苏药“出海”，打开产业升级新空间

Core Insights - The pace of Jiangsu's innovative pharmaceuticals "going global" has significantly accelerated in 2023, with companies like Innovent Biologics, Hengrui Medicine, WuXi Biologics, and Zai Lab achieving international licensing agreements [1][2] - The successful internationalization of these innovative drugs not only benefits global patients but also accelerates the upgrade of Jiangsu's biopharmaceutical industry [1] - By 2024, 20 listed companies in Jiangsu's chemical pharmaceuticals, biological products, and traditional Chinese medicine sectors reported overseas revenues totaling approximately 6.8 billion yuan, accounting for 20% of total revenue [2] Group 1: Key Developments in International Collaborations - Innovent Biologics announced a collaboration with Roche for global development and commercialization rights of a new drug, marking a significant milestone for Chinese innovative drugs in 2025 [1] - WuXi Biologics entered a research service collaboration with a U.S. company, receiving an upfront payment and potential milestone payments totaling up to $925 million [1] - Hengrui Medicine has completed 14 external licensing collaborations, with 9 occurring in the last three years, including partnerships with major international pharmaceutical companies [3] Group 2: Trends and Strategies in Going Global - The mainstream models for Chinese pharmaceutical companies to go global include "self-going," "borrowing a ship," "lightweight approach," and "glorious exit" [4][5] - The "borrowing a ship" model, which involves licensing out drugs to multinational companies, is currently the most prevalent, allowing companies to receive upfront payments and milestone payments without directly participating in overseas operations [5] - The "NewCo" model, where companies establish new overseas entities to manage specific pipelines, has gained traction, providing flexibility and independence in adapting to different international markets [6] Group 3: Challenges in International Expansion - Chinese innovative drug companies face significant challenges in market access, pipeline valuation, global competition, and talent deployment when entering overseas markets [7] - Regulatory hurdles, particularly in the U.S. and EU, complicate the approval processes for clinical trials and drug registrations, posing barriers to entry for Chinese firms [7][8] - Many companies have struggled with patent issues, lacking early international patent strategies, which has hindered their commercialization efforts abroad [8] Group 4: Supportive Policies and Future Outlook - Local governments are actively constructing policy support systems to facilitate the internationalization of Jiangsu's innovative drugs and medical devices [9] - Initiatives include optimizing import and export management for biopharmaceuticals and encouraging participation in global business development activities [9] - Companies are optimistic about the future, with expectations for improved regulatory frameworks and collaborative mechanisms to streamline drug approval processes in key markets [10]