S

Starting Point: Drug Requirement Assessment

• Both parties confirm drug characteristics, clinical needs, and target markets.

• Define drug dosage, indications, target patient populations, dose ranges, and injection platform compatibility.

• Milestone Trigger
NDA signed; preliminary drug-device compatibility assessment report delivered; written confirmation of cooperation intent.

1

Stage 1: Partnership Model Confirmation

• Determine the collaboration mode: co-development / licensing / joint commercialization.

• Clarify responsibilities, milestone points, and deliverables for all parties.

• Milestone Trigger
Signing of commercial framework contract or cooperation agreement; proceed to customized platform development.

2

Stage 2: Customized Platform Development

• Establish drug-device compatibility validation models and design the needle-free delivery solution.

• Establish drug-device compatibility validation models and design the needle-free delivery solution.

• Milestone Trigger Delivery of system verification report (including bench testing and in vitro simulation results) and drug delivery feasibility data (e.g., speed, injection depth, stability); written confirmation from the pharmaceutical partner that the system meets preclinical requirements.

3

Stage 3: Clinical Validation

• Support for Phase I/II/III clinical studies (providing samples and devices).

• Verify adherence, safety, and efficacy through real patient data.

• Joint preparation of IND / NDA documentation.

• Milestone Trigger
Completion of key clinical results from Phase I/II/III (safety, efficacy, adherence data); data meet IND/NDA or equivalent regulatory submission requirements.

4

Stage 4: Regulatory Submission & Approval

• Joint submission of combination drug-device registration files.

• Respond to inquiries from regulatory authorities such as FDA, EMA, or NMPA.

• Respond to inquiries from regulatory authorities such as FDA, EMA, or NMPA.

• Milestone Trigger
Submission of joint registration files accepted; move to pilot-scale production to ensure stable supply of clinical and registration samples.

5

Stage 5: Scale-Up Production & Commercialization

• Support mass production deployment or technology licensing.

• Global commercialization and continuous device supply.

• Long-term strategic partnership agreement.

• Milestone Trigger 1
Completion of commercial terms confirmation (payment/revenue-sharing milestones).

• Milestone Trigger 2
Product approved for market; signing of long-term strategic partnership agreement.