During the Track Record Period, we engaged with (i) five, six and three CROs in 2024, 2025 and the six months ended June 30, 2026, respectively; and (ii) one, two and one SMOs in 2024, 2025 and the six months ended June 30, 2026, respectively.
Business · 第 193 页
Therefore, our Directors are of the view that we do not have any reliance on any individual CRO or SMO for our research and development activities.
Business · 第 193 页
During the Track Record Period, we cooperated with two, three and two CDMOs in 2024, 2025 and the six months ended June 30, 2026, respectively, with corresponding expenses of approximately RMB2.9 million, RMB3.5 million and RMB3.0 million.
At present, we do not own or operate manufacturing facilities and primarily rely on reputable CDMOs for the production of our clinical-stage products.
Business · 第 181 页
During the Track Record Period, we outsourced the manufacture of active pharmaceutical ingredients (APIs) and drug products to industry-recognized CDMOs in China to support the preclinical studies and clinical trials of our drug candidates.
Business · 第 181 页
For GMP production of clinical-stage products, we adopt the MAH model, under which qualified CDMOs with GMP certification manufacture clinical samples pursuant to production service agreements.
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.
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.
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 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.
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.
We do not materially rely on any individual CDMO, as alternative service providers with comparable capabilities are readily available in the market.
Business · 第 201 页
We have adopted measures including onsite audit to ensure our CDMOs comply with both the regulatory and our internal requirements.
Business · 第 201 页
Our research and development costs incurred in relation to our engagement of CDMOs increased by 25.6% from RMB4.3 million in 2024 to RMB5.4 million in 2025, primarily attributable to the preparatory work in relation to the anticipated NDA application, and decreased by 23.3% from RMB3.0 million for the six months ended June 30, 2025 to RMB2.3 million for the six months ended June 30, 2026, primarily attributable to decreasing milestone payments.
During the Track Record Period, we outsourced certain manufacturing activities to CDMOs for preclinical and clinical supply of certain of our drug candidates, such as ZG005, ZG006, ZGGS18, ZGGS15 and ZGGS34, as well as API for Zepsun^®^ and Zepuping.
Business · 第 161 页
We have adopted regulatory procedures to ensure the production qualifications, facilities and processes of CDMOs comply with the relevant regulatory requirements and our internal quality management system.
Business · 第 161 页
Intellectual property rights. We own all product-related intellectual property rights •
In the years ended 31 December 2024 and 2025, and the five months ended 31 May 2026, we engaged 13, 11 and 4 CDMOs, incurring CDMO service fees of RMB7.2 million, RMB8.4 million and RMB0.6 million, respectively.
Summary · 第 7 页
Currently, we engage a number of qualified CDMOs for the production of our drug candidates.
Business · 第 201 页
In line with the practice in the pharmaceutical industry, we engage CROs and third-party research centres to conduct and support our pre-clinical studies and clinical trials.
As of the Latest Practicable Date, we did not have commercialization-scale manufacturing facility.
Business · 第 181 页
During the Track Record Period, we collaborated with nine CDMOs (including CMOs) and 18 key CROs for major R&D activities, including certain leading suppliers of CRO and/or CDMO services in the relevant area.
Summary · 第 6 页
We have entered into quality agreements with our contract manufacturing partners.
During the Track Record Period, we have engaged third party CROs for certain R&D services in relation to our Core Products.
Business · 第 183 页
During the Track Record Period, we have engaged certain qualified third parties as CMOs to provide manufacture services for our pre-clinical and clinical trials for XJN010 and XJN026.
Business · 第 188 页
Additionally, all intellectual properties generated from the collaboration shall be solely and exclusively owned by us.
During the Track Record Period and up to the Latest Practicable Date, most of the manufacturing activities for our product candidates were carried out through CDMO partners.
Business · 第 181 页
During the Track Record Period, OBiO is our exclusive CDMO engaged for manufacturing our oncolytic immunotherapy candidates in China. Notwithstanding this exclusivity, we do not rely on OBiO for the manufacturing of our product candidates, including the Core Product, primarily because we retain ownership and control of the critical manufacturing inputs, namely our qualified virus seed and proprietary CMC know-how.
Business · 第 182 页
Since we can transfer the virus seed and the related CMC package to other qualified CDMOs, our production can be maintained without dependence on OBiO.
In 2023, 2024 and 2025 and the five months ended May 31, 2026, we collaborated with 47, 31, 31 and 11 CROs, respectively. During the same periods, the costs attributable to CROs amounted to RMB53.5 million, RMB24.7 million, RMB20.5 million and RMB4.0 million, respectively.
Business · 第 174 页
We maintain close supervision of our CRO partners to ensure their performance fully complies with our protocols and all applicable regulations. We hold regular meetings with CROs to keep track of project progress and execution details and conduct periodic audits on them.