On April 3, Jianyou Shares (603707) issued an announcement that the company recently received an approval letter for liraglutide injection, 18 mg/3 mL (6 mg/mL), (ANDA No.: 218115) issued by the US Food and Drug Administration. The drug has a specification of 18mg/3mL (6mg/mL) and can be used as an adjunct to diet and exercise to improve blood sugar control in adults and children aged 10 years and above with type 2 diabetes, while reducing the risk of major adverse cardiovascular events in adult patients with type 2 diabetes with cardiovascular disease.

So far, the company has invested approximately RMB 57.37 million in the research and development project of liraglutide injection. The newly approved product will be available in the United States in the near future and is expected to have a positive impact on the company's operating performance. This event has become an important window for observing its global layout and the development trend of Chinese pharmaceutical companies.

Jianyou shares' road to globalization started in the field of heparin. As one of the world's largest suppliers of standard heparin APIs, the company has gained a firm foothold in the international market with strict quality control and cost advantages, accumulated experience in international operations, and cultivated the ability to connect with global regulatory standards.

Since 2019, Jianyou shares have started a strategic transformation and extended to the field of low-molecular-weight heparin preparations such as enoxaparin. Through continuous technological innovation and quality improvement, it has successfully entered the high-end market in Europe and the United States, becoming a pioneer in the international transformation of Chinese pharmaceutical companies. Since then, relying on the FDA/EMA registration advantages, it has opened up access channels to emerging markets, and built a localized marketing system through the acquisition of Meitheal in the United States, achieving a double increase in brand influence and market share.

In the non-heparin field, Jianyou shares have also achieved remarkable results. The company continues to expand its product pipeline at an average annual rate of about 10 new ANDA varieties. By the end of 2024, it has 82 varieties approved by the United States, becoming one of the suppliers with the most complete sales pipeline for injections in the United States. At the same time, we actively promote product registration and sales expansion in more than 20 countries to lay a solid foundation for participating in the global pharmaceutical market competition.

It is worth mentioning that Jianyou shares has built a technical platform based on product scale and scalability, and has also formed various forms of collaboration and coordination platforms. Under the principles of ensuring quality, complying with FDA continuous supervision, and complying with long-term development, Jianyou shares have established a solid cooperative relationship not only with excellent Chinese companies, but also with the best companies in Europe, the United States and Asia.

In China, Jianyou shares cooperated with Tonghua Dongbao to develop insulin injection, and jointly promoted the localization production and application of glargine, aspart, and lispro insulin in the United States; and also cooperated with Shuangcheng Pharmaceuticals on the biosimilar albumin paclitaxel in the US market to achieve complementary advantages. Internationally, we have in-depth cooperation with pharmaceutical giants such as Pfizer, Sagent, and Sandoz to expand overseas markets; long-term cooperation with heparin preparation companies such as Gland to stabilize the heparin API business; acquisition of Meitheal to enter the US market, establish independent brands and sales networks; and obtained FDA approval and patent assets of adalimumab biosimilar YUSIMRY through Coherus.

In the fierce international competition, the extensive cooperation network has enabled Jianyou to have a more stable brand reputation and synergistic relationship, and has given the company greater room for development and a longer-term development path, so that it has a strong ability to resist risks when facing complex international situations.

Jianyou's success in the field of biological drugs is an important achievement of its global layout. The approval of liraglutide biosimilars has further strengthened the company's competitive position in the global biosimilar market. With the arrival of the concentrated expiration of biological drug patents, the scale of the biosimilar market with the US market as the core continues to expand. According to IQVIA's forecast, US biosimilar spending is expected to exceed US$40 billion in 2027, which provides a broad space for development for Chinese pharmaceutical companies.

Jianyou's development path reflects the unique advantages of Chinese pharmaceutical companies. On the one hand, it inherits China's traditional advantages in the field of raw materials and achieves cost control through vertical integration; on the other hand, it actively embraces innovation and boldly invests in cutting-edge fields such as biological drugs. This dual-wheel drive model of "traditional advantages + innovative breakthroughs" provides replicable experience for the internationalization of Chinese pharmaceutical companies.

At present, Chinese pharmaceutical companies are facing a complex international situation. On April 3, Eastern Time, the Reciprocal Tariff Act signed by Trump officially came into effect, and Chinese pharmaceutical export companies were under pressure in the short term. However, this also provides an opportunity for industrial transformation and upgrading. Chinese pharmaceutical companies are expected to accelerate the historic leap from a pharmaceutical power to a pharmaceutical power by continuously strengthening technological innovation, expanding diversified markets, and strengthening international cooperation.

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