Henlius' Hansizhuang (Serplulimab Injection) Approved in the EU: Strategic Insights for Innovative Drugs Going Global

According to search results,

for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) [1]. This is a major breakthrough for Chinese independently developed innovative biopharmaceuticals in the international market.

Hansizhuang chose small cell lung cancer, an area where clinical needs are not fully met, as its breakthrough point, reflecting a

. Compared to the highly competitive non-small cell lung cancer track, small cell lung cancer patients have poorer prognosis and limited treatment options, making it easier for innovative drugs to gain recognition from regulatory authorities and the market [1].

Henlius adopted a

from the beginning of R&D:

• Clinical trial design complies with international standards
• Data management meets regulatory requirements of multiple countries
• Lays the foundation for subsequent multi-country launches

The path from Chinese approval to EU approval shows that successful innovative drug globalization requires:

• Forward-looking regulatory planning
  : Advance layout of marketing applications in major markets
• Flexible strategic rhythm
  : Dynamically adjust according to the approval progress of each country
• Efficient communication mechanism
  : Maintain close communication with various regulatory authorities

A global launch across 40 countries requires strong

:

• Establish international sales networks or partnership relationships
• Global supply chain layout
• Multi-country coordination capability of medical affairs teams

:

• Plan the globalization path early, rather than focusing only on the domestic market
• Prioritize indications with large clinical demand gaps as breakthrough points
• Establish R&D and quality systems that meet international standards

:

• Make full use of accelerated approval channels (such as the EU’s PRIME program and the US’s Breakthrough Therapy Designation)
• Actively seek strategic cooperation with multinational pharmaceutical companies
• Establish a professional international registration team

The successful case of Hansizhuang proves that

. This will encourage more Chinese pharmaceutical companies to increase investment in innovative drug R&D and promote the Chinese pharmaceutical industry to climb to the high end of the value chain [1].

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[1] Sina Finance - “Fosun Pharma (600196.SH): New Indication of Hansizhuang Approved for Drug Registration” (https://finance.sina.com.cn/stock/realstock/company/600196/nc.shtml)

[2] Baidu Encyclopedia - “Shanghai Fosun Pharmaceutical (Group) Co., Ltd.” (https://baike.baidu.com/item/上海复星医药（集团）股份有限公司/15140067)