Experience | AlphaMed Solutions

Selected Experience

From regulatory readiness to launch, reimbursement and market expansion

Selected engagements demonstrate AlphaMed’s ability to connect strategy with in-market execution across medical aesthetics and rare disease programs in China.

CASE STUDY

Medical Aesthetics · Market Expansion

China Market Entry — Before China NMPA Registration Review

Supporting a global top-five medical aesthetics company as it prepared to convert regulatory progress into a practical China market-entry and launch model.

Client Context

Swiss company with a presence in more than 90 countries entering China through a phased market-entry strategy.
China Phase 3 study for the first product completed and filed for registration approval.
Required an integrated proposal spanning market research, business model and launch planning.

ALPHAMED APPROACH

Assembled senior industry experts with deep China market knowledge and relationships.
Connected leading KOLs and key injectors to generate direct market insight.
Translated insight into an actionable market-entry and launch blueprint.

OUTCOME

Excellent results with a lean operating team and optimized expense

Ongoing support secured: 1 expert assigned as APAC medical consultant

KEY TAKEAWAYA lean, expert-led engagement moved from market research to a concrete China launch plan — and evolved into an ongoing APAC advisory relationship.

CASE STUDY

Medical Aesthetics · Commercialization

China Market Entry — From China Approval to 1 Year Launch

Building the operating capability required to move from regulatory approval to commercial launch for an overseas company without an established China team.

Client Context

US company with a presence in more than 60 countries partnered with a leading China pharmaceutical company new to medical aesthetics.
Market research was underway, but senior in-market leadership was required to translate recommendations into launch execution.

ALPHAMED APPROACH

Built local infrastructure and shaped business strategy, financial forecast, distribution model and distributor due diligence.
Connected China KOLs and key injectors with the US headquarters and supported creation of a China injection training center.
Led congress, clinic and HCP education activities to build launch momentum.

OUTCOME

Successfully secured 1st batch product release in China, evaluated and secured China distributor, facilitated 100 clinics listed in.

Built online HCP portal with >1500 HCP registered and launched online education courses and China training center in Beijing.

KEY TAKEAWAYTransforming capability to enable successful operation for oversea company without China team.

CASE STUDY

Rare Disease · Market Access

China Market Entry — China NRDL Application

Creating a lean China market-access model for a European rare disease company balancing post-approval commitments, reimbursement strategy and local operating cost.

Client Context

French rare disease company with a presence in 40+ countries had obtained China approval but had not yet established an effective market-entry path.
Post-approval commitments required real-world studies and a China registry.
National reimbursement required a clear NRDL pathway without building a heavy commercial infrastructure.

ALPHAMED APPROACH

Deployed market access and medical leadership as a lean launch unit.
Established an HCP network across leading China rare disease centers of excellence.
Optimized RWE and registry execution and advanced consecutive NRDL submissions.

OUTCOME

Maximum Cost Efficiency: Delivered complex launch & market access milestones using a highly optimized, lean operating budget and team.

Ongoing support for 2 years and gained trust to expand for Japan market research.

KEY TAKEAWAYIt’s quite challenging for oversea company with limited global presence to enter China market where there is ongoing reforms from regulatory, clinical and to market access or commercialization. With elite industry expert, there will be fast roll-out of operation to gain market opportunity.

CASE STUDY

Rare Disease · Regulatory Strategy

China Market Entry — New Rare Disease Product NMPA Registration

Combining a lean China infrastructure, trial-waiver strategy and pilot-zone early access to accelerate the path from global evidence to China patients.

Client Context

UK-founded rare disease biotech licensed a product for China and needed to establish local infrastructure from the ground up.
The product was approved in the US, EU and Australia with an existing Caucasian-population clinical data package and no local China trial.

ALPHAMED APPROACH

Built a lean China operating infrastructure and engaged patient groups plus leading Peking Union KOLs.
Secured a clinical trial waiver using the existing global data package.
Enabled pre-approval clinical usage through Boao Lecheng and Beijing pilot zones.

OUTCOME

Trial Waiver Secured: Avoided a new local trial via existing Caucasian clinical data to save investment and speed up launch.

Ongoing support for 2 years and continue as external consultant till now.

KEY TAKEAWAYFor rare disease products with a strong existing global data package, pairing a waiver-based regulatory strategy with pilot zone early access can shorten China time-to-patient significantly, without waiting for a new local trial or full NMPA approval.

Company, product and logo references are displayed for representative experience, industry context and professional-network presentation. They do not necessarily indicate endorsement or an active commercial relationship with AlphaMed Solutions.

ADDITIONAL CHINA LAUNCH EXPERIENCE

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