11. 干细胞护肤品
Asia Cell & Gene Therapeutics Group Due Diligent Data Room
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aCGT干细胞护肤品原料及产品.pdf
12.1.1 干细胞新药研发和生产（细胞传代培养）过程中会产生大量干细胞培养液（Conditioned Medium）。干细胞培养液中含大量护肤活性物（Active Ingredients），以及干细胞培养液中的干细胞外泌体（Stem Cell Exosomes）可用作高端护肤品原料（Raw Materials）。
12.1.1 A large quantity of stem cell conditioned medium is generated during the research and development and production (cell subculture) of stem cell new drugs. The stem cell conditioned medium contains a wealth of skincare active ingredients, and the stem cell exosomes in it can be used as raw materials for high-end skincare products.
12.1.2 按照药监局要求，作为细胞药物制剂，干细胞严格受到传代代数限制。对每次费用昂贵的细胞接种，如果在药物规定传代代数后停止培养扩增，是很大浪费。而如果在药物规定传代代数后，作为非药物护肤品原料而继续培养扩增，将极大提高生产和经济效率。
12.1.2 In accordance with the requirements of drug regulatory authorities, stem cells are subject to strict restrictions on subculture passages as cell drug preparations. Ceasing the culture and expansion of stem cells after reaching the specified subculture passages for drugs would result in a huge waste, given the high cost of each cell seeding. In contrast, continuing the culture and expansion for use as non-pharmaceutical skincare raw materials after the specified passages can greatly improve production and economic efficiency.
12.1.3 干细胞药物研发和生产过程中和后续作为非药物的继续传代培养中，可以产生大量的干细胞培养液及其中的干细胞外泌体，这些对新药研发来说是无用的废料或副产品，丢弃还将耗费很大的生物物质安全处理的费用。如果这些新药研发产业的废料或副产品用作护肤品活性物（Active Ingredient）/原料（Raw Materials），生产系列高端护肤品或者直接作为原料出售，将变废为宝而进入一个极具经济效益的护肤品产业。
12.1.3 A massive amount of stem cell conditioned medium and its contained stem cell exosomes are produced both during the R&D and production of stem cell drugs and in the subsequent subculture for non-pharmaceutical purposes. These are useless waste or by-products for new drug R&D, and their disposal incurs significant costs for biosafety treatment. Utilizing such waste or by-products from the new drug R&D industry as active ingredients/raw materials for skincare products to develop a series of high-end skincare products or directly sell them as raw materials can turn waste into wealth and tap into a highly economically viable skincare industry.
12.1.4 中国拥有巨大的脐带干细胞库（Umbilical-cord Stem Cell Banking）和脐带干细胞新药研发产业，aCGT护肤业务立足香港，不仅使用aCGT自己的干细胞新药研发所产生的细胞培养液，同时也依靠aCGT已建立的质控和国际冷链运输体系，集合中国其他干细胞库和新药研发公司的脐带间充质干细胞条件培养液，发展极具前景的aCGT干细胞护肤业务。
12.1.4 China boasts a huge umbilical-cord stem cell banking system and a robust umbilical cord stem cell new drug R&D industry. Based in Hong Kong, aCGT's skincare business not only utilizes the cell conditioned medium generated from its own stem cell new drug R&D but also leverages its established quality control and international cold chain transportation system to aggregate umbilical cord mesenchymal stem cell conditioned medium from other stem cell banks and new drug R&D companies in China, thus developing the promising aCGT stem cell skincare business.
12.1.5 除了脐带间充质干细胞培养液及外泌体外，人诱导多能干细胞(human induced pluripotent stem cells, hiPSC)也是aCGT护肤品原料来源之一。aCGT目前拥有人脐带间充质干细胞hUC-MSC和人诱导多能干细胞hiPSC两个新药研发产品管线。
12.1.5 In addition to umbilical cord mesenchymal stem cell conditioned medium and exosomes, human induced pluripotent stem cells (hiPSC) also serve as one of the raw material sources for aCGT's skincare products. Currently, aCGT has two new drug R&D product pipelines: human umbilical cord mesenchymal stem cells (hUC-MSC) and human induced pluripotent stem cells (hiPSC).
12.1.6 中国内地药监局目前不批准含人源成分化妆品产品的申报注册，而很多国家包括美国、日本和韩国等均允许含人源成分化妆品。aCGT在美国FDA注册的化妆品产品可以进口至中国内地的各大自贸区，再由自贸区内向中国内地顾客“跨境电商”邮寄销售。
12.1.6 At present, the drug regulatory authority in mainland China does not approve the application and registration of cosmetic products containing human-derived ingredients, while many countries including the United States, Japan and South Korea permit such cosmetics. aCGT's cosmetic products registered with the US FDA can be imported into various free trade zones in mainland China and then sold to customers in mainland China via cross-border e-commerce mailing from these free trade zones.
aCGT集团干细胞护肤品业务由其全资子公司 Asia Cell Skincare (HK) Limited（亚洲细胞护肤科技香港有限公司）实施。
The stem cell skincare business of aCGT Group is operated by its wholly-owned subsidiary, Asia Cell Skincare (HK) Limited.
Asia Cell Skincare (HK) Limited主营业务：基于中国脐带干细胞培养液数量和成本优势，专注于干细胞源护肤品活性物质或原料以及护肤品成品的研发、生产或委托生产、美国FDA申报注册及全球销售。
Core Business of Asia Cell Skincare (HK) Limited: Leveraging the advantages in quantity and cost of China's umbilical cord stem cell conditioned medium, the company focuses on the R&D, production or entrusted production of stem cell-derived skincare active substances/raw materials and finished skincare products, as well as the US FDA application, registration and global sales of such products.
12.3.1. 关于人源成分护肤品：
中国内地药监局目前不批准含人源成分化妆品的申报注册；而很多国家包括美国、日本和韩国等均允许含人源成分化妆品。aCGT在美国FDA注册的护肤产品可以进口至中国内地的各大自贸区，再由自贸区内向中国内地顾客“跨境电商”邮寄销售。
12.3.1. Regarding human-derived ingredient skincare products:
The drug regulatory authority in mainland China currently does not approve the application and registration of cosmetic products containing human-derived ingredients, whereas many countries such as the US, Japan and South Korea allow them. aCGT's skincare products registered with the US FDA can be imported into various free trade zones in mainland China and then sold to customers in mainland China through cross-border e-commerce mailing from the free trade zones.
12.3.2. 关于人类遗传物质管理：
《中华人民共和国人类遗传资源管理条例》（国务院令第777号）、《人类遗传资源管理条例实施细则》（科学技术部令第21号）要求（由中国内地国家卫生健康委员会（卫健委）主管）含中国内地人类基因物质出口需要申请许可。
aCGT干细胞条件培养液经过过滤，不含包括细胞在内的人类基因物质，可以方便出口至香港、美国等地进行护肤品生产和申报注册。
12.3.2. Regarding human genetic resource management:
The Regulations on the Administration of Human Genetic Resources of the People's Republic of China (State Council Decree No. 777) and the Implementation Rules for the Regulations on the Administration of Human Genetic Resources (Ministry of Science and Technology Decree No. 21), overseen by the National Health Commission (NHC) of mainland China, stipulate that an approval is required for the export of human genetic materials originating from mainland China.
aCGT's stem cell conditioned medium is filtered and contains no human genetic materials including cells, enabling its convenient export to Hong Kong, the US and other regions for skincare product production, application and registration.
中文: aCell™-UCMSC-CM-过滤液
English: aCell™-UCMSC-CM - Filtration Solution
中文: aCell™-UCMSC-CM-超滤液
English: aCell™-UCMSC-CM - Ultrafiltration Solution
中文: aCell™-UCMSC-CM-冻干粉
English: aCell™-UCMSC-CM - Freeze-dried Powder
数据、报告、实验记录线下提供。
Relevant data, reports and experimental records are provided offline.
举例【ELISA检测报告】：
• [TW202510280005]化妆品功效检测报告(抗氧化作用)20251113.pdf
• [TW202511180005]化妆品功效检测报告(抗皱功效)20251208.pdf
Example [ELISA Test Report]:
• [TW202510280005]Cosmetic Efficacy Test Report (Antioxidant Effect)20251113.pdf
• [TW202511180005]Cosmetic Efficacy Test Report (Anti-wrinkle Efficacy)20251208.pdf
举例：功效检测结果：
• 有效成分(IL-6)ELISA数据20251021.xlsx
• 有效成分(PDGF-AA)ELISA数据20251021.xlsx
Example [Efficacy Test Results]:
• Active Ingredient (IL-6) ELISA Data20251021.xlsx
• Active Ingredient (PDGF-AA) ELISA Data20251021.xlsx
工艺流程：
• 3.Ultrafiltration Concentration Experimental Procedure.pdf
• 超滤浓缩实验流程-wqm20260123.pdf
Production Process:
• 3.Ultrafiltration Concentration Experimental Procedure.pdf
• Ultrafiltration Concentration Experimental Process-wqm2026.01.23.pdf
CRO（美国护肤品申报代理公司）：
• 美国护肤品申报代理公司-20251216.xlsx
CRO (US Skincare Product Application Agencies):
• US Skincare Product Application Agencies-20251216.xlsx
海关文件：
• 1.承诺书.PDF
• 2出入境特殊物品信息表.PDF
• 3项目批准书.PDF
• 5具体用途情况说明.PDF
• 6研究方案.PDF
• 7样品主要操作流程.PDF
• 8运输计划.PDF
• 10情况说明.PDF
• 赠送协议(无需付外汇)-盖章版.pdf
Customs Documents:
• 1 Commitment Letter.PDF
• 2 Special Item Entry/Exit Information Form.PDF
• 3 Project Approval Letter.PDF
• 5 Statement of Specific Intended Use.PDF
• 6 Research Protocol.PDF
• 7 Main Sample Handling Procedure.PDF
• 8 Transportation Plan.PDF
• 10 Situation Explanation.PDF
• Donation Agreement (No Foreign Exchange Required) - Stamped Version.pdf
aCell™-UCMSC-护肤品系列产品（包括：干细胞护肤水系列、干细胞护肤面膜系列、干细胞护肤霜系列、干细胞生发水系列等）目前正在洽谈委托生产和申请注册美国 FDA 过程中。
aCell™-UCMSC skincare product series (including stem cell skincare toner series, stem cell skincare mask series, stem cell skincare cream series, stem cell hair growth tonic series, etc.) is currently in the process of negotiating entrusted production and applying for US FDA registration.
12.6.1. aCGT已申请获得 aCell™-UCMSC-CM 护肤活性物或原料的 INCI* 号。点击查看或下载：
• Assignment Letter 2023-12242-INCI号.pdf
12.6.1. aCGT has applied for and obtained the INCI* number for aCell™-UCMSC-CM skincare active substances/raw materials. Click to view or download:
• Assignment Letter 2023-12242-INCI Number.pdf
* 注解：INCI (International Nomenclature Cosmetic Ingredient) 是 "国际化妆品原料命名" 。它是一个全球公认的、用于识别化妆品和个人护理产品成分的标准化命名系统。INCI 名称由美国个人护理品协会（PCPC）下设的国际命名委员会（INC）负责审定和分配，并最终发布在《国际化妆品原料字典和手册》。
* Note: INCI (International Nomenclature Cosmetic Ingredient) refers to the International Nomenclature of Cosmetic Ingredients. It is a globally recognized standardized naming system for identifying ingredients in cosmetic and personal care products. INCI names are reviewed and assigned by the International Nomenclature Committee (INC) under the Personal Care Products Council (PCPC) of the United States and ultimately published in the International Cosmetic Ingredient Dictionary and Handbook.
12.6.2. 销售情况：aCell™-UCMSC-CM 护肤活性物或原料目前处于启动销售的初期联系洽谈中。潜在客户包括全球护肤品相关公司。
12.6.2. Sales Status: aCell™-UCMSC-CM skincare active substances/raw materials are currently in the initial stage of sales launch with ongoing contact and negotiation. Potential customers include global skincare-related companies.
12.6.3. 预计销售额：参照美国类似产品 2024-2025 年销售额数据，年销售额预计达到 2-3 亿美元。
12.6.3. Projected Sales Volume: Referring to the 2024-2025 sales data of similar products in the US, the annual sales volume is projected to reach 200 to 300 million US dollars.