Advanced therapies, including cell therapy, gene therapy, and nucleic acid therapy, are regulated in two ways: by the National Health Commission (NHC) as a Category III medical technology for clinical use, or by the National Medical Products Administration (NMPA) as a pharmaceutical product.
For therapies regulated under the first category, Investigator-Initiated Clinical Trials (IITs) are conducted to gather safety and efficacy human data by companies, academic institutions, and hospitals.
Although they are non-registrational clinical trials, high-quality IIT studies can be used as supplementary materials for IND submission, licensing decisions, or raising financial rounds.
Explore the world of possibilities with Porton Advanced as we invite you to discover our exceptional suite of services.
The lack of local connections, expertise, and regulatory knowledge makes it challenging to conduct IITs in China, especially for our clients based outside the country. To address this issue, we are partnering with reputable Contract Research Organizations (CROs) to jointly provide comprehensive IIT services. Our collaboration will cover everything from GMP manufacturing, IIT application, connecting with PIs, patient recruitment to clinical data collection and analysis.
Porton Advanced has extensive CMC experience and has completed 18 IIT projects and acquired 17 IND approvals with 300+ successful runs. Additionally, we have 5 ongoing Phase I/II projects.
Porton Advanced Solutions LLC is headquartered in NJ, USA and offers two state-of-the-art GMP facilities in Suzhou, China with a total of 215,000 square feet. We have cell engineering-12 independent suites (2 for infectious donors), Viral Vectors-10 production suites-(50-2000L), Plasmid – 2 independent suites (50L*2), Process Development & cGMP Production, Aseptic Fill and Finish, as well as Analytical development and Quality Control, and more.
We have established strategic alliances with key stakeholders and provide end-to-end IIT support from selecting:
enabling us to leverage our resources and networks effectively to accelerate your projects/clinical trials.
| Investigator-Initiated Trials (IITs) | Industry-Sponsored Trials (ISTs) | |
|---|---|---|
| Dual-Track Regulation Mode | “Medical techonologies” track | “Drug” track |
| Regulatory Authority | National Health Commission (NHC) | National Medical Products Administration (NMPA) |
| Initiation | Hospitals or pharmaceutical, biotech or medical companies | Hospitals or pharmaceutical, biotech or medical companies |
| Purpose | Primarily for scientific research | Focused on new drug approval, marketing and commercialization |
| Approximate Timeline |
Less stringent Four to eight months to connect with principle investigators (PI), clinical centers and apply for ethic review and OHGRA The exact standards and flexibility may vary dependent on district and clinical centers. |
More rigorous One and a half years for IND application Four to eight months to connect with principle investigators (PI), clinical centers and apply for ethic review and OHGRA |
| GMP manufacturing | Madantory | Mandatory |
| Benefits |
|
Generally follows a more traditional clinical trial framework |
China is emerging as a leading destination for IITs, offering:
At Porton Advanced, we help investigators and sponsors leverage these advantages, offering world-class GMP facilities in China, regulatory expertise, and seamless execution support to drive IIT success.
Investigators often face:
Porton Advanced has strong strategic alliances with key stakeholders in the industry, such as principal investigators, hospitals, regulatory agents, etc. We can provide a full range of IIT services with our partners, from regulatory consulting to patient recruitment solutions, ensuring investigators can focus on research while we handle the complexities.
Porton Advanced has a proven track record of IIT, IND CMC, and clinical-phase projects, including:
With world-class GMP facilities, strategic regulatory expertise, and an unwavering commitment to clinical success, Porton Advanced is the trusted partner for IIT excellence.
