科赛拉是先声药业与美国企业合作引进的抗癌创新药，2021年2月在美国获批上市，当时每支售价1400美元1。借助海南乐城先行区的特许政策，该药进入中国市场的速度大幅加快，2022年7月获得国家药监局批准附条件进口注册上市，中美两地获批时间仅相隔一年零五个月1。这一时间差远低于行业常规周期——先声药业集团总裁周云曙表示，过去一款海外创新药从引进到在中国注册获批通常需要3年至5年1。
2024年4月，科赛拉在海口实现本地化生产，年产能达200万支1。进入国家医保目录后，其零售价大幅下降至466元人民币一支，不到海外价格的5%1。这一价格变化得益于海南自贸港优惠政策的支持，包括原辅料"零关税"、加工增值免关税以及15%的企业所得税率等1。预计2027年，"海口造"科赛拉将供应欧美市场1。
Cysayla, an innovative anti-cancer drug developed through collaboration between Xiansheng Pharmaceutical and an American enterprise, has completed a remarkable transformation within China's Hainan free trade port, shifting from imported medicine to domestic manufacturer for global markets.1 The drug received approval in the United States in February 2021 at a price of $1,400 per unit.1 Leveraging the preferential policies of Hainan Lequan Pilot Zone, Cysayla entered China and secured conditional market approval from the National Medical Products Administration in July 2022, approximately one year and five months after its U.S. debut.1
In April 2024, Cysayla achieved localized production in Haikou with an annual production capacity of 2 million units.1 Following inclusion in China's national medical insurance directory, the retail price dropped to 466 yuan per unit—less than 5 percent of overseas pricing.1 Zhou Yunzhu, President of Xiansheng Pharmaceutical Group, noted that historically, bringing an overseas innovative drug from introduction through Chinese regulatory approval typically requires three to five years.1 The Hainan free trade port policies supporting this transformation include zero tariffs on raw and auxiliary materials, tax exemptions on processing value-added activities, and a 15 percent corporate income tax rate.1 Beginning in 2027, Haikou-manufactured Cysayla is expected to supply markets in Europe and North America.1
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