Business Scope

Tissue Engineering

Introduction

Descriptions of each tissue-engineered product are to provide investors an understanding of their application and usage. Each tissue-engineered product is currently at different stages of our Business Development Process. ActivSkin, Acornea, and Gegreen have successfully completed all five steps of the Business Development Process and have begun the implementation of their sales programmes. More information is provided in our published reports and announcements.

In general, the business development process of the Group’s tissue-engineered products (“Business Development Process”) is mainly involved the following five major stages:–

  1. Research and development (“Stage I”) which involves potential market researches; medical application analysis; product development, etc.;
  2. Acquisition of the medical device manufacturer licence (醫療器械生產企業許可證) (the “Manufacturer Licence”) (for clinical trials) and conducting clinical trials (“Stage II”);;
  3. Completion of all of the clinical trials with satisfactory results (“Stage III”) which involves the holding of a result conference with all clinical trials parties and the preparation of a summary report which has to be signed off by all clinical trials participated physicians and hospitals. The report signifies that a particular product is statistically feasible to apply on human beings;
  4. Construction of production line during Stage II and Stage III above, and obtaining of medical device good manufacturing practice inspection result notice (醫療器械生產質量管理規範檢查結果通知書) (the “GMP Result Notice”) after completion of required clinical trials and after 3 successful trial productions. This GMP Result Notice is a proof of passing certain required standards of the production facilities of a particular product (“Stage IV”); and
  5. Obtaining the registration (or re-registration) certificates (“Stage V”) from China Food and Drug Administration (國家食品藥品監督管理總局) (“CFDA”) or provincial Food and Drug Administration. There are total of three certificates required to be obtained prior to commercialisation of products, they are the Manufacturer Licence, the GMP Result Notice and the registration certificate for medical device (醫療器械註冊證書) (the “Product Certificate”). The Manufacturer Licence is issued to the manufacturer for the production of the medical device for a certain group of products whereas the Product Certificate issued for a particular product is the final required certificate prior to selling of a product.

Products

Tissue Engineered Skin with Living Human Cells — ActivSkin®
ActivSkin®, being the first tissue-engineered skin approved by China Food and Drug Administration,is the only tissue-engineered skin containing living ells in the PRC. It is mainly used for healing deep 2nd degree and 3rd degree burn and scald wounds. It can relieve pains, shorten healing time and reduce scars in treating burns and scalds.

Acellular Corneal Stroma — Acornea
Acornea is the world’s first bio-engineering cornea that has completed clinical trials and has been successfully launched to market, making China’s leading position in regenerative medicine research of corneal disease in the world. The total effective rate of clinical trials of Acornea reached 94.44% with the healing effect close to donated cornea. In 2016, Acornea was reported by BBC as one of the five major scientific and technological revolutions from China, which make great contribution to the world. Its academic status makes China seize the initiative in the field of biomedical competition in the world.

Calcined Bovine Bone — Gegreen
Gegreen is a protein-detracted bone substitute material for inducing natural bone regeneration, which is the independently-developed material in the PRC. It is made by extracting material from epiphysis cancellous bone of bovine femur, and then goes through the process of virus inactivation, degreasing, protein detracting and low-temperature calcination. It is extensively used for jawbone defect restoration, particularly in dental implantation and treatment of periodontal defects.

Acellular Anal Fistula Repair Stroma — Asiunin
Asiunin is applied to simple anal fistula disease without going through fistulotomy operation which is traditionally used to cure anal fistula in western medicine. Fistulotomy operation has a chance to harm the sphincter muscle and causes relapses. It is believed that the relapse rate when using Asiunin for simple anal fistula is comparatively lower, bringing in revolutionary changes to anal fistula treatment. It can completely reshape the perianal tissue and protect the anal sphincter mechanism. Through minimally invasive operation, it can speed up the healing rate and shorten the hospitalization period.

Oral Cavity Repair Membrane with Excellent Regeneration Capacity — Megreen
Megreen, a new product developed by Shaanxi Reshine Biotech Co. Ltd., a subsidiary of the Group, is currently applying for registration. Megreen is made from the bovine pericardium tissue with collagen as the main component through decellularization, virus inactivation and other treatments, which retains a natural threedimensional structure. Megreen can be widely used in the repair of oral cavity tissue with its advantages of natural double-layer membrane structure, superior mechanical performance and longer degradation time.

Cell Sheet-Autologous Chondrocyte Implantation — CS-ACI
CS-ACI is a cartilage repair technology based on the world’s leading cell sheet preparative technology. It is used for tissue repair and functional reconstruction of damaged articular cartilage. As the first 4th generation of autologous chondrocyte treatment technology developed by China, CSACI is used to produce transparent cartilage as a substitute for exogenous material to avoid cell loss. In addition, since suture is not necessary and it takes shorter time in the operation, it has a broad clinical prospect.

Company Introduction

SHENZHEN AINEAR CORNEA ENGINEERING CO. LTD.
As a subsidiary of CRMI (8158.HK), Shenzhen AiNear Cornea Engineering Co. Ltd is a Shenzhen-based high-tech enterprise, a tissue engineering laboratory of Shenzhen Municipal Development and Reform Commission (NDRC) and a top 500 enterprise in Guangdong. In addition, with a GMP-compliant production facility of nearly 2,000 m2, the enterprise possesses patented equipment developed in-house, quality control instruments, and a professional R&D and production team.

Address: No. 12, Ganli No. 6 Road, Ganli Industrial Park, Buji Street, Longgang District, Shenzhen City,101-102, Block B, Building 1, Zhonghaixin Science and Technology Park Plant

SHAANXI AIERFU ACTIVTISSUE ENGINEERING CO., LTD
Shaanxi Aierfu ActivTissue Engineering Co., Ltd., a wholly-owned subsidiary of CRMI, was established in February 2002. As the first industrialization base of tissue engineering product in China, this base has a building area of 12,000 m2, the cleanrooms have been built according to Grade C and partially Grade A requirements. CRMI has drafted 2 industrial standards for tissue engineering products, and aided relevant national departments in developing national standards for tissue-engineered products, leading to the first and still the only successfully registered tissue engineered product industrialized in China, “ActivSkin”. This key product in CRMI’s tissue engineering portfolio is manufactured by Aierfu ActivTissue Engineering Co., Ltd.

Address: No. 4, Dengling No. 1 Road, High-tech District, Xi'an city, Shanxi Province

SHAANXI RESHINE BIOTECH CO., LTD
Shaanxi Reshine Biotech Co., Ltd., a subsidiary of CRMI (stock code: 8158.hk), was established on 12 March 2008 . The building area of its new production site is more than 3,000 m2, with around 1,000 m2 of Grade C cleanrooms. In recent years, the company has undertaken various national pivotal research projects, including the “863 Program” and “973 Program”, producing various China’s first domestically-developed products.

Address: No. 2 building, Jingwei Industrial Park of Xi’an Economic Development Zone

IR Contact

China Regenerative Medicine International Limited

A:

10/F, Dah Sing Financial Center, 108 Gloucester Road, Wan chai, Hong Kong

E: info@crmi.hk|

T: +852 3966 8388 |

F: +852 2802 0026