Han Bio Hair Multiplication via Dermal Papilla Cells

At the end of March 2021, I read about a new South Korean company named Han Bio. Apparently, this company has managed to successfully develop a dermal papilla cell culturing technology.

Update: May 22, 2025

An interesting new interview with Han Bio’s chairman Da-witt Kang.

Update: April 9, 2025

Han Bio Aims for Phase 1 Clinical Trials in 2027

Han Bio is back after some prior delays and perhaps over-promises. In a press conference in Seoul on April 8, 2025, the company’s Chairman Kang Da-witt said that they would start Phase 1 clinical trials in 2027. Key quote:

“As the threshold for autologous cell therapy has been lowered with the revision of the Advanced Regenerative Biotechnology Act, we will collaborate with hospitals to promote rapid clinical entry and commercialization.”

Han Bio HSF-101 Mice Hair Growth
Han Bio HSF-101 papilla based tissue engineering product. Before and after hair growth in mice.

Of most significance, the company has developed a mammary papilla-based tissue engineering product called HSF-101, delivered via a new microneedle based system. In an experiment, it led to hair growth of up to 0.6 mm. Moreover, in mice, it led to the formation of new hair follicle structures.

Quote from Mr. Kang:

“We will become a company that conquers hair loss with mammary papilla cells.”

Han Bio CEO Kang
Han Bio CEO Kang.

Interestingly, Mr. Kang mentions that his own hair loss bothered him and is what initially led to the creation of Han Bio.

Update: March 2022 — Hanmo Bio gets approval for manufacturing advanced biopharmaceuticals. Per CEO David Kang:

“We got approval of the cell treatment facility last year, the entry into preclinical trials, and the recent approval for the manufacturing of advanced biopharmaceuticals. We are now standing at a very important start line for the fundamental and complete solution of the hair loss problem that Hanmo Bio is planning.

Update: October 2021 — Clinical trials will start in the first half of 2022. Han Bio will partner with Dt&CRO. The latter is South Korea’s first and only full-service contract research organization (CRO). Non-clinical trials will commence in November 2021.

Another article from March 2021, with CEO David Kang making a bold prediction:

“By collecting 50 to 100 healthy hair follicle tissues from the back of a patient suffering from hair loss, extracting the dermal papilla cells, cultivating them, and transplanting them back to the head, we can fundamentally cure hair loss.”

Of course at first I was incredulous. However, after further research, I decided that I should at least take the company semi-seriously. Han Bio’s blog is especially extensive. Some hair related articles on there go into many pages, so be sure to navigate thoroughly (after translation). Another version here seems to have additional news.

Note that when I contacted the company, they directed me to the above blog.

Han Bio’s Dermal Papilla Cell Storage and Culturing

Note that Han Bio is also called Hanmo Bio and Hanbio Group in news articles and on the company’s site. The externally located blog has some lengthy posts regarding this new technology. Some include images and video (screenshots further below).

In December 2020, Han Bio introduced its dermal papilla cell storage service called HDPC-480. The list price is 4.8 million South Korean Won ($4280 at current exchange rates). They offer a steep discount for the first 500 patients.

Note that in the western world, we have a similar option available via HairClone (UK). Moreover, HairClone has already been active for several years.

Han Bio Dermal Papilla Cell Storage
Dermal Papilla Cell Storage. HDPC-480 procedure from Han Bio.

According to the balding CEO Kang Da-Witt (also called Kang David):

“Han Bio has secured technologies to separate and regroup the dermal papilla cells in hair follicles. It would take just a single strand of a patient’s hair to cultivate enough cells to reproduce around 30,000 hair strands.”

The company’s method is described as “chopping separation technology” after translation from Korean into English.

Han Bio has finished construction of its first plant, where the company stores and cultivates patient dermal papilla cells. These can then be cultured, multiplied and then implanted into the same patient via a hair transplant. This new plant will open by the end of May 2021.

Han Bio Clinical Trials and Patents

Han Bio Presentation
Han Bio video presentation screenshot.

Han Bio will start clinical trials in the second half of 2021. According to CEO Kang Da-Witt, he expects that the time required for clinical trials will be shortened. This is due to a favorable new South Korean law which became effective on August 28, 2020. It is designed to help fast-track the market entry of regenerative medicine and biologics related products. Similar to Japan’s fast-track laws.

Han Bio is now preparing to apply for patents in the US, Japan and China. The are also open to out-licensing the technology.

Transplanting Someone Else’s Dermal Papilla Cells

From Han Bio’s extensive blog, one FAQ section caught my eye. It seems like the parent company of “Hanmo Bio” has successfully transplanted hair stem cells from one person to another. Without any immune reactions.

Dermal Papilla Transplant
Dermal Papilla Cell Transplant from Another Person.

Obviously, this all sounds way too good to be true. But I have to prognosticate.

Asian countries dominate the world in the manufacturing of nano-scale semiconductors, microchips and integrated circuits. Perhaps our invisible-to-the-eye dermal papilla cells are next?

South Korea: Groundbreaking Hair Loss Treatments

South Korea is a world leader when it comes to plastic surgery and cosmetic procedures. When it comes to treating hair loss, South Korea is especially impressive in developing and/or using new technologies. For example:

  • South Korea is one of only two countries in the world where Dutasteride has been approved for treating hair loss.
  • The work of Dr. Kang-Yell Choi and CK Biotech in developing PTD-DBM to target CXXC5.
  • PGD2 inhibition technology via Stemore (link no longer working).
  • DKK-1 research and patent for locally-based Bioneer.
  • My favorite: Allogeneic Person-to-Person Hair Transplants.
  • South Korean companies are also at the forefront of developing stem cell related products, including AAPE and ADSC. Most such currently available products likely have limited to no benefits towards hair growth.
  • Finasteride injections.
  • Moogene.
  • Epibiotech.
  • OliX Pharmaceuticals and its RNAi based hair loss product.
  • A disproportionate amount of research when it comes to hair growth from natural products. Especially from sea vegetables and algae.

Update: January 2022

South Korea’s President Says Government Should Pay for Hair Loss Treatments

South Korea is the first country in the world to suggest that the government should pay for hair loss treatments. Thank you President Lee Jae-myung. It seems like I am not as libertarian as I thought. Please see the middle of this post for much more on South Korea’s leadership in hair loss research.

Lee Jae-myung said on Wednesday that hair loss coverage is necessary from the aspect of “body completeness.”

 

Hope Medicine HMI-115: Phase 2 Trials Complete. Product Release Possible in 2027.

Hope Medicine LogoRead the bottom half of this post for my original report on Hope Medicine (China)’s HMI-115 (licensed from Germany’s Bayer). New updates are on top. This treatment targets the prolactin (PRL) receptor to cure hair loss. Hope Medicine raised $56 million in funding in 2021. See their pipeline page for more information.

The initial reason for all this excitement was due to the spectacular long-lasting hair growth results seen in stump-tailed macaque monkeys. When I originally wrote this post in 2021, these monkeys were still being monitored and had not lost their hair even over four years after stopping prolactin receptor antibody treatment.

Prolactin Hair Growth (Hope Medicine HMI-115).
Hope Medicine and Bayer prolactin receptor antibody (HMI-115) hair growth. Before and after in stump-tail macaque monkeys. The hair growth has remained even years post treatment cessation.

Update: May 25, 2025

Hope Medicine’s HMI-115 could get Released in 2027

I did not update this post for over a year in spite of the significant interest. Recently, “Theo” sent me a link to a detailed December 2024 interview with Hope Medicine’s founder Rui-Ping Xiao (also called Xiao Ruiping). The part that stood out:

“Xiao revealed for the first time in the program that the drug they developed for the treatment of hair loss has completed the second phase of clinical trials and will be available globally as early as 2027!”

So this must be the 180-patient Chinese Phase 2 trials that are completed (they began those in 2023). The results must have been very promising for Dr. Rui-Ping to be so confident about a product release in 2027? And maybe Phase 3 trials have already started?

The delayed US Phase 2 trials likely never started, and perhaps they are not moving forward with Phase 2 trials in Australia either (after conducting successful Phase 1 trials there)? I have not checked out any government clinical trial pages, but perhaps readers can chime in. Dr. Rui-Ping also gave an important video presentation in December 2024, and she seems like the real deal.

Update: January 14, 2024

Positive Outcome for HMI-115 in Phase 1b Study in Australia

Really excellent news to start of 2024. The Phase 1b study for HMI-115 in Australia showed positive results in terms of efficacy and safety. The study included 12 males and 4 females. It seems like “moeman32” from Reddit was not lying and I am glad that I covered him for months in my earlier updates despite his erratic behavior. Key quote from this latest press release:

“Specifically, in the 12 male patients at the end of the trial, the mean non-vellus target area hair count (TAHC) increased by 14 hairs/cm2, compared to that of the baseline. This increase is statistically significant.”

“This study is the first ever to show that prolactin receptor blockade can promote hair growth in patients with androgenic alopecia and may provide a novel therapeutic approach.”

We also got an update from CEO Nathan Chen (who seems to have replaced Henri Doods?) that the Chinese Phase 2 trial recruitment of 180 patients is ongoing. A bit slow considering that they started this process in August 2023. It seems like they were awaiting the final results of the Australian trial before proceeding further in China. They aim to achieve full PoC (proof-of-concept) by the end of 2024. No updates on the delayed Phase 2 US trials.

Update: October 27, 2023

Hope Medicine and Chime Biologics Enter Manufacturing Agreement

Hope Medicine (China) and Chime Biologics (China) have partnered to “speed up” the manufacture of the first-in-class monoclonal antibody drug HMI-115. Chime Biologics is a leading contract development and manufacturing organization (CDMO). The two companies are committed to commercialization of HMI-115 for the treatment of both androgenetic alopecia and endometriosis.

Update: August 1, 2023

Phase 2 Trial Recruitment Begins in China

The HMI-115 Phase II clinical trial recruitment for androgenetic alopecia in China has now started.

Encouraging Updates from Australian Phase 1 Trial Participant

A November 2, 2022 detailed Reddit update from an Australian trial participant (HMI-115 dose 1 and dose 2) is required reading. This 37-year old male described in detail his first two doses of the prolactin blocker via injection. He (along with his 46-year old female partner) will get treatment every two weeks for six months. So a total of 12 doses, all at Sinclair Dermatology in Melbourne. Note that while these are Phase 1 trials in Australia, the same HMI-115 product is scheduled to undergo Phase 2 clinical trials in the US anytime soon.

This Reddit user “moeman32” seems legitimate and has a posting history of over ten years. He has also written about Australia many times in the past. He will do follow-up posts every two weeks. Note that all 20 patients in this Phase 1 safety trial are getting the actual drug injected. i.e., no placebo participants needed to test for efficacy this time around.

Update February 8, 2023: Unfortunately, he had to remove his posts due to some stalker issue. But the below threads have as yet not been deleted.

Update: April 12, 2022

The Australian Phase 1 trials for Hope Medicine’s HMI-115 are starting today. They will involve 20 participants and are expected to be completed in July 2023. The trials will be led by the renowned hair loss expert Dr. Rodney Sinclair. And there is lots of excitement on Reddit.

Meanwhile, US Phase 2 trials should start at any moment now (read further below). This difference in trial progression by country is strange. Perhaps is has to do with some stricter Australian government requirements.

Update: January 26, 2022

Hope Medicine HMI-115 US Phase 2 Trials

Hope Medicine just received FDA approval to commence Phase 2 clinical trials in the US for its HMI-115 product to treat androgenetic alopecia. HMI-115 is a human monoclonal antibody drug that targets the PRL receptor for the treatment of male and female pattern hair loss. Last year, the US FDA also approved Phase 2 trials of the same drug to treat endometriosis.

The Phase II clinical trial of HMI-115 for the treatment of androgenetic alopecia:

“Will be an international multi-center, randomized, double-blind, placebo-controlled study. It will be carried out in the United States, Australia and other countries.”

May 9, 2021

Hope Medicine Raises $56 Million

Recent excitement in the comments of this blog revolved around Kintor Pharmaceutical (China). However, this weekend, the participants on this site’s hair loss chat are discussing Hope Medicine (China). Out of the blue, this startup company received $56 million in a Series B round of financing. Investment firms Qiming Venture Partners and Grand Flight Investment led the way.

Key quote:

“Previously, HopeMed signed an exclusive license agreement with Bayer AG on the development and commercialization of a human antibody (HMI-115) targeting the prolactin (PRL) receptor for the treatment of male and female pattern hair loss. At present, HMI-115 has completed phase I clinical trials in the European Union, with positive safety results. The global multi-center phase II clinical trials for androgenic alopecia and will soon be launched.

Other investors include: HighLight Capital; Sinovation Ventures (a venture capital firm led by former Google China head Kai-Fu Lee); and Trustbridge. More here.

HMI-115 PRL Receptor Targeting: Bayer License

Ruiping Xiao
Dr. Rui-Ping Xiao

Note that I first covered Hope Medicine in my 2019 post on its partnership with Bayer in regards to the prolactin receptor. The company was founded by Dr. Rui-Ping Xiao, the dean of the College of Future Technology of Peking University. Apparently, she is also an associate editor of the New England Journal of Medicine. See this page for much more on Dr. Xiao Ruiping.

The most unusual part of this story is that Hope Medicine’s official website has not worked for weeks.

Update: November 28, 2021

New Interview with CEO Henri Doods

Hope Medicine CEO Henri Doods
Hope Medicine CEO Henri Doods.

There is a cover page listed interview of Hope Medicine’s CEO Dr. Henri Doods in a Chinese magazine “tradetree.cn”. If anyone can gain access to it and translate it into English, please try.

(Update: As of 2024, Hope Medicine has a new CEO called Nathan Chen).

Per reader “Karl”, Phase 2 clinical trials for hair loss product HMI-115 are planned for Q4 2021 (but no proof anywhere else). This matches what we expected per the prior updates that I discussed. Note that HMI-115 is the same as Bayer’s prolactin receptor antibody. Hope Medicine has the rights to the development of this product.

Update: A reader sent me the below screenshot of Hope Medicine CEO Henri Doods’ Chinese magazine interview that I mentioned earlier. If anyone can translate it into English, please post in the comments. Click on the image to expand.

Hope Medicine Doods Interview
Hope Medicine CEO interview.