Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss

[Jackshtbro]

With translations you have to be careful. It isn't necessarily the hair loss trial they are referring to regarding FDA approval. This article isn't specific to hair loss even though it mentions it, it's about the company broadly so it could be referring to the endo trial, and probably is.

I don't know man, seems legit to me. Bet their first patient has already done his second injection by now

 

[Throwaway94]

I don't know man, seems legit to me. Bet their first patient has already done his second injection by now

They're probably jerking away right now thanks to the lack of prolactin

 

[Dimitri001]

产业基地启航！北大分子医学南京转化研究院产业发展基地正式启用 - 园区要闻 - 南京生物医药谷 (njbpv.cn)

View attachment 172955

19-10-2021
HopeMedicine is an innovative biopharmaceutical company based on Professor Xiao Ruiping and his team from the School of Future Technology of Peking University, based on decades of research results in the field of translational medicine. At present, the company has completed the B round of financing, signed a global exclusive license agreement with Bayer for the development and industrialization of the monoclonal antibody HMI-115 targeting the prolactin receptor (PRLR), and is developing and industrializing multiple indications worldwide change. This antibody has the function of promoting hair growth and has a therapeutic effect on hair loss. It has shown excellent characteristics in animal models and human safety, and has obtained the approval of the US FDA Phase II clinical trial. In the near future, the US Phase II clinical trial will be launched. The patient was enrolled. In addition, Herqirui has also carried out the R&D and industrialization of more high-end innovative drugs through the dual-drive model of license-in (authorized introduction) and independent research and development.

--

SOOOO they will start Phase II clinical trial for HMI-115(hair growth) now in the US

Thanks for keeping us up to date with the Chinese sources!

 

[-specter-]

Is there a chance it will already be on the market by 2024?

 

[surfer9]

Just wondering.....do the trials being held in the U.S.A benefit us in anyway? is this one of the best countries we'd wish the trials to be held in?, if so, why?

 

[trialAcc]

Just wondering.....do the trials being held in the U.S.A benefit us in anyway? is this one of the best countries we'd wish the trials to be held in?, if so, why?

US trials are typically the most "legit". The FDA is pretty strict on drug approvals and probably wont accept Chinese trials for drug approvals in the USA.

Most people would question drugs that only have Chinese approval due to lower safety standards and potential for false trial data.

 

[surfer9]

So...

We have something which has shown good safety and good hair growth even in slick bald monkeys...

Someone said these monkeys cost a lot to test on? it's rare to test on these monkeys? if so, is that because of the expense or drugs are only tested on them when they have huge potential?

We have a license agreement with HOPE Medicine, is this a huge indication of the confidence they have in this potential 'cure'? or is it normal for companies to sign these types of agreements at this stage?

Basically what I am asking is.... does all the above point to this likely being a success in helping a lot of humans get back a lot of their hair?

Is it pretty unique/rare in this world to have all these boxes ticked?

 

[pegasus2]

Is there a chance it will already be on the market by 2024?

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

 

[RolfLeeBuckler]

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

what do you mean When will they start the trial in Europe/Germany? If they start in US in december how long they will wait until starting in Europe?

 

[surfer9]

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

Didn't that Chinese article that someone translated say the patients were enrolled......


This antibody has the function of promoting hair growth and has a therapeutic effect on hair loss. It has shown excellent characteristics in animal models and human safety, and has obtained the approval of the US FDA Phase II clinical trial. In the near future, the US Phase II clinical trial will be launched. The patient was enrolled.

 

[baldlygoing]

They should label it as a Covid vaccine so we could have it in our stockings by Christmas.

 

[Dimitri001]

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

In other words, it's a long way off and even when it comes it might be priced out of the reach of some of us, so we'd be smart to focus on experimenting with SMI-6 to find a concentration/frequency that works or on other PRLR antagonists or other methods of attacking the PRL angle.

 

[Janko]

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

If it will show awesome results after phase 2 I am sure it will get available in China. Also the black market would do its magic. Honestly, if it would come out in China and be really effective. I would fuckin swear loyality to chinese regime, sing songs about their communism anything. If that would not work, I would do plan B:

 

[surfer9]

I wish I could inject something into my scalp now and have full head of hair within months.....

I'd be walking around everywhere with a big smile on my face, just walking past people.... wherever most hot ladies are.....

 

[jan_miezda]

If it will show awesome results after phase 2 I am sure it will get available in China. Also the black market would do its magic. Honestly, if it would come out in China and be really effective. I would fuckin swear loyality to chinese regime, sing songs about their communism anything. If that would not work, I would do plan B:View attachment 172995

If it gets approved for endo then we will have a better ability/information about accessing it

 

[Throwaway94]

Yes and if the best case is 5 years, what’s the average case? Worst case?

re: SMI - even the HMI patent references research that shows the high unlikelihood that conventional PRLR antagonists can work similarly…

But if you’ve already crossed the Rubicon by using estrogens (implying you’ve tried everything with good scientific support and are now looking beyond that)…then sure

SMI isn't a conventional PRLR antagonist. It's brand new and still under research, and we all know that prl medication until now has been dopaminergic in terms of MoA. Until 2018 there were no prospective safe and selective PRLR antagonists whatsoever.

 

[Otrebor]

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

Since it will take a while and many of us do not have time we could concentrate on a megathread in which to connect searches and look for the pathways in which prolactin is involved, maybe we understand something more and find an alternative compound to smi that can give us more time for the antibody to be unavailable (assuming it will be)

 

[John Difool]

Let's assume they get approval for the trial and start recruiting by the end of the year. That puts them at least 3 months into 2022 before they are fully enrolled, at least 9 months into 2022 before the end of the trial, then at least 10 months into 2022 for data analysis. Let's say best case scenario they can apply for a pivotal trial at the start of 2023. Let's say 3 months best case before they get the green light, another 5 months+ to recruit and one year for the trial. That puts us 8 months into 2024. A couple months to prepare their application with the FDA. Best case scenario puts approval at q1 2025. It is realistic to say it could be available in 2026 assuming the trials go well.

I came up roughly with the same landing date: 2025. You will probably get a more impressive regrowth if your HF don't continue to be damaged in the interim.

 

[John Difool]

Since it will take a while and many of us do not have time we could concentrate on a megathread in which to connect searches and look for the pathways in which prolactin is involved, maybe we understand something more and find an alternative compound to smi that can give us more time for the antibody to be unavailable (assuming it will be)

Do you really believe this community of broscientists can come up with something better than what is being researched by people who do that for a living? Newsflash: all we can do is leech on published studies and papers and try to get it sooner than the FDA on our scalp by going GBs that other folks here are trying to kill in the nest. The real power of this community is to be guinea pigs by testing the compounds before they are on the market and report their experience. Unfortunately with a gang of hooligans, side-bitchers and naysayers, we can't even manage to do that right. So what gives?

 

[John Difool]

re: SMI - even the HMI patent references research that shows the high unlikelihood that conventional PRLR antagonists can work similarly…

can you outline the paragraph it says that?