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About CHA Biotech



CHA Biotech, a leading biopharmaceutical company, was established in Sept. 2000 by CHA Medical Group to create a central, multidisciplinary research facility where the university’s scientists and hospital physicians could come together and focus their efforts on developing stem cell, gene therapy and regenerative medicine technology.

CHA Biotech headquartered in South Korea with R&D focus in stem cells, and cell therapeutics.
The company is a member of CHA Medical Group, which comprise of medical university, medical centers and hospitals located in the US and Korea with in excess of two thousand five hundred beds under care, fertility centers, stem cell research and development centers, personal & preventive medicine and bio venture divisions.

CHA Biotech has the greatest number of stem cell R&D pipelines in therapeutic areas including Stargardt's Degeneration, Age-related Macular Degeneration, Intermittent Caludication, Stroke, Alzheimer Disease, and Disk Degeneration. Some are in early stages and some are in mid to late development stages.

The Company also successfully operates a cord blood banking business (i-Cord), stem cell banking business (Bio Insurance), and a non-medical business of CHAUM.
As part of its global business strategy, CHA Biotech expanded its operations to the United States in 2002 with the opening of CHA Fertility Center (CFC) in Los Angeles followed by the 2005 acquisition of Hollywood Presbyterian Medical Center (HPMC), a 434-bed general, acute-care hospital also located in LA.
Currently, CHA Healthcare (a subsidiary of CHA Biotech) operates CFC and HPMC.

With seasoned experience and research infra structure, CHA Biotech has built up multiple strategic relations with major research institutions in the field of stem cell research and infertility areas. The company is listed in Korean stock market and it currently has 7 subsidiary companies in Korea and 2 subsidary companies in the United States.

 

CHA Biotech’s Subsidiary Companies




CHA Biotech manages 7 major subsidiary companies in Korea.

(1) CMG Pharmaceutical is a pharmaceutical company specialized in manufacture of generics and oral thin film-type products and it is listed in KOSDAQ market.

(2) Solidus Investment is a venture capital company investing companies in bio/agricultural and green energy/ IT industry.

(3) Seoul CRO is a contract research organization company conducting a great deal of domestic and foreign clinical trials.

(4) CHA Vaccine Institute is a research-oriented biotechnology company focused on the prevention and treatment of infectious diseases.

(5) CHA Healthcare is a hospital investment and operation company specializing in establishment of global healthcare network.

(6) CHA Meditechis a medical device and cosmetic raw material development company.

(7) CHA Cares is a healthcare solution provider company specializing in post-natal care, elderly homecare service, funeral service and IT management service.

CHA Biotech and its subsidiary companies have about 3,015 employees, of which 30% are from R&D.
Total revenue generated in 2016 was about USD 389 million.

 

CHA Biotech’s Business Lines

 
The major sectors of CHA Biotech can be divided into 4 business lines. 

The first business line is cell therapy product development business for future commercialization.
It is a key to CHA Biotech because it explains background of establishment of the company.

The second business line is private cord blood banking business storing newborn’s umbilical cord blood.

The third business line is stem cell banking business also known as bio insurance business offering banking services of various types of cells including adipose stem cells and immune cells.

The last business line is non-medical business line of CHAUM, a future-oriented anti-aging complex.

 

Differentiations of CHA Biotech’s Techniques

 
1) Most of companies are using live cells whereas CHA Biotech is using cryopreservation method. 
Live cells can survive for up to maximum of 24 to 48 hours but frozen cells can last for from 18months to up to 36 months.
CHA  Biotech’s cryopreservation technique has high post-thaw cell survival rates.
 
2) CHA Biotech is keeping stem cells in undifferentiated state by cultivating them under hypoxic conditions.
CHA Biotech has an unique technique of mass-producing cells up to 10 to the power of 13 cells.
CHA Biotech can develop low-cost, high-efficiency cell therapy products.

3) Under research collaboration with CHA Medical Group, CHA Biotech accumulated technological experiences and has the greatest number of cell therapy pipelines in Korea.

4) CHA Biotech has made significant clinical accomplishments through strategic collaborations with global stem cell development companies.

CHA Biotech has a goal to produce a pharmaceutical form of allogenic cell therapy product which is affordable to everyone.
CHA Biotech has key business strengths of reducing R&D expense and development period by utilizing core trusted stem cell resources found with CHA Medical Group.

 

CHA Biotech’s R&D Business


CHA Biotech’s R&D business focuses on various types of cell lines.
There are 8 embryonic and adult stem cell lines and 3 immune cell lines, for a total of 25 different indications.
Some are already entered into SIT(Sponsor Initiated Trial) and some are in IIT(Investigator Initiated Trial) or ready for IIT.

Embryonic stem cell therapies (SMD, AMD)
① StargardtMacular Degeneration (SMD) and ② Age-related Macular Degeneration (AMD).
CHA Biotech is developing embryonic stem cell based cell therapeutics for SMD and AMD. These are eye diseases.
The loss of RPE layer in Patients with Macular Degeneration results in loss of vision.
CHA Biotech’s therapeutic approach is to transplant new RPE cells and help restore vision.
CHA Biotech licensed-in embryonic stem cell technology from AIRM(AstellasInistituteof Regenerative Medine) in US (a subsidiary of AstellasPharmain Japan) and has a market exclusivity for the Korean market.
CHA Biotech is the only company that develops embryonic stem cell therapies in Korea.
Currently, Phase II clinical study for SMD is in preparation and patient enrollment in Phase I/IIaclinical study of AMD is expected to be completed in this year.

Adult stem cell therapies (IC, ST, AD, DD, CD)
CHA Biotech is also interested in developing adult stem cell-based cell therapeutics and has developed various cell sources from the different tissue origins: Platcenta, Umblical Cord, Adipose, and etc. Most of the clinical trials using adult stem cells are currently in the phase I and Phase II status.

③ Intermittent Claudication (IC)
CHA Biotech is participated in a large and multinational clinicaltriaal to Intermittent Claudication phase II with Pluristem, Inc. in Israel.
It is the CHA Biotech’s fastest trial among its trials and an enrollment of all 172 patients  for the trial is completed in January 2017.
Top line efficacy results will be reported in 1st half of 2018.
IC is a subset of peripheral artery disease, caused by atherosclerosis of the arteries in the lower extremities.
IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest.
Current treatments are drug medications to make improving blood circulation, angioplasty, bypass graft etc, however, no regeneration in damaged blood vessels caused by lack of blood flow.
The efficacy was identified through blood flow improvement in preclinical animal studies.
The angiogenicactivity and paracrineeffect were also observed.

④ Stroke (ST)
An umbilical cord derived stem cell therapy for stoke is the CHA Biotech’s 1st in-house pipeline.
A patient enrollment of 18 patients was successfully completed in October 2016 and the study was completed after a review period of 6 months.
CHA Biotech has a goal to obtain MFDS conditional approval based on Phase I/IIaand IIb results.
Stroke is a "brain attack". Stroke occurs due to problems with the blood supply to the brain.
When a stroke happens, brain cells are deprived of oxygen and begin to die.
When brain cells die during a stroke, abilities controlled by that area of the brain such as memory and muscle control are lost.
Stroke is a leading cause of serious long-term disability in the world. The 2/3 of stroke patients are suffering from significant medical paralysis.
The stroke diagnosis and treatment market is massively huge in the world.
Guidelines for current standard treatment recommend administration of tPA within 4.5 hours on symptom onset. Benefit is greater the earlier it is used and no hope for recovery for already damaged brain functions.
CHA Biotech’s umbilical cord derived stem cell therapy for stroke (CB-AC-01) is cryopreserved (frozen) product and it is ready for physician to administer to patient without cultivation for use in therapy.
It is expected this therapy establishes benefit for patients treated for up to 7 days of stroke onset.
CHA Biotech has a goal of expediting commercialization of CB-AC-01 therapy after phase 2b if the Korean MFDS guideline becomes feasible.
In May 2016, the Korean government announced a new guideline on conditional approval system for cell therapies which are intended to facilitate and expedite the review of new drugs to address unmet medical needs in the treatment of serious conditions including Fulminanthepatic failure, Stoke, and Alzheimer’s disease and that means the Korean MFDS may grant a conditional approval based on phase 1 and phase 2 data and a company will continue phase 3 trial as a condition of the Korean MFDS* conditional approval.
* MFDS: Ministry of Food and Drug Safety in Korea

⑤ Alzheimer’s Disease (AD)
The cause of Alzheimer’s Disease is poorly understood and there is no cure for Alzheimer’s disease.
CHA Biotech is currently conducing phase I/IIa  clinical trial and 2 out of 24 patients are treated.
Through a pre-clinical trial, efficacy of the product was found by significantly reducing amyloid-beta deposition in the brain lesion and improving cognitive function.
Alzheimer’s disease is a  chronic neurodegenerative disease that usually starts slowly and gets worse over time. It accounts for 60% to 70% of cases of dementia. The most common early symptom is short-term memory loss. As the disease advances, symptoms can include problems with language, mood swings, disorientation, loss of motivation, not managing self care, and behaviouralissue. 
CHA Biotech’s placenta derived stem cell therapy for Alzheimer’s disease (CB-AC-02) is cryopreserved (frozen) product and it is ready for physician to administer to patient without cultivation for use in therapy.

CHA Biotech has a goal of expediting commercialization of CB-AC-02 therapy after phase 2b trial if the Korean MFDS guideline becomes feasible.
In May 2016, the Korean government announced a new guideline on conditional approval system for cell therapies which are intended to facilitate and expedite the review of new drugs to address unmet medical needs in the treatment of serious conditions including Fulminanthepatic failure, Stoke, and Alzheimer’s disease and that means the Korean MFDS may grant a conditional approval based on phase 1 and phase 2 data and a company will continue phase 3 trial as a condition of the Korean MFDS conditional approval.
 
⑥ Disk Degeneration (DD)
Disk Degeneration causes chronic back and/or leg pain, as well as functional problems such as numbness in bottocksor difficulty walking.
It is typically associated with aging. As age increases, intervertebraldisc can lose flexibility, shock-absorbing characteristics, and elasticity.
Disk degeneration can also stem from an injury to the back.
CHA Biotech’s disk degeneration therapy (CB-AC-03) is a mesenchymalstem cell therapy derived from umbilical cord blood tissue. After receiving MFDS IND approval in May 2016, CHA Biotech is currently in preparation to initiate for phase I/IIaclinical trial.

⑦ Cartilage Defect (CD)
Cartilage Defect most commonly occurs in the knees.
Most cartilage defects are caused by traumatic injuries such as a motor-vehicle accident, bad fall, or athletic injuries but even more commonly occurs spontaneously without associated traumatic causes.
CHA Biotech’s cartilage defect therapy is a mesenchymalstem cell therapy derived from umbilical cord blood tissue. CHA Biotech received MFDS IND approval in September 2016.

Immune cell-based Therapy



CHA Biotech also develops immune cell-based therapies.
Currently, investigator-initiated trials are ongoing for solid tumors including brain cancer, liver cancer and ovarian cancer at Bundang CHA Medical Center.

CHA Biotech has technology to culture massive NK (Natural Killer) cells, and its activated cells were proven safe in many clinical trials.

CHA Biotech’s AKC (Activated Killer Cell) therapy has a high treatment effect of killing cancer cells.
It contains 20 times more perforins and TRAIL and 4.2 time more granzyme B.
The AKC technology requires only small amount of patient blood to generate highly activated NK cells.

The AKC product can be frozen, stored, and shipped to the clinical sites where the cells are thawed and administered without loss of anti-cancer activity.

CHA Biotech also has a plan to develop CAR (Chimeric Antigen Receptor) modified NK cell-based therapy product with one of the world-leading CAR development companies called Sorrento Therapeutics.

Cord Blood Banking Business (i-cord)



Cord blood is a rich source of blood stem cells that can grow into blood vessels, tissues and organs.
Currently, over 80 diseases are treatable using stem cells from cord blood, with more treatments emerging every year.

Over 30,000 transplants worldwide have been performed using stem cells from umbilical cord blood.
Stem cells in cord blood are immature and it is easier to match transplant patients with cord blood than with other sources of stem cells because cord blood stem cells are less likely to reject the transfusion.

CHA Biotech was a late starter in the Korean cord blood banking market, but through close collaboration with CHA Medical Group, CHA Biotech becomes No. 1 in the number of transplant operations including family and donated cord blood in Korea.

Bio Insurance Business (Stem Cell Banking)


CHA Biotech’s bio insurance business provides an integrated stem cell storage solution and immunotherapy.
This business was newly established in 2015 for use in the treatment of disease in the future.

CHA Biotech has various stem cell resources acquired as key competitive element for future cell therapy market.
The premium, integrated stem cell bank was established in collaboration with CHA Medical Group by utilizing its extensive experience in stem cell research and advanced cell cryopreservation technology.

Bio insurance business also provides immunotherapy service in Japan through collaboration with CHA Medical Center. 
Immunotherapy is the treatment that uses certain parts of a person’s immune system to fight diseases such as cancer.

Tokyo Cell Clinic is a specialized medical institution where Japanese and Korean medical teams cooperate to provide immune cell therapies for those who suffer from cancers.
CHA Biotech conducts co-operative studies on immune cell therapies with Tokyo Cell Clinic giving access to the global network.

CHUAM Business (Non-medical)





CHAUM is known as a future-oriented premium medical examination center established the first in Korea.

CHAUM provides highly personalized comprehensive healthcare services from Pre-care and At-care to Post-care.
CHA Biotech’s CHAUM business provides theraspa program and benefit center program.

Theraspa is a combination of therapy and spa.
The personalized spa therapy is planned based on the consultation and diagnosis of doctors, exercise specialists, and spa specialists.

Benefit center program is a fitness program.
The results from medical test and consultation with specialists as well as person’s lifestyle, preferred exercise, and physical condition are taken into consideration to develop personalized trains program.