In line with industry best practices, we engage reputable Contract Research Organizations (CROs) and Site Management Organizations (SMOs) to support the management and execution of our preclinical studies and clinical trials.
Business · 第 179 页
During the Track Record Period, we collaborated with over 20 CROs and SMOs.
Business · 第 179 页
Our clinical studies are overseen by our in-house clinical team responsible for clinical medicine, operations, and quality control, while SMOs provide CRC services at each clinical site and CROs support data management and statistical analysis.
The design, assembly and production of our hardware products (including turnkey appliances) are conducted under a hybrid model combining OEM server manufacturers and our own facilities.
Business · 第 190 页
In all cases, our staff supervise and manage the on-site process to ensure quality and schedule control.
We engaged 36, 36 and 16 CROs in the years ended December 31, 2024 and 2025 and the six months ended June 30, 2026, respectively, except for Viva Biotech, all of which were Independent Third Parties to the best of our knowledge.
Business · 第 208 页
In the years ended December 31, 2024 and 2025 and the six months ended June 30, 2026, we recorded CRO expenses of RMB35.7 million, RMB44.7 million and RMB26.6 million, respectively.
Business · 第 208 页
In the years ended December 31, 2024 and 2025 and the six months ended June 30, 2026, we engaged 12, 8 and 11 CDMOs, respectively, and incurred CDMO expenses of RMB27.0 million, RMB5.9 million and RMB6.0 million, respectively.
On the component level, as of the Latest Practicable Date, we manufactured the main unit in-house and generally outsourced the production of the NO generation reactor and tube accessories to third-party suppliers.
Business · 第 171 页
For the components we outsource to third parties, we enforce stringent protocols to assure the quality of components we procure, including conducting on-site inspections, monitoring manufacture reports and executing periodic tests.
In 2023, 2024, 2025 and the six months ended June 30, 2025 and 2026, we incurred subcontracting charges of RMB1,619.3 million, RMB1,045.3 million, RMB531.3 million, RMB199.4 million and RMB148.1 million, respectively.
Business · 第 126 页
We adopt a range of measures to manage and monitor the performance of our subcontractors to ensure compliance with applicable progress, quality and safety requirements.
Business · 第 127 页
As of the Latest Practicable Date, we had 25 qualified subcontractors on our approved list, which we review and update on a periodic basis.
We perform core functions such as designing clinical development strategies and protocols in-house, and exercise control and oversight over key functions of medical and clinical trial management, including data source validation and analysis of clinical results.
Business · 第 184 页
In the preclinical stage, we use CROs to conduct in vivo preclinical animal studies.
Business · 第 184 页
We had engaged service providers such as CDMOs and CROs primarily to support our clinical trials in China and the United States and to produce our product candidates.
(6) During the Track Record Period, we outsourced the production of bevacizumab injection and pertuzumab injection.
Business · 第 189 页
In 2023, 2024 and 2025 and the six months ended June 30, 2026, our purchases from CDMOs amounted to RMB339.2 million, RMB324.6 million, RMB427.0 million and RMB212.7 million, respectively.
Business · 第 187 页
We retain all intellectual property rights and grant our CDMO partners the right to use our intellectual property solely for manufacturing and packaging activities during the contract period.
杭州糖吉医疗科技股份有限公司HANGZHOU TANGJI MEDICAL TECHNOLOGY CO., LTD.
委托生产及临床试验依赖第三方机构
We have established a supplier management system covering classification, access review and dynamic management, with production environment cleanliness requirements incorporated into outsourced production supplier screening criteria.
Business · 第 207 页
Pursuant to these agreements, the institution is obligated to conduct the trial strictly in accordance with the protocol, collect data, and issue case reports.
Business · 第 185 页
We require our CROs to maintain strict confidentiality of all documents, data, and records generated during clinical trials, and to bind their employees and consultants to these same confidentiality obligations.
征祥医药（南京）集团股份有限公司Zenshine Pharmaceuticals (Nanjing) Group Co., Ltd.
无自有产能依赖CDMO生产
As of the Latest Practicable Date, we had not established any in-house manufacturing facility for clinical and commercial-scale production.
Business · 第 172 页
During the Track Record Period, we engaged six, seven and eight CDMOs in 2024, 2025 and the six months ended June 30, 2026, respectively.
Business · 第 172 页
We require our CDMO partners to strictly comply with applicable GMP and cGMP standards, and our CMC team conducts periodic audits of their manufacturing facilities to verify compliance with applicable standards and our internal quality requirements.
In terms of total production volume, approximately 82.9%, 82.5%, 81.8%, and 80.3% of our products were manufactured by third-party partners in 2023, 2024, 2025, and for the six months ended June 30, 2026, respectively, with the remainder independently and entirely manufactured at our in-house facilities.
Business · 第 172 页
We principally engage in the R&D and design of our products, while the manufacturing of our products is primarily carried out by third-party manufacturing partners.
Business · 第 172 页
To safeguard our core technologies, we have established a comprehensive intellectual property protection framework covering ex-ante segregation, in-process monitoring and ex-post controls.
In 2023, 2024 and 2025, we had approximately 5,800, 7,200 and 7,500 contract manufacturers, respectively, and the products that we procured from these contract manufacturers accounted for a substantial majority of our products in terms of procurement value in each of these years.
Business · 第 183 页
Our SRS audits covered contract manufacturers who accounted for approximately 95% of our companybranded products by procurement value in each of 2023, 2024 and 2025.
Under this business model, we do not own or operate wafer fabrication, assembly, packaging, or testing facilities. Instead, we concentrate on high-value activities across the upstream portion of the value chain, including product definition, system architecture, integrated circuit design, and platform-level innovation, while outsourcing manufacturing-related processes to independent third-party foundries and OSAT partners.
Business · 第 135 页
Because we rely on third-party foundries and OSAT partners for wafer fabrication, assembly, packaging and testing, upstream capacity availability and wafer procurement pricing are primarily driven by our manufacturing partners and broader industry demand-and-supply dynamics, and we generally have limited bargaining power to materially influence such terms.
Business · 第 135 页
Throughout this process, we retain end-to-end responsibility to customers for product functionality, quality, delivery performance, and after-sales technical support, while our manufacturing partners are responsible to us for executing the relevant manufacturing and testing services in accordance with agreed specifications and service levels.
During the Track Record Period, the fees incurred for OEM partners accounted for approximately 0.7%, 2.1%, 1.8% and 2.1% of the carrying amount of inventories sold, the largest component of our cost of sales, in 2023, 2024 and 2025 and the three months ended March 31, 2026, respectively.
Business · 第 189 页
All our OEM partners are selected based on strict quality, capacity and compliance criteria, and they are required to comply with our technical standards and inspection protocols.
Business · 第 189 页
In our production process, key components are procured from third-party suppliers or manufactured by OEM partners based on our specifications, and are subsequently assembled, calibrated and tested in-house to form the final products.
In addition to our in-house R&D activities, we also collaborate with reputable CROs to manage, conduct, and support our preclinical research and clinical trials.
Business · 第 196 页
To date, we outsource most manufacturing activities to reputable CDMOs to support our drug development process in order to enhance efficiency.
Business · 第 197 页
We are entitled to conduct on-site audits and regular inspections to ensure compliance of our CDMOs with the relevant current good manufacturing practice (“cGMP”) and regulatory requirements.
The majority of our on-site deployment services are performed by our in-house team, while under some circumstances, we engage third-party service providers to assist with on-site deployment to meet short-term peak deployment demand and geographical convenience.
Business · 第 161 页
Our adjusted net loss (non-IFRS measures) increased from 2024 to 2025, primarily reflecting increases in R&D expenses and selling and distribution expenses, as well as a decrease in gross profit margin, which was mainly attributable to higher project deployment costs, including increased personnel outsourcing costs incurred during project implementation.
In addition, as of June 30, 2026, we cooperated with over 80 logistics partners, arranging a daily average of over 600 cold-chain vehicles for delivery of products to our stores.
Financial Information · 第 200 页
We provide improved routes and outsource the delivery service to logistics service suppliers, who are responsible for arranging vehicles, drivers and delivery services.
In the ordinary course of our business, we may outsource certain CRO activities to third-party service providers in the following circumstances: (i) where a clinical trial project requires execution in overseas markets in which we have not yet established sufficient local operational resources, we engage local CRO service providers with the relevant on-the-ground capabilities; and (ii) where project-specific circumstances require certain data analysis services to be performed by an independent third party, such as where an independent data monitoring committee requires statistical independence or a sponsor has contractually specified third-party performance.
Business · 第 178 页
In all such arrangements, we act as the principal contractor and retain overall management responsibility and quality oversight for the projects we undertake, remaining fully responsible to our clients for the quality and delivery of services.
Business · 第 178 页
Our PRC Legal Advisors are of the view that our arrangements with third-party service providers in the course of our business operations, including our outsourcing arrangements and our procurement of clinical trial services from specialist third-party service providers as part of the integrated execution of clinical trial projects, are in compliance with applicable PRC laws and regulations, on the basis that Article 33 of the Good Clinical Practice for Drug Clinical Trials (《藥物臨床試驗品質管理規範》) permits the subcontracting of tasks provided that the written approval of the sponsor has been obtained, and we have confirmed that all outsourcing arrangements entered into during the Track Record Period were made with the prior written consent of the respective sponsors.