 Home > Active Ingredient News > Drugs Articles > Life and death speed!

Life and death speed!

 Last Update: 2022-08-15
 Source: Internet
 Author: User

Tags

what herpes simplex virus

what lipids

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

，、，
。~5200（~1000）、，，、、、、、、，，，
。

，、，

20161123，【】solanezumab，

2018214，！APECS
。Verubecestat（MK-8931）

2019130，！

2019322，！(Biogen)
。！

On May 10th, local time in the United States, Endpoints News, a well-known foreign pharmaceutical media, reported that the international phase 3 clinical trial of Phase 1 ® developed by Green Valley Pharmaceuticals has been stoppe.

The five clinical trial centers participating in the project confirmed the ne.

Four of the clinical trial centers said that supply chain problems caused the trial to stop, and the fifth clinical trial center said that the trial stop had nothing to do with the supply chai.

The international phase 3 clinical trial of the 9-phase 1 ® ® ® ® developed by Green Valley Pharmaceuticals has been stopped

For a while, there was an uproar in public opinion, and there were all kinds of speculatio.

So, if the news is true, what are the possible reasons behind the suspension of the Nine Phase One® International Phase 3? From the perspective of the internationalization of Chinese pharmaceutical companies, what does this mean? This article attempts to analyze and interpret from four aspec.

So, if the news is true, what are the possible reasons behind the suspension of the Nine Phase One® ® ® International Phase 3? From the perspective of the internationalization of Chinese pharmaceutical companies, what does this mean?

0 Clinical trials are inherently high risk and uncertain

Academician Ning Guang compared clinical trials to the last mile of new drug developme.

This metaphor underscores the importance of clinical trials and impresses .

From the press releases of new drug companies, we often see and hear more good news such as the approval of the clinical trial application, the first patient medication, and the completion of the clinical trial with positive resul.

These good news make us often ignore the "high risk" feature of the "three highs and one long" of new drug development

As an important part of the long chain of new drug research and development, various problems and situations may arise in clinical tria.

The most ideal situation is to start on schedule, to proceed smoothly, and to complete successfully, and it is one of the many fates of a clinical tri.

Many trials fell on the road before they reached the e.

They may have been stopped by regulatory agencies such as the FDA, or the sponsor may have actively pressed the stop button

These good news make us often ignore the "high risk" feature of the "three highs and one long" of new drug research and developme.

Many trials have not come to an end and have fallen on the road, which may have been stopped by regulatory agencies such as the F.

It may be that the sponsor actively pressed the stop button

On August 23, 2021, global pharmaceutical giant Merck announced that it has decided to terminate Phase 2 of the company's in-house developed PD-L1/TGF-β dual antibody bintrafusp alfa (M7824) based on the recommendations of an independent data monitoring committee after a data revi.

clinical resear.

The study was designed to evaluate bintrafusp alfa in combination with gemcitabine and cisplatin in first-line treatment of patients with locally advanced or metastatic cholangiocarcino.

In February 2019, Merck and GlaxoSmithKline, two pharmaceutical giants, reached a global development cooperation on bintrafusp alfa for refractory cancer, with a total amount of up to 2 billion US dolla.

The termination of this clinical research and development has poured cold water on the fiery dual-antibody track

The termination of this clinical research and development poured cold water on the fiery dual-antibody track

In January of this year, Kaleido Bioscience, a world-renowned biotechnology company incubated by Flagship, the top investment company behind Moderna, decided to terminate the planned clinical study of KB109 in the treatment of chronic obstructive pulmonary disease, and the company laid off 30% of its sta.

On April 9, the news came again, Kaleido announced that the board of directors voted to immediately stop all the company's business, and dismiss all the company's employees, leaving none, and will submit an application to the American Stock Exchange around April 18, Voluntary delisting from Nasdaq

The board of directors voted to immediately cease all operations of the company, and to lay off all of the company's employees, leaving none, and to submit an application to the American stock exchange around April 18 to voluntarily delist from the Nasdaq

In February and March 2021, Bio-Tech announced the termination of 3 new drug projects in clinical research stage, including 1 PD-1 mAb (BAT1306) and 2 ADC drugs (BAT8001, BAT800
At the time of termination, BAT8001 has entered Phase 3 clinical trials, and the company has invested a total of 226 million yuan; BAT8003 is in Phase I, and the company has invested 6565 million yuan; BAT1306 is in Phase II clinical trials, with a cumulative R&D investment of 59745 million yu.

After careful consideration of subsequent clinical development and commercialization risks and huge development costs, the company decided to terminate these projec.

The termination of these new drug programs resulted in about 340 million yuan being wasted

At that time, Bio-Tech stated in the announcement that the termination of the project would not have a significant impact on the current and future production, operation and performance of the company, but at that time only one product of Bio-Tech was in the commercialization stage, and investors still had concer.

As a result, the company's stock price fell as soon as the news came o.

The termination of these new drug programs resulted in about 340 million yuan being wasted

It can be seen that in the face of the high risk of new drug research and development, no matter it is a large and experienced multinational pharmaceutical company, an overseas star biotechnology company supported by top investment companies, or an increasingly international Chinese pharmaceutical company cannot avoid it

It can be seen that in the face of the high risk of new drug research and development, whether it is a large and experienced multinational pharmaceutical company, an overseas star biotechnology company supported by top investment companies, or an increasingly international Chinese pharmaceutical company can not escape

Interested friends are welcome to learn more cases!

Shock! Bankruptcy, delisting, layoffs, not a single one! Moderna's fellow star company can't escape such a fate!

The stock price fell 90% from the peak, layoffs 30%, and the phase 2 clinical trial stopped Kaleido, which was incubated by the top investment company Flagship, suffered a setback

.

stock Biotech in the cold winter: stock price plummet, clinical termination, massive layoffs, bankruptcy liquidation

7 pharmaceutical companies announced the termination of some drug research and development! Xinlitai terminated the introduction of oncology drugs and received a compensation of US$4 million!

Heavy news get together! Eli Lilly's new breast cancer drug began to supply China, Qilu introduced MUC1 ADC drug, Bojian's new multiple sclerosis drug was approved, and Merck terminated the development of a new crown dr.

Heavy news get together! Clinical trials are terminated, FDA approved indications withdrawn, new drugs are approved, large-scale mergers and acquisitions, and cross-border cooperati.

IDO Earthquake! Phase 3 Study of IDO+PD-1 Combination Therapy in Melanoma Failed to Meet Primary Endpoint, Study Terminated Early

It is not easy for a sponsor to start a clinical trial, and it is even more difficult to terminate it early, unless absolutely necessa.

So, what are the reasons for the sponsor to terminate the clinical trial? In 2018, GlobalData, an internationally renowned research and consulting company, analyzed all terminated clinical trials in the clinical trial database to determine the main reasons behind them

These reasons include: (1) the low enrollment rate of clinical trials; (2) clinical studies did not meet pre-set efficacy indicators; (3) adverse events, including patient death, occurred during the trial; (4) financial problems caused the company to Unable to continue clinical research; (5) The company decides to terminate clinical research based on business strategy decisions; (6) The products studied in clinical trials are discontinued; (7) Regulatory issues lead to clinical termination; (8) The clinical research program deviates; (9) The clinical trial results were positive, and the trial was terminated; (10) The trial was terminated due to ethical considerations; (11) Data collection was difficult, and major deviations and problems occurred in the clinical study, making it unsustainable; (12) Other reasons; ( 13) Unspecified reas.

When "Other Reasons" and "Unspecified Reasons" were removed from the dataset, the highest reason for termination of the trial was low participant enrollment at 55%, followed by lack of efficacy (15%), adverse events ( 11%), financial problems (6.

(Image source: globaldata)

The above is the data for 201 In the past two years or more, the new crown virus has swept the world, causing a huge impact, and clinical trials have not been spared, which should be wor.

According to media reports, dozens of pharmaceutical companies will suspend or terminate new drug development projects in 2021 alone

According to media reports, dozens of pharmaceutical companies will suspend or terminate new drug development projects in 2021 alone

0 The impact of the new crown epidemic on clinical trials

In addition to the risks inherent in clinical trials, the new crown epidemic has brought new problems to new drug development companies

The new coronavirus has been raging on the earth for more than two years, causing the new coronavirus pneumonia (COVID-19), a major public health event currently facing the wor.

According to Worldometer real-time statistics, as of around 6:30 on April 29, 2022, Beijing time, there have been 51,203,5430 confirmed cases of new coronary pneumonia in the world and 6,255,517 deat.

Globally, there were 705,091 new confirmed cases and 4,203 new deaths in a single d.

In addition to the loss of life and property, the new crown epidemic has also caused a huge impact on all walks of life, including the pharmaceutical industry

According to foreign media reports, due to the impact of the new crown epidemic, global pharmaceutical giant Eli Lilly decided at the end of March 2020 to put the "brake" on most new clinical studi.

The new crown epidemic has brought new problems to new drug research and development compani.

Suspend or terminate part of the test link or even the entire test if necessary

When analyzing the impact of the epidemic and proposing countermeasures, the impact on the scientificity (quality) of clinical trials should be considered first, and the impact on the progress of the trial should be considered seco.

Under the epidemic, progress can be sacrificed, but quality should not be sacrificed

Any response to plan violations/modifications caused by the outbreak should be carefully evaluat.

Under the epidemic, progress can be sacrificed, but quality should not be sacrificed

During the epidemic, it is generally not recommended to enroll new subjects, unless it is a clinical trial with a very short follow-up observation period (such as <1 wee.

How to effectively respond and minimize the impact of the epidemic on clinical trials is an urgent issue for clinical trial researchers and many stakeholde.

Although pharmaceutical companies and CRO companies have tried their best to develop countermeasures such as remote clinical trials and virtual clinical trials, some clinical trials cannot escape the traditional clinical trial model, such as Alzheimer's disease, Parkinson's disease, e.

Mental cognitive disorders

Medical staff need to observe the patient's response face-to-face, and conduct subjective scale evaluations on the patient's mental, emotional, cognitive and other dimensions to quantify the improvement of these patients after medicati.

This method is difficult to carry out online, and there is no mature remote visit mode for clinical evaluation of such diseases in the indust.

Since 2022, the current situation facing clinical trials in China has become more severe

Taking Shanghai as an example, for a long period of time since mid-March, routine medical institutions including hospitals at all levels were almost clos.

However, some clinical trials cannot get rid of the traditional clinical trial mode, such as Alzheimer's disease, Parkinson's disease and other mental and cognitive disease.

0 The cold winter of capital and the life and death of Chinese innovative pharmaceutical companies

If the inherent risks of clinical trials and the impact of the new crown epidemic are compared to two mountains, then the capital winter is the third mountain that weighs on pharmaceutical compani.

Global pharmaceutical investment enters a dark moment again

(Image source: Caijiandao)

In this wave of capital winter, the response of Chinese new drug companies is even great.

Since the second half of 2021, the stock prices of most listed Biotech companies in China have experienced a correction of more than 50%

In an interview with Drug Times, lawyer Pan Wensen commented, " In a sense, this is a belated industry correction

In a sense, this is a belated industry correction

For unlisted new drug research and development companies, the capital winter makes the company's financing plan difficult, or simply stranded, and the promised investment is far aw.

According to Caijiandao, some professionals estimate that it is difficult for many start-up Biotech companies to reserve funds for two years of operatio.

Many start-up Biotech companies have difficulty keeping funds for two years of operation

Therefore, while the current new drug research and development companies are struggling with the unsmooth progress of clinical trials, they also need to think deeply and prepare carefully for how to survive this capital winter

Therefore, the current new drug research and development companies must think deeply and prepare carefully for how the company will survive this capital winter while doing their best for the progress of clinical tria.

0 Flanking from front and back, attacked by the enemy on the belly and back, Lugu broke his arm to survive

On January 1 this year, China's new version of the medical insurance catalog was officially implement.

®It should be pointed out that after the publication of the National Medical Insurance Catalogue, there is still a process for the drug to land in various provinc.

Let's go back and look at the company's existing major mature produc.

® ® ® A significant source of funding for the company is affected

The international multi-center Phase 3 clinical study, codenamed "Green Memory", is planned to be carried out in about 200 clinical centers in 14 countries and regions including North America, Europe and China, involving 2,046 patients with mild to moderate Alzheimer's disea.

Patients with silent disease, a 52-week double-blind period plus a 26-week extension peri.

The clinical study is expected to cost $300 million

This is a huge investment, especially for a Chinese compa.

Drug Times learned that Green Valley has been in financing since the approval of the third international pha.

It is reported that the financing has entered a mature stage in the second half of last year, and the leading investment company and the co-investing company have been basically determin.

However, I have never heard the news of the financi.

Considering the unsatisfactory situation in the capital market since the beginning of this year and the special circumstances that have occurred in Shanghai since March, can the long-awaited financing be available? If the financing is delayed or stranded, will it also have a direct financial impact on the International Phase 3 of the Nine Phase One®?

®Can the long-awaited financing of this clinical study be expected to require US$300 million ? If the financing is delayed or stranded, will it also have a direct financial impact on the International Phase 3 of the Nine Phase One®?

On the one hand, the cost of clinical trials has risen sharply; on the other hand, the sales of the company's mature products have fallen sharply, revenue has dropped sharply, financing has been stranded again, the capital chain has become thinner and less funds are availab.

Under the double blow of the epidemic and the cold winter of capital, Green Valley Pharmaceutical was attacked from the front and back, and the enemy was attacked from the back and the back

Under the double blow of the epidemic and the cold winter of capital, Green Valley Pharmaceutical was attacked from the front and back, and the enemy on the back

If the trial continues to be extended, more subjects need to be added, and the clinical trial period is lengthened, the company will simultaneously address the challenges of clinical trial quality and cost, as well as the potential for higher safety risks to subjec.

From the overall perspective, in such a special case, early termination of clinical research may be a better choice for many aspec.

From the overall perspective, in such a special case, early termination of clinical research may be a better choice for many aspec.

0 Conclusion and Outlook

To sum up, in addition to the supply chain problems mentioned in the media, the possible reasons for Green Valley to terminate the clinical trial may also include a series of problems caused by the new crown epidemic and the cold capital winter , especially the high screening failure rate/entry rate of subjec.

Funding problems caused by low group rate, sharp decline in sales, shrinking cash flow and stranded financi.

These serious problems related to the survival of companies should not be unique to the Green Valley fami.

I believe that many pharmaceutical companies, especially Chinese new drug R&D companies that are committed to internationalization, are facing these problems and challeng.

The series of problems caused by the new crown epidemic and the cold winter of capital should not be unique to Green Vall.

It is believed that many pharmaceutical companies, especially Chinese new drug R&D companies committed to internationalization, are facing these problems and challeng.

As a famous foreign saying goes, " Those who can't hit you will eventually make you strong.

"

What doesn't hit you will eventually make you strong.

On April 18, 2022, Bio-Tech announced that the company's ADC drug BAT8009 has been approved for clinical tria.

It is worth noting that this is the fourth ADC developed since Bio-Tech terminated the two ADC projec.

dr.

Bio-Tech has started anew after encountering setbacks in the ADC field, and will focus on new targets such as FRα and B7H3, and the future can be expect.

Bio-Tech has started anew after encountering setbacks in the ADC field, and will focus on new targets such as FRα and B7H3, and the future can be expect.

If the news that Green Valley has stopped the Phase 1® International Phase 3 study is true, we regret that another international study in the important field of Alzheimer's disease has failed, and we will also give more to these companies that are committed to new drug research and developme.

many blessin.

I sincerely hope that the epidemic will be more effectively controlled, the cold capital winter will end as soon as possible, and the internationalization journey of Chinese pharmaceutical companies will be smooth sailing and reach the other side!

references:

When we talk about "going to sea", what are we talking about? | Medicine Age Going Overseas Series

UPDATED: Scoop: Green Valley's seaweed-derived Alzheimer's drug, approved in China, is halted in PhIII study

Peking University Clinical Research Institute puts forward ten suggestions to help clinical trial projects effectively respond to the new crown epidemic

Depth｜Innovative pharmaceutical companies' life and death

Reflection: Has China's clinical trials come to an end?

After the termination of 2 ADC drugs, Bio-Tech's new ADC was approved for clinical trials

From Aducanumab to GV-971, can humans jump out of the "five-finger mountain" of Alzheimer's disease?

Double legend: Biogen/Eisai's Aducanumab and Green Valley's GV-971

A milestone in the field of Alzheimer's disease! GV-971 has just been approved!

my country's original new drug for Alzheimer's disease officially launched

Science | Alzheimer's experts greet China's surprising approval of a new drug for brain disease with anticipation and caution

Phase 3 clinical trial in China in patients with mild to moderate Alzheimer's disease shows new drug can improve cognitive performance

Another "jumping grade" for FDA's new drug application: FDA approves mannat sodium capsules to directly conduct international multi-center phase III clinical trials in the United States

Never give up, the night will be bright! Exploring the 18-year quest of AD researchers

AD market attracts countless heroes to bow down! Several Merry Players Also Watch GV-971

"Hidden Killer" Alzheimer's Disease: Inventory of Pathogenesis and Global Drug Development Status

The clinical data of 8 innovative drugs were released for the first time, and the latest Chinese original research drugs are here!

Fighting cattle across the mountain? Drug development exploration targeting the "microbiota-gut-brain axis"

Focusing on Alzheimer's disease, can this ambitious small American company become the next dark horse?

From "stuck neck" to "going out", will Chinese innovative drugs work?

New Progress in Alzheimer's Disease｜Aduhelm's twists and turns and GV-971's rides

Small molecule drug research and development is still the main battlefield of new drug research and development

Other public information