As the innovation capabilities of local pharmaceutical companies continue to improve, China's contribution to global pharmaceutical innovation is also growing. Driven by multiple favorable factors such as policy, capital, and talent, the pace of domestic innovative drug launches is accelerating, and the internationalization of products is also continuously speeding up.
 

On May 18, according to an Endpoint News report, Hengrui Medicine established a wholly-owned subsidiary, Luzsana Biotechnology, responsible for the internationalization (overseas development and commercialization) of Hengrui Medicine's pipeline products. It is understood that Hengrui will transfer some of its assets into Luzsana, which will specialize in drug development and commercialization outside of China. Currently, this involves over 250 clinical studies covering areas with unmet clinical needs such as oncology, cardiovascular diseases, metabolic/diabetes, pain management, immunology, and liver and kidney diseases.
 
In recent years, Hengrui Medicine has indeed been accelerating its international development pace. In addition to establishing a new company, according to incomplete statistics, Hengrui Medicine has initiated nearly 20 international clinical trials, including 7 international multi-center Phase III projects, with over 10 studies in the preparation stage.
 
Currently, several capable local innovative drug companies are accelerating the pace of product internationalization. Besides Hengrui Medicine, BeiGene is also one of the companies with extensive international布局 and relatively rapid progress. It is reported that on February 19 this year, BeiGene announced that its zanubrutinib received approval from Swissmedic for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or as a first-line treatment for WM patients unsuitable for chemoimmunotherapy.
 
This product received its first global approval in the United States in November 2019, becoming a domestically developed anti-cancer new drug to go global. Subsequently, it has been approved for marketing in China, Canada, Australia, Russia, the European Union, and many other countries and regions. Its commercial footprint now covers 44 markets worldwide. Additionally, over 40 regulatory submissions are currently under review globally.
 

Furthermore, Huiyu Pharmaceutical has also stated that it will leverage its established international sales channels and teams to further advance and refine its work in the international market. The company plans to enhance its partner management system based on conditions in different countries and regions, strengthen market information collection and analysis capabilities, establish a unique global market and partner database, track global pharmaceutical development trends, thoroughly analyze the market environment and operational models in key regions, and focus on meticulous cultivation to become an international pharmaceutical company.
 
It is important to note, however, that under the major trend of pharmaceutical companies accelerating their "global expansion," the path to internationalization is not always smooth. On May 6, Innovent Biologics and Coherus jointly announced the termination of their collaboration on IBI-305, a bevacizumab biosimilar. Innovent stated that this business decision was made after evaluating the dynamics of the North American bevacizumab biosimilar market and the development delays caused by the ongoing impact of the pandemic.
 
Recently, Junshi Biosciences' application for the marketing of its tumor immunotherapy drug PD-1 for nasopharyngeal carcinoma in the United States was denied by the FDA. Previously, the US launch process for Hutchmed's surufatinib was also put on hold. Additionally, Innovent Biologics and Coherus jointly announced the termination of their collaboration on the bevacizumab biosimilar IBI-305...
 
Given the current situation of companies going global, the overseas expansion of domestic biopharmaceutical companies is not going smoothly, and the path for domestic drugs to achieve international development remains long and arduous. In this regard, industry insiders believe that the globalization strategy for innovative drug companies should focus on high-quality product pipelines – it is essential to develop the best products first, as only good products can be successfully introduced to the international market. Secondly, drug development should adhere to the principle of engaging internationally as early as possible, rather than only considering internationalization when approaching market launch. Furthermore, companies should establish corresponding clinical operations teams overseas at an early stage, build a specialized local talent research team, and be able to communicate directly with the FDA.
 
Overall, there is still a broad consensus within the industry that the globalization of Chinese innovative drugs is an inevitable path. However, simultaneously, understanding international market conditions, addressing internal weaknesses, and seeking strong external partners will be crucial strategies for the development of innovative drug companies.