For the years ended December 31, 2023, 2024 and 2025, expenses incurred for outsourced research and development services that were expensed and recognized in profit or loss amounted to approximately RMB61.9 million, RMB6.9 million and RMB14.5 million, respectively, and were recorded as research and development expenses.
Business · 第 159 页
During the Track Record Period, we also outsourced certain manufacturing-related activities to third-party contract development and manufacturing organizations, or CDMOs, primarily for certain drug candidates at the research and development stage.
Business · 第 173 页
We generally outsource such manufacturing-related activities at the relevant development stages primarily because (i) the required production scale and batch size for toxicology and clinical trial materials are not economical or efficient to manufacture on our existing commercial-scale production lines; (ii) the number of batches required is limited (typically two to three batches), and therefore in-house manufacturing may result in lower utilization efficiency; and (iii) producing such early-stage batches on shared production lines may increase operational complexity and potential risks associated with multi-product co-line manufacturing.
We engaged 54 and 51 CROs/SMOs in 2024 and 2025, respectively. We incurred CRO/SMO expenses of RMB85.9 million and RMB42.4 million in 2024 and 2025.
Business · 第 215 页
This was primarily attributable to our transition from a fully outsourced model to a selective functional outsourcing model, under which key functions such as study-level management, vendor management, domestic site management, medical monitoring, and eTMF management were performed in-house to enhance operational efficiency and reduce clinical development expenditures.
Business · 第 215 页
With key functions performed in-house and the standardization of CRO/SMO services, we do not believe we have undue reliance on our current or any CRO/SMO service providers.
During the course of our R&D, certain specialized activities–such as lipid synthesis, non-human primate (NHP) experiments, specialty animal disease models, immunohistochemistry/immunofluorescence, sequencing, VHH antibody discovery, alpaca immunization and titer screening, as well as non-GLP pilot and GLP toxicology studies–are outsourced to reputable CROs.
Business · 第 197 页
As we do not possess GMP-compliant production facilities, clinical drug manufacturing is outsourced to contract development and manufacturing organizations (CDMOs).
Business · 第 197 页
In 2023, 2024 and 2025, our external R&D outsourcing expenses were RMB82.2 million, RMB99.2 million and RMB84.3 million, respectively.
In line with industry practices, we engage reputable CROs to support various stages of our non-clinical and clinical development.
Business · 第 170 页
Clinical CROs are selected through a formal tendering and evaluation process to ensure that the chosen partners meet our quality expectations and project needs.
Business · 第 171 页
We maintain close oversight of our CRO partners through routine communication, progress monitoring and periodic audits to ensure full compliance with our protocols, contractual obligations and applicable regulatory requirements.
During the Track Record Period, we outsourced manufacturing activities to industryrecognized CDMOs in China for preclinical and clinical supply.
Business · 第 176 页
We collaborated with six and nine CDMOs in 2024 and 2025, respectively.
Business · 第 176 页
(ii) Quality control. CDMOs are obliged to ensure that the quality of products meet the quality standards set out in the agreement and requirements of cGMP and other regulations, and to provide Certificate of Analysis.
We also collaborate with CDMOs (including CMOs) to conduct and support our preclinical and clinical trials in line with industry practice.
Business · 第 204 页
Our CDMO partners are responsible for manufacturing our required products in accordance with certain product specifications, in compliance with cGMP requirements (where applicable), our quality standards and other applicable laws and regulations.
Business · 第 204 页
We did not experience any material product quality issues in respect of the products manufactured by our CDMO partners during the Track Record Period.
We engage industry-recognized CDMOs to manufacture our injectable products, such as Xiweina and Zuoyu, to supplement our in-house manufacturing capacity, enabling us to optimize resource allocation and maintain cost efficiency.
Business · 第 156 页
During the Track Record Period, we primarily outsourced the production activities of injectable products, such as Xiweina, Zuoyu, Weidagan and Pirui, and hormonal tablets, such as Dinuo’an, to CDMOs in China.
Business · 第 159 页
We conduct quality assurance audit programs to monitor and evaluate the services of our CDMOs.
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 156 页
We closely supervise our CROs with an aim to ensure their performance in a manner that complies with our protocols and applicable laws, which in turn protects the integrity and authenticity of the data from our trials and studies.
In addition to our in-house R&D activities, we also collaborate with reputable CROs to support our preclinical research and clinical trials.
Business · 第 202 页
Under our oversight such as regular progress meetings, execution reviews, and periodic audits, CROs provide services including site identification, medical and scientific management, data operations and statistical analysis, trial implementation monitoring, regulatory communication, and record keeping and report preparation.
Business · 第 202 页
(iv) we own all intellectual property rights arising from clinical research projects conducted within the stipulated work scope
We collaborate with CDMOs (including CMOs) to manufacture and supply raw materials and drug substances for our preclinical studies and clinical trials.
Business · 第 187 页
We retain all intellectual property rights and only grant our CDMO partners a limited right to use such rights for manufacturing and packaging activities during the contract period.
Business · 第 187 页
We do not share our intellectual property, know-how or trade secrets with CDMOs.
In terms of the involvement and contributions of each of the major CDMOs (including CMOs) to the development of our product candidates, we collaborate with our CDMOs to manufacture a portion of our product candidates to supply for preclinical studies and clinical trials.
Business · 第 195 页
We are entitled to inspect and audit our CDMOs manufacturing process.
Business · 第 195 页
We believe it is more cost efficient to leverage the existing production facilities of the available CDMOs, which could potentially drive down the unit costs of our drug candidates.
苏州瑞博生物技术股份有限公司Suzhou Ribo Life Science Co., Ltd.06938.HK
研发及临床服务外包予逾90家CRO
For the years ended December 31, 2023 and 2024 and the six months ended June 30, 2025, we engaged the services of 94, 119 and 94 CROs, respectively, incurring related research and development expenses of RMB95.7 million, RMB66.9 million and RMB25.4 million for the same periods, respectively.
Business · 第 331 页
Our in-house R&D team oversees these CROs while maintaining substantial control over all core functions, including clinical protocol design, quality control, product specification, and strategic decision-making.
Business · 第 331 页
We have established standard operating procedures for CRO management, setting out stringent protocols for CRO selection, audits, laboratory management, and process supervision.
We currently work with qualified CMOs and CDMOs to manufacture product candidates for pre-clinical and clinical supply.
Business · 第 384 页
During the Track Record Period and up to the Latest Practicable Date, the raw materials of our candidates and the placebo were produced by third-party CMOs and supplied by us, and the raw materials of other experimental products for clinical trials were supplied by us.
Business · 第 383 页
Certain aspects of our clinical trials, such as clinical monitoring, data management and statistical analysis, are outsourced to a CRO.
上海宝济药业股份有限公司Shanghai Bao Pharmaceuticals Co., Ltd.02659.HK
委聘CRO及境外CDMO外包服务
In alignment with industry standards, we engage contract research organizations (CROs) to conduct and support our preclinical studies and clinical trials under our close supervision and overall management.
Summary · 第 19 页
We have also collaborated with a third-party industry-recognized contract development and manufacturing organization (CDMO) outside the PRC for the potential preparation of overseas supply in the future.
Summary · 第 19 页
We are also entitled to conduct on-site audits to ensure our CDMO partner's compliance with the relevant GMP requirements.
We mainly engage preclinical CROs to conduct toxicology studies on animals, which require specific licenses and qualifications, along with certain testing activities related to CMC.
Business · 第 431 页
For preclinical R&D, our expenses attributable to preclinical CROs accounted for 7.5%, 10.3%, 6.3% and 1.0% of our total research and development expenses in 2022, 2023, 2024 and the six months ended June 30, 2025, respectively. For clinical trials, the expenses attributable to SMOs and CROs accounted for 6.2%, 10.8%, 15.6% and 23.3% of the total research and development expenses for the same periods, respectively.
Business · 第 431 页
Based on the service requirements of each project, we typically select at least two or more CROs to participate in competitive bidding and negotiations, and have alternatives in place for each service supplier.
During the Track Record and Period and up to the Latest Practicable Date, we had worked with qualified CMOs to manufacture our drug candidates and drugs mainly under following circumstances: (i) before Lianyungang Facility commenced operations; (ii) to manufacture certain drug candidates requiring manufacturing conditions that are not yet available in Lianyungang Facility.
Business · 第 368 页
We own all intellectual property rights arising from the outsourced manufacturing processes.
During the Track Record Period and as of the Latest Practicable Date, we outsourced the manufacturing of our commercialized drugs to qualified CMOs, using the APIs, excipients and packaging materials that we procured.
Business · 第 287 页
We believe that there is no material concentration risk in relation to the CMOs we procured, and that alternative CMOs with similar quality are available in the market at comparable terms.
Business · 第 288 页
We have also established a quality assurance team and a quality control team to work with our CMOs to efficiently manage our outsourced production and ensure the quality of our drugs that are distributed to the market.
As of the Latest Practicable Date, we did not have in-house manufacturing facility.
Business · 第 418 页
We do not manufacture the active pharmaceutical ingredient ("API") in-house; rather, we engage a reputable and qualified CDMO to produce the API according to our proprietary process and specifications.
Business · 第 419 页
We did not experience any material product quality issues in respect of the products manufactured by our CDMO partners during the Track Record Period.
In 2023, 2024 and the three months ended March 31, 2025, we engaged 24, 16 and 14 CROs and incurred related expenses of RMB87.3 million, RMB34.0 million and RMB3.8 million, respectively.
Business · 第 300 页
We conduct regular and ad hoc on-site audits of CROs, including interviewing their employees, reviewing documentations and records, such as relevant trial data and reports.