【Pharmaceutical Network Industry DynamicsIn recent years, Chinese pharmaceutical companies have been accelerating their expansion overseas. Among them, the European market, with its mature regulatory system, strong payment capabilities, and cutting-edge research ecosystem, is becoming a key target market for an increasing number of pharmaceutical enterprises.
On April 28, Fosun Pharmaceutical announced that the marketing authorization application for the 420mg/14mL specification injection (for intravenous use, EU trade name: POHERDY®) of Pertuzumab (Project Code: HLX11), independently developed by its holding subsidiary Henlius Biotech, Inc. and its holding subsidiary, has been approved by the European Commission. The approved indications are all the indications for which the reference drug Perjeta® is marketed in the EU.
It is reported that in February 2026, the drug had already received a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of the Marketing Authorization Application (MAA) for POHERDY. This approval is mainly based on the data generated from the comparison between HLX11 and the reference drug PERJETA (Pertuzumab), including analytical similarity studies, pharmacokinetic similarity studies, and clinical comparative studies. These data all demonstrate the high similarity between HLX11 and the reference drug PERJETA in terms of quality, safety, and efficacy.
On April 20, Yuan Cheng, Party Secretary and Chairman of Guangzhou Hanfang Pharmaceutical Company Limited, successfully signed a strategic cooperation agreement with Bernardo Mendia, Secretary General of the Portuguese-Chinese Chamber of Commerce and Industry, at the Macao-Lisbon, Portugal Economic and Trade Cooperation Promotion Conference. This marks the formal establishment of an in-depth cooperative relationship, building an important bridge for the company to expand into the Portuguese and Portuguese-speaking countries markets.
On April 22, Guangzhou Hanfang Pharmaceutical Company Limited and Antonio Miguel Carmona, Chairman of the Spain-China Friendship Association, jointly signed a strategic framework cooperation agreement in the pharmaceuticals and health sector. This agreement lays a solid foundation for in-depth cooperation between the two parties in areas such as market access, channel co-construction, and research collaboration.
On April 2, Yifan Pharmaceutical announced that its controlling subsidiary, Yifan Biologics, had granted INTSEL CHIMOS SAS the commercial rights in France for its self-developed innovative biologic drug Ryzneuta® (efbemalenograstim alfa, also known as Ibelis®, with the Chinese trade name "Yilishu®"). INTSEL CHIMOS SAS has been granted exclusive development and commercialization rights in France.
On February 20, it was reported that Hansoh Pharma's self-developed third-generation EGFR tyrosine kinase inhibitor, Almonertinib, has been approved by the European Commission for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer who have previously received EGFR-TKI treatment and have the T790M mutation. In January, Gan&Lee Pharmaceuticals' insulin glargine (Ondibta®) received marketing approval from the European Commission, becoming the first China-produced third-generation insulin to enter Europe, covering the EU, Iceland, Liechtenstein, and Norway.
From the above, since 2026, several pharmaceutical companies in China have made substantial progress in entering the European market. Some of these companies have achieved direct product approval for market entry, while others have established commercial channels through strategic cooperation and licensing.
The industry expects that, driven by multiple factors such as domestic competition, the window of opportunity in Europe's high-value market, and the restructuring of global industrial chains, Chinese pharmaceutical companies will accelerate their expansion into Europe. At the same time, their strategic focus will shift comprehensively from the early "product export" to the "system building" and "ecosystem integration" required for deeply cultivating overseas markets.
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