From Nobel Prize to Miracle Drug, Why did rat nerve growth Factor fall from its pedestal?

Niuniu, a three-and-a-half-year-old girl who was diagnosed with autism because she was unable to speak, was given rat nerve growth factor at the suggestion of her doctor.

However, after two courses of treatment, the cost is spent tens of thousands of yuan, but the symptoms did not improve.

Real patient feedback, "mysterious" clinical trial results, and a Nobel-winning aura cast a pall over rat nerve growth factor.

From the Nobel Prize to the "miracle medicine,"
I love you all the time

Speaking of mouse nerve growth factor, as a Nobel Prize-winning drug product, it certainly has a starring role.

In 1986, the Nobel Prize in Physiology or Medicine was awarded to two American scientists, RitaLevi-Montaleini and SranleyCohen, for their discoveries of nerve growth factor (NGF) and epidermal growth factor (EGF).

From then on, the rat nerve growth factor will gradually go to the road of "gods".

One may ask why rat nerve growth factor was chosen when snake, mouse or placenta can be extracted.

The first is that rat nerve growth factor has high homology with humans, and the second is that it is easier to obtain. The combination of high homology and easy access to rat nerve growth factor has established its position in the world.

In 2003, China's first rat nerve growth factor for injection was officially approved for production, becoming the world's first nerve growth factor product, and the journey of "miracle medicine" began.

Since then, there have been 3 more products on the market, a total of 4 products. With China's new drug research and development ability at that time, nerve growth factor products are the first in the world and take the lead, and there is no nerve growth factor subcategory products on the market in Europe and the United States, which still seems inconceivable.

Why did you fall from the pedestal?

Talking about the sales and market of "miracle medicine", the following chart shows the sales changes of rat nerve growth factor for injection in recent years.

As early as 2011, the total sales volume of rat nerve growth factor for injection was about 340 million yuan, and by the end of 2016, the total sales volume had reached the peak of 3.3 billion yuan, nearly increasing 10 times in 5 years.

The turning point for sales was 2017.

It maintained a stable growth before 2017, but the market sales continued to decrease from 2017, and even dropped off a cliff after 2018. What is the reason for the current situation of "magic medicine"? This also starts from the country's "love" for it.

First of all, the national quality standard for rat nerve growth factor was blank before 2015, that is, there was no clear quality standard, only the enterprise standard. The real specification with quality standards started from the 2015 edition of Chinese Pharmacopoeia, which was included in the third part. Since then, the drug has had national quality standards, providing it with strict and standardized production and quality specifications. From then on, the "care" for rat nerve growth factor began.

In 2017, Chinese medical insurance took the first step towards "miracle drugs", restricting the indications for which they can be paid by Medicare to traumatic optic nerve injury and n-hexane poisoning. It should be known that the indications of "miracle medicine" before restriction are various. Take Enjingfu as an example, it has many indications for the treatment of peripheral nerve injury caused by chemicals and drugs, neonatal cerebral palsy, cerebral atrophy and so on. And insurance limits on reimbursement indications, which naturally hurt sales.

In 2018, the National Health Commission explicitly required the formulation of a list of adjuvant drugs, and rat nerve growth factor was included in it. The so-called adjuvant drugs, naturally refers to the disease has no substantial effect on some drugs. In 2016, the sales volume of irrational drug use reached a staggering 960 billion yuan, with adjuvant drugs accounting for the vast majority. It should be known that China's total sales volume was only about 1.7 trillion yuan at that time. Adjunct drug so, the state naturally to its good remediation.

If restricting their indications for Medicare payments is a simple first step, then focusing on monitoring them in 2019 and then removing them outright from health insurance is a death sentence. Since its clinical effect was not significant, rat nerve growth factor was officially removed from the National Medical Insurance directory in 2019. Since then, the glorious past of rat nerve growth factor seems to have ended completely.

Dismal sales in 2020 will also be enough to see the impact of the removal.

In 2021, the state continued to increase the requirements on rat nerve growth factor, and issued the Announcement on Revising the Instruction Manual of Rat Nerve Growth Factor for Injection to rectify any improper contents in the instruction manual.

So what did the "miracle medicine" do wrong enough to be "sentenced to death"?

After all, this is not immune to the two most important aspects of medicine, namely safety and efficacy. How do you prove the safety and efficacy of a drug? That, of course, is clinical data.

Embarrassingly, no Phase 3 data has been released since the drug was launched. The following figure shows the clinical trial information about rat nerve growth factor obtained by Xiaobian on the drug clinical trial registration and information announcement platform, including a total of 6 related clinical trials.

The registration number CTR20170195 is Sutaishen Company. Phase 2 clinical trial has been completed on April 29, 2022. The applicant (registration number CTR20170195), Xiamen Beidouzhi Road Biological Engineering Co., LTD., completed the Phase 2 clinical trial on May 7, 2013.

Interestingly, the registration number CTR20132891 has been in the state of recruitment for phase 3 clinical trials for nearly 10 years since its publicity in 2014.

summary

The absence of Phase 3 data, the removal of Medicare, and patient feedback that the drug was not effective have led to the end of this miracle drug. Hopefully, at some point in the future, there will be enough clinical data to clear his name.

References:

1. "Nobel Prize" achievements raised doubts.

2.http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

3. Ding Xuanzhou.1986 Nobel Prize in Physiology or Medicine: Discoveries of nerve growth factor and epidermal growth factor [J]. Advances in Physiological Science,1987(02):97-98.

4. The world's first nerve growth factor product is approved by the state _ Sun Hongtao.