Chinese Pharmaceutical Companies Accelerate Global Expansion with Innovative Drug Approvals and International Commercialization

　　【Pharmaceutical Network Industry DynamicsIn recent years, Chinese pharmaceutical companies have been going global, stepping into overseas markets, showing a trend of global layout. For instance, Lunan Pharmaceutical has recently accelerated its international process, with its new drug being approved by the U.S. Food and Drug Administration (FDA).
 

On March 28, Lunan Pharmaceutical Group announced that it had received the ANDA TENTATIVE APPROVAL LETTER for Zoledronic Acid Injection Concentrate from the U.S. Food and Drug Administration (FDA). A relevant responsible person from Lunan Pharmaceutical stated that the International Drug Research and Development Center of Lunan Pharmaceutical has always adhered to its internationalization strategy. As more products are developed and launched, the company will accelerate its pace into the international market, enhance the brand image and reputation of Lunan Pharmaceutical both in China and abroad, and lay the foundation for “Lunan Pharmaceutical, Healthy World.”
 

Data show that zoledronic acid is a new and highly effective third-generation bisphosphonate bone resorption inhibitor. Its main function is to inhibit bone resorption, reduce the recruitment and activation of osteoclasts, suppress osteoclast activity, and increase osteoclast apoptosis. The concentrated solution for injection of zoledronic acid was initially developed by Novartis. Its indications include use in combination with standard anti-tumor drug therapy to treat skeletal damage in patients with bone metastases from solid tumors and multiple myeloma, as well as to treat hypercalcemia of malignancy (HCM).
 

Another example is Junshi Biosciences, which, with the smooth progress of its international layout, is also set to experience a surge in global market commercialization. It was reported that in October 2023, the FDA approved the marketing application for Junshi Biosciences' toripalimab for the treatment of nasopharyngeal carcinoma, making it the first drug approved in the United States for this indication. With toripalimab entering the U.S. market, Junshi Biosciences has officially embarked on its "going global" journey. On March 28, Junshi Biosciences released its 2023 annual report, showing improvements in both quality and efficiency of its performance throughout the year. The annual report revealed that in 2023, the company achieved a revenue of 1.503 billion yuan. Revenue from pharmaceuticals increased by 58% year-on-year; among them, the core product toripalimab (Tuoyi®) recorded cumulative sales of 919 million yuan for the entire year, representing a year-on-year increase of 25%.
 

It is reported that Fosun Pharmaceutical also mentioned in its financial report that the group focuses on innovation and internationalization to address unmet clinical needs. Relevant representatives stated that the company’s international strategy remains unchanged, hoping that through internationalization, it can better realize the company's value while improving drug accessibility. "Good drugs will still be actively introduced to overseas markets, and there are various ways to do so — some may build their own commercial teams, while others may seek partners, etc. The most suitable approach will be adopted for different markets."
 

On the path to internationalization, Yifan Pharmaceutical has also continuously achieved breakthroughs. On March 25, Yifan Pharmaceutical announced that its research product Eibegsestim Alpha Injection (referred to as "Ryzneuta®") had been approved for marketing in the European Union. It is reported that this is another approval obtained from a global pharmaceutical regulatory agency after its approval in China and the United States, once again verifying Yifan Pharmaceutical's comprehensive ability to independently complete global R&D, clinical trials, registration, and production of innovative biopharmaceuticals, and fully demonstrating the company's capability to execute and implement the "innovation, internationalization" strategy.
 

Experts in the industry indicate that innovation and internationalization have almost become a consensus among some Chinese pharmaceutical companies. In recent years, China's pharmaceutical enterprises have sparked an overseas expansion wave, with the heat of China-produced innovative drugs going global on the rise, and cross-border cooperation continuing to unleash vitality.
 

According to incomplete statistics, so far, China has achieved "going global" for hundreds of innovative drugs. In the second half of 2023, four domestically produced innovative drugs were successively launched in Europe and the United States: Tislelizumab from BeiGene, Toripalimab from Junshi Biosciences, Fruquintinib from Hutchmed, and Efgartigimod Alfa Injection from Yifan Pharmaceutical. Entering 2024, the momentum of Chinese innovative drugs going global remains strong. Data shows that in January 2024, there were a total of 18 license out deals by Chinese pharmaceutical companies, marking a year-on-year increase of 260%.
 

Analysts say that domestically produced innovative drugs have now entered a new phase of large-scale overseas expansion, showing three trends: First, more active, with the number and amount of overseas transactions rising sharply; Second, becoming more familiar with international markets and regulatory requirements, making fewer mistakes than before; Third, starting to explore more markets beyond Europe and America, such as the Middle East, Japan, South Korea, India, and other countries and regions. For instance, Junshi Biosciences stated that so far, in addition to co-developing the North American market with Coherus, it has reached commercial cooperation in over 50 countries, including the Middle East, North Africa, Latin America, India, South Africa, Southeast Asia, Australia, and New Zealand, with partners such as Hikma, Dr. Reddy's, and Conlayda. Its global commercial network has been basically established.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.