China Early-Access Case Studies: GBA and Hainan

From Regulatory Access to Hospital Use: Three China Early-Access Case Studies

For an innovative medicine, securing permission to enter China is only part of the work.

The product must also be matched to the right access pathway, supported by a qualified hospital, imported through a compliant supply chain, introduced to physicians, and made available to appropriate patients under clearly defined prescribing and safety procedures.

ACA Pharma has supported this end-to-end process for three recent hospital placements across two of China’s principal early-access frameworks: the Guangdong–Hong Kong–Macao Greater Bay Area Medicines and Devices Connect program and the Hainan Boao Lecheng International Medical Tourism Pilot Zone.

Together, these cases demonstrate how regulatory access can be converted into practical hospital use across different therapeutic areas and institutional settings.

Three case studies show how ACA Pharma supports innovative medicines from pathway assessment through hospital onboarding and patient access in China.

Two pathways, with different eligibility requirements

The Greater Bay Area’s Medicines and Devices Connect program—often called GBA Connect—allows designated hospitals in nine mainland GBA cities to apply to use clinically urgent medicines and medical devices that are already marketed in Hong Kong or Macao but have not yet received national approval in mainland China.

This is a controlled institutional pathway rather than a national marketing authorization. Products remain subject to hospital sponsorship, regulatory review, approved sourcing, traceability, informed-consent requirements and ongoing safety monitoring.

Hainan Boao Lecheng operates under a separate policy framework. Designated medical institutions can apply to import certain overseas-approved medicines that are not yet registered in China when there is an urgent clinical need and an appropriate domestic alternative is not available.

ACA Pharma evaluates these pathways product by product. The correct route depends on factors including the product’s overseas approval status, availability in Hong Kong or Macao, clinical differentiation, hospital demand and the intended patient population.

Case study 1: Pridinol mesylate for neuro-rehabilitation in Guangzhou

ACA Pharma supported the placement of imported pridinol mesylate 3 mg tablets at Guangzhou Fosun Chancheng Hospital, also known as Guangzhou Xinshi Hospital and affiliated with Guangdong Pharmaceutical University.

Pridinol is a centrally acting muscle relaxant authorized in Germany for the treatment of central and peripheral muscle spasms in adults, including conditions such as lumbago, torticollis and generalized muscle pain.

The hospital introduced the medicine through the GBA Connect pathway as an additional treatment option for eligible adult patients experiencing muscle spasm, stiffness and associated pain during rehabilitation.

This placement addressed an important practical challenge in rehabilitation medicine. Persistent muscle spasm and pain can restrict movement, interfere with daily activities and make it more difficult for patients to participate consistently in physical rehabilitation.

ACA’s role extended beyond identifying an eligible product. The work required alignment among the product owner, cross-border supply partners, the hospital’s clinical team, pharmacy and relevant regulatory stakeholders so that the medicine could progress from initial assessment to controlled hospital use.

The result was a new physician-supervised treatment option available locally to eligible patients who might otherwise have needed to seek treatment outside mainland China.

Case study 2: Varenicline nasal spray for dry eye in a public GBA hospital

ACA Pharma also supported the introduction of varenicline nasal spray at Guangzhou First People’s Hospital Nansha, a public hospital and designated GBA Connect institution.

Varenicline nasal spray offers a different treatment approach from conventional eye drops. Administered through the nose, it stimulates the trigeminal parasympathetic pathway to promote the production of the patient’s own tear film. The U.S. Food and Drug Administration first approved varenicline nasal spray for the signs and symptoms of dry eye disease in 2021.

The Nansha hospital established a defined clinical pathway for its use:

Patients receive an ophthalmology consultation and appropriate dry-eye testing.
A specialist determines whether the patient is suitable for treatment.
The patient receives a prescription and completes the required informed-consent process.
The medicine is dispensed through the hospital, with an initial observation period.
The treating physician arranges follow-up based on the patient’s condition.

This case is significant because it demonstrates more than regulatory eligibility. It shows the operationalization of an innovative imported medicine inside a mainland public hospital, including patient identification, diagnosis, consent, dispensing and follow-up.

It also illustrates the potential value of GBA Connect in therapeutic areas with large patient populations—not only rare diseases or oncology—when a medicine offers a differentiated approach and a hospital identifies a genuine clinical need.

Case study 3: Axhidrox for severe primary axillary hyperhidrosis in Hainan

The third placement followed the Hainan Boao Lecheng pathway rather than GBA Connect.

ACA Pharma supported the introduction of Axhidrox, a topical glycopyrronium cream, at Shulan (Boao) Hospital in the Lecheng pilot zone. Axhidrox is authorized in European markets for the topical treatment of severe primary axillary hyperhidrosis in adults.

Primary axillary hyperhidrosis causes excessive underarm sweating beyond what is required for normal temperature regulation. Although sometimes underestimated, it can materially affect clothing choices, work, social interaction and emotional wellbeing.

Axhidrox acts locally by blocking the acetylcholine-mediated stimulation of sweat glands. Its cream formulation provides a non-invasive alternative for suitable patients whose condition may not be adequately managed by conventional antiperspirants or who wish to avoid more invasive procedures.

As with the GBA cases, the placement required more than importing a product. It involved confirming pathway eligibility, working with a qualified institution, coordinating the supply route and ensuring that prescribing and patient management occurred within the Lecheng framework.

This case demonstrates how Hainan can provide an early-access route for differentiated products outside the areas most commonly associated with pilot-zone access, provided that the clinical need and applicable regulatory criteria are satisfied.

What these placements demonstrate

Although the three products address very different conditions, the underlying execution model is consistent.

Pathway selection must come first

GBA Connect and Hainan Lecheng are not interchangeable. A product’s approval history, Hong Kong or Macao status, clinical positioning and hospital demand must be assessed before deciding which pathway is viable.

Hospital engagement is central to market validation

Pilot-zone access is hospital-led. Identifying appropriate clinical departments and developing genuine physician interest are therefore essential parts of both regulatory execution and early commercial diligence.

Approval does not automatically create patient access

A successful placement requires coordinated work across regulatory affairs, medical teams, importation, distribution, hospital pharmacy, physician education, informed consent, product traceability and pharmacovigilance.

Early access is not the same as national approval

These pathways provide controlled access at designated institutions. They do not replace an NMPA marketing authorization and should not be presented as unrestricted commercialization in mainland China.

However, they can help companies establish early clinical experience, test hospital demand, better understand patient identification and refine the longer-term China market-entry strategy.

Supporting innovative medicines from assessment to hospital use

ACA Pharma works with international pharmaceutical companies to evaluate and execute early-access opportunities in Greater China.

Our support can include:

Product and pathway eligibility assessment
Clinical need and competitive landscape analysis
Hospital and key opinion leader engagement
Regulatory submission coordination
Cross-border importation and supply-chain management
Hospital pharmacy onboarding
Medical-information and physician-education support
Pharmacovigilance and post-use monitoring
Longer-term regulatory and commercialization planning

The objective is not simply to obtain a pathway approval. It is to build a compliant, clinically credible route that allows an innovative medicine to reach appropriate patients and provides the product owner with meaningful evidence for future market decisions.

To discuss whether a product may be suitable for GBA Connect, Hainan Lecheng or another Greater China access pathway, contact ACA Pharma.

This article is provided for informational purposes only and does not constitute medical advice. The medicines described are prescription products and may only be used by eligible patients under the supervision of qualified healthcare professionals and in accordance with applicable regulatory approvals.