The self -rescue road of a Biotech company is worth learning from Chinese colleagues

On June 21, the updated data of the authoritative clinical trial registration website ClinicalTrics showed that Bo Jian's observation test on ADucanumab, ADUCANUMAB, the drug of Aldzheimer (AD).

Study started in October 2021. It was originally planned to carry out 5 years and recruited 6,000 patients. As a result, it was completely abandoned in less than one year, because only 29 patients have been recruited so far.

Aducanumab was launched in June 2021 and is the first AD drug approved by the FDA since 2003. At the beginning of the birth, this medicine was regarded by some people as the last bullet that humans captured AD. It was just that no one expected that in less than a year, this new medicine was quickly sentenced to "death penalty" by the market.

Earlier this year, the two major public medical insurance funds in the United States decided to restrict the use and reimbursement of this drug. Bo Jian expects that this drug will hardly be sold: it is predicted that the number of drugs in the next few years will be up to 2,000, and the number of clinical studies is not enough to make up for the number of clinical studies. Essence

Bo Jian seems to have been unlucky recently. It stands to reason that there are many products developed by this innovative drug company, such as the treatment of multimodarate dihydride with multiple sclerosis, and the "sky -high drug" Nosina sodium for the treatment of spinal muscle atrophy. These medicines were praised by "revolutionary" when they came out, but after listing, they encountered patent expiration, competing pursuit, or clinical failure.

BooTech uses his own experience: Biotech is never an easy task if he wants to stand for your foothold.

The first explosion, failed due to a patent war

Bo Jian was founded in 1978 and is mainly engaged in the development of diseases in the nervous system.

Many diseases in the neural field are not clear, so the failure rate of drug research and development is very high. The world's first biotechnology company, Genak, specially avoided this field. Regenerative Yuan Company has not taken a new medicine here for 20 years.

It is not easy to get up to the difficulties.

Bo Jian's core founding team comes from the University of Harvard, Massachusetts and Edinburgh, and is a well -known person in the academic world. The company has developed a monoclonal resistance and studied hepatitis B. It was not until 2013 that it really launched products in the neurological field: Fogaic acid dihymethyl.

Fogaic acid dyshaxye is an ordinary chemical raw material, which is commonly used to make fresh -keeping agents. Some doctors use it to treat psoriasis with experience. Because the structure is too simple, this compound is even difficult to enjoy patent protection.

In 2008, Bo Jian cleverly deployed a series of dose patents of pomanolic acid dysharodolia, setting the active ingredients to 480mg a day, thereby extending the patent protection period of its own products to 2028.

With this drug, the first year of the first year of recentric acid dyshaxyl ester was sold at nearly $ 900 million, and the annual sales of the following then rose to $ 4 billion.

The scientists' tricks were later known. In February 2019, the Indian generic drug giant Mailan officially launched a patent challenge to Bo Jian. The two sides saw for more than a year, and eventually Bo Jian lost in June 2020. Mailan quickly pushed his products to the US market. Affected by this, Bo Jian's fumate dihydride sales fell by nearly 15%in 2020, and in 2021 fell by about 40%.

Bo Jian's market failure can not blame Mailan. New medicines that treat multi -sclerosis are flowing all over the place. The products of Novartis, Roche, Sanofi, and Takeda have all been listed. Among them, Ocrevus of Roche has increased by 170% since its listing in 2017. $ 100 million, close to the total sales of the "three carriages" of the tumor.

Bo Jian also wanted to work hard. In October 2019, Bo Jian launched an upgraded version of Fogaicate's upgraded version of Fogaolin. In contrast, the clinical effect of Foga Solo Weilville is better and the side effects are not strong, but it has not stimulated the splash in the market. In the first quarter, the sales were only millions of dollars.

Data predict that under the current situation, the market share of the varieties of patelite diacerne by 2028 may be less than $ 300 million.

Bo Jian urgently needed a new "explosion", so he thought of the treatment of Alzheimer's disease.

Drilling "horns", but was defeated by the market

In October 2019, when the patent battle of the reptomic acid was fired, Bo Jian announced that it restarted ADUCANUMAB's listing procedure in the United States.

This drug has actually failed once. In March 2019, the US Independent Data Supervision Commission analyzed the invalidity of Bo Jian's new pharmaceutical pharmaceutical pharmaceutical pharmaceuticals, and believed that the possibility of this drug achieved the expected results was very small.

Bo Jian then terminated four clinical trials of Aducanumab. The company's stock price plummeted, and the market value once removed nearly $ 20 billion.

However, due to the challenge of the pamanol, Bo Jian could only reappear the AD drug in the scalp.

It stands to reason that Bo Jian's idea is based. Data show that in 2020, Alzheimer's patients have exceeded 34 million, and this number may rise to 38.5 million after 10 years. Bo Jian should be able to lay down to make money.

Treatment of Alzheimer's disease is a world problem, because humans have not figured out the cause of pathogenic causes. For more than 100 years, Alzheimer's disease has only had 6 treatment drugs in the world, including the "971" Magot Sodium, which was listed in my country in 2019. Major pharmaceutical companies have said that more than 320 clinical clinicals have been carried out, and they are all successful. If Bo Jian succeeds, the market prospects will indeed be amazing. The scientific community believes that a β starch -like protein reaches abnormal levels in the human brain and forms plaques, which will disturb the cell function in neurons and make people to Alzheimer's disease. The role of traditional AD drugs such as "U.S." is to slow down the aggregation speed of β amyloid protein. The drugs developed by Bo Jian can significantly reduce β amyloid protein in the patient's brain.

But Bo Jian has not been able to prove: can reduce the β amyloid protein in the patient's brain, can he cure Alzheimer's disease?

In order to prove that its own products are effective, after the clinical clinic in 2019, Bo Jian changed his research and development idea. This idea is actually not unusual, and most people can come up with:

Increase the dose.

According to the results of the clinical trials of Bo Jian's increased dose, it is said that some patients' cognitive and memory, language and other functional test results have improved significantly, and some can even travel alone.

The FDA finally approved the listing of this drug, but clinically, this drug became a "inspection IQ" test gold stone. Many doctors believe that this medicine is invalid, and they even publicly declare: "will never prescribe this prescription for patients."

In the question, Aducanumab handed over the first bad transcript in October: a total of $ 300,000 in the third quarter, and the number of users was not more than 30. Bo Jian is also more stubborn. Since the doctor does not give the prescription, it will be sold online. Bo Jian proposed the "900 websites to sell medicines", but now it seems that only more than 100 websites have been laid.

According to statistics from the Jianzhi Bureau, as of the first quarter of this year, ADUCANUMAB's sales were not over 4 million US dollars.

In February of this year, this "magic medicine" was exposed to security problems: 3 patients who ate this medicine died unfortunately. This made Medicare and Medicaid, known as "American Medical Insurance", decided not to reimburse this medicine. Bo Jian was completely in despair, CEO was forced to leave, and the company had to lay off.

Hope to fall out a few times, the small company grows up is the knowledge of the door

Bo Jian's most famous medicine in China is to be regarded as "700,000 pins" Nosnina sodium, which triggers public opinion sensation.

Nosna sodium is used to treat spinal muscle atrophy. This is a rare disease, which mainly occurs in the infantile period. The global incidence is less than 1/6000. In 2016, Bo Jian's Nosnina Sodium was approved in the United States, becoming the first treatment of this disease in this disease.

Bo Jian can often create "the world's first", but often cannot convert technological advantages into market advantages.

The variety of Nosyasheng sodium is very good. He has not made a patent dispute or a clinical accident. Except for the bargaining by the Medical Insurance Bureau in China, there is almost no negative evaluation.

However, opponents are also targeting this market. Roche's oral drug Lisi Panlan, due to the advantages of price and medication, set a performance of $ 659 million in the first year of listing. In addition, Nuohua's more price -priced genetic drug Zolgensma was sold to US $ 2.125 million, but it only took one shot to be effective for life.

Bo Jian's financial report shows that the sales of this drug have continued to decline in the past three years, and it has fallen to $ 2 billion in 2021. Among them, the US market is only $ 587 million.

Bo Jian is always ambitious, but it is contrary to his wishes. In mid -June this year, Bo Jian announced that it would terminate a cooperation agreement with Karyopharm Therapeutics. The two companies originally intended to cooperate with the drugs of "frozen disease", but did not expect to fail.

In addition, Bo Jian's two ophthalmology therapy drugs have also failed. Both drugs were obtained when Bo Jian acquired Nightstar therapeutics Nightstar therapeutics in March 2019, which cost $ 877 million.

But these failures did not prevent Bo Jian from becoming an excellent biomedical startup company.

In 1978, the newly established company, like Bo Jian and Genak, represented a trend in the biomedical industry: the rise of BIOTECH.

Biotech, Biotech, has been suspected of being suspected of some large pharmaceutical factories. How many years can the scientist team from the ivory tower persist? It's better to go back to research and development.

Bo Jian had at least survived and made several medicines that could be called by the market. The only regret is that Bo Jian failed to achieve imagination in the market. After more than 40 years, it is still a pair of Biotech.

In the first half of this year, a survey initiated by Canada RBC Capital Markets showed that about 40%of Bo Jian's investors hope that the company can take a little bit of heart and choose a CEO with successful business experience. As for how strong this future CEO's academic research and development ability is, they don't care very much.

Today, Bo Jian has decided to cancel the commercial team of Aducanumab, layoffs to stop losses, and transform the R & D attitude. He has not focused on neuroscience, but has a "open attitude" in other diseases.Many innovative pharmaceutical companies in China are also facing problems such as poor research and development direction and lack of business ideas.Scientists rely on one or two R & D results to obtain capital recognition by accident.How to circulate and operate is not only personal scientific research capabilities, but also R & D strategies and business planning two -wheeled rolling.

If it is said that the achievements of Chinese Biotech in the past few years have come from abroad.Today, companies like Bo Jian have changed their ideas. Do domestic companies intend to follow?

Writing | Guyue

Edit ｜ Jiang Yun Jia Ting

Operation | Valley

Illustration | Visual China

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