海南政策解读：海外医药企业进入中国的四大快车道

中国是全球第二大医疗市场。对于希望进入中国市场的海外医药和医疗器械企业而言，机遇与挑战并存。但是产品上市的漫长审批流程、高昂的准入成本和复杂的法规体系构成了显著壁垒。

如今，海南自贸港正在改变这一局面。作为中国唯一的“医疗先行区”，海南承担着国家医药政策试验田的角色。从博鳌乐城的真实世界数据研究，到关税减免、快速审评通道，再到资金支持，海南为海外药企进入中国打造了一条前所未有的快车道。

本文将聚焦海南政策的四大亮点，看看它们如何帮助海外企业快速、高效地打开中国市场。

亮点一：研发与临床支持，加速进入中国

Hainan continues to implement its “R&D voucher” program, providing up to RMB 10 million (approx. USD 1.39 million) to support pre-clinical studies, clinical trials, and commercialization of innovative drugs. At the same time, the Boao Lecheng Pilot Zone allows overseas-approved but not yet China-approved drugs and devices to be imported. The drugs can use Real World Data as auxiliary evidence to accelerate the registration and listing of products in China

As a result, enterprises can begin clinical activities earlier while saving tens of millions of dollars in trial costs.

亮点二：国际认证与生产奖励，降低前期成本

Products that obtain recognized international certifications qualify for a one-time reward of RMB 2 million (approx. USD 278,000). In addition, drugs and devices introduced via Lecheng’s Real-World Data and manufactured in Hainan may receive further rewards—up to RMB 5 million (USD 695,000) for drugs and RMB 2 million (USD 278,000) for devices.

这些资金补贴让企业不仅能够快速开展应用，还能在生产环节降低投入，大幅减轻在中国市场落地的前期资金压力。

亮点三：快速审评通道，审批时间压缩到 30 天

Hainan has set up a dedicated Innovation Service Center with priority review channels. Specifically, drugs on the national key R&D list and Category II innovative devices qualify for fast-track review. The technical review timeline for Category II devices has been shortened to just 30 working days, much faster than traditional approval processes.

Therefore, overseas companies gain not only efficiency but also a valuable first-mover advantage in China’s competitive healthcare market.

亮点四：产业集群与免关税，打造一站式生态

Hainan has developed a complementary cluster that links Haikou Pharma Valley, Boao Lecheng Pilot Zone, and Sanya Yazhou Bay. Enterprises can conduct clinical studies in Lecheng, establish production in Haikou, and benefit from tariff-free policies for goods exported to the Chinese mainland with more than 30% added value in Hainan.

This “Lecheng Research + Haikou Production” model allows overseas enterprises to integrate R&D, manufacturing, and commercialization in one location. Consequently, supply chain costs are reduced and competitive strength in China is enhanced.

结论：现在就是窗口期

Hainan’s policy framework—from R&D support and clinical data, to production incentives and tariff-free advantages—has created a full-process fast track into China. It addresses the two greatest challenges overseas enterprises face: time and cost.

Hainan has evolved from an ‘alternative’ to a strategic gateway. Those who seize this opportunity early will be strategic positioned to capture the world’s second-largest healthcare market and build long-term growth.

现在行动，正是抢占中国市场战略高地的关键一步。

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