Log in
Show password
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Dynamic quotes 
  1. Homepage
  2. Equities
  3. Japan
  4. Japan Exchange
  5. Chugai Pharmaceutical Co., Ltd
  6. News
  7. Summary
    4519   JP3519400000


SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

Completion of Enrollment in Phase III Comparative Study for Investigational Regenerative Cellular Medicine (gMSC®1) for Knee Chondrogenesis Using Allogeneic 3D Artificial Tissue of MSC

10/26/2021 | 10:48pm EST

Chugai Pharmaceutical Co., Ltd.


Completion of Enrollment in Phase III Comparative Study for

Investigational Regenerative Cellular Medicine (gMSC®1) for Knee Chondrogenesis Using Allogeneic 3D Artificial Tissue of MSC

TOKYO, October 27, 2021 --Chugai Pharmaceutical Co., Ltd.(TOKYO: 4519) and TWOCELLS Co., Ltd.

(Head Office: Hiroshima City, Hiroshima; President and CEO: Toshiki Hiura; hereafter, TWOCELLS) announced completion of target enrollment into a Phase III comparative study for an investigational regenerative cellular medicine for chondrogenesis in the knee (development number "gMSC®1"), with surgery on the 70th patient.

This study examines the safety and efficacy of transplanting gMSC®1, a three-dimensional artificial tissue of allogeneic MSCs, in comparison with microfracture surgery for patients with symptomatic traumatic cartilage defects or osteochondritis dissecans in the knee. The enrollment had started on November 29, 2017 and completed with the 70th surgery, fully enrolling the target number of patients. Going forward, the primary endpoints of histological evaluation of the cartilage and subjective symptoms will be analyzed at week 52 after surgery.

"The articular cartilage in the knee plays an important role in assisting with smooth leg movement. It has a very limited regenerative capacity, and various methods of treatment are under investigation for damages on the cartilage. gMSC®1 aims to repair the cartilage in the knee as a regenerative cell therapy which does not require the patient's own tissue taken from their joint, potentially paving the way for solving unmet medical needs in existing treatments. We hope that the assessment ahead will prove the value of gMSC®1, Chugai's first regenerative medicine project, and its benefit for patients," said Dr. Osamu Okuda, President and CEO of Chugai.

Toshiki Hiura, President and CEO of TWOCELLS, said, "Despite significant impact from COVID-19 pandemic, we have successfully completed enrollment in the study. Supported by the partnership with Chugai, we, here in Hiroshima, are smoothly advancing the development of basic technologies required for allogenic tissues, the provision of tissues from donors and establishing a GCTP-compatible facility to manufacture final products in Japan for the first time. We will build commercial production capacity as early as possible and strive to make regenerative medicine a familiar treatment option."

Chugai and TWOCELLS concluded a licensing agreement for gMSC®1 in 2016. Under the agreement, TWOCELLS is conducting the clinical trial, and responsible for manufacture and supply of gMSC®1. Chugai has joint development and exclusive distribution rights for gMSC®1 in Japan and is responsible for regulatory application.

To provide more patients with an innovative treatment option as soon as possible, Chugai and TWOCELLS will work on the practical application of the cartilage regenerative therapy using allogenic synovium-derived mesenchymal stem cell, which is the first of its kind in the world.

TWOCELLS and Chugai Announce Performing Surgery of the First Patient in Phase III Trial for "gMSC®1," a Regenerative Cellular Medicine for Chondrogenesis in the Knee (press release on November 29, 2017) https://www.chugai-pharm.co.jp/english/news/detail/20171129170000_50.html

Chugai and TWO CELLS Announce a License Agreement for "gMSC®1" a Regenerative Cellular Medicine for Chondrogenesis in the Knee (press release on April 25, 2016) https://www.chugai-pharm.co.jp/english/news/detail/20160425150000_144.html

Sources of reference for the study:

Japan Pharmaceutical Information Center (JAPIC) Drug Information Database


About gMSC®

gMSC®1 is a tissue-engineered medical product currently developed by TWOCELLS and was prepared for the regenerative chondrogenesis using synovium-derived mesenchymal stem cell (MSC) in collaboration with Osaka University and Hiroshima University. This product is a scaffold-free allogeneic 3D artificial tissue of MSC provided by TWOCELLS with their own technologies and serum-free medium (STK®1 and STK®2), which is expected to provide an effective treatment for cartilage regeneration. Development of gMSC®1 has been supported by JST (Japan Science and Technology Agency), NEDO (New Energy and Industrial Technology Development Organization), the Ministry of Economy, Trade and Industry, and AMED (Japan Agency for Medical Research and Development).

About Chugai

Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs.


TWOCELLS is a bio-venture company established in Hiroshima in 2003, aiming to promote regenerative medicine so that patients may have a new treatment option. By particularly targeting MSC (mesenchymal stem cell), it is engaging in the development of cellular medicine with MSC, peri-MSC culturing technique and a system for regenerative medicine.

2 / 3


Chugai Pharmaceutical Co., Ltd.


Corporate Communications Dept.

Head Office of Business Management

Media Relations Group

Management Division

Tel: +81-3-3273-0881

Tel: +81-82-250-3138

Email: pr@chugai-pharm.co.jp

Fax: +81-82-250-3148

Email: website-info@twocells.com

Investor Relations Group

Tel: +81-3-3273-0554

Email: ir@chugai-pharm.co.jp


3 / 3


Chugai Pharmaceutical Co. Ltd. published this content on 27 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 October 2021 02:47:01 UTC.

© Publicnow 2021
2021CHUGAI PHARMACEUTICAL CO., LTD. : Ex-dividend day for final dividend
2021CHUGAI PHARMACEUTICAL : Signs Joint Research Agreement with NCC for Asian International Co..
2021Launch of Chugai's New TV Commercial 'Protect the Ordinary Days People Cherish' Featuri..
2021CHUGAI PHARMACEUTICAL : Anti-CD20 Monoclonal Antibody Rituxan Approved for Additional Indi..
2021CHUGAI PHARMACEUTICAL : Launch of Chugai's New TV Commercial “Protect the Ordinary D..
2021Chugai Pharmaceutical Co., Ltd. - Notice of Board of Director's Resolution on Applicati..
2021Chugai Obtained Highest A-Rating by CDP in Two Categories and SBT Validation for Greenh..
2021Chugai Pharmaceutical Co. - Update on the Development of Oral COVID-19 Drug Candidate A..
2021Nikkei 225 Declines 1.8% on Central Bank Outlooks
2021CHUGAI PHARMACEUTICAL : Obtained Highest A-Rating by CDP in Two Categories and SBT Validat..
More news
Analyst Recommendations on CHUGAI PHARMACEUTICAL CO., LTD
More recommendations
Sales 2021 975 B 8 530 M 8 530 M
Net income 2021 292 B 2 555 M 2 555 M
Net cash 2021 461 B 4 034 M 4 034 M
P/E ratio 2021 20,5x
Yield 2021 1,90%
Capitalization 5 979 B 52 177 M 52 288 M
EV / Sales 2021 5,66x
EV / Sales 2022 5,30x
Nbr of Employees 7 555
Free-Float -
Duration : Period :
Chugai Pharmaceutical Co., Ltd Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends CHUGAI PHARMACEUTICAL CO., LTD
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 12
Last Close Price 3 636,00 JPY
Average target price 4 823,85 JPY
Spread / Average Target 32,7%
EPS Revisions
Managers and Directors
Tatsuro Kosaka Manager-Pharmaceutical Business Strategy Office
Osamu Okuda Manager-Life Cycle Management II
Itagaki Toshiaki CFO, Manager-Information Technology & Accounting
Hisafumi Okabe Senior Executive Officer & Head-Research
Junichi Nezu Executive Officer, GM-Research & Development
Sector and Competitors
1st jan.Capi. (M$)
JOHNSON & JOHNSON-2.32%439 907
ROCHE HOLDING AG-3.75%322 066
PFIZER, INC.-8.37%303 712
ABBVIE INC.1.02%241 811