During the Track Record Period, our suppliers are mainly comprised of CROs and CDMOs for our R&D activities.
Business · 第 203 页
In the United States, we have initiated the Phase III clinical trials for MHB018A with trial operations being outsourced to an experienced CRO.
Business · 第 203 页
The team is responsible for overseeing the end-to-end production and quality management of our drug candidates, with functions spanning drug substance manufacturing, ADC conjugation, and drug product formulation, as well as quality system management, process governance, and in-process and release testing to ensure product consistency, safety, and compliance with applicable GMP standards.
During the Track Record Period, we engaged a CMO in China to produce development and clinical trial materials for JZB30 while we calibrated and tested our self-operated facility in preparation of commercial production.
Business · 第 196 页
This engagement has concluded as we submitted the change of manufacturing site filing for JZB30 in December 2025 to directly transition to full in-house commercial manufacturing of JZB30 at our Chengdu facility from the start of commercialization, as our Chengdu facility has been purpose-built with dedicated commercial-scale production lines capable of meeting JZB30’s manufacturing demands, making in-house production a more cost-effective and supply-stable alternative to continued reliance on a third-party CMO.
Business · 第 196 页
In addition, to maintain strict quality and consistency oversight, we implement an on-site (resident) QA arrangement to perform spot checks and supervision and conduct initial and annual audits of the CMO’s laboratory management and testing procedures.
We engaged 38, 30 and 11 CROs in 2024, 2025 and the four months ended April 30, 2026, respectively, at the clinical stage.
Business · 第 191 页
We incurred expenses for services provided by CROs of approximately RMB19.8 million in 2024, RMB13.5 million in 2025 and RMB2.4 million in the four months ended April 30, 2026, which are included in our R&D expenses.
Business · 第 191 页
We require CROs to comply with our quality control and anti-corruption/anti-bribery policies and monitor compliance through internal quality control and third-party audits in accordance with our Audit Procedures and Quality Control Procedures.
To supplement our in-house manufacturing capacity, we have historically engaged and will continue to engage industry-recognized contract manufacturing organizations (“CMOs”) to empower an optimized resource allocation and cost efficiency.
Business · 第 159 页
Following the execution of the marketing authorization transfer agreement for Keppra SR, we outsourced the manufacturing and supply of Keppra SR to Anbison and no finished products had been produced as of the Latest Practicable Date.
Business · 第 161 页
We conduct quality assurance audit programs to monitor and evaluate the services of our CMOs.
During the Track Record Period, we also outsourced certain manufacturing activities to industry-recognized CDMOs in China for preclinical and clinical supply of our drug candidates.
Business · 第 207 页
As of the Latest Practicable Date, we did not have in-house manufacturing facility that was operational.
Business · 第 209 页
Given that we do not currently operate in-house manufacturing facilities and relies on established CDMOs with robust infrastructure and quality systems, the scope of internal CMC activities remains manageable.
广东真健康医疗科技开发股份有限公司Guangdong True Health Medical Technology Development Co., Ltd.02697.HK
临床前研究及临床试验外包予CRO/SMO
In alignment with industry standards, we engage CROs to conduct and support our preclinical studies and clinical trials under our close supervision and overall management.
Business · 第 184 页
During the Track Record Period, we cooperated with eight and 11 CROs in 2024 and 2025, respectively, which were all independent third parties of our Group.
Business · 第 185 页
We ensure CROs and SMOs comply with applicable regulatory requirements and our internal policies through (i) selective engagement of experienced service providers with proven track records; (ii) contractual controls, pursuant to which the agreements require requisite qualifications, compliance with applicable laws and regulations, and periodic quality assurance audits by us; and (iii) ongoing oversight by dedicated clinical project managers through remote monitoring, on-site inspections and milestone reviews.
江西生物制品研究所股份有限公司Jiangxi Institute of Biological Products Inc.06915.HK
研发外包予第三方CRO
In line with industry practice, we engage Independent Third Party CROs to conduct and support our process and preclinical research and clinical trials.
Business · 第 161 页
In 2023, 2024 and 2025, the expenses attributable to CROs were RMB10.3 million, RMB2.1 million and RMB2.2 million, respectively, accounted for 42.5%, 15.0% and 9.3% of our research and development expenses for the same periods, respectively.
Business · 第 162 页
We closely monitor and manage the activities of these CROs to ensure their work progress and the quality of their work.
For manufacturing of AP301 and our other product candidates for preclinical and clinical study, we outsourced all manufacturing activities to a number of CDMOs during the Track Record Period.
Business · 第 194 页
We are entitled to inspect and audit our CDMO partner’s manufacturing process.
We collaborate with CROs and SMOs to support the execution of our clinical trials.
Business · 第 180 页
In both 2024 and 2025, we engaged a total number of 11 and two CROs and SMOs, respectively.
Business · 第 180 页
During our clinical trials, we also engage independent third-party auditors to conduct inspections, and our internal personnel conduct on-site checks at study centers, in each case with a view to strengthen quality control and protecting subjects' rights and safety.
During the Track Record Period, our major suppliers primarily consisted of CROs, SMOs, CDMOs, landlords of our leased property and providers of other services.
Business · 第 187 页
Typically, we provide an upfront payment ranging from 10% to 20% of the total contract value upon execution of the agreement or work order.
Business · 第 188 页
Besides, we conduct annual or on-demand supplier audits based on the importance of services undertaken by service providers and the risk management level of our Company.
We currently collaborate with CMOs/CDMOs for the manufacturing of our drug candidates for preclinical studies and clinical trials.
Business · 第 196 页
We have adopted procedures to ensure that production qualifications, facilities and processes of CMOs/CDMOs comply with the relevant regulatory requirements and our internal guidelines.
Business · 第 196 页
We have completed the construction of our new manufacturing facility occupying a site area of approximately 4,886 square meters in Yantai, Shandong province, which is designed to meet the stringent cGMP standards.
Currently, our manufacturing activities are conducted through CDMOs to support our drug development. We engage reputable CDMOs in China and expect to maintain this model in the near term and during the initial stage of commercialization.
Business · 第 222 页
We currently do not operate any self-owned manufacturing facilities, and as of the Latest Practicable Date, we had no plan to establish our own manufacturing facilities within the next 12 months.
Business · 第 222 页
We had engaged an aggregate of 41 and 51 CROs as of December 31, 2024 and 2025, respectively, all of which were Independent Third Parties to the best of our knowledge.
In 2024 and 2025, we have cooperated with three and two CMOs and 16 and 15 CROs, respectively.
Business · 第 198 页
To ensure the quality and integrity of outsourced activities, our Company implements ongoing supervision of CRO performance through periodic audits, review of key deliverables, and regular project meetings.
Business · 第 197 页
We have the right to inspect and audit the manufacturing processes of our CMO partners to ensure compliance with our standards.
To date, our manufacturing activities are conducted through CDMOs to support our drug development process.
Business · 第 204 页
As of the Latest Practicable Date, we do not have any in-house manufacturing facility that was operational.
Business · 第 204 页
We select CROs based on professional qualifications, relevant research experience, service quality, efficiency, industry reputation, and costs, and ensure that all intellectual property generated from such collaborations belongs to us.
During the Track Record Period, we engaged seven drug manufacturers (“CMOs”) in China, all of which are Independent Third Parties, to manufacture azvudine.
Business · 第 202 页
After February 2023 when our own production facilities were completed and sufficient to cover product demand, we did not outsource manufacturing to the CMOs, and subsequently terminated the cooperation with five of the collaborating CMOs as of December 31, 2025.
Business · 第 202 页
Under the agreement, we are the sole owner of any proprietary rights to azvudine, including the right to market and sell azvudine after obtaining the NMPA approval.
In addition to conducting our core R&D activities in-house, we also engage reputable CROs and SMOs to manage, conduct, and support our pre-clinical research and clinical trials.
Business · 第 182 页
For the years ended December 31, 2024 and 2025, we collaborated with 46 CROs and seven SMOs, and 58 CROs and 15 SMOs, and the expenses attributable to our CROs and SMOs for the respective periods were RMB27.2 million and RMB2.9 million, and RMB42.6 million and RMB4.8 million, respectively.
Business · 第 182 页
Under our respective agreements with the CROs and SMOs, we own all intellectual property rights and trial results resulting from the agreed work scope of the projects conducted by them.
For the years ended December 31, 2024 and 2025, we collaborated with two and one CDMO(s), and the expenses attributable to our CDMO(s) were RMB24.3 million and RMB17.9 million, respectively.
Business · 第 183 页
The second phase focuses on key clinical trials and future commercial production, which we plan to outsource to CDMOs.
Business · 第 184 页
For the commercial production of LP-003 and LP-005, we plan to fully outsource to qualified CDMOs to produce drugs for commercial supply.
As of the Latest Practicable Date, we did not have beyond-lab-scale manufacturing facility.
Business · 第 181 页
During the Track Record Period, we have cooperated with five CDMO partners.
Business · 第 181 页
We retain all the intellectual property rights and grant our CDMO partners the right to use our intellectual property rights for such manufacturing and packaging activities during the contract period.
To date, our manufacturing activities are primarily limited to supporting our drug development process. We maintain stable relationships with reputable CDMOs to meet the needs of our pipeline.
Business · 第 200 页
To monitor and evaluate the services of our CDMOs, we conduct quality assurance audit programs to ensure, among other criteria, full compliance of our CDMOs with the relevant regulatory requirements.
Business · 第 200 页
We expect collaboration with CDMOs to remain an important part of our production plan to support the ongoing preclinical and clinical development of our drug candidates.
We engaged 71, 91 and 108 CROs for the years ended December 31, 2023, 2024 and 2025, respectively, with associated service fees of approximately RMB53.9 million, RMB87.7 million and RMB351.8 million for the same periods.
Business · 第 178 页
During the Track Record Period, we outsourced a small portion of our manufacturing activities, primarily for the production of (i) drug products with relatively simple synthesis processes, lower technical complexity, minimal confidentiality requirements, or less stringent quality specifications, and (ii) drug products with limited market size that do not justify the costs of establishing new in-house production lines.
Business · 第 183 页
We engaged three, two and one CDMO for the years ended December 31, 2023, 2024 and 2025, respectively, with associated service fees of approximately RMB1.9 million, RMB6.8 million and RMB0.5 million for the corresponding years.