在中国上海,位于张江高科技园区的“张江药谷”正成为全球生物医药创新的热土。这一区域不仅是国内生物医药研发机构最集中、创新实力最强、创新成果最突出的区域,更是上海推动生物医药产业高质量发展的核心引擎。近期,一系列生物医药领域的重大突破与创新成果在张江药谷不断涌现,标志着上海乃至中国生物医药产业正迈向全球创新高地。

#### 张江药谷:创新引领发展的核心区域

张江药谷依托上海市政府的政策支持与前瞻规划,重点集聚发展生物技术和现代医药产业,吸引了众多国际国内领先的生物医药企业入驻。这里的创新企业涵盖了从研发、生产到临床应用的全链条,形成了集科研、转化、生产、服务于一体的生物医药产业集群。

#### 创新成果频现,生物医药产业持续攀升

据统计,张江药谷目前拥有各类创新主体2300余家,从业人员规模达到9.5万人。2023年,生物医药营收总额达到1630亿元人民币,同比增长23%。今年前5个月,这一数字增长至660亿元,同比增长11%。这一增长态势表明,张江药谷正以强劲的创新动力引领生物医药产业的持续发展。

#### 制度创新助力生物医药产业升级

张江药谷在生物医药领域的创新不仅体现在产业规模的扩大,更体现在制度层面的革新。早在2011年,张江就率先提出药品上市许可持有人制度(MAH)改革需求,成为全国首批试点省市的重点园区之一。这一制度的试点不仅缩短了新药从项目启动到获批的中间环节,还缓解了初创企业资金压力,推动了国产创新药的快速发展。

#### 国产创新药成功出海,实现全球布局

和黄医药自主研发的抗肿瘤新药——呋喹替尼,是张江药谷生物医药创新的标志性成果之一。2023年11月,该药成功登陆美国市场,获美国食品药品监督管理局(FDA)批准用于治疗经治转移性结直肠癌。这是上海首个成功出海美国的中国原创新药,标志着中国生物医药产业在国际市场的竞争力显著提升。

#### 结语

张江药谷的成功,不仅是中国生物医药产业创新发展的缩影,更是全球生物医药领域的重要一员。通过不断深化创新制度、集聚优质资源、推动产业升级,张江药谷正为全球生物医药产业的未来贡献中国智慧和力量。随着更多创新成果的涌现和国际市场的拓展,张江药谷的影响力将进一步扩大,助力上海乃至中国生物医药产业在全球舞台上发挥更加重要的作用。

英语如下:

### Zhangjiang BioValley: Fruits of Innovation Abound, Leading Industrial Upgrades

In Shanghai, China, Zhangjiang BioValley is emerging as a global hotbed for biopharmaceutical innovation. This area is distinguished as the region with the highest concentration of domestic biopharmaceutical R&D institutions, the strongest innovative capacity, and the most outstanding innovation outcomes. It is also the core driver for high-quality development of the biopharmaceutical industry in Shanghai.

#### Zhangjiang BioValley: The Heart of Innovation

Zhangjiang BioValley, leveraging the policy support and forward-looking planning from the Shanghai Municipal Government, has been a focal point for the development of biotechnology and modern pharmaceutical industries. It has attracted numerous leading biopharmaceutical enterprises from both domestic and international markets. The innovative companies here cover the entire spectrum from research and development to production and clinical application, forming a comprehensive biopharmaceutical cluster that integrates research, conversion, production, and services.

#### Innovation Outcomes Pile Up, Driving the Rise of the Biopharmaceutical Industry

Statistically, Zhangjiang BioValley currently houses over 2,300 innovation entities, with a workforce of 95,000. In 2023, the biopharmaceutical revenue总额 reached 163 billion RMB, marking a 23% increase from the previous year. The first five months of this year saw a growth of 66 billion RMB, representing a 11% increase. This growth trajectory signifies that Zhangjiang BioValley is leading the continuous development of the biopharmaceutical industry with its strong innovative momentum.

#### Policy Innovation Accelerates Industrial Upgrades in Biopharmaceuticals

Zhangjiang BioValley’s innovation in the biopharmaceutical sector is not confined to the expansion of the industry’s scale but also encompasses the transformation of policies. As early as 2011, Zhangjiang was among the first pilot areas for the implementation of the pharmaceutical marketing authorization holder (MAH) system, which significantly shortened the process from project initiation to approval. This system has alleviated financial pressures on startup companies, accelerating the development of domestically produced innovative drugs.

#### Domestic Innovative Drugs Successfully Enter the Global Market

Fruquintinib, an anti-cancer drug developed by Zai Lab, is a hallmark achievement of Zhangjiang BioValley’s biopharmaceutical innovation. In November 2023, this drug successfully entered the US market, receiving approval from the US Food and Drug Administration (FDA) for treating metastatic colorectal cancer after treatment. This marks the first Chinese-originated drug to enter the US market from Shanghai, significantly enhancing China’s biopharmaceutical industry’s competitiveness in the global market.

#### Conclusion

Zhangjiang BioValley’s success represents a microcosm of China’s biopharmaceutical industry’s innovative development and a significant player in the global biopharmaceutical field. By deepening innovation policies, aggregating high-quality resources, and driving industrial upgrades, Zhangjiang BioValley is contributing Chinese wisdom and strength to the global biopharmaceutical industry. As more innovative outcomes emerge and international markets expand, the influence of Zhangjiang BioValley is expected to grow, further enhancing the role of Shanghai and China in the global biopharmaceutical sector.

【来源】http://www.chinanews.com/cj/2024/07-27/10258640.shtml

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