China's innovative pharmaceutical companies face new challenges in expanding overseas markets
In recent years, China's innovative pharmaceutical companies have made significant progress in R&D capabilities and international layout, but with the intensification of global market competition and changes in policy environment, overseas expansion faces new challenges. This article combines hot topics and data from the past 10 days to analyze the current situation and difficulties of Chinese pharmaceutical companies going overseas.
1. Current status of overseas markets of innovative pharmaceutical companies in China
According to public data statistics, the performance of Chinese innovative pharmaceutical companies in overseas markets in 2023 is as follows:
| index | 2023 data | Year-on-year growth |
|---|---|---|
| Number of overseas clinical trials | 120 items | 15% |
| FDA/EMA approved drugs | 8 models | 33% |
| Amount of overseas authorized transactions | $5 billion | -10% |
Judging from the data, Chinese pharmaceutical companies have maintained growth in overseas clinical trials and approved drugs, but the amount of authorized transactions has declined, reflecting the increase in cooperation thresholds or the increase in valuation differences.
2. Analysis of the main challenges
1. Policy and regulations barriers
The European and American markets have become more stringent in drug safety and clinical data, and some Chinese pharmaceutical companies have encountered delays in approval due to experimental design or data integrity issues. For example, a PD-1 drug recently was requested by the FDA to supplement data due to differences in patient enrollment criteria.
2. Market competition intensifies
Investment and financing in the global biomedical field have cooled down, and overseas pharmaceutical companies are more inclined to internal research and development or prefer mature partners. The following table compares the R&D investment of Chinese and American pharmaceutical companies:
| Business Type | Average R&D investment (US$ 100 million) | As a proportion of revenue |
|---|---|---|
| China's innovative pharmaceutical companies | 2.5 | 18% |
| Top American pharmaceutical companies | 60 | twenty two% |
3. Geopolitical Influence
Some countries have strengthened their review of Chinese biotech enterprises and restricted technology transfer or capital cooperation. For example, recently, the US BIS added several new Chinese pharmaceutical companies to the "unverified list", affecting the stability of the supply chain.
3. Suggestions for breaking the deadlock
1. Differentiated layout
Focus on unmet clinical needs, such as rare diseases or emerging technology fields (ADC, bimand, etc.), and avoid homogeneous competition.
2. Strengthen localization cooperation
Deeply tied to overseas clinical institutions and CRO companies to enhance the international recognition of experimental data. For example, by establishing a global team, BeiGene's overseas revenue accounted for 42% in 2023.
3. Flexible response to supervision
Adopt the "China-US dual report" strategy and conduct clinical trials simultaneously to shorten the time-to-market difference. Recently, Legend Bio's CAR-T products have achieved synchronous commercialization of China, the United States and Europe through this path.
Conclusion
Despite the increasing challenges, Chinese innovative pharmaceutical companies still have the opportunity to open up overseas markets through technological breakthroughs and strategic adjustments. In the future, we need to continuously improve compliance, innovation and commercialization capabilities in order to gain a place in the global track.
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