2. 公司信息

2. Celzyva公司信息 Celzyva Corporate Information

2.1. Celzyva主营业务 Celzyva Business Focuses

Celzyva集团下辖在香港和美国加州的运营实体,专注于:货架型、通用型细胞与基因治疗(CGT)新药研发、临床试验样品生产、全球注册申报、全球多中心临床试验。同时,依托细胞药物生产过程中高价值副产物,研发、生产并全球销售干细胞护肤原料及产品。

Celzyva Group has operating entities in Hong Kong and California, USA, focused on: the development of off-the-shelf, universal (genetically engineered to reduce immune rejection) cell and gene therapy (CGT) novel therapeutics; the manufacturing of clinical trial materials; global regulatory filings; and the conduct of global multi-center clinical trials. In parallel, leveraging high-value by-products generated during cell therapy manufacturing, the Group researches, develops, manufactures, and globally commercializes stem cell–based skincare active ingredients and finished products.

2.2. Celzyva公司股权、业务与组织结构 Celzyva Corporate Shareholding, Business & Organizational Structures

图片关键词


图片关键词

  • Independent Directors: ??

  • Non-Independent Directors: ??

  • Full-Time Employees - Hong Kong: 10

  • Full-Time Employees - California: 1

2.3. Celzyva公司注册与法律文件 Celzyva Company Registration & Legal Documents

Click to review or download the following company registration and legal documents of this company:

2.3.1. Celzyva Therapeutics, Inc.

Celzyva Therapeutics, Inc. will be registered shortly prior to the de-SPAC. The name has been reserved in Delaware, USA. The trade mark of Celzyva has been filed in USPTO. The domain name of Celzyva.com has been registed.

图片关键词Delaware Comapny Name Reservation for Celzyva.pdf

图片关键词US Trademark-Celzyva-50066473.pdf

http://www.Celzyva.com

2.3.2. Asia Cell & Gene Therapeutics Group

Palm Grove Unit 4, 265 Smith Road, George Town, P.O. Box 52A Edgewater Way, #1653, Grand Cayman KY1-9006, Cayman lslands

2.3.3. Asia Cell Skincare (CI) Co., Ltd

Palm Grove Unit 4, 265 Smith Road, George Town, P.O. Box 52A Edgewater Way, #1653, Grand Cayman KY1-9006, Cayman lslands

2.3.4. aCGT USA Inc.,

4540 MACKINAW STREETUNION CITY, CA 94587

2.3.5. Asia Cell & Gene Therapeutics, Co. Ltd./亚洲细胞与基因药物(香港)有限公司

Unit 510C of the 5th Floor of Building 9W, Phase Two, Hong Kong Science Park, Pak Shek Kok, New Territories, Hong Kong

2.3.6. China Biophamaceutical Institute of Industrialization中国生物医药产业化研究院

Unit 539, 5/F, Building 5W, Phase One, Hong Kong Science Park, Pak Shek Kok,

2.3.7. Asia Cell Skincare (HK) Limited

UNIT 510C OF THE 5TH FLOOR OF BUILDING 9W, PHASE TWO, HONG KONG SCIENCE PARK, PAK SHEK KOK, NEW TERRITORIES, HONG KONG

2.4. Celzyva公司穿透股东名册 Celzyva Ultimate Beneficial Ownership (UBO) Register

穿透个人股东信息涉及隐私,线下提供。  Disclosure of look-through individual shareholder information involves personal privacy and will be provided separately offline.

2.5. 【Celzyva香港】设施与设备 [Celzyva Hong Kong] Facilities & Instruments

[Celzyva Hong Kong] consists of ① Asia Cell & Gene Therapeutics (HK) Co., Ltd. 亞洲細胞與基因藥物(香港)有限公司 (formerly known as: China Stem Cell Therapy (HK) Co., Ltd. 中國幹細胞治療有限公司) and its wholly-owned ② China Biopharmaceutical Institute of Industrialization 中國生物醫藥產業化研究院, and ③ Asia Cell Skincare (HK) Limited 亞洲細胞護膚科技(香港)有限公司。

The above three companies share the same facilities in Hong Kong Science and Technology Park (HKSTP; https://www.hkstp.org/ ):

Laboratory address: Unit 510C of the 5th Floor of Building 9W, Phase Two, Hong Kong Science Park, Pak Shek Kok, New Territories, Hong Kong

Office address: Unit 539 of the 5th Floor of Building 5W, Phase One, Hong Kong Science Park, Pak Shek Kok, New Territories, Hong Kong

生物技术新药研发企业除了使用自有实验室外,往往采用共享实验室和CRO/CDMO委托GMP生产的方式,进行临床前研发和临床试验样品生产。【aCGT香港】所在的香港科技园(HKSTP)及紧邻的香港生物技术研究院(HKIB)是香港政府资金建立和支持的非盈利机构。前者拥有极其完善和高效的共享实验室体系,后者是拥有PIC/S-GMP标准车间的专业CDMO。【aCGT香港】通过合同和支付费用充分利用上述共享实验室和PIC/S-GMP标准CDMO车间进行研发和生产。【aCGT香港】研发和生产的硬件条件如下:

In addition to using their own laboratories, biotech companies engaged in new drug R&D often utilize shared laboratories and entrust GMP production to CROs/CDMOs for preclinical research and the production of clinical trial samples. The Hong Kong Science and Technology Parks (HKSTP), where [aCGT Hong Kong] is located, and the adjacent Hong Kong Institute of Biotechnology (HKIB) are non-profit organizations established and supported by Hong Kong government funds. The former boasts an extremely comprehensive and efficient shared laboratory system, while the latter is a specialized CDMO with a PIC/S-GMP standard facility. [aCGT Hong Kong] fully utilizes these shared laboratories and the PIC/S-GMP standard CDMO facility through contracts and fee payments for its R&D and production activities. The hardware conditions for [aCGT Hong Kong]'s R&D and production are as follows:

2.5.1. 自有设备仪器清单 List of Self-Owned Equipment and Instruments

#NamePurchasing Price [HK$]
1医用低温保存箱 Low Temperature Medical Freezer38000
2双开门冰箱 French Door Refrigerator3500
3液氮罐Liquid Nitrogen Tank(175L)45000
4液氮罐Liquid Nitrogen Tank(65L)12000
5液氮罐Liquid Nitrogen Tank(65L)12000
6高频热合机High Frequency Heat Sealer5100
7电热恒温水槽Electrically Heated Constant Temperature Water Bath3500
8台式低速离心机 Benchtop Low-Speed Centrifuge12300
9医用离心机 Medical Centrifuge24000
10台式低速离心机 Benchtop Low-Speed Centrifuge23000
11荧光细胞分析仪 Fluorescence Cell Analyzer185000
12新颖立式小容量恒温培养摇床 Novel Vertical Small-Capacity Constant Temperature Incubation Shaker8000
13二氧化碳培养箱 Carbon Dioxide Incubator85000
14二氧化碳培养箱 Carbon Dioxide Incubator85000
15二氧化碳培养箱 Carbon Dioxide Incubator85000
16二氧化碳培养箱 Carbon Dioxide Incubator85000
17生物安全柜 Biological Safety Cabinet62000
18生物安全柜 Biological Safety Cabinet62000
19标签打印机 Label Printer5500
20流式细胞仪 Flow Cytometer300000
21倒置显微镜 Inverted Microscope150000

2.5.2. 位于香港科技园9、11、15、17号楼约22,000平方英尺共享按时付费细胞生物学非GMP实验平台

Shared Pay-Per-Use Non-GMP Cell Biology Experimental Platform (Approximately 22,000 sq. ft.) Located in Buildings 9, 11, 15, and 17 at Hong Kong Science Park

该实验平台具有世界领先的实验室设备及灵活的共享实验室条件,可提供以下服务:

  1. 细胞培养、细胞储存

  2. 流式分析、细胞影像

  3. 蛋白质组及代谢组学分析

  4. 基因组学等分析检测服务

可满足细胞治疗产品早研、工艺探索及检测方法开发的要求。

This experimental platform is equipped with world-leading laboratory instruments and offers flexible shared lab conditions, providing the following services:

  1. Cell Culture, Cell Storage

  2. Flow Cytometry Analysis, Cell Imaging

  3. Proteomics and Metabolomics Analysis

  4. Genomics and other Analytical Testing Services

It can meet the requirements for early research, process exploration, and analytical method development of cell therapy products.

2.5.3. 位于香港科技园生物科技大道2号的香港生物技术研究院PIC/S GMP车间(约3800平方英尺)

PIC/S GMP Facility (Approximately 3,800 sq. ft.) at Hong Kong Institute of Biotechnology, located at 2 Biotech Avenue, Hong Kong Science Park

合作机构:香港生物技术研究院 Hong Kong Institute of Biotechnology(https://atp.hkib.org.hk/)

车间性质:CRO/CDMO付费临床级细胞制剂PIC/S GMP车间,采用现行药品生产管理规范(cGMP)的先进治疗产品生产基地。

Collaborating Institution: Hong Kong Institute of Biotechnology (https://atp.hkib.org.hk/)

Facility Nature: A CRO/CDMO fee-based clinical-grade cell preparation PIC/S GMP facility. It is an advanced therapy medicinal product (ATMP) production base operating under current Good Manufacturing Practice (cGMP).

车间设施配置 Facility Configuration:

  1. 2间B级洁净室和4间C级洁净室

  2. 经验证的先进治疗产品生产设备

  3. 中央合成空气、二氧化碳及氮气供应系统

  4. 层流传递窗和VHP灭菌设备(用于物料安全传递)

  5. 完善的细胞产品质控设备(可完成关键质控检测项目)

  1. 2 Class B cleanrooms and 4 Class C cleanrooms

  2. Validated advanced therapy product manufacturing equipment

  3. Centralized synthetic air, carbon dioxide, and nitrogen supply systems

  4. Laminar flow pass-through windows and Vaporized Hydrogen Peroxide (VHP) sterilization equipment (for safe material transfer)

  5. Comprehensive cell product quality control equipment (capable of completing key quality control testing items)

2. 公司信息-Asia Cell & Gene Therapeutics Group Due Diligent Data Room