1. 概述 (包括BP)

aCGT operates through three wholly owned R&D and operating entities: ①aCGT Hong Kong-CGT drug R&D (Established in 2014), ②aCGT Hong Kong-Skincare Products R&D & Manufacturing (Established in 2024) and ③aCGT California-CGT drug clinical trials worldwide (Established in 2025).

Celzyva拥有三家全资运营实体：①Celzyva香港-CGT新药临床前研发(成立于2014 年)、②Celzyva香港-护肤产品开发和生产(成立于2024 年)以及③Celzyva美国加州-CGT新药全球生产和临床试验(成立于2025年)。

To leverage the significant cost advantages of preclinical research and clinical trials in mainland China, as well as Shanghai’s well-established upstream and downstream supporting industrial ecosystem, [Celzyva Hong Kong] has entered into a co-development partnership with [Quansheng Company] in mainland China, which is under the same individual control. [Celzyva Hong Kong] provides the R&D direction, concepts, and overall plans; [Quansheng Company] organizes and conducts labor-intensive and routine preclinical research in Shanghai, as well as carries out clinical trials in China. All intellectual property and rights and interests within mainland China (excluding Hong Kong, Macau, and Taiwan) arising from this co-development shall belong to [Quansheng Company]; all intellectual property and rights and interests outside mainland China (including Hong Kong, Macau, and Taiwan) shall belong to [Celzyva Hong Kong].

为利用中国内地临床前研发/临床试验巨大的成本优势以及上海完善的上下游配套产业，[Celzyva香港]与同实际控制人的中国内地[泉生公司]进行共同研发。[Celzyva香港]提供研发的方向、思路和总体方案；泉生公司在上海组织人力实施劳动力密集和固定程序性部分的临床前研发和进行中国临床试验。其全部共同研发成果中国内地(不含港澳台)知识产权和权益归属[泉生公司]；全部共同研发成果中国内地外全球(含港澳台)知识产权和权益归属[Celzyva香港]。

As a pre-revenue innovative drug development enterprise, Celzyva Group has no reliance on mainland China for its raw materials, consumables, equipment and instruments, laboratory or GMP manufacturing facilities, core technologies, or high-end scientific and technical personnel.

Upon regulatory approval and commercial launch of Celzyva's drug products, it is estimated that ≥85% of total sales revenue will be generated outside mainland China, with ≤15% derived from mainland China. Following the launch of Celzyva's skincare products, it is estimated that ≥70% of sales revenue will be generated outside mainland China, with ≤30% from mainland China.

The ultimate controlling shareholder of Celzyva is a U.S. citizen. Accordingly, Celzyva Group is not a China-concept stock company and does not require approval from the China Securities Regulatory Commission (CSRC) for an overseas listing. It plans to list on the U.S. Nasdaq in Q4 2026.

Celzyva集团作为研发药物尚未获批上市销售的新药研发企业，其试剂耗材、设备仪器、实验室/GMP车间、技术、高端科技人才等均对中国内地无任何依赖。Celzyva研发药物获批上市后销售额估算中国海外≧85%、中国内地≦15%。Celzyva研发护肤品上市后销售额估算中国海外≧70%、中国内地≦30%。Celzyva实际控制人是美国国籍。因此，Celzyva集团是非中概股企业，不需要中国证监会批准赴海外上市，其计划于2026年四季度于美国NASDAQ上市。

All Celzyva drug candidates are off-the-shelf allogeneic human cell therapies.

Based on clinical data from China, Celzyva USA plans to submit IND applications to the U.S. FDA by the end of 2027 for:

   1. Eight UC-MSC products for Phase I trials;

   2. Three UC-MSC products for direct Phase II trials; and

   3. One iPSC-derived cell therapy product for a Phase I trial.

Notably, one UC-MSC product for ankylosing spondylitis has already received FDA IND clearance for a direct Phase II trial.

Meanwhile, in China, five UC-MSC intravenous products are in Phase I/II clinical trials, and one iPSC-NPC product is in a Phase I trial under NMPA oversight.

Celzyva全部在研新药均为“货架式”异体人细胞制剂。[Celzyva美国]基于中国临床试验结果计划截止2027年底向美国FDA提交：(1) 约八款UC-MSC 产品申请进入美国I期临床试验；(2) 三款UC-MSC 产品申请美国直接II期临床试验；(3) 一款 iPSC 衍生细胞治疗产品申请美国I期临床试验。其中一款用于治疗强直性脊柱炎的细胞药物，现已获得美国直接II期临床试验IND许可。与此同时，我们目前正在中国药监局(NMPA)开展五款UC-MSC 静脉注射制剂的I&II期临床试验，以及一款iPSC-NPC制剂处于I期临床试验的产品。

Celzyva has built a robust technology and manufacturing infrastructure, including:

ü  Universal low-immunogenicity iPSC technology platform

ü  iPSC differentiation platform

ü  Functional gene design and screening platform

ü  Bioreactor engineering platform

ü  High-stability formulation technology platform

ü  Domestic and international CGT manufacturing facilities

ü  AI and cloud-enabled R&D management platform

China-U.S. dual-IND filing platform

Celzyva已构建完备的技术与生产体系，包括：

• 通用型低免疫原性 iPSC技术平台

• iPSC分化技术平台

• 功能基因设计与筛选平台

• 生物反应器工程技术平台

• 高稳定性制剂技术平台

• 境内外CGT药物制剂生产基地

• 人工智能与云技术赋能的研发管理平台

• 中美双IND申报技术与管理平台