Copyright © 2025 Shenyang Dasan Pharmaceutical Technology Co., Ltd.
Leveraging the Marketing Authorization Holder system to build cross-border collaboration ecosystems, flexibly matching assets at different stages with funding needs.
Technical Synergy: Integrating complex formulations, process transfer, and stability management to meet multi-country filing requirements.
Manufacturing Synergy: Rigorously selected CMOs, on-site quality oversight, and dual-release to minimize quality risks.
Commercial Synergy: Leveraging in-house marketing networks and partner channels to achieve full coverage in tenders, hospital listings, and retail.
Co-License-in + MAH
MAH + Multi-country Filing (China data for US/EU submissions)
Technology Licensing + MAH (Technology transfer + sales royalty)
Domestic Agent (DA) Services for Overseas Pharmaceutical Companies
Dual-system Integration: R&D (GMP-like) and MAH quality systems integrated, covering the entire process of R&D, manufacturing, and batch release.
Robust Audit Capability: Successfully passed multiple NMPA inspections.
Supplier Management: Material classification and full-process auditing.
R&D Capability: Advanced formulation technology platforms.
Technology Transfer: Optimized process (R&D → manufacturing center review → CMO) to accelerate industrialization.
Stability Study Management: Independent stability protocol design and dedicated QC equipment plan (dedicated QC and stability study equipment to be established in 2025).
CMO Selection: Evaluation of scope, cross-contamination risks, and quality systems.
On-site Oversight: Dedicated QA personnel stationed at CMO sites; approval of critical documents (process validation protocols, validation plans).
Closed-loop Accountability: Dual batch release verification (CMO batch release + MAH final release).
Partner Network: Collaborations with industry leaders such as Shangyao Group, Liaoning Daewoong, Haisco, etc.
Korea-China Synergy: Introduction of Korean Dasan technology to drive technology transfer and market expansion.
Establish and operate a manufacturing quality management and pharmacovigilance system covering the entire drug lifecycle.
Transforming from a pure R&D service provider to an R&D and manufacturing company, enhancing Shenyang DASAN's brand reputation and company value. Product launches are imminent.
Leverage the MAH model to enter new business sectors such as health products and cosmetics, utilizing both online and offline channels.
Customized MAH liability insurance to mitigate risks; implementing systems for data traceability from R&D to manufacturing to distribution.
Introduce Korean technology for transformation, registration, manufacturing, and sales in China. Korean partners receive a share of China market sales profits based on their investment ratio.
Leverage Korean distribution channels to export products manufactured in China to overseas markets.
Collaborate with various partners in China, including pharmaceutical manufacturers, clinical research organizations, and pharmaceutical sales companies, to develop MAH products.
Support the construction of the Anhui joint venture factory, enabling it to become a CMO facility meeting international standards.
Focus on drug launch
&
healthcare expansion
Deepen local partnerships
&
global tech transfer
Collaborate with Korean investors to introduce innovative Korean drugs. DASAN holds the MAH in China and manages contract manufacturing and sales.
Leverage China MAH data and collaborate with Chinese CMOs to expedite filings in the US and EU markets via bridging studies.
Korean pharmaceutical companies license technology to DASAN. Following successful technology transfer and market approval in China, the MAH holder (DASAN) shares sales revenue with the technology licensor based on a tiered royalty structure.
Collaborate with Korean CSOs and distributors to market Chinese traditional medicine products and APIs in Korea and globally.
Foundation: MAH system seamlessly assumes DA statutory responsibilities.
Core Services: Bilingual compliance support + Accelerated Korea-China parallel filing.
Value-added Modules: End-to-end localization services (from customs clearance to patient management).
Risk Management Innovation: Pioneering DA liability insurance to mitigate cross-border cooperation risks.
Establish a dual-quality center in Shenyang and Seoul: Korean team leading international audits; Chinese team focusing on NMPA compliance. This dual-track synergy minimizes risks associated with cross-border contract manufacturing and assists Korean and Chinese clients in efficiently navigating global regulatory inspections.