On March 24, 2025, Hengrui Pharmaceutical announced that it had received a complete response letter from the US FDA regarding the BLA for the first-line treatment of hepatocellular carcinoma using the combination of Carilizumab and Apatinib mesylate. This is the second time that Hengrui Pharmaceutical has received a CRL, and the FDA has not clearly stated the reason, only stating the need for further submission of a response. Hengrui Pharmaceutical stated that the relevant production site underwent FDA inspection in January 2025, and the issues from last year have been rectified with only three new improvement requirements. The company has actively responded and maintained communication, and will resubmit the application as soon as possible.
Previously, Hengrui Pharmaceutical received CRL for the first time in May 2024, but due to defects in the production site inspection and travel restrictions, the BIMO clinical examination was not fully completed, and the application was not approved. In October of the same year, Hengrui resubmitted the application and was accepted.
Domestic biopharmaceutical companies are accelerating their pace of going global, with frequent cooperation cases since 2025. As for Simcere Pharmaceutical Group, Simcere Zaiming and AbbVie have reached a license selection agreement for SIM0500, a subsidiary of Shiyao Group, Shiyao Jushi, has signed an exclusive licensing agreement with Radiance Biopharma for SYS6005, and Xinda Biotechnology has reached a global exclusive cooperation and licensing agreement with Roche Pharmaceuticals for IBI3009. In 2024, there will be over 100 authorized transactions by domestic biopharmaceutical companies, with a total transaction amount of nearly 50 billion US dollars, and 88 overseas authorized transactions, indicating a clear trend towards going global.
However, pharmaceutical companies still face the challenge of obtaining approval when going global. There are differences between the international market and the domestic market. Although going abroad can bring broad market space and strict admission standards, and improve the R&D and production level of enterprises, there are significant challenges in obtaining approval and commercialization. However, with the development of the industry, going global may become a normalized strategic choice, helping enterprises cope with the challenges of globalization and obtain considerable profits. In 2025, large pharmaceutical companies that break free from the drag of generic drug procurement, drive growth with innovative drugs, and have good pipeline quality are expected to stand out through channels such as going global.
