy
.
Because Lamberthy was involved in the counterfeiting scandal, a total of 39.
9 billion yen was accrued in fiscal year 2008 for the US Department of Justice's claims
.

Also in 2008, the first three authorized the introduction of Seagen ADC technology platform, after several twists and turns, in 2019, the first three total r & D day held in Tokyo, Japan, to become the world's number one antibody conjugated drug company, its first ADC drug Enhertu (DS-8201) from the beginning of the clinic to the market in less than 5 years, by The Peer Pharma as the first
of the top ten most anticipated new drugs in 2020.

Since the beginning of the merger, the first and third parties have been determined to self-research and innovation, and the R&D investment has always remained at about 20%, and after 2014, it will invest $13 billion in new drug research and development in 2021-2025, and the core R&D products are 3 ADC drugs: Enhertu, Dato-DXd, HER3-DXd
.
The first and third parties are still focusing on the development of nucleic acid drugs, cell therapy and gene therapy, laying out rare diseases and rare tumors that currently lack treatment plans, and always focusing on frontier and differentiated areas
.

According to CITIC Construction Investment, the first and third ADC research is driven by researchers from the bottom up, and it was not in the company's development focus at the
beginning.
However, after the clinical phase I experiment began to have good results in 2015, the company resolutely tilted its resources, hired AstraZeneca's global oncology director Antoine Yve to be responsible for the company's tumor pipeline, and established an ADC research and development department to fully support the ADC business
from research and development, clinical to production facilities.

The road is not at the beginning, but stepping on the mud to come out, willing to be in the gray period of domestic innovative pharmaceutical companies, do not quit, out of a new road
.