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China News Service, August 12 (Wang Yuling) Recently, BeiGene, known as the "No. 1 innovative drug company", disclosed its 2024 semi-annual report. The global sales of its star product Zebutinib exceeded 8 billion yuan in the first half of the year, of which sales from the US market were 5.903 billion yuan, a year-on-year increase of 134.4%.

At the 17th Health Industry (International) Ecological Conference - 2024 SIP Conference held on the 11th, the guests discussed the international development trend of innovative drugs. The guests believed that compared with the previous years when they were only at the strategic level, Chinese pharmaceutical companies now have a clearer direction for going overseas, and some companies have benefited from internationalization and their performance has gradually been realized.

Xie Xin, executive director and senior vice president of Sino Biopharmaceuticals, believes that the current policy has put forward new requirements for innovation, and regulatory support has accelerated the integration with international standards. In terms of innovation, large pharmaceutical companies have many advantages, including a strong cooperation network to support original innovation and clinical transformation, a mature intellectual property system to protect innovative achievements, and a mature sales system to support market-oriented realization.

Xie Xin mentioned that for Chinese pharmaceutical companies, the main overseas models include self-built overseas teams, cooperative development and external authorization. However, it may be difficult to build a team for overseas expansion, and the more compromise is cooperative development. For example, China Biopharmaceuticals will also cooperate with other pharmaceutical companies on the rights of overseas markets for innovative drugs.

However, Xie Xin also said that although the innovation level of Chinese pharmaceutical companies has begun to show the potential to embrace the international market and the drug pipeline is growing rapidly, China's innovative drugs are still insufficient in terms of the degree of innovation.

Gan & Lee Pharmaceuticals CFO Sun Cheng said that the internationalization process is becoming increasingly important for improving performance. In 2023, Gan & Lee Pharmaceuticals' international sales revenue will reach 327 million yuan, and it is expected that the contribution of international business to operating income will increase in 2024.

Sun Cheng mentioned that from the perspective of internationalization, Gan & Lee Pharmaceuticals is currently mainly concentrated in emerging market countries, mainly exporting raw materials, combined with the export of some equipment, and selling through finding local partners for filling and OEM.

At the same time, Ganli Pharmaceuticals is also promoting market access in Europe and the United States. Currently, the three generations of long-acting insulin glargine, rapid-acting insulin aspart, and rapid-acting insulin lispro have been accepted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and have been inspected. "We compared the average terminal sales price of insulin products in the European and American markets with that in the Chinese market. We can see that the price difference between the European and American markets and the Chinese market is still relatively large. For us, we must strive to advance in the European and American markets as soon as possible and strive to seek differentiation to cope with future market competition." Sun Cheng said.

Hu Huiguo, director and senior vice president of Mywell Biopharma, said that for Chinese pharmaceutical companies, they initially exported low-value-added APIs and generic drugs; then moved on to "Made in China", exporting innovative and high-end generic drugs; and then to China's "smart" manufacturing, with innovation as the core, to globally optimize and configure the industrial chain.

Regarding the overseas strategies of different types of enterprises, Hu Huiguo said that internationalization is a systematic project. When developing drugs, a good path should be designed and the overseas strategy should be selected according to the product. The target market for innovative drugs should be mainly the European and American markets, with fewer opportunities in emerging markets; biosimilar drugs should go to emerging markets first and be cautious about the European and American markets; chemical generic drugs should give priority to the European and American markets and cover emerging markets.

Hu Huiguo mentioned that different target markets also differentiate products in development models, overseas routes, and timing. As to why there are few opportunities for innovative drugs in emerging markets, Hu Huiguo said it is related to the systems of emerging markets. "Because the laws of most emerging market countries are based on the reference country system, their approved products must first be approved in the reference country, so the export market for innovative drugs is still mainly in Europe and the United States, and foreign licensing cooperation may be a wise path." Hu Huiguo said.

Regarding the future internationalization opportunities for innovative drugs, Hu Huiguo mentioned that, on the one hand, we should focus on globally differentiated clinical advantages and solve unmet clinical needs; on the other hand, the antibody and ADC fields will continue to be important highlights for future overseas expansion.

(For more reporting clues, please contact the author of this article, Wang Yuling: [email protected]) (China News Service APP)

　(The views in this article are for reference only and do not constitute investment advice. Investment is risky and you should be cautious when entering the market.)

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Editors: Xue Yufei and Li Zhongyuan