Lancore Pharma

Boao Lecheng International Medical Tourism Pilot Zone is China's designated zone for accelerated access to overseas-approved drugs, devices, and biomedical technologies that are not yet registered in mainland China. It supports two main tracks: (A) special import of drugs and medical devices already approved by ICH/IMDRF regulatory authorities, and (B) clinical translational application of biomedical new technologies such as cell therapy, gene therapy, and tissue engineering. Lecheng is a commercialization sandbox — not a research platform.

No. Lecheng special import requires the product to hold approval from a recognized ICH/IMDRF regulatory authority. Pre-IND or early clinical-stage assets do not qualify for the special import pathway. Such assets should instead consider top-tier hospital IIT in China — a separate pathway that Lancore can build from the ground up.

It may qualify if the product is approved overseas (FDA/EMA/PMDA), is not registered in China, addresses clinically urgent need, and lacks adequate domestic alternatives. Rare disease products often receive priority consideration. Lancore runs a structured eligibility screen before any external engagement.

Four criteria: (1) overseas marketing approval from an ICH/IMDRF jurisdiction, (2) no equivalent product registered in China, (3) clinically urgent need that cannot be met by available domestic alternatives, and (4) importation through a licensed Lecheng medical institution. Eligibility is assessed case by case — not every approved product automatically qualifies.

The process involves: institution sponsor alignment, pre-review material preparation and submission, expert evaluation (by the Lecheng Administration Bureau via a pre-review mechanism), and import logistics coordination. Timelines are project-specific and depend on product type, documentation completeness, and the designated institution's readiness. Specific day counts are discussed only after project scoping.

Only institutions licensed by the Lecheng Administration Bureau can serve as sponsors for special import. These include public hospital branches (such as Ruijin Hainan Hospital) and specialized private institutions (such as West China Lecheng Hospital). Each institution has different therapeutic strengths, patient volumes, approval experience, and operational capabilities. Lancore assists with institution matching based on product profile.

Clinical data generated during Lecheng patient use can be structured as real-world evidence (RWE) to support NMPA marketing authorization. Multiple products have successfully used Lecheng RWE for full NMPA registration. However, RWE supplements — it does not replace — formal NMPA requirements. RWD protocol design must be planned early to maximize regulatory utility.

Lecheng special import may allow compliant patient access through a licensed medical institution when eligibility requirements are met. Clinical trial or IIT stage use should not be treated as commercialization. Lancore separates the two pathways clearly at the outset — commercial and research-stage activities have different legal, compliance, and operational frameworks.

For Lecheng special import of overseas-approved drugs/devices: yes, compliant patient access through a licensed medical institution is permitted when eligibility requirements are met. For IIT, clinical trials, or any research-stage activity: patient-charging is not permitted. Investigational products must be provided free of charge to subjects. These boundaries are strictly enforced under Chinese law.

Yes. Under the Biomedical New Technologies Regulation (effective February 2025), Lecheng provides a dedicated translational application pathway for cell therapy, gene therapy, and tissue engineering products. If the product is overseas-approved, it may enter via Track A (special import). If it has completed domestic IIT, it may enter via Track B (clinical translational application with price registration). Each track has distinct eligibility requirements and compliance obligations.

Investigator-Initiated Trial (IIT) in China refers to clinical research initiated and conducted by a qualified medical institution, typically to evaluate the safety and efficacy of an investigational product. IIT is the appropriate first step for Pre-IND or early clinical-stage assets that need physician validation and clinical signal. It is not a commercialization pathway — subjects cannot be charged for investigational products or procedures under IIT.

State Council Decree No. 818 (effective May 1, 2026) is China's primary regulation governing the clinical research and translational application of biomedical new technologies — including gene therapy, cell therapy, tissue engineering, and other modalities operating at the cellular/molecular level. It mandates: (1) clinical research must be conducted at a Grade 3A (tertiary) hospital, (2) prior non-clinical safety/efficacy evidence is required, (3) academic and ethics review must precede filing, and (4) filing with the National Health Commission is required within 5 working days of dual review approval. Non-compliance can trigger study suspension or termination.

Under Order 818, clinical research institutions must be Grade 3A (tertiary) hospitals with: a qualified academic review committee and ethics committee, appropriate facilities and equipment for the specific technology, qualified investigators (PI must hold a medical license with senior professional title), sufficient research funding, and management systems for quality, ethics, and subject protection. The hospital is the accountable legal entity for all IIT activities.

The process: (1) Non-clinical safety/efficacy evidence package preparation, (2) Sponsor and clinical research institution agreement execution, (3) Protocol development, (4) Academic review by the hospital's clinical research academic committee, (5) Ethics review by the hospital's ethics committee, (6) Filing with the National Health Commission within 5 working days of dual review approval. Required filing materials include: sponsor and institution information, investigator qualifications, non-clinical study reports, protocol, risk assessment, review opinions, informed consent template, and funding documentation. Technology-specific filing guidance checklists have been published for 14 categories including gene therapy, stem cells, and immune cells.

Under Order 818, the clinical research sponsor must be a legally established entity within China. An overseas biotech without a China-incorporated entity cannot directly serve as the sponsor. However, the sponsor role can be fulfilled by the clinical research institution itself (hospital-sponsored IIT) or by a qualified domestic partner entity. Lancore advises on sponsor structure options based on the product profile, IP strategy, and commercial objectives.

Order 818 is supported by a risk classification guide that categorizes biomedical new technologies based on their novelty, invasiveness, and potential harm. Technologies are assigned risk levels that determine the intensity of regulatory oversight, review requirements, and post-filing monitoring obligations. High-risk technologies face more rigorous evaluation by the National Health Commission, including potential third-party expert assessment. The risk level should be determined early in the planning process.

Investigational product import for IIT in China remains a common execution bottleneck. There are currently no unified national rules specifying which authority issues import clearance for IIT materials. Hospitals, as the accountable legal entities, typically will not sign ethics approval documents without confirmed import compliance. This has stalled numerous overseas programs. Lancore treats import compliance as a structural workstream to be addressed before operational commitments are made. Approaches include free trade zone import models and hospital-specific import pathways, each with different regulatory and practical tradeoffs.

China's HGR regulations govern the collection, storage, use, and cross-border transfer of human genetic materials and associated data. Key considerations: (1) Samples collected from Chinese subjects fall under HGR jurisdiction, (2) Foreign parties require a Chinese party to collaborate for HGR-related activities, (3) Data export may require approval or filing depending on classification, (4) Clinical data, medical imaging, and protein data have been excluded from HGR definition in 2025-2026 updates — simplifying export for certain study types. HGR strategy should be addressed early, as it impacts protocol design, site selection, and partner structure.

Hainan FTP provides several advantages: (1) data export approval for Lecheng-generated clinical data may be processed at the provincial level rather than through central authorities in Beijing, (2) zero import tariff applies to Lecheng special import products, (3) anonymized clinical data export pathways are more established than in many mainland settings. However, these benefits apply within specific regulatory frameworks and are not automatic — each project requires case-by-case confirmation.

The decision turns primarily on the asset's regulatory status. If the product is FDA/EMA/PMDA approved, Lecheng special import is usually the most direct pathway — enabling patient access, potential revenue generation, and RWD collection. If the product is Pre-IND or in early clinical development, top-tier hospital IIT is the appropriate first step. IIT builds clinical data and physician relationships; Lecheng leverages existing approvals. Some assets may need to sequence through both (IIT first, then transition to Lecheng upon overseas approval).

For an initial pathway assessment, Lancore typically needs: asset stage (Pre-IND / clinical / approved), product type (drug / device / CGT), overseas approval jurisdiction if applicable, China objective (IIT signal / Lecheng patient access / NMPA registration preparation / vendor evaluation), and whether any China hospital, institution, CRO, or CDMO is already under discussion. No confidential data, unpublished results, or patient-level information is required at this stage.