医药CDMO及CRO外包

During the Track Record Period, we also outsourced certain manufacturing activities to industry-recognized contract development and manufacturing organizations (CDMOs) in China for preclinical and clinical supply of our drug candidates.

We have adopted procedures to ensure that the production qualifications, facilities and processes of CDMOs comply with the relevant regulatory requirements and our internal quality management system.

We maintain rigorous oversight of CROs to ensure that their performance adheres to our protocols and applicable laws, safeguarding data integrity and the overall quality of our research.

Prior to May 2023 before our pilot production facility in Suzhou was put into use, we outsourced all drug product manufacturing work (which needs to comply with GMP requirements) to qualified CDMOs.

During the Track Record Period, we engaged 18, 22 and 41 CROs in 2022, 2023 and 2024, respectively. We also engaged seven, four and six CDMOs in 2022, 2023 and 2024, respectively.

We plan to outsource large-scale manufacturing of CBT-001 for phase 3 MRCT in each region, and commercial production, once approved.

We collaborate with CDMOs (including CMOs) to conduct and support our preclinical and clinical studies in line with industry practice.

During the Track Record Period, we engaged eight and three CDMOs in 2023 and 2024, respectively.

We plan to continue to collaborate with CDMO partners for the commercial production of PB-119, which will mainly consist of raw material production and formulation production, and we expect to scale up the current in-house and external manufacturing activities to achieve the commercial scale.

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.

During the Track Record Period, we collaborated with over 200 CROs.

We maintain close supervision of our CRO partners to ensure their performance fully complies with our protocols and all applicable regulations.

In the medium term, we will collaborate with WuXi Biologics for the commercial production of lonapegsomatropin.

As advised by Frost & Sullivan, in the context of rapidly growing new drug development costs, increasingly complex development processes, and even more intense competition, multinational pharmaceutical and biotechnology companies have continued to increase outsourcing to CDMOs, and the reliance on CDMO services is in line with the industry norm.

In the long term, we will build internal capabilities for manufacturing our products in-house to reduce our reliance on CDMO.

We subcontract some parts of our development modules or assignments to such software development companies, which are Independent Third Parties, because of (i) the flexibility of engaging software development companies on an as-needed basis; (ii) the relatively lower cost compared to our own research and development team and (iii) the convenience of simultaneously developing multiple software development projects as supported by these software development companies.

We primarily engage third-party agencies and, to a lesser extent, collaborate with physicians to collect clinical data for real-world study.

We set out strict credentials for selecting third parties who would like to participate in our real-world data collection, including the national or regional service scope, responsiveness, professional know-how, and registered capital.

In addition to conducting our core R&D activities in-house, we also engage reputable CROs to manage, conduct, and support our preclinical research and clinical trials.

During the Track Record Period and up to the Latest Practicable Date, we had worked with qualified CDMOs to manufacture and test drug candidates for preclinical and clinical supply.

After the commencement of manufacturing by the end of 2025, we may continue to rely on CDMOs to manufacture drug candidates or a portion of the approved drugs when necessary.

As is customary in the pharmaceutical industry, we use CROs and other contract service providers to support our preclinical studies and/or clinical trials under our close supervision and overall management.

We take the lead in preclinical research, and design the clinical trials and protocols by ourselves.

We closely supervise the activities of these third-party collaborators.

We engaged 28, 37 and 31 CROs in 2021, 2022 and the nine months ended September 30, 2023, respectively, all of which were Independent Third Parties to the best of our knowledge.

We have set in place various procedures regarding the management and monitoring of the performance by CROs.

Pursuant to the Tigermed Framework Agreement, we will treat Tigermed as a preferred CRO service provider and Tigermed will set up a strategic service group responsible for future coordination.

In terms of the involvement and contributions of each of the major CDMO partners (including CMOs) to the development of our product candidates, we collaborate with our CDMO partners to manufacture a portion of our product candidates to supply for preclinical studies and clinical trials.

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.

CIC is of the view that there are alternative CDMOs on comparable terms with similar quality available in the market.

Due to surging demand for our services, we started outsourcing externally manufacturing of antibody intermediates in 2021, which significantly increased our indirect production cost and overhead.

Our net profit margin decreased from 29.8% in the six months ended June 30, 2022 to 17.8% in the six months ended June 30, 2023, primarily due to the increase in our indirect production cost and overheads incurred for the outsourcing of antibody intermediate manufacturing.

We expect the dual-function production line to enable us to meet a large portion of our own antibody intermediate requirements.

In line with the practice in the pharmaceutical industry, we engage CROs, SMOs, CMOs/CDMOs and third-party research centers (i.e., hospitals and laboratory centers) to conduct and support our pre-clinical studies and clinical trials.

Besides manufacturing conducted at our own facilities, we currently also engage third-party CMOs/CDMOs for (i) the production for pivotal clinical trials of M701, (ii) the manufacturing for pre-clinical studies and clinical trials of Y101D, which require larger production volumes.

M701 and Y101D, the drug candidates that we expect to be firstly commercialized, will be initially manufactured by CDMOs upon marketing approval and later transferred to our own expanded manufacturing facility upon approval by competent regulatory authorities.

As is customary in the pharmaceutical industry, we use CROs to conduct and support our preclinical studies and clinical trials under our close supervision and overall management.

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.

To ensure the production process consistency, we will collaborate with reputable CMOs/CDMOs to manufacture certain drug candidates for pivotal clinical trials, followed by initial commercialization.

We currently outsource certain manufacturing activities, primarily the production of small molecules, to industry-recognized CMOs in China, and we intend to continue doing so in the future.

To monitor and evaluate the services of our CMOs, we conduct quality assurance audit programs to ensure, among other criteria, full compliance of our CMOs with the relevant regulatory requirements.

In addition to conducting our core R&D activities in-house, we also engage reputable CROs to manage, conduct, and support our preclinical research and clinical trials.

We collaborate with our CDMO partners (including both CMOs and CDMOs) to manufacture a portion of our drug candidates to supply for pre-clinical studies, clinical trials and potentially for the commercial-scale production of large molecule drugs.

In 2021 and 2022, the expenses related to CDMO partners included in our research and development expenses were RMB42.6 million and RMB98.3 million, respectively.

LAE002, the drug candidate that we expect to first commercialize, will be initially manufactured by CDMOs upon marketing approval and later transferred to our own manufacturing facility upon approval by competent regulatory authority.

For other product dosage forms that cannot be produced at this stage in our Wuxi plant, we engage CDMO for shared production facilities, reduced investment in fixed assets, and reduced R&D and conversion time.

In terms of the involvement and contributions of each of the major CDMO partners (including CMOs) to the development of our product candidates, we collaborate with our CDMO partners to manufacture a portion of our product candidates to supply for pre-clinical studies and clinical trials.

We maintained cooperation relationship with 27 and 39 CRO and CDMO partners in 2021 and 2022, respectively.

During the Track Record Period, our major suppliers primarily consisted of (i) suppliers of raw materials and consumables for our vaccine and therapeutic biologics development, (ii) construction service providers, (iii) property leasing providers and (iv) CROs, who provide third-party contracting services for research and development.

During the Track Record Period, we engaged 18 CROs and one SMO based on the needs of our pre-clinical and clinical studies.

Our procurement of CRO and SMO services will continue to depend on the cadence of our clinical and pre-clinical studies.